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| ID | Type | Description | Link |
|---|---|---|---|
| JADE REGIMEN | Other Identifier | Alias Study Number | |
| 2018-000501-23 | EudraCT Number | ||
| REGIMEN | Other Identifier | Alias Study Number |
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B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
Responder criteria for randomization at week 12 are defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from IGA baseline of 2 or more points, and c) reaching an EASI-75 response compared to baseline. Flare requiring rescue treatment is defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04965842 100 mg QD | Experimental | Double-blind randomized treatment following open label run-in period. |
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| PF-04965842 200 mg QD | Experimental | Double-blind randomized treatment following open label run-in period. |
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| Placebo QD | Placebo Comparator | Double-blind randomized treatment following open label run-in period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04965842 100 mg | Drug | PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Loss of Response: Double-blind (DB) Period | Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. EASI total score range from 0.0 to 72.0, with higher scores representing greater severity of AD. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores = more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate and 4 = severe. | From Day 1 of up to Week 40 of double blind period |
| Time to Loss of Response: Double-blind Period | Time (in days) to loss of response based on achieving IGA >=2 was measured from date of first dose of randomized treatment until last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) and based on EASI, loss of at least 50% of EASI response at Week 12 and IGA score of 2 or higher. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling with scores 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. EASI composite score evaluates degree of erythema, induration/papulation, excoriation, and lichenification. | From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window was extended +/- 45 Days due to COVID 19) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period | Time (in days) to loss of response based on achieving IGA >=2 (for the first time) as measured from date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue). IGA assesses severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | 35205 | United States | ||
| University of Alabama at Birmingham, Dermatology at the Whitaker Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42165315 | Derived | Guttman-Yassky E, Bieber T, Kabashima K, Gutermuth J, Weidinger S, Wollenberg A, Lazariciu I, Encinas G, Mikheil M, Watkins M. Sustained on/off-treatment disease control with abrocitinib for moderate-to-severe atopic dermatitis. J Dermatolog Treat. 2026 Dec;37(1):2672328. doi: 10.1080/09546634.2026.2672328. Epub 2026 May 21. | |
| 42162528 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Study Baseline: was defined as the last observation collected on or prior to Day 1 (first dose day) of study treatment. Randomization Baseline: was defined as the last observation collected between last dose of run-in treatment and Day 1 (first dose day) of randomized treatment. Rescue Baseline: was defined as the last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment.
Total 1235 participants were enrolled in 236 sites in 21 countries. Study started from 11 June 2018 and completed on 07 October 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-04965842 200 mg OL | Participants received 12 weeks induction treatment of 200 milligram (mg) oral tablets (each tablet of 100 mg) PF-04965842 once daily (QD) during an OL run-in period. Responders at the end of the 12-week OL run-in period entered the 40 week, double-blind (DB), maintenance treatment period. Responder criteria was defined as a) achieving an Investigator's Global Assessment (IGA) of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of greater than or equal to (>= 2) points, and c) reaching an Eczema Area and Severity Index (EASI)-75 response compared to baseline score. Baseline score was the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 Long Term Extension (LTE) study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label (OL) Run-in Period (12 Weeks) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2019 | Aug 3, 2021 |
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| PF-04965842 200 mg | Drug | PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks |
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| Placebo | Drug | Placebo, administered as two tablets to be taken orally once daily for 40 weeks |
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| From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window +/- 7 Days) |
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period | IGA assessed severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep dark red lesions. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) was scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin] and lower limbs [l] [including buttocks]) on 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score = 0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); where A = area score. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score = 0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score = 0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated worse disease status. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period | 4 body regions evaluated: head and neck, upper limbs, trunk (including axillae, groin/genitals), lower limbs (including buttocks) excluding scalp, palms, soles. BSA calculated by handprint method. Number (No) of handprints (size of participant's hand with fingers in closed position) fitting in affected area of a body region was estimated. Maximum No of handprints were 10, 20, 30, 40 for head and neck, upper limbs, trunk, and lower limbs respectively. Surface area (SA) of body region equivalent to 1 handprint: 1 handprint=10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. %Change BSA for a body region was calculated as=total No of handprints in a body region* %SA equivalent to 1 handprint. %BSA for an individual: arithmetic mean of %BSA of all 4 body regions, ranged from 0-100%, higher values=greater AD severity. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores added to give B (0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region-head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period | IGA assessed severity of AD on a 5-point scale (0-4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions. | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
| Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
| Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period | Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated greater severity. | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
| Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period | 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Overall % BSA for an individual % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD. | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
| Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
| Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
| Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
| Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a 5-point scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period | DLQI was a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period | CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all , 1 = only a little, 2 = quite a lot, 3 = very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give CDLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period | HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period | HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period | POEM was a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item scored as following: no days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3 and, every day = 4. The total POEM score ranges from 0 to 28, where higher score indicated greater severity. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period | PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [darker or lighter], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participants had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. | Baseline, Weeks 12, 16, 28, 40 and 52 |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Clinical Research Center of Alabama, LLC | Birmingham | Alabama | 35244 | United States |
| Tien Q Nguyen MD Inc dba First OC Dermatology | Fountain Valley | California | 92708 | United States |
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| Beach Allergy and Asthma Specialty Group, A Medical Corporation | Long Beach | California | 90808 | United States |
| Dermatology Specialists, Inc. | Oceanside | California | 92056 | United States |
| University of California San Diego | San Diego | California | 92122 | United States |
| San Luis Dermatology and Laser Clinic | San Luis Obispo | California | 93405 | United States |
| Southern California Dermatology, Inc. | Santa Ana | California | 92701 | United States |
| Mosaic Dermatology | Santa Monica | California | 90403 | United States |
| Bay Pines VAHCS | Bay Pines | Florida | 33744 | United States |
| Skin Care Research, LLC | Boca Raton | Florida | 33486 | United States |
| Skin Research Institute | Coral Gables | Florida | 33146 | United States |
| Baumann Cosmetic and Research Institute | Miami | Florida | 33137 | United States |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | United States |
| USF Asthma, Allergy & Immunology Clinical Research Unit | Tampa | Florida | 33613 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Dermatologic Surgery Specialists, PC | Macon | Georgia | 31217 | United States |
| Midwest Allergy Sinus Asthma, SC | Normal | Illinois | 61761 | United States |
| NorthShore University HealthSystem Dermatology Clinical Trials Unit | Skokie | Illinois | 60077 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| Ds Research | New Albany | Indiana | 47150 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| Kansas City Dermatology, P.A. | Overland Park | Kansas | 66215 | United States |
| DXP Imaging | Louisville | Kentucky | 40216 | United States |
| Skin Sciences PLLC | Louisville | Kentucky | 40217 | United States |
| Qualmedica Research, LLC | Owensboro | Kentucky | 42301 | United States |
| Owensboro Dermatology Associates | Owensboro | Kentucky | 42303 | United States |
| Meridian Clinical Research, LLC | Baton Rouge | Louisiana | 70808 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Saint Louis University Dermatology | St Louis | Missouri | 63104 | United States |
| Forest Hills Dermatology Group | Kew Gardens | New York | 11374 | United States |
| Juva Skin and Laser Center | New York | New York | 10022 | United States |
| UR Dermatology at College Town | Rochester | New York | 14620 | United States |
| M3 - Wake Research, Inc. | Raleigh | North Carolina | 27612 | United States |
| Bexley Dermatology Research | Bexley | Ohio | 43209 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Newton Clinical Research | Oklahoma City | Oklahoma | 73120 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| Paddington Testing Co, Inc. | Philadelphia | Pennsylvania | 19103 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Dermatology Treatment & Research Center, PA | Dallas | Texas | 75230 | United States |
| Innovate Research, LLC | Fort Worth | Texas | 76244 | United States |
| The University of Texas Health Science Center Houston | Houston | Texas | 77030 | United States |
| Ventavia Research Group Hurst | Hurst | Texas | 76054 | United States |
| Virginia Clinical Research, Inc | Norfolk | Virginia | 23502 | United States |
| Dermatology Associates of Seattle | Seattle | Washington | 98101 | United States |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | United States |
| Framingham Centro Medico | La Plata | Buenos Aires | B1902COS | Argentina |
| Hospital Universitario Austral | Pilar | Buenos Aires | B1629ODT | Argentina |
| Servicio de Investigacion de Patolog-ias Alergicas del Instituto ABC | Rosario | Santa Fe Province | 2000 | Argentina |
| CINME Centro de Investigaciones Metabolicas | C.a.b.a. | C1027AAP | Argentina |
| Buenos Aires Skin | C.a.b.a. | C1055AAO | Argentina |
| Psoriahue Medicina Interdisciplinaria | C.a.b.a | C1425DKG | Argentina |
| University Hospital Brussels | Brussels | 1090 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| University Hospital Antwerp | Edegem | 2650 | Belgium |
| CETI - Centro de Estudos em Terapias Inovadoras LTDA. | Curitiba | Paraná | 80030-110 | Brazil |
| Instituto de Dermatologia e Estética do Brasil LTDA | Rio de Janeiro | Rio de Janeiro | 22470-220 | Brazil |
| Hospital De Clinicas De Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Associacao dos Funcionarios Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dornelles | Porto Alegre | Rio Grande do Sul | 90160-093 | Brazil |
| Pesquisare Saude S/S Ltda | Santo André | São Paulo | 09.080-110 | Brazil |
| Fundacao do ABC - Faculdade de Medicina do ABC | Santo André | São Paulo | 09060-870 | Brazil |
| IBPClin Pesquisa Clinica | Rio de Janeiro | 20241-180 | Brazil |
| MC Asklepii" OOD | Dupnitsa | 2600 | Bulgaria |
| MHAT "Dr. Tota Venkova" AD | Gabrovo | 5300 | Bulgaria |
| "Center of skin-venereal diseases" EOOD, Sofia | Sofia | 1404 | Bulgaria |
| "DCC Fokus-5-Medical Establishment for OutpatientCare"EOOD | Sofia | 1463 | Bulgaria |
| "Mc Sinexus Sofia" Eood | Sofia | 1784 | Bulgaria |
| ACIBADEM City Clinic Diagnostic-Consultative Center EOOD | Sofia | 1784 | Bulgaria |
| "ACIBADEM City Clinic Medical Center Varna" EOOD | Varna | 9000 | Bulgaria |
| Dermatology Research Institute | Calgary | Alberta | T1Y0B4 | Canada |
| Stratica Medical | Edmonton | Alberta | T5K 1X3 | Canada |
| Alberta Dermasurgery Center | Edmonton | Alberta | T6G1C3 | Canada |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Karma Clinical Trials, Inc. | St. John's | Newfoundland and Labrador | A1A 4Y3 | Canada |
| CCA Medical Research | Ajax | Ontario | L1S 7K8 | Canada |
| SimcoDerm Medical and Surgical Dermatology Center | Barrie | Ontario | L4M 7G1 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| DermEdge Research | Mississauga | Ontario | L5H 1G9 | Canada |
| Dermatology Ottawa Research Centre | Ottawa | Ontario | K2C 3N2 | Canada |
| SKiN Centre for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| Office of Dr. Paul Adam | Scarborough Village | Ontario | M1B 4Z8 | Canada |
| AvantDerm | Toronto | Ontario | M5A 3R6 | Canada |
| K. Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| XLR8 Medical Research Inc. | Windsor | Ontario | N8W 1E6 | Canada |
| Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ) | Québec | Quebec | G1V 4X7 | Canada |
| Centro Medico SkinMed Limitada | Santiago | Santiago Metropolitan | 7580206 | Chile |
| Clinica Dermacross S.A. | Santiago | Santiago Metropolitan | 7640881 | Chile |
| Hospital Clinico Universidad de Chile | Santiago | Santiago Metropolitan | 8380456 | Chile |
| Centro Internacional de Estudios Clinicos - CIEC | Santiago | Santiago Metropolitan | 8420383 | Chile |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| The Second Affiliated Hospital of Army Medical University, PLA | Chongqing | Chongqing Municipality | 400037 | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| The Third Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
| The University of Hong Kong - Shenzhen Hospital | Shenzhen | Guangdong | 518053 | China |
| Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| The First Affiliated Hospital With Nanjing University | Nanjing | Jiangsu | 210000 | China |
| Dermatology Hospital of Jiangxi Province | Nanchang | Jiangxi | 330000 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Tianjin Medical University General Hospital, Dermatological Department | Tianjin | Tianjin Municipality | 300052 | China |
| The First Affiliated Hospital of Zhejiang University School of Medicine/Dermatology and STD Dept | Hangzhou | Zhejiang | 310003 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept | Hangzhou | Zhejiang | 310009 | China |
| Zhejiang Provincial People's Hospital/Dermatology Department | Hangzhou | Zhejiang | 310014 | China |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310016 | China |
| Peking University First Hospital | Beijing | 100034 | China |
| Shanghai Changzheng Hospital | Shanghai | 200003 | China |
| Shanghai Dermatology Hospital | Shanghai | 200443 | China |
| Charite - Universitaetsmedizin Berlin, Klinik fuer Dermatologie, Venerologie und Allergologie | Berlin | 10117 | Germany |
| Hautzentrum Friedrichshain Studien | Berlin | 10247 | Germany |
| Rothhaar Studien GmbH | Berlin | 10783 | Germany |
| Klinikum Bielefeld Rosenhoehe | Bielefeld | 33647 | Germany |
| Universitaetsklinikum Bonn | Bonn | 53127 | Germany |
| Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden | Dresden | 01307 | Germany |
| Universitaetsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| SRH Wald-Klinikum Gera GmbH | Gera | 07548 | Germany |
| Universitätsklinikum und Poliklinik für Dermatologie und Venerologie | Halle | 06120 | Germany |
| Klinische Forschung Hamburg GmbH | Hamburg | 20253 | Germany |
| TFS Trial Form Support GmbH | Hamburg | 20537 | Germany |
| Katholisches Kinderkrankenhaus Wilhemstift | Hamburg | 22149 | Germany |
| MENSINGDERMA research GmbH | Hamburg | 22391 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Praxis Dr. med. Beate Schwarz | Langenau | 89129 | Germany |
| Universitaetsklinikum Schleswig-Holstein | Lübeck | 23538 | Germany |
| Hautaerztliche Gemeinschaftspraxis Dres. Leitz und Kollegen | Stuttgart | 70178 | Germany |
| Soroka University Medical Center | Beersheba | 8410101 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Rabin Medical Center | Petah Tikva | 4941492 | Israel |
| The Chaim Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Tel-Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| AOU Policlinico Sant'Orsola Malpighi | Bologna | BO | 40138 | Italy |
| Universita' degli Studi G. D'Annunzio -CeSi-MeT | Chieti | CH | 66100 | Italy |
| IFO Istituto Dermatologico San Gallicano IRCCS, | Roma | RM | 00144 | Italy |
| Ospedale Cristo Re | Roma | ROME | 00167 | Italy |
| Azienda Ospedaliero Universitaria San Martino di Genova | Genova | 16132 | Italy |
| Ospedale Luigi Sacco | Milan | 20157 | Italy |
| Prof. Giovanni Pellacani AOU Policlinico di Modena Struttura Complessa di Dermatologia | Modena | 41124 | Italy |
| Universita del Sacro Cuore, Policlinico Agostino Gemelli, Istituto Di Dermatologia | Rome | 00168 | Italy |
| Riga 1st Hospital, Clinic of Dermatology and STD | Riga | LV - 1001 | Latvia |
| Health and Aesthetics Ltd | Riga | LV-1009 | Latvia |
| Health Centre 4 Ltd, Dermatology Clinics | Riga | LV-1013 | Latvia |
| Outpatient Clinic Of Ventspils | Ventspils | LV3601 | Latvia |
| Arke Estudios Clinicos S.A. de C.V. | Cuauhtémoc | Mexico City | 06700 | Mexico |
| JM Research SC | Cuernavaca | Morelos | 62290 | Mexico |
| Centro de Dermatologia de Monterrey | Monterrey | Nuevo León | 64460 | Mexico |
| Phylasis Clinicas Research S. de R.L. de C.V. | Cuautitlán Izcalli | State of Mexico | 54769 | Mexico |
| Derma Norte del Bajio S.C | Aguascalientes | 20127 | Mexico |
| Centro de Investigacion Integral Medivest S.C. | Chihuahua City | 31203 | Mexico |
| Universitair Medisch Centrum (UMC) Utrecht | Utrecht | 3584 CX | Netherlands |
| Nasz Lekarz Osrodek Badan Klinicznych | Bydgoszcz | 85-065 | Poland |
| Centrum Medyczne SENSEMED | Chorzów | 41-500 | Poland |
| Copernicus Podmiot Leczniczy Sp. z.o.o., Oddzial Dermatologii | Gdansk | 80-152 | Poland |
| Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii | Gdansk | 80-214 | Poland |
| Silmedic Sp. z o.o., Oddzial w Katowicach | Katowice | 40-282 | Poland |
| Centrum Medyczne Angelius Provita | Katowice | 40-611 | Poland |
| Pro Familia Altera Sp. z o.o. | Katowice | 40-648 | Poland |
| Malopolskie Centrum Kliniczne | Krakow | 30-149 | Poland |
| Centrum Badan Klinicznych JCI | Krakow | 30-348 | Poland |
| Krakowskie Centrum Medyczne Sp. z o.o. | Krakow | 31-501 | Poland |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | 90-242 | Poland |
| NZOZ "DERMED" Centrum Medyczne Sp. z o.o. - Oddzial w Lodzi | Lodz | 90-265 | Poland |
| O?rodek Bada? Klinicznych Appletreeclinics | Lodz | 90-349 | Poland |
| Dermoklinika-Centrum Medyczne s.c. | Lodz | 90-436 | Poland |
| KO-MED Centra Kliniczne Lublin II | Lublin | 20-362 | Poland |
| Dermedic Jacek Zdybski | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Krolicki | Szczecin | 70-332 | Poland |
| Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. | Tarnów | 33-100 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Warszawie | Warsaw | 01-192 | Poland |
| MTZ Clinical Research Sp. z o.o. | Warsaw | 02-106 | Poland |
| Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie | Warsaw | 02-507 | Poland |
| RCMed Oddzial Warszawa | Warsaw | 02-657 | Poland |
| Klinika Ambroziak Sp. z o.o. | Warsaw | 02-758 | Poland |
| ETG Warszawa | Warsaw | 02-793 | Poland |
| Wojskowy Instytut Medyczny, Klinika Dermatologiczna | Warsaw | 04-141 | Poland |
| Synexus Polska Sp. z o.o. Oddzial we Wroclawiu | Wroclaw | 50-381 | Poland |
| Lukasz Matusiak "4Health' | Wroclaw | 50-566 | Poland |
| Kliniczny Oddzial Chorob Wewnetrznych, Dermatologii i Alergologii | Zabrze | 41-800 | Poland |
| SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL | Brasov | JUD. Brasov | 500283 | Romania |
| Cabinet Medical de Dermatovenerologie Prof. Dr. Orasan Remus Ioan | Cluj-Napoca | JUD. CLUJ | 400105 | Romania |
| SC Delta Health Care SRL | Bucharest | 014142 | Romania |
| SBIH "Chelyabinsk Regional Clinical Dermatovenerology dispensary" | Chelyabinsk | 454048 | Russia |
| Limited Liability Company "Medical Center "Rheuma-Med" | Kemerovo | 650070 | Russia |
| Clinic of FSBEI HE Kirov SMU MOH Russia | Kirov | 610014 | Russia |
| FSBI "State Research Centre of Dermatovenereology and Cosmetology" MoH RF | Moscow | 107076 | Russia |
| NRC Institute of Immunology FMBA of Russia | Moscow | 115478 | Russia |
| SBI RR "Skin and Venereal Dispensary" | Rostov-on-Don | 344007 | Russia |
| SBI RR "Regional Clinical Skin and Veneral Dispensary" | Ryazan | 390046 | Russia |
| LLC "Pierre Wolkenstein Clinic of Skin Diseases" | Saint Petersburg | 191123 | Russia |
| Vitiligo center | Saint Petersburg | 191123 | Russia |
| SPb SBIH "Dermatovenerologic Dispensary #10 - Clinic of dermatology and venerology" | Saint Petersburg | 194021 | Russia |
| FSBEI HE "St. Petersburg State Pediatric Medical University" MoH RF | Saint Petersburg | 194100 | Russia |
| Limited Liability Company "Sanavita" | Saint Petersburg | 195257 | Russia |
| Medical Research Institute, LLC | Saint Petersburg | 196084 | Russia |
| FSBEI HE I.P.Pavlov SPbSMU MOH Russia | Saint Petersburg | 197022 | Russia |
| RSBIH "Smolensk Regional Clinical Hospital" | Smolensk | 214018 | Russia |
| Military Medical Academy | Belgrade | 11000 | Serbia |
| Clinical Centre Nis | Niš | 18000 | Serbia |
| General Hospital Pancevo | Pančevo | 26000 | Serbia |
| Fakultna Nemocnica s Poliklinikou F. D. Roosevelta Banska Bystrica | Banská Bystrica | 975 17 | Slovakia |
| Narodny ustav detskych chorob, Detska dermatovenerologicka klinika LF UK a NUDCH | Bratislava | 833 40 | Slovakia |
| BeneDerma s.r.o. | Bratislava | 841 02 | Slovakia |
| Derma therapy spol. s.r.o, Dermatovenerologicka ambulancia | Bratislava | 85101 | Slovakia |
| Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica, Kozna ambulancia | Kosice-Saca | 040 15 | Slovakia |
| Pedi-Derma s.r.o., Dermatovenerologicka ambulancia | Košice | 04001 | Slovakia |
| Derma-beauty, s.r.o., Dermatovenerologicka ambulancia | Nitra | 949 01 | Slovakia |
| SANARE spol. s.r.o., Dermatovenerologicka ambulancia | Svidník | 089 01 | Slovakia |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Sant Joan de Deu | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital del Nino Jesus | Madrid | 28089 | Spain |
| Hospital Universitario Virgen de la Macarena | Seville | 41009 | Spain |
| Consorcio Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Universitario y Politecnico La Fe | Valencia | 46026 | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Taipei Medical University-Shuang Ho Hospital | New Taipei City | 23561 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | R.O.C 402 | Taiwan |
| National Cheng-Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Chang Gung Memorial Hospital Linkou Branch | Taoyuan City | 333 | Taiwan |
| Silverberg JI, Simpson EL, Farooqui SA, Chan G, Biswas P, Guler E. Efficacy and Safety of Variable-Dose Versus Continuous-Dose Abrocitinib Treatment in Patients with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis. Dermatol Ther (Heidelb). 2026 May 20. doi: 10.1007/s13555-026-01778-y. Online ahead of print. |
| 40028832 | Derived | Paller AS, Eichenfield LF, Irvine AD, Flohr C, Wollenberg A, Barbarot S, Bangert C, Spergel JM, Selfridge A, Biswas P, Fan H, Alderfer J, Watkins M, Koppensteiner H. Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis. Allergy. 2025 Aug;80(8):2213-2224. doi: 10.1111/all.16512. Epub 2025 Mar 3. |
| 38896380 | Derived | Armstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19. |
| 37036183 | Derived | Flohr C, Cork MJ, Ardern-Jones MR, Eichenfield LF, Barbarot S, Feeney C, Rojo R, Lazariciu I, Nesnas J. Efficacy and safety of abrocitinib monotherapy in adolescents and adults: a post hoc analysis of the phase 3 JAK1 atopic dermatitis efficacy and safety (JADE) REGIMEN clinical trial. J Dermatolog Treat. 2023 Dec;34(1):2200866. doi: 10.1080/09546634.2023.2200866. |
| 35342978 | Derived | Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib. Br J Clin Pharmacol. 2022 Aug;88(8):3856-3871. doi: 10.1111/bcp.15334. Epub 2022 Apr 11. |
| 34406619 | Derived | Simpson EL, Silverberg JI, Nosbaum A, Winthrop KL, Guttman-Yassky E, Hoffmeister KM, Egeberg A, Valdez H, Zhang M, Farooqui SA, Romero W, Thorpe AJ, Rojo R, Johnson S. Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Am J Clin Dermatol. 2021 Sep;22(5):693-707. doi: 10.1007/s40257-021-00618-3. Epub 2021 Aug 18. |
| FG001 | PF-04965842 200 mg OL to Placebo DB | Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| FG002 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| FG003 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| FG004 | PF-04965842 200 mg Rescue Period | Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Double-blind Treatment Period (40 Weeks) |
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| Open-label Rescue Period (12 Weeks) |
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Full analysis set-randomized (FAS-RA) included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within Double-blind (DB) phase.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-04965842 200 mg OL to Placebo DB | Responders from OL run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| BG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| BG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Loss of Response: Double-blind (DB) Period | Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, induration/papulation, excoriation, and lichenification for each of 4 body regions. EASI total score range from 0.0 to 72.0, with higher scores representing greater severity of AD. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores = more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate and 4 = severe. | Full analysis set-randomized (FAS-RA) included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment. | Posted | Number | percentage of participants | From Day 1 of up to Week 40 of double blind period |
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| Secondary | Time to First Loss of Response Based on Investigator's Global Assessment (IGA) Score of 2 or Higher: Double-blind Period | Time (in days) to loss of response based on achieving IGA >=2 (for the first time) as measured from date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue). IGA assesses severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions. | FAS-RA included as all participants who were randomized at Week 12 and received at least one dose of study medication within the double-blind phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment. Here, Overall 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window +/- 7 Days) |
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| Secondary | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Weeks 12, 16, 28, 40, and 52: Double-blind Period | IGA assessed severity of AD on a 5-point scale (0 to 4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0 = clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep dark red lesions. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for the specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=50% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) was scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin] and lower limbs [l] [including buttocks]) on 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score = 0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); where A = area score. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score = 0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=90% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score = 0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=100% Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Percentage of Participants With Greater Than or Equal 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated worse disease status. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Percent Change From Baseline in Body Surface Area (BSA) at Weeks 12, 16, 28, 40 and 52: Double-blind Period | 4 body regions evaluated: head and neck, upper limbs, trunk (including axillae, groin/genitals), lower limbs (including buttocks) excluding scalp, palms, soles. BSA calculated by handprint method. Number (No) of handprints (size of participant's hand with fingers in closed position) fitting in affected area of a body region was estimated. Maximum No of handprints were 10, 20, 30, 40 for head and neck, upper limbs, trunk, and lower limbs respectively. Surface area (SA) of body region equivalent to 1 handprint: 1 handprint=10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. %Change BSA for a body region was calculated as=total No of handprints in a body region* %SA equivalent to 1 handprint. %BSA for an individual: arithmetic mean of %BSA of all 4 body regions, ranged from 0-100%, higher values=greater AD severity. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | Posted | Median | Inter-Quartile Range | percent change | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3); severity scores added to give B (0-18). C: pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | Posted | Median | Inter-Quartile Range | percent change | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch and Sleep Loss at Weeks 12, 16, 28, 40 and 52: Double-blind Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region-head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Percentage of Participants With >=50% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Percentage of Participants With >=75% Improvement From Baseline in Scoring Atopic Dermatitis (SCORAD) Response at Weeks 12, 16, 28, 40 and 52: Double-blind Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period | IGA assessed severity of AD on a 5-point scale (0-4, higher scores indicated more severity), reflecting global consideration of erythema, induration and scaling. Where, 0=clear, AD is cleared; 1 = almost clear, AD not entirely cleared, light pink residual lesions; 2 = mild, AD with light red lesions; 3 = moderate, AD with red lesions; 4 = severe, AD with deep, dark red lesions. | Full analysis set-rescue (FAS-RE) included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
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| Secondary | Percent Change From Rescue Baseline in Total Eczema Area and Severity Index (EASI) Score at Rescue Weeks 2, 4, 8 and 12: Rescue Period | EASI quantifies severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll). Total EASI score ranged from 0.0 to 72.0, higher scores=greater severity of AD. | FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
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| Secondary | Percentage of Participants Achieving Greater Than or Equal to 4 Points Improvement From Rescue Baseline in Peak Pruritus Numeric Rating Scale (PP-NRS) at Rescue Weeks 2, 4, 8 and 12: Rescue Period | Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated greater severity. | FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
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| Secondary | Percent Change From Rescue Baseline in Percent Body Surface Area (BSA) at Rescue Weeks 2, 4, 8 and 12: Rescue Period | 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin/genitals) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Overall % BSA for an individual % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD. | FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
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| Secondary | Percent Change From Rescue Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Score of Itch and Sleep Loss at Rescue Weeks 2, 4, 8 and 12: Rescue Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment.. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
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| Secondary | Percentage of Participants With 50% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
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| Secondary | Percentage of Participants With 75% Improvement in Scoring Atopic Dermatitis (SCORAD) From Rescue Baseline at Rescue Weeks 2, 4, 8 and 12: Rescue Period | SCORAD: scoring index for AD combining extent (A), severity (B), subjective symptoms (C). A: rule of 9 used to calculate BSA affected by AD as % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; genitals 1%. Score of each body region added to determine A (0-100). B: severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2), severe (3). Severity scores added to give B (0-18). C: pruritus and sleep loss, each were scored by participant/caregiver using VAS where, 0=no itch/no sleep loss and 10=worst imaginable itch/sleep loss, higher scores=worse symptoms. Scores for itch and sleep loss added to give 'C' (0-20). SCORAD calculated as: A/5+7*B/2+C; range (0-103); higher values=worse outcome. | FAS-RE included all participants who met the protocol definition of a flare during the DB phase and received at least 1 dose of rescue treatment. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Rescue Baseline: last observation collected between last dose of blinded treatment and Day 1 (first dose day) of rescue treatment, Rescue Weeks 2, 4, 8 and 12 |
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| Secondary | Percentage of Participants Achieving Patient Global Assessment (PtGA) Response of 'Clear (0)' or 'Almost Clear (1)' and Greater Than or Equal to 2 Points Improvement From Baseline at Weeks 12, 16, 28, 40 and 52: Double-blind Period | Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a 5-point scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified time points. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Score for Adults at Weeks 12, 16, 28, 40 and 52: Double-blind Period | DLQI was a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for adults, aged 18 years and above. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score for Adolescents at Weeks 12, 16, 28, 40 and 52: Double-blind Period | CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale (range 0 to 3) where, 0 = not at all , 1 = only a little, 2 = quite a lot, 3 = very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give CDLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for adolescents, aged 12-17 years. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Primary | Time to Loss of Response: Double-blind Period | Time (in days) to loss of response based on achieving IGA >=2 was measured from date of first dose of randomized treatment until last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) and based on EASI, loss of at least 50% of EASI response at Week 12 and IGA score of 2 or higher. IGA assesses severity of AD on 5-point scale (0 to 4, higher scores=more severity), reflecting global consideration of erythema, induration and scaling with scores 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. EASI quantifies severity of AD based on severity of lesion clinical signs and % of BSA affected. EASI composite score evaluates degree of erythema, induration/papulation, excoriation, and lichenification. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Missing event times were considered as right censored (CAR) on last date of randomized treatment. Here 'Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | From date of first dose of randomized treatment until the last dose of randomized treatment (if not entered rescue) or first day of rescue treatment (if entered rescue) (maximum up to Week 40, visit window was extended +/- 45 Days due to COVID 19) |
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| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period | HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression Scale at Weeks 12, 16, 28, 40 and 52: Double-blind Period | HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period | POEM was a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item scored as following: no days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3 and, every day = 4. The total POEM score ranges from 0 to 28, where higher score indicated greater severity. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Weeks 12, 16, 28, 40 and 52 |
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| Secondary | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Score at Weeks 12, 16, 28, 40 and 52: Double-blind Period | PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [darker or lighter], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participants had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. | FAS-RA included as all participants who were randomized at Week 12 and received at least 1 dose of study medication within DB phase. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Weeks 12, 16, 28, 40 and 52 |
|
From screening up to 28 days after last dose of study treatment (maximum up to Week 56)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who received at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-04965842 200 mg OL | Participants received 12 weeks induction treatment of 200 mg oral tablets (each tablet of 100 mg) PF-04965842 QD during an OL run-in period. Responders at the end of the 12-week open-label run-in period entered the 40 weeks, DB, maintenance treatment period. Responder criteria was defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5-point scale), b) a reduction from IGA baseline of >= 2 points, and c) reaching an EASI-75 response compared to baseline score. Baseline score was the IGA score and EASI score obtained prior to dosing on Day 1. Non-responders had a choice to enroll into the PF-04965842 LTE study B7451015 (NCT03422822) otherwise, they were permanently discontinued from treatment and were followed-up for 4-week in this study. | 1 | 1,233 | 20 | 1,233 | 482 | 1,233 |
| EG001 | PF-04965842 200 mg OL to Placebo DB | Responders from open-label run-in period received two placebo tablets matched to PF-04965842 orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period (RP). Flare was define as a loss of at least 50 percent (%) of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. | 0 | 267 | 3 | 267 | 158 | 267 |
| EG002 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. | 0 | 265 | 9 | 265 | 130 | 265 |
| EG003 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. | 0 | 266 | 14 | 266 | 152 | 266 |
| EG004 | PF-04965842 200 mg Rescue Period | Participants who met the protocol defined flare criteria in DB period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during open-label Rescue Period for up to 12 weeks. After completing the 12-week rescue period, participants had the choice to enter the LTE study B7451015 (NCT03422822), if eligible. Participants who discontinued early from treatment, or who were otherwise ineligible for the LTE study, were followed-up for 4 week in this study. | 0 | 351 | 4 | 351 | 75 | 351 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitello-intestinal duct remnant | Congenital, familial and genetic disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Retinal vein thrombosis | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Eczema herpeticum | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Adnexa uteri cyst | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
For outcome measure, Time to loss of response, the data collection window was extended for 45 days beyond the scheduled visit due to COVID 19.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 22, 2020 | Aug 3, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D012871 | Skin Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D017443 | Skin Diseases, Eczematous |
| D006967 | Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C000634427 | abrocitinib |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Withdrawal By Parent/Guardian |
|
| Other |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
|
|
|
| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
|
|
|
| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
|
|
|
| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
|
|
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| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| Units | Counts |
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| Participants |
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Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB |
Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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| OG001 | PF-04965842 200 mg OL to PF-04965842 100 mg+Placebo DB | Responders from open-label run-in period received a tablet of 100 mg PF-04965842 and a tablet of matching placebo orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
| OG002 | PF-04965842 200 mg OL to PF-04965842 200 mg DB | Responders from open-label run-in period received 200 mg PF-04965842 (2 tablets of 100 mg each) orally QD during DB period for up to 40 weeks. Participants who met the protocol defined flare criteria entered in open-label rescue period. Flare was define as a loss of at least 50% of the EASI response at Week 12 and had an IGA score of 2 or higher. Participants who did not met the flare criteria had a choice to enroll into the LTE study, otherwise they were permanently discontinued from treatment and were followed-up for 4-week in this study. |
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