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| ID | Type | Description | Link |
|---|---|---|---|
| J2T-MC-KGBO | Other Identifier | Eli Lilly and Company |
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The study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD) previously treated with Dupilumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lebrikizumab 250 mg Q2W | Experimental | Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. |
|
| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W | Experimental | Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve Investigator Global Assessment (IGA) 0 or 1 (clear or almost clear) or a 75% reduction in the Eczema Area and Severity Index (EASI) score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. Eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met. |
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| Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Experimental | Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. Eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75) at Week 16 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-75 responder is defined as a ≥ 75% improvement from baseline in the EASI score. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving EASI-75 at Week 24 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-75 responder is defined as a ≥ 75% improvement from baseline in the EASI score. |
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Inclusion Criteria:
All participants must have prior treatment with dupilumab meeting one of the following conditions:
Participants who have chronic AD that has been present for ≥1 year before screening.
Have EASI ≥16 at baseline
Have IGA score ≥3 (Scale of 0 to 4) at baseline
Have ≥10% body surface area (BSA) of AD involvement at baseline
Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
Adolescents body weight must be ≥40 kg at baseline.
Exclusion Criteria:
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
Have a current infection or chronic infection with hepatitis B virus (HBV) at screening (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA
Have a current infection with hepatitis C virus (HCV) at screening (that is, positive for HCV RNA
Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator.
Have uncontrolled asthma that
might require bursts of oral or systemic corticosteroids, or
required the following due to ≥1 exacerbations within 12 months before baseline
Have known liver cirrhosis and/or chronic hepatitis of any etiology.
Had Dupilumab treatment within 4 weeks prior to baseline
Had prior treatment with tralokinumab.
Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline
Treatment with any of the following agents within 4 weeks prior to the baseline
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| River Region Dermatology and Laser | Montgomery | Alabama | 36117 | United States | ||
| Medical Dermatology Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41553700 | Derived | Silverberg JI, Ackerman L, Bagel J, Stein Gold L, Blauvelt A, Rosmarin D, Chovatiya R, Zirwas M, Yosipovitch G, Waibel J, Murase JE, Lockshin B, Weisman J, Atwater AR, Proper J, Silk M, Pierce E, Piruzeli MLB, Montmayeur S, Schuster C, Zhong J, Rueda MJ, Pillai S, Simpson E. Lebrikizumab Improves Clinical Manifestations, Symptoms, and Quality of Life in Patients with Moderate-to-Severe Atopic Dermatitis Previously Treated with Dupilumab: Results from the ADapt Study. Dermatol Ther (Heidelb). 2026 Feb;16(2):1309-1330. doi: 10.1007/s13555-025-01644-3. Epub 2026 Jan 19. |
| Label | URL |
|---|---|
| A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab | View source |
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Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lebrikizumab 250 mg Q2W | Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. |
| FG001 | Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Treatment Period 1: Week 0 to Week 16 |
|
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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 | Apr 27, 2023 | Jan 10, 2025 |
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| Week 24 |
| Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 | The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on the descriptors that best describe the overall appearance of the lesions at a given time point. | Baseline to Week 16 |
| Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24 | The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on the descriptors that best describe the overall appearance of the lesions at a given time point. | Baseline to Week 24 |
| Percentage Change From Baseline in EASI Total Score From Baseline to Week 16 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). | Baseline, Week 16 |
| Percentage Change From Baseline in EASI Score From Baseline to Week 24 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). | Baseline, Week 24 |
| Change in EASI Score From Baseline to Week 16 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). | Baseline, Week 16 |
| Change in EASI Score From Baseline to Week 24 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). | Baseline, Week 24 |
| Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) at Week 16 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score. | Week 16 |
| Percentage of Participants Achieving EASI-90 From Baseline to Week 24 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score. | Baseline to Week 24 |
| Percentage of Participants With a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 16 | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." | Baseline to Week 16 |
| Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 24 | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." | Baseline to Week 24 |
| Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 16 | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." | Baseline to Week 16 |
| Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 24 | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." | Baseline to Week 24 |
| Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 16 | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Assessments were recorded daily by the participant using an electronic diary. | Baseline, Week 16 |
| Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24 | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Assessments were recorded daily by the participant using an electronic diary. | Baseline, Week 24 |
| Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 16 | Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.](streamdown:incomplete-link) | Baseline to Week 16 |
| Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 24 | Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.](streamdown:incomplete-link) | Baseline to Week 24 |
| Change From Baseline in Sleep-Loss Scale From Baseline to Week 16 | Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.](streamdown:incomplete-link) | Baseline, Week 16 |
| Change From Baseline in Sleep-Loss Scale From Baseline to Week 24 | Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.](streamdown:incomplete-link) | Baseline, Week 24 |
| Change From Baseline in Skin Pain NRS From Baseline to Week 16 | The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable." | Baseline, Week 16 |
| Change From Baseline in Skin Pain NRS From Baseline to Week 24 | The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable." | Baseline, Week 24 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16 | The DLQI questionnaire designed for participants aged >=16 years or more is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. | Baseline, Week 16 |
| Change From Baseline in DLQI From Baseline to Week 24 | The DLQI questionnaire for participants aged 16 and above is a 10-item tool used to assess the impact of skin disease on quality of life. The 10 questions cover topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment over the previous week. Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively. Questions 3-10 have an additional response category of "not relevant," which is scored as "0." Questions are scored from 0 to 3. Total score ranges from 0 (no impact) to 30 (maximum impact), with higher scores indicating poorer quality of life. | Baseline, Week 24 |
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) From Baseline to Week 16 | The CDLQI questionnaire designed for participants aged <16 years and It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment). | Baseline, Week 16 |
| Change From Baseline in CDLQI From Baseline to Week 24 | The CDLQI questionnaire designed for participants aged <16 years and It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment). | Baseline, Week 24 |
| Percentage Change From Baseline in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16 | SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. | Baseline, Week 16 |
| Percentage Change From Baseline in SCORAD From Baseline to Week 24 | SCORAD is a validated tool for assessing the extent and intensity of AD. It consists of three components: A) the extent of AD as a percentage of each body area, with a maximum score of 100%; B) the severity of six specific symptoms (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) rated from 0 (none) to 3 (severe) for a maximum of 18 points; and C) the subjective assessment of itch and sleeplessness on a visual analog scale (VAS) from 0 (no itch/sleeplessness) to 10 (worst imaginable itch/sleeplessness) with a maximum score of 20. The total SCORAD score is calculated as A/5 + 7*B/2 + C, ranging from 0 (no disease) to 103 (severe disease). | Baseline, Week 24 |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| Axon Clinical Research | Inglewood | California | 90301 | United States |
| Avance Clinical Trials Inc | Laguna Niguel | California | 92677 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Wallace Medical Group, Inc. | Los Angeles | California | 90056 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Cura Clinical Research | Sherman Oaks | California | 91403 | United States |
| UConn Health | Farmington | Connecticut | 06030-2840 | United States |
| Encore Medical Research of Boynton Beach | Boynton Beach | Florida | 33436 | United States |
| Total Vein and Skin LLC | Boynton Beach | Florida | 33437 | United States |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | United States |
| Hollywood Dermatology | Hollywood | Florida | 33021 | United States |
| Miami Dermatology and Laser Research | Miami | Florida | 33173 | United States |
| Ziaderm Research, LLC. | North Miami Beach | Florida | 33162 | United States |
| Olympian Clinical Research | Tampa | Florida | 33615 | United States |
| Skin Care Physicians of Georgia | Macon | Georgia | 31217 | United States |
| Advanced Medical Research | Sandy Springs | Georgia | 30328 | United States |
| Dundee Dermatology | West Dundee | Illinois | 60118 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| Dermatology and Advanced Aesthetics | Lake Charles | Louisiana | 70605 | United States |
| Dermatology and Skin Cancer Specialists, LLC | Rockville | Maryland | 20850 | United States |
| Allcutis Research, Inc. | Beverly | Massachusetts | 01915 | United States |
| Oakland Hills Dermatology | Auburn Hills | Michigan | 48326 | United States |
| The Derm Institute of West Michigan | Caledonia | Michigan | 49316 | United States |
| Revival Research Institute - Troy | Troy | Michigan | 48084 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Allcutis Research, Inc | Portsmouth | New Hampshire | 03801 | United States |
| Windsor Dermatology, P.C. | East Windsor | New Jersey | 08520 | United States |
| Sadick Research Group | New York | New York | 10075 | United States |
| OptiSkin Medical | New York | New York | 10128 | United States |
| Dermatologists of Greater Columbus | Bexley | Ohio | 43209 | United States |
| Dermatology and Skin Surgery Center, PC | Exton | Pennsylvania | 19341 | United States |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| Complete Dermatology | Sugar Land | Texas | 77479 | United States |
| Spokane Dermatology Clinic | Spokane | Washington | 99202 | United States |
Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve Investigator Global Assessment (IGA) 0 or 1 (clear or almost clear) or a 75% reduction in the Eczema Area and Severity Index (EASI) score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. Eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met. |
| FG002 | Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W | Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. Eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met. |
|
| Received at Least One Dose of Drug |
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| Intent-to-Treat (ITT) Population |
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| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period 2: Week 16 to Week 24 |
|
|
| Continued Access Period |
|
|
The intent-to-treat (ITT) population included all enrolled participants according to their planned intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lebrikizumab 250mg Q2W | Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75) at Week 16 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-75 responder is defined as a ≥ 75% improvement from baseline in the EASI score. | ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI 75 data. Observed Cases (OC) analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Achieving EASI-75 at Week 24 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-75 responder is defined as a ≥ 75% improvement from baseline in the EASI score. | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 EASI-75 data. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16 | The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on the descriptors that best describe the overall appearance of the lesions at a given time point. | ITT population included all enrolled participants according to their planned intervention and had Baseline IGA of at least 2. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to Week 16 |
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| Secondary | Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24 | The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on the descriptors that best describe the overall appearance of the lesions at a given time point. | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 IGA score data. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to Week 24 |
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| Secondary | Percentage Change From Baseline in EASI Total Score From Baseline to Week 16 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). | ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI data. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 16 |
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| Secondary | Percentage Change From Baseline in EASI Score From Baseline to Week 24 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had EASI score data. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 24 |
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| Secondary | Change in EASI Score From Baseline to Week 16 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). | ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI data. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16 |
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| Secondary | Change in EASI Score From Baseline to Week 24 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 EASI score data. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 24 |
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| Secondary | Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) at Week 16 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score. | ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI 90 data. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Achieving EASI-90 From Baseline to Week 24 | The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score. | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 EASI 90 data. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to Week 24 |
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| Secondary | Percentage of Participants With a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 16 | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." | ITT population included all enrolled participants according to their planned intervention and had a Baseline Pruritus NRS score of at least 4. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to Week 16 |
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| Secondary | Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 24 | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had a >=4-point improvement from baseline in week 24 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to Week 24 |
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| Secondary | Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 16 | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." | ITT population included all enrolled participants according to their planned intervention and had a Baseline Pruritus NRS score of at least 3. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to Week 16 |
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| Secondary | Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 24 | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had a >=3-point improvement from baseline in week 24 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to Week 24 |
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| Secondary | Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 16 | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Assessments were recorded daily by the participant using an electronic diary. | ITT population included all enrolled participants according to their planned intervention and had week 16 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 16 |
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| Secondary | Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24 | Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Assessments were recorded daily by the participant using an electronic diary. | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had week 24 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 24 |
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| Secondary | Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 16 | Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.](streamdown:incomplete-link) | ITT population included all enrolled participants according to their planned intervention and had a baseline Sleep-Loss scale score of at least 2. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to Week 16 |
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| Secondary | Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 24 | Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.](streamdown:incomplete-link) | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had a >=2-point improvement from baseline in week 24 Sleep-Loss scale score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline to Week 24 |
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| Secondary | Change From Baseline in Sleep-Loss Scale From Baseline to Week 16 | Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.](streamdown:incomplete-link) | ITT population included all enrolled participants according to their planned intervention and had week 16 Sleep-Loss scale score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline in Sleep-Loss Scale From Baseline to Week 24 | Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.](streamdown:incomplete-link) | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had week 24 Sleep-Loss scale score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 24 |
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| Secondary | Change From Baseline in Skin Pain NRS From Baseline to Week 16 | The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable." | ITT population included all enrolled participants according to their planned intervention and had week 16 skin pain NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline in Skin Pain NRS From Baseline to Week 24 | The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable." | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had week 24 skin pain NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 24 |
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| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16 | The DLQI questionnaire designed for participants aged >=16 years or more is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. | ITT population included all enrolled participants according to their planned intervention and had week 16 DLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline in DLQI From Baseline to Week 24 | The DLQI questionnaire for participants aged 16 and above is a 10-item tool used to assess the impact of skin disease on quality of life. The 10 questions cover topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment over the previous week. Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively. Questions 3-10 have an additional response category of "not relevant," which is scored as "0." Questions are scored from 0 to 3. Total score ranges from 0 (no impact) to 30 (maximum impact), with higher scores indicating poorer quality of life. | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had week 24 DLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 24 |
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| Secondary | Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) From Baseline to Week 16 | The CDLQI questionnaire designed for participants aged <16 years and It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment). | ITT population included all enrolled participants according to their planned intervention and had week 16 CDLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16 |
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| Secondary | Change From Baseline in CDLQI From Baseline to Week 24 | The CDLQI questionnaire designed for participants aged <16 years and It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment). | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had week 24 cDLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 24 |
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| Secondary | Percentage Change From Baseline in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16 | SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. | ITT population included all enrolled participants according to their planned intervention and had week 16 SCORAD score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 16 |
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| Secondary | Percentage Change From Baseline in SCORAD From Baseline to Week 24 | SCORAD is a validated tool for assessing the extent and intensity of AD. It consists of three components: A) the extent of AD as a percentage of each body area, with a maximum score of 100%; B) the severity of six specific symptoms (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) rated from 0 (none) to 3 (severe) for a maximum of 18 points; and C) the subjective assessment of itch and sleeplessness on a visual analog scale (VAS) from 0 (no itch/sleeplessness) to 10 (worst imaginable itch/sleeplessness) with a maximum score of 20. The total SCORAD score is calculated as A/5 + 7*B/2 + C, ranging from 0 (no disease) to 103 (severe disease). | Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had week 24 SCORAD score. OC analysis is applied here, where analysis is using all the observed data at each time point. | Posted | Mean | Standard Deviation | percentage change | Baseline, Week 24 |
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Baseline up to end of follow-up including continued access period (Up to 102 Weeks)
All enrolled participants who received at least one confirmed dose of 250 mg lebrikizumab. MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. Participants were summarized as per the treatment they actually received.
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 | Lebrikizumab 250 mg Q2W | Participants received 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. | 0 | 86 | 1 | 86 | 38 | 86 |
| EG001 | Lebrikizumab 250 mg Q2W to Q2W |
| 0 | 18 | 0 | 18 | 7 | 18 |
| EG002 | Lebrikizumab 250 mg Q2W to Q4W |
| 0 | 41 | 1 | 41 | 14 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral vascular occlusion | Nervous system disorders | MedDRA 25.1 and 27.1 | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
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| Rash morbilliform | Skin and subcutaneous tissue disorders | MedDRA 25.1 and 27.1 | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Eye pruritus | Eye disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Swelling of eyelid | Eye disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Tooth impacted | Gastrointestinal disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Injection site erythema | General disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Injection site pain | General disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Injection site reaction | General disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
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| Conjunctivitis | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Covid-19 | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Hordeolum | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Viral abdominal infection | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Immune-mediated dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Gilbert's syndrome | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Hereditary non-polyposis colorectal cancer syndrome | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Peripheral swelling | General disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Impetigo | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Onychomycosis | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Otitis externa | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Skin infection | Infections and infestations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Human bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Nail avulsion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Thermal burns of eye | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Blood bicarbonate decreased | Investigations | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Craniopharyngioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Cutaneous t-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment | MedDRA versions used were v25.1 for Lebrikizumab 250 mg Q2W cohort and v27.1 for Lebrikizumab 250 mg Q2W to Q2W and Lebrikizumab 250 mg Q2W to Q4W cohorts. |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800- 545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2023 | Jan 10, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C561806 | lebrikizumab |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| Non-compliance with Study Drug |
|
| Physician Decision |
|
| Participant did not transition to commercially available Lebrikizumab |
|
| Discontinued in error-site failed to provide continued access protocol amendment with updated schema |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24. |
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| Counts |
|---|
| Participants |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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|
Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24. |
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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|
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| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.
|
|