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| ID | Type | Description | Link |
|---|---|---|---|
| I4V-MC-JAHL | Other Identifier | Eli Lilly and Company | |
| 2017-000870-12 | EudraCT Number |
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| Name | Class |
|---|---|
| Incyte Corporation | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 milligram (mg) Baricitinib | Experimental | 4 mg Baricitinib administered orally once daily. Placebo 1 mg and 2 mg administered orally every day to match. |
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| 2 mg Baricitinib | Experimental | 2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match. |
|
| 1 mg Baricitinib | Experimental | 1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match. |
|
| Placebo | Placebo Comparator | Placebo administered orally once daily. |
|
| 4 mg Baricitinib Maximum Extended Enrollment Cohort | Experimental | 4 mg Baricitinib administered orally once daily. Placebo 1 mg, and 2 mg administered orally every day to match. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2 mg, or 4 mg Baricitinib) | The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1 mg Baricitinib) | 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 an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. |
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Inclusion Criteria:
Exclusion Criteria:
Are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus), or a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections.
A history of eczema herpeticum within 12 months, and/or a history of 2 or more episode of eczema herpeticum in the past.
Participants who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics.
Have any serious illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma).
Have been treated with the following therapies:
Have high blood pressure characterized by a repeated systolic blood pressure >160 millimeters of mercury (mm Hg) or diastolic blood pressure >100 mm Hg.
Have had major surgery within the past eight weeks or are planning major surgery during the study.
Have experienced any of the following within 12 weeks of screening: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
Have a history of recurrent (≥ 2) VTE or are considered at high risk of VTE as deemed by the investigator.
Have a history or presence of cardiovascular, respiratory, hepatic, chronic liver disease gastrointestinal, endocrine, hematological, neurological, lymphoproliferative disease or neuropsychiatric disorders or any other serious and/or unstable illness.
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection including herpes zoster, tuberculosis.
Have specific laboratory abnormalities.
Have received certain treatments that are contraindicated.
Pregnant or breastfeeding.
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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 |
|---|---|---|---|---|---|---|
| Kozni ambulance Kutna Hora, s.r.o. | Kutná Hora | Central Bohemia | 28401 | Czechia | ||
| Clintrial, s.r.o. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36255569 | Derived | Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18. | |
| 34688290 |
| Label | URL |
|---|---|
| A Study of Baricitinib (LY3009104) in Adults With Moderate to Severe Atopic Dermatitis (Eczema) (BREEZE-AD1) | View source |
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Anonymized individual patient 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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Participants who completed double blind treatment phase had option to enter extension study I4V-MC-JAHN (NCT03334435).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered orally once daily. |
| FG001 | 1 mg Baricitinib | 1 mg Baricitinib administered orally once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Dec 15, 2017 | Oct 8, 2019 |
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| 2 mg Baricitinib Maximum Extended Enrollment Cohort |
| Experimental |
2 mg Baricitinib administered orally once daily. Placebo 1 mg and 4 mg administered orally every day to match. |
|
| 1 mg Baricitinib Maximum Extended Enrollment Cohort | Experimental | 1 mg Baricitinib administered orally once daily. Placebo 2 mg and 4 mg administered orally every day to match. |
|
| Placebo Maximum Extended Enrollment Cohort | Placebo Comparator | Placebo administered orally once daily. |
|
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| Placebo | Drug | Administered orally. |
|
| 16 Weeks |
| Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) | 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 EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. | 16 Weeks |
| Percentage of Participants Achieving EASI90 | 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 is defined as a ≥ 90% improvement from baseline in the EASI score. | 16 Weeks |
| Percent Change From Baseline in EASI Score | The EASI assesses objective physician estimates of 2 dimensions of AD - 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). Least Square (LS) Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effect | Baseline, 16 Weeks |
| Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75) | The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score. | 16 Weeks |
| Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) | The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. | 16 Weeks |
| Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) | Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times,where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects. | Baseline, 16 Weeks |
| Change From Baseline in the Skin Pain Numeric Rating Scale (NRS) | Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | Baseline, 16 Weeks |
| Percentage of Participants Achieving EASI50 | 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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and 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 EASI50 is defined as a ≥ 50% improvement from baseline in EASI score. | 16 Weeks |
| Percentage of Participants Achieving IGA of 0 | 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 an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. | 16 Weeks |
| Change From Baseline in SCORAD | The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | Baseline, 16 Weeks |
| Percentage of Participants Achieving SCORAD90 | The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score. | 16 Weeks |
| Change From Baseline in Body Surface Area (BSA) Affected | Body surface area affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSAhead and neck + 0.3*BSAtrunk + 0.2* BSAupper limbs + 0.4*BSAlower limbs. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | Baseline, 16 Weeks |
| Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment | Percentage of participants developing skin infections requiring antibiotic treatment. | 16 Weeks |
| Percent Change From Baseline in Itch NRS | The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | Baseline, 16 Weeks |
| Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM) | The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | Baseline, 16 Weeks |
| Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score | The PGI-S-AD asked the participant to evaluate the severity of the disease at that point in time on a single-item, 5-point scale, using a daily diary. The same category labels used in the Physician's Global Assessment were used for the PGI-S-AD, i.e., "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe." LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | Baseline, 16 Weeks |
| Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) | The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | Baseline, 16 Weeks |
| Change From Baseline in the Dermatology Life Quality Index (DLQI) | The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and at unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | Baseline, 16 Weeks |
| Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire | The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | Baseline, 16 Weeks |
| Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm | EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | Baseline, 16 Weeks |
| Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS) | EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | Baseline, 16 Weeks |
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement | 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 an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. | 4 Weeks |
| Prague |
| Hl. M. Praha |
| 100 00 |
| Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Hl. M. Praha | 100 34 | Czechia |
| Fakultni Nemocnice v Motole | Prague | Hl. M. Praha | 150 06 | Czechia |
| Nemocnice Na Bulovce | Prague | Hl. M. Praha | 180 81 | Czechia |
| Nemocnice Novy Jicin a.s. | Nový Jičín | Moravian-Silesian Region | 741 01 | Czechia |
| Fakultni Nemocnice Plzen | Plzen, Jizni Predmesti | Plzeň Region | 301 00 | Czechia |
| Fakultni Nemocnice U svate Anny | Brno | South Moravian | 656 91 | Czechia |
| Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z. | Ústí nad Labem | Ustecký Kraj | 40113 | Czechia |
| Aarhus Universitehospital Marselisborg Centret | Aarhus | 8200 | Denmark |
| Hopital Saint-Louis | Paris | Cedex 10 | 75475 | France |
| CHU de Bordeaux Hopital Saint Andre | Bordeaux | 33075 | France |
| CHRU de Brest - Hôpital Morvan | Brest | 29200 | France |
| CHU Grenoble Alpes | Grenoble Cédex 9 | 38043 | France |
| Chru De Nantes Hotel-Dieu | Nantes | 44093 | France |
| CHU de Nice Hopital de L'Archet | Nice | 06202 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Hopital Larrey | Toulouse | 31059 | France |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79104 | Germany |
| Klinikum der Universität München | München | Bavaria | 80337 | Germany |
| Gemeinschaftspraxis Mahlow | Blankenfelde-Mahlow | Brandenburg | 15831 | Germany |
| Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH | Darmstadt | Hesse | 64283 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universität Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| Dermatologisches Zentrum Osnabrück Nord | Bramsche | Lower Saxony | 49565 | Germany |
| Universitätsmedizin Göttingen | Göttingen | Lower Saxony | 37075 | Germany |
| Universitätsmedizin Rostock | Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
| Universitätsklinikum Bonn | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Praxis Dr. Thomas Dirschka | Wuppertal | North Rhine-Westphalia | 42287 | Germany |
| Praxis Gerlach | Dresden | Saxony | 01097 | Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | Saxony | 01307 | Germany |
| Universität Leipzig - Universitätsklinikum | Leipzig | Saxony | 04103 | Germany |
| Universitätsklinikum Otto-von-Guericke-Universität | Magdeburg | Saxony-Anhalt | 39120 | Germany |
| Hautarztzentrum Kiel | Kiel | Schleswig-Holstein | 24103 | Germany |
| Universitätsklinikum Schleswig-Holstein | Kiel | Schleswig-Holstein | 24105 | Germany |
| Universitätsklinikum Schleswig-Holstein | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Rothhaar Studien GmbH | Berlin | 10783 | Germany |
| ISA GmbH | Berlin | 10789 | Germany |
| Praxis für Ganzheitliche Dermatologie im Ärztehaus | Berlin | 13055 | Germany |
| TFS Trial Form Support GmbH | Hamburg | 20537 | Germany |
| King George Hospital | Vizag | Andhra Pradesh | 530002 | India |
| Panchshil Hospital | Ahmedabad | Gujarat | 380005 | India |
| Byramjee Jeejeebhoy Medical College & Civil Hospital | Ahmedabad | Gujarat | 380016 | India |
| M S Ramaiah Medical College Hospital | Bangalore | Karnataka | 560054 | India |
| Dr. D. Y. Patil Medical College & Hospital | Navi Mumbai | Maharashtra | 400706 | India |
| Jehangir Hospital | Pune | Maharashtra | 411001 | India |
| Seth GS Medical College & KEM Hospital | Mumbai | Maharshtra | 400012 | India |
| All India Institue of Medical Sciences (AIIMS) | New Delhi | National Capital Territory of Delhi | 110 029 | India |
| Sir Ganga Ram Hospital | New Delhi | National Capital Territory of Delhi | 110060 | India |
| Chennai Meenakshi Multispeciality Hospital | Chennai | Tamil Nadu | 600004 | India |
| Gandhi Hospital | Secunderabad | Telangana | 500003 | India |
| MV Hospital and Research Centre | Lucknow | Uttar Pradesh | 226003 | India |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | 80131 | Italy |
| Azienda Ospedaliera - Universitaria Pisana | Pisa | 56126 | Italy |
| Policlinico di Tor Vergata | Roma | 00133 | Italy |
| Ospedale Policlinico Giambattista Rossi, Borgo Roma | Verona | 37134 | Italy |
| Kawashima Dermatology Clinic | Ichikawa-shi | Chiba | 272-0033 | Japan |
| Fumimori Clinic | Fukuoka | Fukuoka | 815-0082 | Japan |
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan |
| Queen's Square Dermatology and Allergology | Nishi-ku, Yokohama-city | Kanagawa | 220-6208 | Japan |
| Yokohama City Minato Red Cross Hospital | Yokohama | Kanagawa | 231-8682 | Japan |
| Kyoto Prefectural University of Medicine | Kyoto | Kyoto | 602-8566 | Japan |
| Kume Clinic | Nishi-ku Sakai-shi | Osaka | 593-8324 | Japan |
| Shimane University Hospital | Izumo | Shimane | 693-8501 | Japan |
| JA Shizuoka Kohseiren Enshu Hospital | Hamamatsu | Shizuoka | 430-0929 | Japan |
| Iidabashi Clinic | Chiyoda-ku | Tokyo | 102-0072 | Japan |
| Nihonbashi Sakura Clinic | Chuo-ku | Tokyo | 103-0025 | Japan |
| Sumire Dermatology Clinic | Edogawa-ku | Tokyo | 133-0057 | Japan |
| NTT Medical Center Tokyo | Shinagawa-KU | Tokyo | 141-8625 | Japan |
| Shirasaki Clinic | Takaoka-shi | Toyama | 9330871 | Japan |
| Yamanashi Prefectural Central Hospital | Kofu | Yamanashi | 400-8506 | Japan |
| Fukuoka University Hospital | Fukuoka | 814-0180 | Japan |
| Grupo Médico CAMINO S.C. | Mexico City | Mexico City | 03310 | Mexico |
| Hospital de Jesus I.A.P. | Mexico City | Mexico City | 06090 | Mexico |
| Clínica Enfermedades Crónicas y Procedimientos Especiales SC | Morella | Michoacán | 58249 | Mexico |
| CRI Centro Regiomontano de Investigacion S.C. | Monterrey | Nuevo León | 64060 | Mexico |
| Hospital Univ. Dr. Jose Eleuterio Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
| JM Research S.C. | Cuernavaca | 62290 | Mexico |
| RM Pharma Specialists S.A. de C.V. | Distrito Federal | 3100 | Mexico |
| Instituto de Investigaciones Aplicadas a la Neurociencia A.C | Durango | 34000 | Mexico |
| GBUZ Clinical dermatology and venereological dispensary | Krasnodar | 350020 | Russia |
| State scientific centre for dermatovenerology and cosmetolog | Moscow | 107076 | Russia |
| Russian state medical-stomatological university n.a. Evdokimov | Moscow | 111398 | Russia |
| SPb SBHI Skin-venerologic dispensary #10 | Saint Petersburg | 194021 | Russia |
| LLC ArsVitae NorthWest | Saint Petersburg | 194223 | Russia |
| LLC Medical Center "Kurator" | Saint Petersburg | 196240 | Russia |
| Chang Gung Memorial Hospital - Kaohsiung | Kaohsiung City | 83301 | Taiwan |
| Taipei Medical University- Shuang Ho Hospital | New Taipei City | 23561 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 40201 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Chang Gung Memorial Hospital - Taipei | Taipei | 10508 | Taiwan |
| Chang Gung Memorial Hospital - Linkou | Taoyuan City | 33305 | Taiwan |
| Silverberg JI, DeLozier A, Sun L, Thyssen JP, Kim B, Yosipovitch G, Nunes FP, Gugiu PC, Doll HA, Eichenfield LF. Psychometric properties of the itch numeric rating scale, skin pain numeric rating scale, and atopic dermatitis sleep scale in adult patients with moderate-to-severe atopic dermatitis. Health Qual Life Outcomes. 2021 Oct 23;19(1):247. doi: 10.1186/s12955-021-01877-8. |
| 34275122 | Derived | Thyssen JP, Buhl T, Fernandez-Penas P, Kabashima K, Chen S, Lu N, DeLozier AM, Casillas M, Stander S. Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7. Dermatol Ther (Heidelb). 2021 Oct;11(5):1599-1611. doi: 10.1007/s13555-021-00577-x. Epub 2021 Jul 18. |
| 33826132 | Derived | King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7. |
| 33222559 | Derived | Reich K, DeLozier AM, Nunes FP, Thyssen JP, Eichenfield LF, Wollenberg A, Ross Terres JA, Watts SD, Chen YF, Simpson EL, Silverberg JI. Baricitinib improves symptoms in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: patient-reported outcomes from two randomized monotherapy phase III trials. J Dermatolog Treat. 2022 May;33(3):1521-1530. doi: 10.1080/09546634.2020.1839008. Epub 2020 Nov 22. |
| FG002 | 2 mg Baricitinib | 2 mg Baricitinib administered orally once daily. |
| FG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
| FG004 | Placebo Maximum Extended Enrollment (MEE) | Placebo administered orally once daily. |
| FG005 | 1 mg Baricitinib MEE | 1 mg Baricitinib administered orally once daily. |
| FG006 | 2 mg Baricitinib MEE | 2 mg Baricitinib administered orally once daily. |
| FG007 | 4 mg Baricitinib MEE | 4 mg Baricitinib administered orally once daily. |
| Received at Least One Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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All randomized participants. Results for maximum extended enrollment (MEE) participants will be reported within 1-year after the study completion.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered orally once daily. |
| BG001 | 1 mg Baricitinib | 1 mg Baricitinib administered orally once daily. |
| BG002 | 2 mg Baricitinib | 2 mg Baricitinib administered orally once daily. |
| BG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
| BG004 | Placebo Maximum Extended Enrollment (MEE) | Placebo administered orally once daily. |
| BG005 | 1 mg Baricitinib MEE | 1 mg Baricitinib administered orally once daily. . |
| BG006 | 2 mg Baricitinib MEE | 2 mg Baricitinib administered orally once daily. |
| BG007 | 4 mg Baricitinib MEE | 4 mg Baricitinib administered orally once daily. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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, Categorical | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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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 Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2 mg, or 4 mg Baricitinib) | The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. | All participants randomized to placebo, 2 mg, or 4 mg of study drug. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1 mg Baricitinib) | 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 an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. | All participants randomized to placebo or 1 mg of study drug. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) | 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 EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. | All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Participants Achieving EASI90 | 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 is defined as a ≥ 90% improvement from baseline in the EASI score. | All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percent Change From Baseline in EASI Score | The EASI assesses objective physician estimates of 2 dimensions of AD - 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). Least Square (LS) Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effect | All randomized participants who had Week 16 EASI data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, 16 Weeks |
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| Secondary | Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75) | The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score. | All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS) | The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. | All randomized participants with a Baseline Itch NRS score >=4. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS) | Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times,where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep "last night." Each item is scored individually. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects. | All randomized participants with Week 16 ADSS Item 2 (frequency of waking) data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline in the Skin Pain Numeric Rating Scale (NRS) | Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 Skin Pain NRS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Percentage of Participants Achieving EASI50 | 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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and 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 EASI50 is defined as a ≥ 50% improvement from baseline in EASI score. | All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percentage of Participants Achieving IGA of 0 | 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 an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. | All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Change From Baseline in SCORAD | The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 SCORAD data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Percentage of Participants Achieving SCORAD90 | The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score. | All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Change From Baseline in Body Surface Area (BSA) Affected | Body surface area affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSAhead and neck + 0.3*BSAtrunk + 0.2* BSAupper limbs + 0.4*BSAlower limbs. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 BSA data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment | Percentage of participants developing skin infections requiring antibiotic treatment. | All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | percentage of participants | 16 Weeks |
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| Secondary | Percent Change From Baseline in Itch NRS | The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 Itch NRS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline, 16 Weeks |
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| Secondary | Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM) | The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 POEM data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline in the Patient Global Impression of Severity-Atopic Dermatitis (PGI-S-AD) Score | The PGI-S-AD asked the participant to evaluate the severity of the disease at that point in time on a single-item, 5-point scale, using a daily diary. The same category labels used in the Physician's Global Assessment were used for the PGI-S-AD, i.e., "(0) no symptoms", "(1) very mild", "(2) mild" "(3) moderate", and "(4) severe." LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 PGI-S-AD data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) | The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 HADS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline in the Dermatology Life Quality Index (DLQI) | The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and at unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 DLQI data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire | The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 WPAI-AD data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm | EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 EQ-5D-5L Health State Index US and UK data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS) | EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects. | All randomized participants with Week 16 EQ-5D-5L VAS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Least Squares Mean | Standard Error | millimeters | Baseline, 16 Weeks |
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| Secondary | Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement | 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 an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. | All randomized participants. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Posted | Number | percentage of participants | 4 Weeks |
|
Baseline Up to 20 weeks
All randomized participants who received at least one dose of study drug.
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 | Placebo | Placebo administered orally once daily. | 0 | 249 | 6 | 249 | 55 | 249 |
| EG001 | 1 mg Baricitinib | 1 mg Baricitinib administered orally once daily. | 0 | 127 | 1 | 127 | 37 | 127 |
| EG002 | 2 mg Baricitinib | 2 mg Baricitinib administered orally once daily. | 0 | 123 | 0 | 123 | 34 | 123 |
| EG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. | 0 | 125 | 2 | 125 | 29 | 125 |
| EG004 | Placebo Maximum Extended Enrollment | Placebo administered orally once daily. | 0 | 15 | 0 | 15 | 3 | 15 |
| EG005 | 1 mg Baricitinib Maximum Extended Enrollment | 1 mg Baricitinib administered orally once daily. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG006 | 2 mg Baricitinib Maximum Extended Enrollment | 2 mg Baricitinib administered orally once daily. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG007 | 4 mg Baricitinib Maximum Extended Enrollment | 4 mg Baricitinib administered orally once daily. | 0 | 8 | 0 | 8 | 3 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
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 | Jan 16, 2019 | Oct 8, 2019 | SAP_001.pdf |
| 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 |
|---|---|
| C000596027 | baricitinib |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Japan |
|
| Taiwan |
|
| Italy |
|
| Mexico |
|
| France |
|
| Germany |
|
| India |
|
| Russia |
|
| Odds Ratio (OR) |
| 4.10 |
| 2-Sided |
| 95 |
| 1.93 |
| 8.70 |
| Superiority |
|
|
2 mg Baricitinib administered orally once daily.
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
2 mg Baricitinib administered orally once daily.
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
| OG002 |
| 2 mg Baricitinib |
2 mg Baricitinib administered orally once daily. |
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
| OG002 |
| 2 mg Baricitinib |
2 mg Baricitinib administered orally once daily. |
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
4 mg Baricitinib administered orally once daily. |
|
|
|
| OG002 | 2 mg Baricitinib | 2 mg Baricitinib administered orally once daily. |
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
|
|
|
| OG002 | 2 mg Baricitinib | 2 mg Baricitinib administered orally once daily. |
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
2 mg Baricitinib administered orally once daily. |
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
1 mg Baricitinib administered orally once daily.
| OG002 | 2 mg Baricitinib | 2 mg Baricitinib administered orally once daily. |
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
2 mg Baricitinib administered orally once daily.
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
2 mg Baricitinib administered orally once daily.
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
| OG002 | 2 mg Baricitinib | 2 mg Baricitinib administered orally once daily. |
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
| OG002 |
| 2 mg Baricitinib |
2 mg Baricitinib administered orally once daily. |
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
| OG002 | 2 mg Baricitinib | 2 mg Baricitinib administered orally once daily. |
| OG003 | 4 mg Baricitinib | 4 mg Baricitinib administered orally once daily. |
|
|
|
| OG003 |
| 4 mg Baricitinib |
4 mg Baricitinib administered orally once daily. |
|
|
|
4 mg Baricitinib administered orally once daily.
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|