Health Condition 1: null- Adult Patients with Moderate to Severe Atopic Dermatitis Health Condition 2: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Baricitinib 1-mg once daily (QD), 2-mg QD, and 4-mg QD: Study I4V-MC-JAHL (JAHL) is a Phase 3, multicenter, randomized, double-blind,
placebo-controlled, parallel-group, outpatient stud
120 patients in each baricitinib treatment group).
Control Intervention1: Placebo: Patients who meet all criteria for enrollment will be randomized in a 2:1:1:1 ratio (placebo,
baricitinib 1-mg
baricitinib 2-mg
baricitinib 4-mg) to double-blind treatment at Visit 2
(Week 0). Randomization will be stratified by geographic region (North America [NA], Europe
[EU], Japan [JPN], rest-of-world [ROW]) and disease s
Sponsors
Eli Lilly and Company India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: [1] are at least 18 years of age at the time of informed consent. [2] are able to read, understand, and give documented (electronic or paper signature) informed consent. [3] have a diagnosis of AD at least 12 months prior to screening, as defined by the American Academy of Dermatology: Guidelines of care for the management of AD; Section 1. Diagnosis and assessment of atopic dermatitis [4] have moderate to severe AD, including all of the following: a. Eczema Area and Severity Index (EASI) score >=16 at screening (Visit 1) and at randomization (Visit 2) b. IGA score of >=3 at screening (Visit 1) and at randomization (Visit 2) c. >=10% of BSA involvement at screening (Visit 1) and at randomization(Visit 2). [5] have a documented history by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening,or history of intolerance to topical therapy as defined by at least 1 of the following: a. inability to achieve good disease control defined as mild disease or better(e.g., IGA b. Patients who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, methotrexate, azathioprine, mycophenolate mofetil will also be considered as a surrogate for having inadequate response to topical therapy. c. documented history of clinically significant adverse reactions with the use of TCS such as skin atrophy, allergic reactions, systemic effects that in the opinion of the investigator outweigh the benefits of retreatment. [6] agree to discontinue use of the following excluded medications/treatments for at least 4 weeks prior to randomization (Visit 2) and throughout the study: a. systemic corticosteroids and leukotriene inhibitors b. systemic immunomodulators, including, but not limited to, cyclosporine,methotrexate, mycophenolate mofetil, and azathioprine c. sedating antihistamines, including, but not limited to, alimemazine, chlorphenamine, clemastine, cyproheptadine, diphenhydramine, hydroxyzine, ketotifen, and promethazine Note: Patients may use newer, less sedating antihistamines (e.g.,fexofenadine, loratadine, cetirizine). d. any other systemic therapy used to treat AD or symptoms of AD(approved or off-label use) e. phototherapy, includes therapeutic phototherapy (psoralen plus ultraviolet-A, ultraviolet-B), excimer laser as well as self-treatment with tanning beds. [7] agree to discontinue use of the following excluded medications for at least 2 weeks prior to randomization (Visit 2) and throughout the study: a. TCS or topical immune modulators (e.g., tacrolimus or pimecrolimus) b. Topical phosphodiesterase type 4 (PDE-4) inhibitor (crisaborole) c. Topical JAK inhibitor (e.g., tofacitinib or ruxolitinib) and/or any other investigative topical treatments. [8] have applied emollients daily for at least 14 days prior to randomization and agree to use emollient daily throughout the treatment period. [9] Patients who are receiving chronic treatments to improve sleep sh
Exclusion criteria
Exclusion criteria: [1] are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus) that would interfere with evaluations of the effect of study medication on AD. [2] patients who, in the opinion of the investigator, are currently experiencing or have a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections that may interfere with participation in the study. [3] a history of eczema herpeticum within 12 months prior to screening. [4] a history of 2 or more episodes of eczema herpeticum in the past. [5] patients who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics. [6] have any serious concomitant 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). [7] have been treated with the following therapies: a. monoclonal antibody (e.g., ustekinumab, omalizumab, dupilumab) for less than 5 half-lives prior to randomization. b. received prior treatment with any oral JAK inhibitor (e.g., tofacitinib,ruxolitinib) c. received any parenteral corticosteroid administered by intramuscular or intravenous injection within 2 weeks prior to study entry (Visit 1) or within 6 weeks prior to planned randomization (Visit 2) or are anticipated to require parenteral injection of corticosteroids during the study. d. have had an intra-articular corticosteroid injection within 2 weeks prior to study entry (Visit 1) or within 6 weeks prior to planned randomization (Visit 2). [8] are largely or wholly incapacitated permitting little or no self-care, such as being bedridden. [9] have uncontrolled arterial hypertension characterized by a repeated systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg in a seated position. [10] have had any major surgery within 8 weeks prior to screening or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the patient. [11] are immunocompromised and, in the opinion of the investigator, at an unacceptable risk for participating in the study. [12] 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. [13] have a history of recurrent (>= 2) VTE or are considered at high risk of VTE as deemed by the investigator. [14] have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data. [15] have a history of lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test the hypothesis that baricitinib 4-mg QD is superior to placebo in the treatment of patients with moderate to severe AD.Timepoint: Proportion of patients achieving IGA of 0 or 1 with a â?¥2-point improvement at Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the efficacy of baricitinib 1-mg QD, 2-mg QD, or 4-mg QD to placebo in AD during the 16-week double-blind placebo-controlled treatment period as assessed by patient-reported outcome measures.Timepoint: 1.Proportions of patients achieving a 4-point improvement in Itch NRS at 1 week, 2 weeks,4 weeks, and 16 weeks 2.Mean change from baseline in the score of Item 2 of the ADSS at 1 week and 16 weeks 3.Mean change from baseline in Skin Pain NRS at 16 weeks.;To compare the efficacy of baricitinib 1-mg QD, 2-mg QD, or 4-mg QD to placebo in AD during the 16-week double-blind placebo-controlled treatment period as measured by improvement in signs and symptoms of AD.Timepoint: 1. Poportion of patients achieving EASI75 at 16 weeks 2. Proportion of patients achieving EASI90 at 16 weeks 3. Percent change from baseline in EASI score at 16 weeks. 4. Proportion of patients achieving SCORAD75 at 16 weeks.;To test the hypothesis that baricitinib 2-mg QD or baricitinib 1-mg QD is superior to placebo in the treatment of patients with moderate to severe ADTimepoint: Proportion of patients achieving IGA of 0 or 1 with a â?¥2-point improvement at Week 16. | — |
Countries
Canada, Czech Republic, France, Germany, India, Italy, Japan, Mexico, Russian Federation, Taiwan, United States of America
Contacts
Public ContactDr Rajeev Sharan Shrivastava
Eli Lilly and Company (India) Pvt. Ltd.
Outcome results
None listed