Health Condition 1: null- Adult Patients with Atopic Dermatitis Health Condition 2: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Baricitinib 1-mg, 2-mg, and 4-mg: Study I4V-MC-JAHN (JAHN) is a Phase 3, multicenter, double-blind study to evaluate the
long-term safety and efficacy of daily baricitinib 1-mg, 2-mg, a
the final visit of Study JAHL will be the first visit of Study JAHN.
Control Intervention1: NA: NA
Sponsors
Eli Lilly and Company India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: [1] Have completed the final active treatment visit for an originating study (i.e., Visit 8, Week 16 of JAHL or JAHM) eligible to enroll patients directly into Study JAHN. [2] Are able to read, understand, and give documented (electronic or paper signature) informed consent. [3] Are male or nonpregnant, nonbreastfeeding female patients, except a. Male patients must agree to use 2 forms of birth control (one must be highly effective, see below) while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 4 weeks following the last dose of IP. b. Female patients of childbearing potential must agree to use 2 forms of birth control when engaging in sexual intercourse with a male partner while enrolled in the study and for at least 4 weeks following the last dose of IP. The following birth control methods are considered acceptable (the patient should choose 2 methods to be used with her male partner, and 1 must be highly effective): o Highly effective birth control methods: oral, injectable, or implanted hormonal contraceptives (combined estrogen/progesterone or progesterone only, associated with inhibition of ovulation); intrauterine device or intrauterine system (e.g., progestin-releasing coil); or vasectomized male (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate) o Effective birth control methods: condom with a spermicidal foam, gel, film, cream, or suppository; occlusive cap (diaphragm or cervical/vault caps) with a spermicidal foam, gel, film, cream, or suppository; or oral hormonal contraceptives c. Females of nonchildbearing potential are not required to use birth control and they are defined as: o women =60 years of age or women who are congenitally sterile, or o women =40 and menses for =12 months and a follicle-stimulating hormone test from baseline in originating study, confirming nonchildbearing potential (=40 mIU/mL or =40 IU/L), or o women who are surgically sterile (i.e., have had a hysterectomy or bilateral oophorectomy or tubal ligation).
Exclusion criteria
Exclusion criteria: [1] Are currently enrolled in any other clinical trial involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study. [2] Have significant uncontrolled cerebro-cardiovascular (e.g., myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the patient if IP continues to be administered. [3] Have a known hypersensitivity to baricitinib or any component of this IP. [4] Had IP permanently discontinued at any time during a previous baricitinib study, except for patients who had IP discontinued during originating study due to rescue with an oral systemic AD therapy (e.g., corticosteroid, cyclosporine, methotrexate) [5] Had temporary IP interruption continue at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the patient’s participation in the study. [6] Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol. [7] Are unwilling or unable to comply with the use of a data collection device to directly record data from the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the effect of long-term therapy with baricitinib on responders and partial responders at entry of JAHNTimepoint: Proportion of patients with a response of IGA 0 or 1 assessed at Weeks 16, 36, and 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Baricitinib Patients at Entry to Study JAHN To evaluate the effect of increasing or maintaining baricitinib dose on clinical measures and patient-reported outcomes.Timepoint: 1.Proportion of patients with a response of IGA 0, 1, or 2 assessed at Weeks 16, 36, and 52 2.Proportion of patients with a response of IGA 0 or 1 assessed at Weeks 16, 36, and 52 (nonresponders) 3.Proportion of patients achieving response of EASI75 from baseline of originating study assessed at Weeks 16, 36, 52 4.Proportion of patients with a 4-point improvement from baseline of originating study in Itch NRS at 16 weeks;Placebo Nonresponders at Entry to Study JAHN To evaluate the effect of starting baricitinib 2-mg versus 4-mg on clinical measures and patient-reported outcomes.Timepoint: 1.Proportion of patients with a response of IGA 0, 1,or 2 assessed at Weeks 4, 16, 24, 52 2.Proportion of patients with a response of IGA 0 or 1 assessed at Weeks 4, 16, 24, 52 3. Proportion of patients achieving response of EASI75 from baseline of originating study assessed 4.Proportion of patients with a 4-point improvement from baseline of originating study in Itch NRS at 16 weeks | — |
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