Atopic Dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have completed the final active treatment visit for an originator study (such as JAHL or JAHM) - Are male or nonpregnant, nonbreastfeeding female patients. - Male patients, and female patients of childbearing potential, must agree to use a reliable method of birth control during the study and for at least 4 weeks following the last dose of investigational product. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1425 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: - Have significant uncontrolled cerebro-cardiovascular, 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. - 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) - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this long term extention trial is to estimate the effect of long term therapy with baricitinib on responders and partial responders at entry of JAHN. ;Secondary Objective: To evaluate the effect of increasing or maintaining baricitinib dose on clinical measures and patient reported outcomes. To evaluate the effect of starting baricitinib on clinical measures and patient reported outcomes. To evaluate the effect of maintaining baricitinib dose on clinical measures.;Primary end point(s): Proportion of patients with a response of IGA 0 or 1 ;Timepoint(s) of evaluation of this end point: 16, 36 and 52 weeks after re-randomization of feeder trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients with a response of IGA 0, 1, or 2 2. Proportion of patients achieving response of EASI75 from baseline of originating study 3. Proportion of patients with a 4-point improvement in Itch NRS from baseline of originating study 4. Proportion of patients with a response of IGA 0 or 1 ;Timepoint(s) of evaluation of this end point: 1 and 2: assessed at Weeks 16, 36, and 52 3: assessed at week 16 4: assessed at Weeks 16, 36, and 52 (nonresponders) | — |
Countries
Argentina, Australia, Austria, Czechia, Czech Republic, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, Slovenia, Spain, Switzerland, Taiwan
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed