This is a long term extention study in patients with Atopic Dermatitis, also named eczema, that helps to understand how Baricitinib works

Phase 1

• Conditions: Atopic Dermatitis; MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-000873-35-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-04
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1645

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>;Secondary Objective: To evaluate the effect of increasing or maintaining baricitinib dose on clinical measures and patient reported outcomes.<br>To evaluate the effect of starting baricitinib on clinical measures and patient reported outcomes.<br>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 <br>;Timepoint(s) of evaluation of this end point: 16, 36 and 52 weeks after re-randomization of feeder trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Proportion of patients with a response of IGA 0, 1, or 2 <br>2. Proportion of patients achieving response of EASI75 from baseline of originating study<br>3. Proportion of patients with a 4-point improvement in Itch NRS from baseline of originating study <br>4. Proportion of patients with a response of IGA 0 or 1<br>;Timepoint(s) of evaluation of this end point: 1 and 2: assessed at Weeks 16, 36, and 52<br>3: assessed at week 16<br>4: assessed at Weeks 16, 36, and 52 (nonresponders)