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

• Register: EUCTR
• Last refreshed on: 12 March 2024
• Main ID: EUCTR2017-000873-35-AT
• Date of registration: 05/10/2017
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: This is a long term extention study in patients with Atopic Dermatitis, also named eczema, that helps to understand how Baricitinib works
• Scientific title: Protocol I4V-MC-JAHN: A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients with Atopic Dermatitis - BREEZE AD-3: BaRicitinib in moderate to sEvere EcZEma in Atopic Dermatitis-3
• Date of first enrolment: 11/12/2017
• Target sample size: 1500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000873-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Czech Republic, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, Slovenia, Spain, Switzerland, Taiwan

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion 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:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Atopic Dermatitis
MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858

Intervention(s)

Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BARICITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BARICITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Olumiant
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BARICITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 16, 36 and 52 weeks after re-randomization of feeder trial

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.

Primary end point(s): Proportion of patients with a response of IGA 0 or 1

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.

Secondary Outcome(s)

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)

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

Secondary ID(s)

I4V-MC-JAHN

2017-000873-35-DE

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 11/12/2017
Contact:

Results

• Results available: Yes
• Date Posted: 02/06/2022
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-000873-35/results