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Janus Kinase (JAK) Inhibitor

Baricitinib for Atopic Dermatitis (BREEZE-AD6 Trial)

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights

BREEZE-AD6 Trial Summary

This study is evaluating whether a drug called baricitinib may help treat atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

BREEZE-AD6 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Eczema
Secondary outcome measures
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1
Serum albumin, bovine
Percentage of Participants Achieving a ≥4-Point Improvement in Itch Numeric Rating Scale (NRS)

Side effects data

From 2015 Phase 3 trial • 1307 Patients • NCT01710358
10%
Nasopharyngitis
4%
Upper respiratory tract infection
4%
Urinary tract infection
4%
Headache
4%
Pharyngitis
3%
Alanine aminotransferase increased
3%
Back pain
3%
Erectile dysfunction
3%
Nausea
3%
Hypertension
2%
Diarrhoea
2%
Cough
2%
Dyspepsia
2%
Bronchitis
2%
Influenza
2%
Rash
1%
Hypercholesterolaemia
1%
Hyperlipidaemia
1%
Rheumatoid arthritis
1%
Anaemia
1%
Blood creatine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adalimumab Treatment A
Adalimumab Treatment B
Placebo Treatment B
Baricitinib Follow-up
Baricitinib Treatment A
Placebo Follow-up
BaricitinibTreatment B
Adalimumab Follow-up
Placebo Treatment A
Rescue

BREEZE-AD6 Trial Design

4Treatment groups
Experimental Treatment
Group I: Placebo/Baricitinib 2-milligram (mg)Experimental Treatment1 Intervention
Open-label 2 mg baricitinib administered orally once daily (QD) to participants who randomized to placebo in the originating study (JAIW).
Group II: Baricitinib 2-mg/Baricitinib 2-mgExperimental Treatment1 Intervention
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
Group III: Baricitinib 2-mg Open-Label AddendumExperimental Treatment1 Intervention
Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
Group IV: Baricitinib 1-mg/Baricitinib 2-mgExperimental Treatment1 Intervention
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
2017
Completed Phase 3
~9510

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,618 Previous Clinical Trials
3,201,186 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
54,791 Total Patients Enrolled
1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
5 Previous Clinical Trials
289 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis
2018. "A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03559270.
~55 spots leftby Apr 2025
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