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Janus Kinase (JAK) Inhibitor

A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis (BREEZE-AD5 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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) (2 mg Baricitinib)
Secondary study objectives
Change From Baseline in Body Surface Area (BSA) Affected
Change From Baseline in SCORAD
Change From Baseline in Skin Pain NRS
+19 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2 milligram (mg) BaricitinibExperimental Treatment2 Interventions
2 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
Group II: 1 mg BaricitinibExperimental Treatment2 Interventions
1 mg Baricitinib administered orally every day. Placebo administered orally to maintain the blind.
Group III: PlaceboPlacebo Group1 Intervention
Placebo administered orally every day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
FDA approved
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,679 Previous Clinical Trials
3,465,554 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
393 Previous Clinical Trials
63,517 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,389 Previous Clinical Trials
427,779 Total Patients Enrolled
~57 spots leftby Dec 2025
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