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Janus Kinase (JAK) Inhibitor
Baricitinib for Atopic Dermatitis
Phase 2
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 (wk) 0: predose, 15-30 minutes (min) postdose; wk 4: 1.5 - 4 hour (hr) postdose; wk 8: 4 - 8 hr postdose; wk 12: predose; wk 16: 30 - 90 min postdose.
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Summary
The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in eczema.
Eligible Conditions
- Atopic Dermatitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week (wk) 0: predose, 15-30 minutes (min) postdose; wk 4: 1.5 - 4 hour (hr) postdose; wk 8: 4 - 8 hr postdose; wk 12: predose; wk 16: 30 - 90 min postdose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week (wk) 0: predose, 15-30 minutes (min) postdose; wk 4: 1.5 - 4 hour (hr) postdose; wk 8: 4 - 8 hr postdose; wk 12: predose; wk 16: 30 - 90 min postdose.
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 With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)
Secondary study objectives
Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16
Change From Baseline in the EASI at Week 16
Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16
+4 moreAwards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BaricitinibExperimental Treatment2 Interventions
Administered once daily in multiple oral dose cohorts for 16 weeks
(Triamcinolone 0.1% topical also permitted)
Group II: PlaceboPlacebo Group2 Interventions
Administered orally once daily, for 16 weeks
(Triamcinolone 0.1% topical also permitted)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triamcinolone
FDA approved
Baricitinib
FDA approved
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,677 Previous Clinical Trials
3,465,507 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,388 Previous Clinical Trials
428,000 Total Patients Enrolled
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