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Monoclonal Antibodies

Lebrikizumab + Topical Corticosteroid for Atopic Dermatitis (ADhere 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 16
Awards & highlights

Summary

This trial is testing a new drug for atopic dermatitis, to see if it is safe and effective. The trial will last 16 weeks, and compare the new drug to a placebo.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 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 (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16
Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16.
Secondary study objectives
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
+26 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lebrikizumab + Topical CorticosteroidExperimental Treatment2 Interventions
500 mg Lebrikizumab (2 x 250 mg) subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection of 250 mg Lebrikizumab every 2 weeks (Q2W) from Week 4 until Week 14. Topical corticosteroid (TCS) will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
Group II: Placebo + Topical CorticosteroidPlacebo Group2 Interventions
Two placebo subcutaneous (SC) injections as a loading dose at Baseline and Week 2 followed by a single injection of placebo every Q2W from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lebrikizumab
2014
Completed Phase 3
~6770

Find a Location

Who is running the clinical trial?

Dermira, Inc.Industry Sponsor
16 Previous Clinical Trials
5,843 Total Patients Enrolled
Eli Lilly and CompanyLead Sponsor
2,652 Previous Clinical Trials
3,224,258 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,375 Previous Clinical Trials
422,680 Total Patients Enrolled
~40 spots leftby Oct 2025