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A Study of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

Study acronym: ADhope 2
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Primary and study completion dates: Apr 2027 to Apr 25, 2027 · Site details revised at 4 of 4 sitesv3 Show 2 more changesShow less
    • Primary and study completion dates: Apr 2027 to Apr 25, 2027
    • Site details revised at 4 of 4 sites
  2. Primary and study completion dates: Apr 2026 to Apr 2027 Primary endpoints: 1 to 3 · Interventions: Lebrikizumab (Biological) to Lebrikizumab (Biological), Placebo (Other) · Eligibility criteria shortened, about 80 words · 4 morev2 Show 7 more changesShow less
    • Primary endpoints: 1 to 3
    • Interventions: Lebrikizumab (Biological) to Lebrikizumab (Biological), Placebo (Other)
    • Eligibility criteria shortened, about 80 words
    • Secondary endpoints: 14 to 25
    • Study description expanded, about 84 words
    • Study arms: 1 to 5
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The main purpose of this study is to evaluate the effectiveness of 24 weeks of lebrikizumab in improving disease severity, signs, and symptoms in adults and adolescents with moderate-to-severe AD in Part 1 and to describe how similar is the current maintenance dosing regimen of lebrikizumab 250 mg every 4 weeks (Q4W) to the new proposed; lebrikizumab 500 mg every 12 weeks (Q12W), in terms of efficacy, safety, PK, ADA and blood biomarkers.
Trial Details
NCT Number NCT06526182
Lead Sponsor Almirall, S.A.
Conditions Dermatitis, Atopic, Eczema
Enrollment 520 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov