Lebrikizumab
DrugLebrikizumab will be administered SC as per the schedule specified in the respective arms.
NCT Number: NCT02340234
This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of lebrikizumab administered subcutaneously (SC) in adult participants with persistent moderate to severe atopic dermatitis (AD) who are inadequately controlled by topical corticosteroids (TCS). The study includes a screening visit, a 2-week run-in period, a 12-week blinded treatment period, and an 8-week safety follow-up period. Following screening visit, eligible participants will enter in run-in period (Days - 14 to - 1) during which a protocol-specified topical therapy regimen will be initiated. At the end of the run-in period, participants who have: 1) demonstrated compliance with the protocol-specified TCS regimen, and 2) who continue to fulfill the eligibility criteria will be randomized.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
St George Dermatology and Skin Cancer Centre, Kogarah, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lebrikizumab will be administered SC as per the schedule specified in the respective arms.
Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.
TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
Time frame: Week 12
Time frame: Baseline, Week 12
Time frame: Baseline, Week 12
Time frame: Week 12
Time frame: Week 12
Time frame: Week 12
Time frame: Baseline, Week 12
Time frame: Week 12
Time frame: Week 12
Time frame: Baseline, Week 12
Time frame: Baseline, Week 12
Time frame: Baseline, Week 12
Time frame: Week 12
Time frame: Weeks 12, 16
Time frame: Weeks 12, 16, 20
Time frame: Weeks 12, 16
Time frame: Weeks 12, 16, 20
Time frame: Weeks 12, 16
Time frame: Weeks 12, 16, 20
Time frame: Weeks 12, 16
Time frame: Weeks 12, 16, 20
Time frame: Baseline, Week 12
Time frame: Baseline, Week 12
Time frame: Baseline, Week 12
Time frame: Baseline, Week 12
Time frame: Baseline, Week 12
Time frame: From Baseline to Week 12
Time frame: From Week 12 to end of study or early termination (up to approximately 20 weeks)
Time frame: From Baseline to Week 12
Time frame: Baseline, Week 12
Time frame: Baseline, Week 12
Time frame: Baseline, Week 12
Time frame: From start of run-in period (Day -14) until study completion (up to approximately 20 Weeks)
Time frame: Pre-dose on Days 1, 29, 85, 141, study discontinuation visit (up to Day 141)
Time frame: Pre-dose on Days 1, 29, 85, 141, study discontinuation visit (up to Day 141)
Time frame: From Week 12 up to approximately 20 weeks
Time frame: After first dose of lebrikizumab at Week 1
Time frame: After first dose of lebrikizumab at Week 1
Time frame: Pre-dose at Weeks 4, 8, 12
Time frame: Pre-dose on Days 1, 8, 29, 43, 57, 85, 113, 141, study discontinuation visit (up to Day 141)
Hoffmann-La Roche
Industry
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lebrikizumab in Patients With Persistent Moderate to Severe Atopic Dermatitis That is Inadequately Controlled by Topical Corticosteroids
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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