Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT04392154|
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : September 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Biological: Lebrikizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double-blind, parallel group, placebo controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis|
|Actual Study Start Date :||June 15, 2020|
|Estimated Primary Completion Date :||May 30, 2024|
|Estimated Study Completion Date :||May 30, 2024|
Experimental: Lebrikizumab Q2W
Participants randomized to Lebrikizumab Q2W arm will receive investigational product on a once every 2 week schedule.
Experimental: Lebrikizumab Q4W
Participants randomized to Lebrikizumab Q4W arm will receive investigational product on a once every 4 week schedule.
Intervention assigned: Lebrikizumab balanced with Placebo to maintain the blind between treatment arms.
- Proportion of participants discontinued from study treatment due to adverse events through the last treatment visit. [ Time Frame: Baseline to Week 52 ]
- Proportion of participants with a response of IGA 0 or 1 [ Time Frame: Baseline to Week 52 ]
- Proportion of participants achieving response of EASI-75 from baseline of parent study. [ Time Frame: Baseline to Week 52 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392154
|Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) firstname.lastname@example.org|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|