Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis

Completed · Phase 3

Conditions studied: Atopic Dermatitis

In brief

This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to \<18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.

Key facts

Study ID

NCT04250350

Run by

Eli Lilly and Company

People needed

206

Starts

2020-02-11

Expected to finish

2022-06-22

Last updated by the study team

2023-02-24

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female adolescent (≥12 years to <18 years, and weighing ≥40 kg).
• Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
• Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
• Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
• ≥10% body surface area (BSA) of AD involvement at the baseline visit.
• History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.

You may not qualify if…

• Participation in a prior lebrikizumab clinical study.
• Treatment with the following prior to the baseline visit:
• An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
• Dupilumab within 8 weeks.
• B-cell-depleting biologics, including to rituximab, within 6 months.
• Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
• Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
• Uncontrolled chronic disease that might require bursts of oral corticosteroids.
• Evidence of active acute or chronic hepatitis
• History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
• History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Where it is running

• Arkansas Research Trials, LLC — North Little Rock, Arkansas, United States
• Hope Clinical Research — Canoga Park, California, United States
• First OC Dermatology — Fountain Valley, California, United States
• MD Studies — Fountain Valley, California, United States
• Integrative Skin Science and Research — Sacramento, California, United States
• University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology — San Diego, California, United States
• Southern California Dermatology, Inc. — Santa Ana, California, United States
• IMMUNOe International Research Centers — Centennial, Colorado, United States
• C&R Research Services USA — Coral Gables, Florida, United States
• Florida Academic Centers Research and Education, LLC — Coral Gables, Florida, United States
• Pediatric Skin Research, LLC — Coral Gables, Florida, United States
• Encore Medical Research — Hollywood, Florida, United States
• Solutions Through Advanced Research, Inc. — Jacksonville, Florida, United States
• Well Pharma Medical Research Corp. — Miami, Florida, United States
• Sanchez Clinical Research Inc — Miami, Florida, United States
• Miami Dermatology and Laser Research — Miami, Florida, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• Georgia Pollens Clinical Research Centers, Inc — Albany, Georgia, United States
• Advanced Medical Research — Sandy Springs, Georgia, United States
• Georgia Skin & Cancer Clinic — Savannah, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Sneeze, Wheeze, & Itch Associates LLC — Normal, Illinois, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Pinnacle Research Group — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.