Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

NCT ID: NCT04250337

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2021-09-16

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lebrikizumab + Topical Corticosteroid

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 Type: EXPERIMENTAL

Lebrikizumab

Intervention Type: BIOLOGICAL

Subcutaneous injection

Topical Corticosteroid

Intervention Type: OTHER

Topical Corticosteroid

Placebo + Topical Corticosteroid

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Subcutaneous injection

Topical Corticosteroid

Intervention Type: OTHER

Topical Corticosteroid

Interventions

Lebrikizumab

Subcutaneous injection

Intervention Type: BIOLOGICAL

Placebo

Subcutaneous injection

Intervention Type: OTHER

Topical Corticosteroid

Topical Corticosteroid

Intervention Type: OTHER

Other Intervention Names

LY3650150; DRM06

Eligibility Criteria

Inclusion Criteria

1. Male or female adult and adolescents (≥12 years to <18 years, and weighing ≥40 kg).

2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.

3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.

4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit

5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.

6. History of inadequate response to treatment with topical medications.

Exclusion Criteria

1. Participation in a prior lebrikizumab clinical study.

2. Treatment with the following prior to the baseline visit:

1. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.

2. Dupilumab within 8 weeks.

3. B-cell-depleting biologics, including to rituximab, within 6 months.

4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.

3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.

4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.

5. Evidence of active acute or chronic hepatitis

6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.

7. 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.

8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dermira, Inc.

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Investigate MD

Scottsdale, Arizona, United States

Orange County Research Institute

Anaheim, California, United States

Bakersfield Dermatology and Skin Cancer Medical Group

Bakersfield, California, United States

Wallace Medical Group, Inc.

Beverly Hills, California, United States

First OC Dermatology

Fountain Valley, California, United States

Center For Dermatology Clinical Research, Inc.

Fremont, California, United States

California Allergy and Asthma Medical Group + Research Center

Los Angeles, California, United States

Keck School of Medicine University of Southern California

Los Angeles, California, United States

Dermatology Research Associates

Los Angeles, California, United States

LA Universal Research Center, INC

Los Angeles, California, United States

ACRC Studies

San Diego, California, United States

University Clinical Trials, Inc.

San Diego, California, United States

Southern California Dermatology, Inc.

Santa Ana, California, United States

Foxhall Dermatology

Washington D.C., District of Columbia, United States

St. Francis Medical Institute

Clearwater, Florida, United States

University of Florida - Gainesville

Gainesville, Florida, United States

Direct Helpers Medical Center

Hialeah, Florida, United States

The Community Research of South Florida

Hialeah, Florida, United States

GSI Clinical Research, LLC

Margate, Florida, United States

Vitae Research Center, LLC

Miami, Florida, United States

Well Pharma Medical Research Corp.

Miami, Florida, United States

ForCare Clinical Research

Tampa, Florida, United States

Advanced Medical Research

Sandy Springs, Georgia, United States

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Dermatology and Skin Cancer Specialists

Rockville, Maryland, United States

ActivMed Practices and Research

Beverly, Massachusetts, United States

Beacon Clinical Research LLC

Quincy, Massachusetts, United States

Fivenson Dermatology

Ann Arbor, Michigan, United States

Clarkston Skin Research

Clarkston, Michigan, United States

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

ALLCUTIS Research

Portsmouth, New Hampshire, United States

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Sadick Research Group

New York, New York, United States

OnSite Clinical Solutions

Charlotte, North Carolina, United States

Wilmington Dermatology Center

Wilmington, North Carolina, United States

Clinical Research Institute

Medford, Oregon, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Oregon Medical Research Center

Portland, Oregon, United States

OHSU Center for Health and Healing

Portland, Oregon, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

Clinical Research Center of the Carolinas

Charleston, South Carolina, United States

Arlington Research Center, Inc

Arlington, Texas, United States

Dermatology Treatment and Research Center

Dallas, Texas, United States

CARe Clinic

Red Deer, Alberta, Canada

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, Canada

Enverus Medical Research

Surrey, British Columbia, Canada

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

SKiN Centre for Dermatology

Peterborough, Ontario, Canada

International Dermatology Research

Montreal, Quebec, Canada

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, Germany

Elbe Klinikum Buxtehude

Buxtehude, Lower Saxony, Germany

Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer

Dresden, Saxony, Germany

Praxis für Ganzheitliche Dermatologie im Ärztehaus

Berlin, , Germany

TFS Trial Form Support GmbH

Hamburg, , Germany

DermMEDICA Sp. z o.o.

Wroclaw, Lower Silesian Voivodeship, Poland

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

Tarnów, Malopolska, Poland

Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii

Rzeszów, Podkarpackie Voivodeship, Poland

COPERNICUS Podmiot Leczniczy sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland

Labderm s.c.

Ossy, Silesian Voivodeship, Poland

Clinica Vitae Sp. z o.o.

Gdansk, Woj. Pomorskie, Poland

Clinical Research Group Sp. z o.o.

Warsaw, , Poland

Centralny Szpital Kliniczny MSWiA

Warsaw, , Poland

Gabinet Dermatlogiczny. Beata Krecisz

Kielce, Świętokrzyskie Voivodeship, Poland

Countries

United States; Canada; Germany; Poland

References

Simpson EL, Gooderham M, Wollenberg A, Weidinger S, Armstrong A, Soung J, Ferrucci S, Lima RG, Witte MM, Xu W, ElMaraghy H, Natalie CR, Pierce E, Blauvelt A; ADhere Investigators. Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere). JAMA Dermatol. 2023 Feb 1;159(2):182-191. doi: 10.1001/jamadermatol.2022.5534.

Reference Type: DERIVED

PMID: 36630140 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lillytrialguide.com/en-US/trial/4gJ6pg3ypXbcm8LEXb9M3b

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis. (ADhere)

Other Identifiers

2019-004300-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

J2T-DM-KGAD

Identifier Type: OTHER

Identifier Source: secondary_id

DRM06-AD06

Identifier Type: OTHER

Identifier Source: secondary_id

17803

Identifier Type: -

Identifier Source: org_study_id