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

NCT04250337 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: 178032019-004300-34J2T-DM-KGADDRM06-AD06
• Study Type: interventional
• Target: 228
• Locations: 4 countries
• Sites: 63

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

Keywords

Eczema; Dermatitis; Dermatitis, Atopic; Skin Diseases

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline to Week 16.

  The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

  Baseline to Week 16

• Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction From Baseline in EASI Score) at Week 16

  The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.

  Baseline to Week 16

Secondary Outcomes (29)

• Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) at Week 16

  Baseline to Week 16

• Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

  Baseline, Week 16

• Percentage of Participants With a Pruritus NRS of ≥4-Points at Baseline Who Achieve a ≥4-Point Reduction From Baseline to Week 16

  Baseline to Week 16

• Percentage of Participants With a Pruritus NRS of ≥5-points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 16

  Baseline to Week 16

• Percent Change in EASI Score From Baseline at Week 16

  Baseline, Week 16

Study Arms (2)

Lebrikizumab + Topical Corticosteroid

EXPERIMENTAL

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.

Biological: Lebrikizumab; Other: Topical Corticosteroid

Placebo + Topical Corticosteroid

PLACEBO COMPARATOR

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

Other: Placebo; Other: Topical Corticosteroid

Interventions

Lebrikizumab BIOLOGICAL

Subcutaneous injection

Also known as: LY3650150, DRM06

Lebrikizumab + Topical Corticosteroid

Placebo OTHER

Subcutaneous injection

Placebo + Topical Corticosteroid

Topical Corticosteroid OTHER

Topical Corticosteroid

Lebrikizumab + Topical Corticosteroid; Placebo + Topical Corticosteroid

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult and adolescents (≥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.

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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Dermira, Inc.: collaborator

Study Sites (63)

Investigate MD

Scottsdale, Arizona, 85255, United States

Location

Orange County Research Institute

Anaheim, California, 92801, United States

Location

Bakersfield Dermatology and Skin Cancer Medical Group

Bakersfield, California, 93309, United States

Location

Wallace Medical Group, Inc.

Beverly Hills, California, 90211, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Center For Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

California Allergy and Asthma Medical Group + Research Center

Los Angeles, California, 90025, United States

Location

Keck School of Medicine University of Southern California

Los Angeles, California, 90033, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

LA Universal Research Center, INC

Los Angeles, California, 90057, United States

Location

ACRC Studies

San Diego, California, 92119, United States

Location

University Clinical Trials, Inc.

San Diego, California, 92123, United States

Location

Southern California Dermatology, Inc.

Santa Ana, California, 92701, United States

Location

Foxhall Dermatology

Washington D.C., District of Columbia, 20016, United States

Location

St. Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

University of Florida - Gainesville

Gainesville, Florida, 32606, United States

Location

Direct Helpers Medical Center

Hialeah, Florida, 33012, United States

Location

The Community Research of South Florida

Hialeah, Florida, 33016, United States

Location

GSI Clinical Research, LLC

Margate, Florida, 33063, United States

Location

Vitae Research Center, LLC

Miami, Florida, 33135, United States

Location

Well Pharma Medical Research Corp.

Miami, Florida, 33143, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613-1244, United States

Location

Advanced Medical Research

Sandy Springs, Georgia, 30328, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Dermatology and Skin Cancer Specialists

Rockville, Maryland, 20850, United States

Location

ActivMed Practices and Research

Beverly, Massachusetts, 01915, United States

Location

Beacon Clinical Research LLC

Quincy, Massachusetts, 02169, United States

Location

Fivenson Dermatology

Ann Arbor, Michigan, 48103, United States

Location

Clarkston Skin Research

Clarkston, Michigan, 48346, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

ALLCUTIS Research

Portsmouth, New Hampshire, 03801, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

OnSite Clinical Solutions

Charlotte, North Carolina, 28277, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States

Location

Clinical Research Institute

Medford, Oregon, 97504, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

OHSU Center for Health and Healing

Portland, Oregon, 97239, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

Arlington Research Center, Inc

Arlington, Texas, 76011, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

CARe Clinic

Red Deer, Alberta, T4N 6V7, Canada

Location

Dr. Chih-ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

Location

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

International Dermatology Research

Montreal, Quebec, H3H1V4, Canada

Location

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Elbe Klinikum Buxtehude

Buxtehude, Lower Saxony, 21614, Germany

Location

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

Dresden, Saxony, 01307, Germany

Location

Praxis für Ganzheitliche Dermatologie im Ärztehaus

Berlin, 13055, Germany

Location

TFS Trial Form Support GmbH

Hamburg, 20537, Germany

Location

DermMEDICA Sp. z o.o.

Wroclaw, Lower Silesian Voivodeship, 51-318, Poland

Location

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

Tarnów, Malopolska, 33100, Poland

Location

Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

COPERNICUS Podmiot Leczniczy sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80-219, Poland

Location

Labderm s.c.

Ossy, Silesian Voivodeship, 42-624, Poland

Location

Clinica Vitae Sp. z o.o.

Gdansk, Woj. Pomorskie, 80-405, Poland

Location

Clinical Research Group Sp. z o.o.

Warsaw, 01-142, Poland

Location

Centralny Szpital Kliniczny MSWiA

Warsaw, 02-507, Poland

Location

Gabinet Dermatlogiczny. Beata Krecisz

Kielce, Świętokrzyskie Voivodeship, 25-155, Poland

Location

Related Publications (1)

• 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.

  PMID: 36630140 DERIVED

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Dermatitis; Skin Diseases

Interventions

lebrikizumab; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

One investigational site with seventeen participants was excluded from analysis due to GCP issues. Because of an error in the electronic data collection tool, the actual maximum score for each of the SCORAD symptoms was 9 instead of 10, resulting in a total maximum SCORAD score of 101 instead of 103. During the study, discussions with the SCORAD copyright owner resulted in a decision not to adjust the scale used or notify investigators as the altered scale was not expected to bias the results.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, parallel group, placebo controlled

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: January 31, 2020
• Study Start: February 3, 2020
• Primary Completion: August 11, 2021
• Study Completion: September 16, 2021
• Last Updated: May 9, 2022
• Results First Posted: May 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

DE (5); US (43); CA (6); PL (9)