A Study of Lebrikizumab in Participants With Persistent Moderate to Severe Atopic Dermatitis

NCT02340234 | Completed Phase 2

• 2 other identifiers: GS292502014-000049-56
• Study Type: interventional
• Target: 212
• Locations: 14 countries
• Sites: 74

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50) at Week 12

  Week 12

Secondary Outcomes (39)

• Percent Change From Baseline in EASI Score at Week 12

  Baseline, Week 12

• Absolute Change From Baseline in EASI Score at Week 12

  Baseline, Week 12

• Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 12

  Week 12

• Percentage of Participants Achieving an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 12

  Week 12

• Percentage of Participants With a Greater Than or Equal to (>/=) 2 Point Reduction From Baseline in IGA at Week 12

  Week 12

Study Arms (4)

Lebrikizumab 250 mg Single Dose + TCS Cream

EXPERIMENTAL

Participants will receive lebrikizumab 250 milligrams (mg) SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

Drug: Lebrikizumab; Drug: Placebo; Drug: TCS Cream

Lebrikizumab 125 mg Single Dose + TCS Cream

EXPERIMENTAL

Participants will receive lebrikizumab 125 mg SC single dose on Day 1 followed by placebo on Week 4 and Week 8. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

Drug: Lebrikizumab; Drug: Placebo; Drug: TCS Cream

Lebrikizumab 125 mg Q4W + TCS Cream

EXPERIMENTAL

Participants will receive lebrikizumab 125 mg SC every 4 weeks (Q4W) for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

Drug: Lebrikizumab; Drug: TCS Cream

Placebo Q4W + TCS Cream

PLACEBO COMPARATOR

Participants will receive placebo Q4W for a total of 3 doses. Participants will continue to apply TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily to active skin lesions throughout the 12-week treatment period.

Drug: Placebo; Drug: TCS Cream

Interventions

Lebrikizumab DRUG

Lebrikizumab will be administered SC as per the schedule specified in the respective arms.

Lebrikizumab 125 mg Q4W + TCS Cream; Lebrikizumab 125 mg Single Dose + TCS Cream; Lebrikizumab 250 mg Single Dose + TCS Cream

Placebo DRUG

Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.

Lebrikizumab 125 mg Single Dose + TCS Cream; Lebrikizumab 250 mg Single Dose + TCS Cream; Placebo Q4W + TCS Cream

TCS Cream DRUG

TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily

Lebrikizumab 125 mg Q4W + TCS Cream; Lebrikizumab 125 mg Single Dose + TCS Cream; Lebrikizumab 250 mg Single Dose + TCS Cream; Placebo Q4W + TCS Cream

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AD diagnosed by the Hanifin/Rajka criteria and that has been present for at least 1 year at screening
• Moderate to severe AD as graded by the Rajka/Langeland criteria at screening
• History of inadequate response to a \>/= 1 month (within the 3 months prior to the screening visit) treatment regimen of at least daily TCS and regular emollient for treatment of AD
• EASI score \>/= 14 at screening and end of the run-in period
• IGA score \>/= 3 (5-point scale) at screening and end of the run-in period
• AD involvement of \>/= 10% BSA at screening
• Pruritus VAS score \>/= 3 at screening

You may not qualify if:

• Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab
• Use of an investigational agent within 4 weeks prior to screening or within 5 half-lives of the investigational agent, whichever is longer
• History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
• Use of any complementary, alternative, or homeopathic medicines including, but not limited to, phytotherapies, traditional or non-traditional herbal medications, essential fatty acids, or acupuncture within 7 days prior to the run-in period or need for such medications during the study
• Evidence of other skin conditions; including, but not limited to, T-cell lymphoma or allergic contact dermatitis
• Evidence of, or ongoing treatment (including topical antibiotics) for active skin infection at screening
• Other recent infections meeting protocol criteria
• Active tuberculosis requiring treatment within the 12 months prior to Visit 1
• Evidence of acute or chronic hepatitis or known liver cirrhosis
• Known immunodeficiency, including human immunodeficiency virus (HIV) infection
• Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the participant is willing to stop TCI use during the study (including the run-in period) and, in the investigator's opinion, it is safe to do so
• Clinically significant abnormality on screening electrocardiogram (ECG) or laboratory tests that, in the opinion of the investigator, may pose an additional risk in administering study drug or TCS to the participant
• Known current malignancy or current evaluation for a potential malignancy, including basal or squamous cell carcinoma of the skin or carcinoma in situ
• History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (74)

Dermatology Research Associate

Los Angeles, California, 90045, United States

Location

UCSD Division of Dermatology

San Diego, California, 92122, United States

Location

Univ of Calif-San Francisco

San Francisco, California, 94115, United States

Location

University of Colorado; Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Olympian Clinical Research

Tampa, Florida, 33609, United States

Location

Northwestern University Feinberg School Of Medicine

Chicago, Illinois, 60611, United States

Location

University of Iowa Healthcare; Dermatology

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Washington University; Dermatology

St Louis, Missouri, 63110, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Oregon Health & Science University; Department of Dermatology

Portland, Oregon, 97239-4501, United States

Location

University of Texas Medical School-Houston

Houston, Texas, 77030, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Virginia Clinical Research Inc.

Norfolk, Virginia, 23502, United States

Location

St George Dermatology and Skin Cancer Centre

Kogarah, New South Wales, 2217, Australia

Location

Skin & Cancer Foundation

Carlton, Victoria, 3053, Australia

Location

Royal Melbourne Hospital; Dermatology Department

Parkville, Victoria, 3050, Australia

Location

Fremantle Dermatology

Fremantle, Western Australia, 6160, Australia

Location

Institute for Skin Advancement

Calgary, Alberta, T3A 2N1, Canada

Location

Guildford Dermatology Specialists

Surrey, British Columbia, V3R 6A7, Canada

Location

Dr. Melinda Gooderham Medicine Professional Corporation

Peterborough, Ontario, K9J 5K2, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

XLR8 Medical Research Inc.

Windsor, Ontario, N8W 1E6, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, L2K 4L5, Canada

Location

Faculty Hospital; Department of Dermatology

Pilsen, 305 99, Czechia

Location

Charles University School of Medicine; Deptartment of Dermatology

Prague, 100 34, Czechia

Location

Masarykova nemocnice o.z; kozni oddeleni

Ústí nad Labem, 401 13, Czechia

Location

Helsinki University Central Hospital; Skin & Allergy Hospital

Helsinki, 00029, Finland

Location

Tampere University Hospital; Dermatology and allergology

Tampere, 33520, Finland

Location

Turku Central University Hospital; Dermatology and allergology

Turku, 20250, Finland

Location

Hopital Saint Andre CHU De Bordeaux; Dermatologie

Bordeaux, 33075, France

Location

Hopital du Bocage; Dermatologie

Dijon, 21079, France

Location

Hopital Hotel Dieu Et Hme; Clinique Dermatologique

Nantes, 44093, France

Location

Hopital l Archet 2; Ginestriere, Service de; Dermatologie

Nice, 06200, France

Location

Centre Hospitalier Lyon Sud; Dermatologie

Pierre-Bénite, 69495, France

Location

Charite Mitte; Klinik fur Dermatologie

Berlin, 10117, Germany

Location

Universitätsklinik Bonn

Bonn, 53127, Germany

Location

Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

Frankfurt, 60590, Germany

Location

SRH Wald-Klinikum Gera GmbH; Hautkrankheiten und Allergologie

Gera, 07548, Germany

Location

UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie

Kiel, 24105, Germany

Location

Universitätsklinikum Mainz

Mainz, 55131, Germany

Location

Academisch Medisch Centrum Universiteit Amsterdam; Dermatology and VU University Medical Center

Amsterdam, 1100 DD, Netherlands

Location

University Medical Center Groningen; Department of Dermatology

Groningen, 9700RB, Netherlands

Location

UMC Utrecht; Dermatology

Utrecht, 3584 CX, Netherlands

Location

Uniwersyteckie Centeum Kliniczne GUMed; Klinika Dermatologii, Wenerologii i Alergologii

Gdansk, 80-402, Poland

Location

DERMED Centrum Medyczne; Sp zoo

Lodz, 90-265, Poland

Location

Laser Clinic

Szczecin, 70-322, Poland

Location

ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o

Tarnów, 33-100, Poland

Location

dermMedica sp.z o.o.

Wroclaw, 51-318, Poland

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

ChungAng University Hospital

Seoul, 06973, South Korea

Location

Clinica Universitaria de Navarra; Servicio de Dermatologia

Pamplona, Navarre, 31008, Spain

Location

Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia

Barcelona, 08025, Spain

Location

Hospital Universitario La Princesa, Servicio dermatologia

Madrid, 28006, Spain

Location

HUGregorio Marañón, Servicio de dermatología

Madrid, 28007, Spain

Location

Hospital Ramon y Cajal; servicio dermatologia

Madrid, 28034, Spain

Location

Hospital Universitario La Paz; Servicio de dermatologia

Madrid, 28046, Spain

Location

Hospital General Universitario de Valencia; servicio de dermatología

Valencia, 46014, Spain

Location

Inselspital Bern; Dermatologie

Bern, 3000, Switzerland

Location

CHUV; Dermatologie

Lausanne, 1011, Switzerland

Location

Universitätsspital Zürich; Dermatologische Klinik

Zurich, 8091, Switzerland

Location

Chang Gung Medical Foundation;Kaohsiung Branch; Department of Dermatology

Kaohsiung City, 83301, Taiwan

Location

National Cheng-Kung University Hospital; Department of Dermatology

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital; Department of Dermatology

Taipei, 10048, Taiwan

Location

Russells Hall Hospital

Dudley, DY1 2HQ, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust, Guys Hospital; Skin Therapy Research Unit

London, SE1 9RT, United Kingdom

Location

Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Poole Hospital

Poole, BH15 2JB, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 2, 2017

Record last verified: 2017-09

Locations

CZ (3); TW (3); NL (3); GB (6); AU (4); DE (6); ES (7); PL (5); CH (3); KR (3); US (16); CA (7); FI (3); FR (5)