A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis

An Open-Label Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Persistent, Moderate to Severe Atopic Dermatitis

The primary objective for this study is to evaluate the safety of lebrikizumab compared with Topical Corticosteroids (TCS) alone in patients with persistent moderate to severe Atopic Dermatitis (AD) that is inadequately controlled with TCS.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Lebrikizumab; Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Dr. Lorne E. Albrecht Inc.
    • Vancouver, British Columbia, Canada, V5Z 4E8
      • Skin Care Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Inc.
  • Ontario
    • London, Ontario, Canada, N6A 3H7
      • Guenther Research Inc.
    • Oakville, Ontario, Canada, L6J 7W5
      • The Centre for Clinical Trials Inc.
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • York Dermatology Center
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research Inc.
• United States
  • California
    • Encino, California, United States, 91436
      • T. Joseph Raoof Md, Inc.
    • Granada Hills, California, United States, 91344
      • Allergy and Asthma Relief Experts
    • Mission Viejo, California, United States, 92691
      • Allergy And Asthma Associates Of Southern California - CRN
  • Florida
    • Tampa, Florida, United States, 33624
      • Forward Clinical Trials
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Dermatology Specialists Research, LLC
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Respiratory Medicine Research; Institue of Michigan P.L.C.
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10075
      • Sadick Research Group
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • Rhode Island
    • Warwick, Rhode Island, United States, 02865
      • Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
  • Texas
    • Cypress, Texas, United States, 77433
      • Center for Clinical Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 to 75 years, inclusive, at the start of the run-in period
• 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
• IGA score >/= 3
• AD involvement of >/= 10% body surface area
• Pruritus Visual Analog Scale score >/= 3

Exclusion Criteria:

• Past and/or current use of any anti-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
• Evidence of other skin conditions, including, but not limited to, T-cell lymphoma or allergic contact dermatitis
• 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 HIV infection
• Use of a topical calcineurin inhibitor (TCI) at the time of screening, unless the patient 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 ECG or laboratory tests
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Lebrikizumab Dose Level 1 Monotherapy; During the 2-week run-in period, participants will receive topical corticosteroid creams to be self-applied two times per day to active skin lesions only. During the 12-week treatment period, lebrikizumab monotherapy will be administered by subcutaneous (SC) injection, but participants assigned to this group will not receive topical corticosteroids. During the 8-week safety follow-up period, all participants will receive topical corticosteroids to be self-applied to active skin lesions as decided by the participant and study investigator.	Drug: Lebrikizumab; Lebrikizumab Dose Level 1 subcutaneous monotherapy was administered SC once every 4 weeks for a total of 3 doses.; Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%); Triamcinolone acetonide 0.1% cream will be supplied as single 454-g jars to be used on the body. Hydrocortisone 2.5% cream will be supplied as single 28-g tubes to be used on the face and intertriginous areas as indicated.
Active Comparator: Group 2: Topical Corticosteroid Creams Only; During the 2-week run-in period and during the 12-week treatment period, participants assigned to this group will receive topical corticosteroid creams to be self-applied two times per day to active skin lesions only. During the 8-week safety follow-up period, all participants will receive topical corticosteroids to be self-applied to active skin lesions as decided by the participant and study investigator.	Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%); Triamcinolone acetonide 0.1% cream will be supplied as single 454-g jars to be used on the body. Hydrocortisone 2.5% cream will be supplied as single 28-g tubes to be used on the face and intertriginous areas as indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-emergent adverse events (TEAEs)	From baseline to week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity: Percentage of participants with anti-Lebrikizumab antibodies	From baseline to week 20
Number of participants with disease rebound following discontinuation of study drug	within 20 weeks
Serum lebrikizumab concentration at Week 12	Week 12
Elimination half-life	Week 4
Number of participants with skin and other organ system infections	From baseline to week 12
Number of participants with injection site reactions	From baseline to week 12

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2015
• Primary Completion (Actual): May 30, 2016
• Study Completion (Actual): May 30, 2016

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Hydrocortisone
• Other Study ID Numbers: GS29735