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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465606
• Other study ID #: GS29735
• Status: Completed
• Phase: Phase 2
• Start date: July 30, 2015
• Est. completion date: May 30, 2016

Study information

• Verified date: January 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 30, 2016
• Est. primary completion date: May 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Lebrikizumab
Lebrikizumab Dose Level 1 subcutaneous monotherapy was administered SC once every 4 weeks for a total of 3 doses.
• 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.

Locations

Country	Name	City	State
Canada	Guenther Research Inc.	London	Ontario
Canada	The Centre for Clinical Trials Inc.	Oakville	Ontario
Canada	York Dermatology Center	Richmond Hill	Ontario
Canada	Dr. Lorne E. Albrecht Inc.	Surrey	British Columbia
Canada	Skin Care Centre	Vancouver	British Columbia
Canada	K. Papp Clinical Research Inc.	Waterloo	Ontario
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
United States	Montefiore Medical Center	Bronx	New York
United States	Center for Clinical Studies	Cypress	Texas
United States	T. Joseph Raoof Md, Inc.	Encino	California
United States	Allergy and Asthma Relief Experts	Granada Hills	California
United States	Dermatology Specialists Research, LLC	Louisville	Kentucky
United States	Allergy and Asthma Associates of Southern California - CRN	Mission Viejo	California
United States	Sadick Research Group	New York	New York
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Oregon Medical Research Center	Portland	Oregon
United States	Forward Clinical Trials	Tampa	Florida
United States	Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)	Warwick	Rhode Island
United States	Respiratory Medicine Research; Institue of Michigan P.L.C.	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-emergent adverse events (TEAEs)		From baseline to week 12
Secondary	Immunogenicity: Percentage of participants with anti-Lebrikizumab antibodies		From baseline to week 20
Secondary	Number of participants with disease rebound following discontinuation of study drug		within 20 weeks
Secondary	Serum lebrikizumab concentration at Week 12		Week 12
Secondary	Elimination half-life		Week 4
Secondary	Number of participants with skin and other organ system infections		From baseline to week 12
Secondary	Number of participants with injection site reactions		From baseline to week 12