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

Roche

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%); Drug: Lebrikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02465606

GS29735

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Group 1: Lebrikizumab Dose Level 1 Monotherapy

Experimental group

Description:

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.

Treatment:

Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)

Drug: Lebrikizumab

Group 2: Topical Corticosteroid Creams Only

Active Comparator group

Description:

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.

Treatment:

Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)