A phase II, randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of lebrikizumab in patients with persistent moderate to severe atopic dermatitis that is inadequately controlled by topical corticosteroids

Phase 2

Completed

• Conditions: atopic dermatitis; eczema; 10014982

• Registration Number: NL-OMON42001
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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;- 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 investigators 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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy outcome measure is the percentage of patients achieving<br /><br>EASI-50<br /><br>(a 50% reduction in EASI score from baseline) at Week 12.<br /><br></p><br>