A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects with Moderate to Severe Atopic Dermatitis [M16-813]

Phase 3

Completed

• Conditions: atopic dermatitis (AD)

• Registration Number: JPRN-jRCT2080224583
• Lead Sponsor: AbbVie G.K.

Brief Summary

In Study M16-813, the primary endpoint, EASI 75 at Week 16, was not met. In the All Risankizumab Treated population, the most frequently reported AE was AD. Most AEs were mild or moderate in severity and few led to discontinuation of risankizumab. The most frequently reported SAE in the All Risankizumab Treated population was AD, which reflects the underlying disease and the lack of efficacy of the study drug. Risankizumab was safe and well-tolerated, and no new safety signals have been identified.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-06
• Study Completion: 2021-04-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

adults who are >= 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old
- a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria
- moderate to severe AD at the Baseline Visit
- history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments

Exclusion Criteria

- prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor
- concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Percentage of Participants Achieving At Least a 75% Reduction from Baseline in Eczema Area and Severity Index (EASI 75) [ Time Frame: Week 16 ]

Secondary Outcome Measures

Name	Time	Method
efficacy<br>- Percentage of Participants Achieving Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Score of 0 Or 1 With a Reduction From Baseline of >= 2 Points [ Time Frame: Week 16 ]<br>- Percentage of Participants Achieving a Reduction of >= 4 Points in Worst Pruritus Numerical Rating Scale (NRS) from Baseline [ Time Frame: Baseline, Week 16 ]