A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis

AbbVie

Status and phase: Completed; Phase 2

Conditions: Dermatitis

Treatments: Biological: Risankizumab; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03706040

2021-002203-34 (EudraCT Number)

M16-813

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.

Full description

This study includes a screening period of up to 35 days, a 16-week double-blind treatment period (Period A), and a 36-week double-blind treatment period (Period B).

Participants who meet eligibility criteria will be randomized at Baseline in a 2:2:1 ratio to one of 3 treatment groups: (1) risankizumab 150 mg, (2) risankizumab 300 mg, or (3) matching placebo. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and geographic region (Japan versus rest of world).

At Week 16, participants in the placebo group will be re-randomized in a 1:1 ratio to receive either risankizumab 150 mg or 300 mg for the remainder of the study. Participants originally randomized to the risankizumab 150 mg or 300 mg arms will stay on their previously-assigned treatment through the end of the study.

Enrollment: 172 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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172 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants randomized to receive placebo for 16 weeks in Period A followed by either risankizumab 150 mg or risankizumab 300 mg for 36 weeks in Period B.

Treatment:

Biological: Placebo

Biological: Risankizumab

Risankizumab 150 mg

Experimental group

Description:

Participants randomized to receive risankizumab 150 mg for 16 weeks in Period A followed by risankizumab 150 mg for 36 weeks in Period B.

Treatment:

Biological: Risankizumab

Risankizumab 300 mg

Experimental group

Description:

Participants randomized to receive risankizumab 300 mg for 16 weeks in Period A followed by risankizumab 300 mg for 36 weeks in Period B.

Treatment:

Biological: Risankizumab