EUCTR2021-002203-34-Outside-EU/EEA
Active, not recruiting
Phase 1
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
AbbVie Deutschland0 sitesApril 28, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AbbVie Deutschland
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 155
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 153
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
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
Outcomes
Primary Outcomes
Not specified
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