atopic dermatitis (AD)
Conditions
Interventions
investigational material(s)
Generic name etc : ABBV-066
INN of investigational material : risankizumab
Therapeutic category code : 639 Other biological preparations
Dosage and Administration for Inves
Sponsors
AbbVie G.K.
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage of Participants Achieving At Least a 75% Reduction from Baseline in Eczema Area and Severity Index (EASI 75) [ Time Frame: Week 16 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - 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 ] - Percentage of Participants Achieving a Reduction of >= 4 Points in Worst Pruritus Numerical Rating Scale (NRS) from Baseline [ Time Frame: Baseline, Week 16 ] | — |
Countries
Japan, North America, Oceania
Outcome results
None listed