A Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD)Therapy (KEEPsAKE 1)

Phase 1

• Conditions: Psoriatic Arthritis.; MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-002465-22-SK
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 880

Inclusion Criteria

• Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit.

• Subject has active disease at Baseline

• Diagnosis of active plaque psoriasis with at least one psoriatic plaque of = 2 centimeter (cm) diameter or nail changes consistent with psoriasis at Screening Visit.

• Presence of either at Screening:
1. = 1 erosion on radiograph as determined by central imaging review or;
2. hs-CRP = 3.0 mg/L.

• Subject must have demonstrated an inadequate response (lack of efficacy after minimum 12 week duration of therapy) to previous or current treatment with at least 1 csDMARD at maximally tolerated dose.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 712
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168

Exclusion Criteria

• Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.
• Subject has a known hypersensitivity to Risankizumab.
• Subject has previous treatment with biologic agent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified