KEEPsAKE2

A Study Comparing an Active Drug to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(les)

Brief summary

The purpose of this study is to evaluate the safety and efficacy of an active drug in patients with moderately to severely active psoriatic arthritis (PsA).

Interventional

Interventional study

Status:
Active, not recruiting
Conditions:
Psoriatic Arthritis (PsA)
Enrollment:
444 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M15-998
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

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

- Participant has active disease defined as ≥ 5 tender joints (based on 68 joint
counts) and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening
Visit and Baseline.

- Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm
diameter or nail changes consistent with psoriasis at Screening Visit.

- Participant has demonstrated an inadequate response or intolerance to biologic
therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs
(csDMARD) therapy(ies).

Exclusion Criteria:

- Participant is considered by investigator, for any reason, to be an unsuitable
candidate for the study.

- Participant has a known hypersensitivity to risankizumab.

All the cities where the clinical studies are located

Victoria - V8V 3M9
Hamilton - L8N 1Y2
Waterloo - N2J 1C4
Rimouski - G5L 8W1
Winnipeg - R3N 0K6

British Columbia

Victoria

Manitoba

Winnipeg

Ontario

Hamilton
Waterloo

Quebec

Rimouski

More information about this study

clinicaltrials.gov