KEEPsAKE 1
Brief summary
The purpose of this study is to compare the safety and efficacy of an active drug versus placebo in subjects with moderately to severely active psoriatic arthritis (PsA).
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
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.
- Participant has active disease at Baseline defined as ≥ 5 tender joints (based on 68
joint counts) and ≥ 5 swollen joints (based on 66 joint counts)
- 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 or
contraindication for conventional synthetic disease modifying anti-rheumatic drugs
(csDMARD) therapy(ies).
- Presence of either at Screening:
- ≥ 1 erosion on radiograph as determined by central imaging review or;
- High sensitivity C-reactive protein (hsCRP) ≥ 3.0 mg/L.
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.
- Participant has previous treatment with biologic agent.