NCT03675308

A Study Comparing an Active Drug 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

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

Status:
Active, not recruiting
Conditions:
Psoriatic Arthritis
Enrollment:
964 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-011
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

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

- Diagnosis of active plaque psoriasis.

- Participant has demonstrated an inadequate response or intolerance to 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.

All the cities where the clinical studies are located

Victoria - V8V 3M9

Peterborough - K9J 5K2

Waterloo - N2J 1C4

Sainte-foy - G1V 3M7

Saskatoon - S7K 3H3

Winnipeg - R3A 1M3

Winnipeg - R3N 0K6

British Columbia

Manitoba

Quebec

Saskatchewan