Risankizumab for Psoriatic Arthritis
(KEEPsAKE 1 Trial)

Recruiting in Palo Alto (17 mi)

+268 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).

Eligibility Criteria

This trial is for people with active Psoriatic Arthritis who haven't responded well to or can't tolerate at least one standard anti-rheumatic drug. They should have had symptoms for over 6 months, meet specific criteria including certain blood protein levels or skin/nail psoriasis signs, and have joint inflammation.

Inclusion Criteria

I have been diagnosed with Psoriatic Arthritis for at least 6 months.

You have at least one erosion on a radiograph as checked by a central imaging review.

Your high sensitivity C-reactive protein (hsCRP) level is higher than 3.0 mg/L.

+4 more

Exclusion Criteria

I have been treated with a biologic agent before.

Participant has a known hypersensitivity to risankizumab.

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

Participant Groups

The study is testing the effectiveness of Risankizumab compared to a placebo in treating Psoriatic Arthritis. Participants will be randomly assigned to receive either the actual medication or a placebo without knowing which one they are getting.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RisankizumabExperimental Treatment2 Interventions

Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive blinded placebo followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.

Group II: PlaceboPlacebo Group2 Interventions

Participants randomized to receive double-blind placebo at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive 150 mg risankizumab followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.

Risankizumab is already approved in Canada, United States, European Union for the following indications:

🇨🇦 Approved in Canada as Skyrizi for: