Risankizumab for Psoriatic Arthritis
(KEEPsAKE2 Trial)

Recruiting in Palo Alto (17 mi)

+197 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

Trial Summary

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

Eligibility Criteria

This trial is for adults with active psoriatic arthritis, having at least 5 tender and swollen joints, plaque psoriasis or nail changes. It's specifically for those who didn't respond well to or couldn't tolerate previous biologic therapies or conventional treatments.

Inclusion Criteria

I have been diagnosed with psoriatic arthritis for at least 6 months.

I have at least 5 tender and 5 swollen joints.

I have active plaque psoriasis with a plaque larger than 2 cm or nail changes.

+1 more

Exclusion Criteria

You are allergic to risankizumab.

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

Participant Groups

The study tests the safety and effectiveness of a drug called Risankizumab against a placebo in treating moderate to severe psoriatic arthritis. Participants are randomly assigned to receive either the drug or placebo.

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.