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Monoclonal Antibodies

Risankizumab for Psoriatic Arthritis (KEEPsAKE 1 Trial)

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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).

Must not have

Participant has previous treatment with biologic agent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial compares the safety and effectiveness of a new drug, risankizumab, to a placebo in people with psoriatic arthritis.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects of drugs like Risankizumab may include injection site reactions, upper respiratory infections, headache, and fatigue. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I haven't responded well to standard rheumatic disease treatments.

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I have at least 5 tender and 5 swollen joints currently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a biologic agent before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24

Secondary study objectives

Change From Baseline In 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24

Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24

Change From Baseline In Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24

+10 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Isopropyl alcohol

FDA approved

Placebo

1995

Completed Phase 3

~2670

0 / 4Eligibility criteria met