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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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

KEEPsAKE 1 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.Check my eligibility

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.See study design

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.

KEEPsAKE 1 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.

KEEPsAKE 1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

KEEPsAKE 1 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

Placebo

1995

Completed Phase 3

~2670

Isopropyl alcohol

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

500,141 Total Patients Enrolled

22 Trials studying Psoriatic Arthritis

107,941 Patients Enrolled for Psoriatic Arthritis

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

144,975 Total Patients Enrolled

6 Trials studying Psoriatic Arthritis

8,706 Patients Enrolled for Psoriatic Arthritis

Media Library

Risankizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03675308 — Phase 3

Psoriatic Arthritis Research Study Groups: Placebo, Risankizumab

Psoriatic Arthritis Clinical Trial 2023: Risankizumab Highlights & Side Effects. Trial Name: NCT03675308 — Phase 3

Risankizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03675308 — Phase 3

Psoriatic Arthritis Patient Testimony for trial: Trial Name: NCT03675308 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there previous data on risankizumab's efficacy?

"The first study involving risankizumab was completed in 2011 at Memorial Sloan Kettering Cancer Center. Since that time, there have been a total of 18386 studies (29 of which are ongoing). The majority of these studies take place in Wyomissing, Pennsylvania."

Answered by AI

When will risankizumab be available to patients in the United States?

"Risankizumab has received a score of 3 for safety. This is due to the fact that it is currently in Phase 3 trials, which suggests that not only does this medication show efficacy, but also that there is extensive data supporting its safety."

Answered by AI

For what purpose is risankizumab most often utilized?

"risankizumab is most often used to treat dental plaque, but it can also be used for psoriatic arthritis, psoriasis, and skin disinfection therapy."

Answered by AI

Why did researchers design this experiment in this way?

"The primary outcome of this study, which will be measured over roughly Week 24, is the Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24. Secondary outcomes include the Percentage of Participants With Resolution of Dactylitis at Week 24, Change From Baseline in PsA Modified Total Sharp Score (mTSS) at Week 24, and Change From Baseline In 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24."

Answered by AI

Are participants being recruited for this research project at present?

"The clinicaltrials.gov website shows that, as of the latest update on February 23rd, 2022, this study is not looking for patients to participate. Although this research isn't currently conducted with human participants, there are 416 other studies that are presently seeking patients."

Answered by AI

In how many institutions is this research being conducted?

"Patients can enroll in this study at any of the 71 locations, which include Clinical Research Ctr Reading /ID# 168070 in Wyomissing, Pennsylvania, Amarillo Ctr for Clin Research /ID# 208347 in Amarillo, Texas, and Precision Comprehensive Clinical Research Solutions /ID# 208386 in Colleyville."

Answered by AI

How many individuals are being signed up for this clinical trial?

"Note that this clinical trial is not actively seeking participants at the moment. It was originally posted on 3/25/2019 but the most recent update occurred on 2/23/2022. However, if you are interested in other studies, there are 387 clinical trials for psoriatic arthritis and 29 trials testing risankizumab that are looking for volunteers right now."

Answered by AI

Who else is applying?

What state do they live in?

Texas

What site did they apply to?

Amarillo Ctr for Clin Research /ID# 208347

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I tried to edit the note on the prior page to let you know that I live in Amarillo. And I'm certainly willing to go to the clinic if I can get some relief from psoradic arthritis. Please call me, afternoons are better and if possible, Text me, I don't always answer the phone with all the scammers out there. Thank you for your time. I look forward to hearing from you.

PatientReceived 1 prior treatment

Recent research and studies

Annals of the Rheumatic DiseasesJournal

Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-week Results from the Randomised, Double-blind, Phase 3 Keepsake 1 Trial

Kristensen, Lars Erik, Mauro Keiserman, Kim Papp, Leslie McCasland, Douglas White, Wenjing Lu, Zailong Wang, et al.. 2021. “Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-week Results from the Randomised, Double-blind, Phase 3 Keepsake 1 Trial”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/annrheumdis-2021-221019.

Annals of the Rheumatic DiseasesJournal

Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 24-week Results from the Randomised, Double-blind, Phase 3 Keepsake 1 Trial

RheumatologyJournal

Risankizumab Improved Health-related Quality of Life, Fatigue, Pain and Work Productivity in Psoriatic Arthritis: Results of Keepsake 1

Kristensen, Lars Erik, Ahmed M Soliman, Kim Papp, Douglas White, Lisa Barcomb, Wenjing Lu, Ann Eldred, and Frank Behrens. 2022. “Risankizumab Improved Health-related Quality of Life, Fatigue, Pain and Work Productivity in Psoriatic Arthritis: Results of Keepsake 1”. Rheumatology. Oxford University Press (OUP). doi:10.1093/rheumatology/keac342.

clinicaltrials.govStudy

A Study Comparing Risankizumab to Placebo in Participants 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