A Study Comparing Risankizumab 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 (KEEPsAKE 1)

A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab 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 (KEEPsAKE 1) - KEEPsAKE 1

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002465-22-NL

Enrollment

880

Registered

2018-11-13

Start date

2019-07-17

Completion date

Unknown

Last updated

2022-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis. MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Interventions

Product Name: RISANKIZUMAB Product Code: ABBV-066 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: RISANKIZUMAB CAS Number: 1612838-76-2 Current Sponsor code: ABB

Eligibility

Sex/Gender

All

Inclusion criteria

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. • Subject has active disease at Baseline • Diagnosis of active plaque psoriasis with at least one psoriatic plaque of = 2 centimeter (cm) diameter or nail changes consistent with psoriasis at Screening Visit. • Presence of either at Screening: 1. = 1 erosion on radiograph as determined by central imaging review or; 2. hs-CRP = 3.0 mg/L. • Subject has demonstrated an inadequate response to previous or current treatment with at least 1 csDMARD OR subject must have an intolerance to or contraindication for csDMARDs as determined by the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 712 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 168

Exclusion criteria

Exclusion criteria: • Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study. • Subject has a known hypersensitivity to Risankizumab. • Subject has previous treatment with biologic agent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of Risankizumab 150 mg versus placebo for the treatment of signs and symptoms of PsA in patients with psoriatic arthritis. ;Secondary Objective: Period 1 (Double Blind): 1.To compare the efficacy of Risankizumab 150 mg versus placebo for the inhibition of progression of structural damage as assessed by radiographs in the study population. 2.To compare the safety and tolerability of Risankizumab 150 mg versus placebo in patients with psoriatic arthritis. Period 2: To evaluate the long-term, safety, tolerability and efficacy of Risankizumab 150 mg in subjects who have completed Period 1. ;Primary end point(s): The primary endpoint is the proportion of subjects achieving American College of Rheumatology (ACR)20 Response (ACR20) at Week 24.;Timepoint(s) of evaluation of this end point: Week 24.	—

Measure

Time frame

Main Objective: To compare the efficacy of Risankizumab 150 mg versus placebo for the treatment of signs and symptoms of PsA in patients with psoriatic arthritis. ;Secondary Objective: Period 1 (Double Blind): 1.To compare the efficacy of Risankizumab 150 mg versus placebo for the inhibition of progression of structural damage as assessed by radiographs in the study population. 2.To compare the safety and tolerability of Risankizumab 150 mg versus placebo in patients with psoriatic arthritis. Period 2: To evaluate the long-term, safety, tolerability and efficacy of Risankizumab 150 mg in subjects who have completed Period 1. ;Primary end point(s): The primary endpoint is the proportion of subjects achieving American College of Rheumatology (ACR)20 Response (ACR20) at Week 24.;Timepoint(s) of evaluation of this end point: Week 24.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change from Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI) at Week 24. 2. Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 90 response at Week 24 (in the subset of subjects with a body surface area (BSA) = 3% at Baseline). 3. Proportion of subjects achieving ACR20 at Week 16. 4. Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24. 5. Change from Baseline in modified Nail Psoriasis Severity Index (mNAPSI) at Week 24 in the subset of subjects with nail psoriasis at Baseline. 6. Change from Baseline in Fingernail-Physician Global Assessment (PGA-F) at Week 24 in the subset of subjects with nail psoriasis at Baseline. 7. Proportion of subjects with resolution of enthesitis (LEI = 0) at Week 24 in subjects with enthesitis at Baseline. 8. Proportion of subjects with resolution of dactylitis (LDI = 0) at Week 24 in subjects with dactylitis at Baseline. 9. Change from Baseline in modified Total Sharp Score (PsA-mTSS) at Week 24. 10. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24. 11. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24. Other secondary endpoints without multiplicity adjustment are: 1. Proportion of subjects achieving ACR50 response at Week 24. 2. Proportion of subjects achieving ACR70 response at Week 24. ;Timepoint(s) of evaluation of this end point: Week 24.	—

Measure

Time frame

Secondary end point(s): 1. Change from Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI) at Week 24. 2. Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 90 response at Week 24 (in the subset of subjects with a body surface area (BSA) = 3% at Baseline). 3. Proportion of subjects achieving ACR20 at Week 16. 4. Proportion of subjects achieving Minimal Disease Activity (MDA) at Week 24. 5. Change from Baseline in modified Nail Psoriasis Severity Index (mNAPSI) at Week 24 in the subset of subjects with nail psoriasis at Baseline. 6. Change from Baseline in Fingernail-Physician Global Assessment (PGA-F) at Week 24 in the subset of subjects with nail psoriasis at Baseline. 7. Proportion of subjects with resolution of enthesitis (LEI = 0) at Week 24 in subjects with enthesitis at Baseline. 8. Proportion of subjects with resolution of dactylitis (LDI = 0) at Week 24 in subjects with dactylitis at Baseline. 9. Change from Baseline in modified Total Sharp Score (PsA-mTSS) at Week 24. 10. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Week 24. 11. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT Fatigue) Questionnaire at Week 24. Other secondary endpoints without multiplicity adjustment are: 1. Proportion of subjects achieving ACR50 response at Week 24. 2. Proportion of subjects achieving ACR70 response at Week 24. ;Timepoint(s) of evaluation of this end point: Week 24.

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Countries

Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, Estonia, Finland, Germany, Greece, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States

Contacts

Public ContactGlobal clinical trials helpdesk

AbbVie Ltd.

global-clinical-trials@abbvie.com+441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026