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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

9 May 2019 → ongoing

Decision date (initial)

2024-03-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2023-505478-14-00

EudraCT number

2017-002465-22

ClinicalTrials.gov

NCT03675308

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Therapy, Efficacy, Pharmacogenomic, Pharmacogenetic

Period 1 Double-Blind - To compare the efficacy of risankizumab 150 mg versus placebo for the treatment of signs and symptoms of PsA in the study population

Secondary objectives 3

1. Period 1 Double-Blind - 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. Period 1 Double-Blind - To compare the safety and tolerability of risankizumab 150 mg versus placebo in the study population.
3. Period 2 Open-Label - To evaluate the long-term safety, tolerability, and efficacy of risankizumab 150 mg in subjects with PsA who have completed Period 1.

Conditions and MedDRA coding

Psoriatic Arthritis

Study design 4 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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.
2. Subject has active disease at Baseline
3. 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.
4. Presence of either at Screening: 1. ≥ 1 erosion on radiograph as determined by central imaging review or; 2. hs-CRP ≥ 3.0 mg/L.
5. Subject must have demonstrated an inadequate response (lack of efficacy after minimum 12 week duration of therapy) to previous or current treatment with at least 1 csDMARD at maximally tolerated dose.

Exclusion criteria 3

1. Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.
2. Subject has a known hypersensitivity to Risankizumab.
3. Subject has previous treatment with biologic agent.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of subjects achieving ACR 20 response (ACR20) at Week 24.

Secondary endpoints 13

1. Change from Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI) at Week 24.
2. Proportion of subjects achieving 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 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 PsO at Baseline.
6. Change from Baseline in Physician Global Assessment of Fingernail Psoriasis (PGA-F) at Week 24 in the subset of subjects with nail PsO at Baseline.
7. Proportion of subjects with resolution of enthesitis (Leeds Enthesitis Index [LEI] = 0) at Week 24 in subjects with enthesitis at Baseline.
8. Proportion of subjects with resolution of dactylitis (Leeds Dactylitis Index [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 (FACITFatigue) Questionnaire at Week 24.
12. Proportion of subjects achieving ACR50 response at Week 24.
13. Proportion of subjects achieving ACR70 response at Week 24.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 6

Locations

17 EU/EEA countries · 64 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 101 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications