A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Active Psoriatic Arthritis

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]

Trial duration

25 Jul 2025 → ongoing

Decision date (initial)

2025-07-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

- To evaluate the efficacy of lutikizumab and risankizumab combination therapy and the respective monotherapies for the treatment of active psoriatic arthritis

- To assess the safety and tolerability of lutikizumab and risankizumab combination therapy and the respective monotherapies for the treatment of active psoriatic arthritis

Conditions and MedDRA coding

Psoriatic Arthritis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Subject is willing and able to comply with procedures required in the Master Protocol and substudies.
2. Subject has a documented clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) at Screening Visit.
3. Subject has active disease defined as ≥ 3 tender joints (based on 68 joint count) and ≥ 3 swollen joints (based on 66 joint count) at both the Screening Visit and Baseline.
4. Subject has active plaque PsO and/or a documented history of plaque PsO.

Exclusion criteria 4

1. Subjects who have had major surgery performed within 12 weeks prior to randomization or plan to have a major surgery during conduct of the study (e.g., aneurysm removal, stomach ligation).
2. Subjects with the following chronic or active infections: Are infected with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus(HCV) infection, active tuberculosis(TB)
3. Active skin disease other than PsO which could interfere with the assessment of PsO.
4. History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 16

Secondary endpoints 4

1. Percentage of Participants Achieving Minimal Disease Activity (MDA) Response at Week 16
2. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16
3. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 16
4. Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16 (in the subset of participants with a PsO BSA ≥ 3% at Baseline)

Investigational products

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

Test 2

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 4

Locations

4 EU/EEA countries · 21 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 31 files

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

Application history

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