Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis

December 16, 2025 updated by: AbbVie

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

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms.

The therapies being assessed in this sub-study are risankizumab and lutikizumab. Participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. Around 120 participants will be enrolled in the study at approximately 40 sites worldwide.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Trois-Rivières, Quebec, Canada, G9A 3X2
        • Recruiting
        • Centre de Recherche Musculo-Squelettique /ID# 274397
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7H 0P4
        • Recruiting
        • Dr. Latha Naik Medical Professional Corporation /ID# 272803
  • Czechia
      • Uherské Hradiště, Czechia, 686 01
        • Recruiting
        • Medical Plus s.r.o. /ID# 272363
      • Zlín, Czechia, 760 01
        • Recruiting
        • PV Medical Services s.r.o. /ID# 272368
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 638 00
        • Recruiting
        • Revmatologie /ID# 272367
    • Moravskoslezský kraj
      • Hlučín, Moravskoslezský kraj, Czechia, 748 01
        • Recruiting
        • L.K.N. Arthrocentrum /ID# 272366
  • France
      • Orléans, France, 45067
        • Recruiting
        • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06001
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 272771
    • Auvergne-Rhône-Alpes
      • Caluire-et-Cuire, Auvergne-Rhône-Alpes, France, 69300
        • Recruiting
        • Infirmerie Protestante De Lyon /ID# 273731
    • Indre-et-Loire
      • Chambray-lès-Tours, Indre-et-Loire, France, 37170
        • Recruiting
        • Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762
    • Nouvelle-Aquitaine
      • Bordeaux, Nouvelle-Aquitaine, France, 33076
        • Recruiting
        • CHU Bordeaux - Hopital Pellegrin /ID# 273390
  • Hungary
      • Budapest, Hungary, 1027
        • Recruiting
        • Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857
      • Budapest, Hungary, 1023
        • Recruiting
        • Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195
    • Borsod-Abauj Zemplen county
      • Miskolc, Borsod-Abauj Zemplen county, Hungary, 3529
        • Recruiting
        • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572
    • Fejér
      • Székesfehérvár, Fejér, Hungary, 8000
        • Recruiting
        • Complex Rendelo Med Zrt. /ID# 272570
      • Veszprém, Fejér, Hungary, 8200
        • Recruiting
        • Vital-Medicina Kft. /ID# 272855
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-068
        • Recruiting
        • Mics Centrum Medyczne Bydgoszcz /ID# 273297
    • Masovian Voivodeship
      • Pruszków, Masovian Voivodeship, Poland, 05-800
        • Recruiting
        • MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305
      • Warsaw, Masovian Voivodeship, Poland, 02-665
        • Recruiting
        • Centrum Medyczne Reuma Park /ID# 273301
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-351
        • Recruiting
        • Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304
    • Warmian-Masurian Voivodeship
      • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
        • Recruiting
        • Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306
  • United States
    • California
      • Huntington Beach, California, United States, 92648-5994
        • Recruiting
        • Newport Huntington Medical Group /ID# 272764
        • Contact:
          • Site Coordinator
          • Phone Number: 714-923-7112
    • Florida
      • Avon Park, Florida, United States, 33825
        • Recruiting
        • Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085
        • Contact:
          • Site Coordinator
          • Phone Number: 863-314-8555
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Research Of West Florida - Phase I Unit /ID# 273198
      • Orlando, Florida, United States, 32819
        • Recruiting
        • HMD Research LLC /ID# 273086
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • West Broward Rheumatology Associates /ID# 272892
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199
        • Contact:
          • Site Coordinator
          • Phone Number: (813) 870-1292
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Recruiting
        • Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879
        • Contact:
          • Site Coordinator
          • Phone Number: 847-599-2492
      • Willowbrook, Illinois, United States, 60527
        • Recruiting
        • Willow Rheumatology and Wellness, PLLC /ID# 277354
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Completed
        • Klein And Associates /ID# 272829
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Paramount Medical Research and Consulting /ID# 272757
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Altoona Center For Clinical Research /ID# 272593
        • Contact:
          • Site Coordinator
          • Phone Number: 814-296-6108
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Private Practice - Dr. Ramesh C. Gupta I /ID# 272897
    • Texas
      • Austin, Texas, United States, 78745
        • Recruiting
        • Tekton Research - West Gate /ID# 272765
      • Houston, Texas, United States, 77089-6142
        • Recruiting
        • Accurate Clinical Research - Houston /ID# 272754
        • Contact:
          • Site Coordinator
          • Phone Number: 281-481-8557
      • San Antonio, Texas, United States, 78251
        • Recruiting
        • Tekton Research, LLC /ID# 272901
      • Tomball, Texas, United States, 77375
        • Recruiting
        • Dynamed Clinical Research - Tomball /ID# 272760

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant is willing and able to comply with procedures required in the Master Protocol and substudies.
  • Participant 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.
  • Participant has active disease defined as greater than or equal to 3 tender joints (based on 68 joint count) and greater than or equal to 3 swollen joints (based on 66 joint count) at both the Screening Visit and Baseline.
  • Participant has active plaque PsO and/or a documented history of plaque PsO.
  • Participant must demonstrate intolerance or inadequate response to 1 to 2 targeted therapies (biologic or targeted synthetic disease-modifying antirheumatic drugs) approved for the treatment of PsA

Exclusion Criteria:

  • Participants 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).
  • Participants 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)
  • Active skin disease other than psoriasis (PsO) which could interfere with the assessment of PsO.
  • History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than psoriatic arthritis (PsA) (including but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sub-Study 1: Risankizumab Monotherapy
Participants will receive Risankizumab
Drug: Risankizumab
Subcutaneous (SC) Injection
Experimental: Sub-Study 1: Lutikizumab Monotherapy
Participants will initially receive Lutikizumab Dose A followed by Lutikizumab Dose B every other week.
Drug: Lutikizumab
Subcutaneous (SC) Injection
Experimental: SubStudy 1: Lutikizumab and Risankizumab Combination Therapy
Participants will be administered Lutikizumab and Risankizumab at the same time following the same dosing regimen as the monotherapy arms.
Drug: Risankizumab
Subcutaneous (SC) Injection
Drug: Lutikizumab
Subcutaneous (SC) Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Time Frame: At Week 16

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:

  1. ≥ 50% improvement in 68-tender joint count;
  2. ≥ 50% improvement in 66-swollen joint count; and

  3. ≥ 50% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).
At Week 16
Number of Participants With Adverse Events (AEs)
Time Frame: Up to Week 52
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Minimal Disease Activity (MDA) Response
Time Frame: At Week 16

A participant was classified as achieving MDA if 5 of the following 7 criteria were met:

  • Tender joint count (out of 68 joints) ≤ 1
  • Swollen joint count (out of 66 joints) ≤ 1
  • PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3%
  • Participant's assessment of pain ≤ 1.5 (NRS from 0 to 10)
  • Participant's Global Assessment of disease activity ≤ 2 (NRS from 0 to 10)
  • HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3)
  • Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6)
At Week 16
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
Time Frame: At Week 16

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:

  1. ≥ 20% improvement in 68-tender joint count;
  2. ≥ 20% improvement in 66-swollen joint count; and

  3. ≥ 20% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).
At Week 16
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
Time Frame: At Week 16

Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:

  1. ≥ 70% improvement in 68-tender joint count;
  2. ≥ 70% improvement in 66-swollen joint count; and

  3. ≥ 70% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).
At Week 16
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response (in the subset of participants with a PsO BSA ≥ 3% at Baseline)
Time Frame: At Week 16

PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked).

The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score, and was assessed in participants with Baseline psoriasis BSA involvement ≥ 3%.
At Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M25-191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (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.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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