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

NCT06865105 | Recruiting Phase 2 FDA Drug

• 1 other identifier: M25-191
• Study Type: interventional
• Target: 120
• Locations: 6 countries
• Sites: 37

Brief Summary

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.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response

  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)

  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 Outcomes (4)

• Percentage of Participants Achieving Minimal Disease Activity (MDA) Response

  At Week 16

• Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response

  At Week 16

• Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response

  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)

  At Week 16

Study Arms (3)

Sub-Study 1: Risankizumab Monotherapy

EXPERIMENTAL

Participants will receive Risankizumab

Drug: Risankizumab

Sub-Study 1: Lutikizumab Monotherapy

EXPERIMENTAL

Participants will initially receive Lutikizumab Dose A followed by Lutikizumab Dose B every other week.

Drug: Lutikizumab

SubStudy 1: Lutikizumab and Risankizumab Combination Therapy

EXPERIMENTAL

Participants will be administered Lutikizumab and Risankizumab at the same time following the same dosing regimen as the monotherapy arms.

Drug: Lutikizumab; Drug: Risankizumab

Interventions

Risankizumab DRUG

Subcutaneous (SC) Injection

Sub-Study 1: Risankizumab Monotherapy; SubStudy 1: Lutikizumab and Risankizumab Combination Therapy

Lutikizumab DRUG

Subcutaneous (SC) Injection

Sub-Study 1: Lutikizumab Monotherapy; SubStudy 1: Lutikizumab and Risankizumab Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (37)

Newport Huntington Medical Group /ID# 272764

Huntington Beach, California, 92648-5994, United States

RECRUITING

Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085

Avon Park, Florida, 33825, United States

RECRUITING

Clinical Research Of West Florida - Phase I Unit /ID# 273198

Clearwater, Florida, 33765, United States

RECRUITING

HMD Research LLC /ID# 273086

Orlando, Florida, 32819, United States

RECRUITING

West Broward Rheumatology Associates /ID# 272892

Tamarac, Florida, 33321, United States

RECRUITING

Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199

Tampa, Florida, 33606, United States

RECRUITING

Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879

Skokie, Illinois, 60076, United States

RECRUITING

Willow Rheumatology and Wellness, PLLC /ID# 277354

Willowbrook, Illinois, 60527, United States

RECRUITING

Klein And Associates /ID# 272829

Hagerstown, Maryland, 21740, United States

COMPLETED

Paramount Medical Research and Consulting /ID# 272757

Middleburg Heights, Ohio, 44130, United States

RECRUITING

Altoona Center For Clinical Research /ID# 272593

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Private Practice - Dr. Ramesh C. Gupta I /ID# 272897

Memphis, Tennessee, 38119, United States

RECRUITING

Tekton Research - West Gate /ID# 272765

Austin, Texas, 78745, United States

RECRUITING

Accurate Clinical Research - Houston /ID# 272754

Houston, Texas, 77089-6142, United States

RECRUITING

Tekton Research, LLC /ID# 272901

San Antonio, Texas, 78251, United States

RECRUITING

Dynamed Clinical Research - Tomball /ID# 272760

Tomball, Texas, 77375, United States

RECRUITING

Centre de Recherche Musculo-Squelettique /ID# 274397

Trois-Rivières, Quebec, G9A 3X2, Canada

RECRUITING

Dr. Latha Naik Medical Professional Corporation /ID# 272803

Saskatoon, Saskatchewan, S7H 0P4, Canada

RECRUITING

Revmatologie /ID# 272367

Brno, Brno-mesto, 638 00, Czechia

RECRUITING

L.K.N. Arthrocentrum /ID# 272366

Hlučín, Moravskoslezský kraj, 748 01, Czechia

RECRUITING

Medical Plus s.r.o. /ID# 272363

Uherské Hradiště, 686 01, Czechia

RECRUITING

PV Medical Services s.r.o. /ID# 272368

Zlín, 760 01, Czechia

RECRUITING

Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 272771

Nice, Alpes-Maritimes, 06001, France

RECRUITING

Infirmerie Protestante De Lyon /ID# 273731

Caluire-et-Cuire, Auvergne-Rhône-Alpes, 69300, France

RECRUITING

Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762

Chambray-lès-Tours, Indre-et-Loire, 37170, France

RECRUITING

CHU Bordeaux - Hopital Pellegrin /ID# 273390

Bordeaux, Nouvelle-Aquitaine, 33076, France

RECRUITING

Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877

Orléans, 45067, France

RECRUITING

Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572

Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary

RECRUITING

Complex Rendelo Med Zrt. /ID# 272570

Székesfehérvár, Fejér, 8000, Hungary

RECRUITING

Vital-Medicina Kft. /ID# 272855

Veszprém, Fejér, 8200, Hungary

RECRUITING

Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195

Budapest, 1023, Hungary

RECRUITING

Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857

Budapest, 1027, Hungary

RECRUITING

Mics Centrum Medyczne Bydgoszcz /ID# 273297

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-068, Poland

RECRUITING

MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305

Pruszków, Masovian Voivodeship, 05-800, Poland

RECRUITING

Centrum Medyczne Reuma Park /ID# 273301

Warsaw, Masovian Voivodeship, 02-665, Poland

RECRUITING

Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304

Bialystok, Podlaskie Voivodeship, 15-351, Poland

RECRUITING

Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

lutikizumab; risankizumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

FR (5); CA (2); HU (5); CZ (4); US (16); PL (5)