Recruiting
Phase 2

Targeted Therapies

Sponsor:

AbbVie

Code:

NCT06865105

Conditions

Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lutikizumab

Risankizumab

Study Details

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

Study ID

NCT06865105

Start date

Apr 11, 2025

Status verified date

Dec, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sub-Study 1: Risankizumab Monotherapy

Participants will receive Risankizumab

experimental: Sub-Study 1: Lutikizumab Monotherapy

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

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.

Interventions

Lutikizumab

Subcutaneous (SC) Injection

Risankizumab

Subcutaneous (SC) Injection

Primary outcome measure

  • Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response [ Time Frame: At Week 16 ]
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Up to Week 52 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Newport Huntington Medical Group /ID# 272764

Recruiting

Huntington Beach, California, United States, 92648-5994

Contacts

Site Coordinator

714-923-7112

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

Recruiting

Avon Park, Florida, United States, 33825

Contacts

Site Coordinator

863-314-8555

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

Recruiting

Clearwater, Florida, United States, 33765

HMD Research LLC /ID# 273086

Recruiting

Orlando, Florida, United States, 32819

West Broward Rheumatology Associates /ID# 272892

Recruiting

Tamarac, Florida, United States, 33321

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

Recruiting

Tampa, Florida, United States, 33606

Contacts

Site Coordinator

(813) 870-1292

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

Recruiting

Skokie, Illinois, United States, 60076

Contacts

Site Coordinator

847-599-2492

Willow Rheumatology and Wellness, PLLC /ID# 277354

Recruiting

Willowbrook, Illinois, United States, 60527

Paramount Medical Research and Consulting /ID# 272757

Recruiting

Middleburg Heights, Ohio, United States, 44130

Altoona Center For Clinical Research /ID# 272593

Recruiting

Duncansville, Pennsylvania, United States, 16635

Contacts

Site Coordinator

814-296-6108

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

Recruiting

Memphis, Tennessee, United States, 38119

Tekton Research - West Gate /ID# 272765

Recruiting

Austin, Texas, United States, 78745

Accurate Clinical Research - Houston /ID# 272754

Recruiting

Houston, Texas, United States, 77089-6142

Contacts

Site Coordinator

281-481-8557

Tekton Research, LLC /ID# 272901

Recruiting

San Antonio, Texas, United States, 78251

Dynamed Clinical Research - Tomball /ID# 272760

Recruiting

Tomball, Texas, United States, 77375

Centre de Recherche Musculo-Squelettique /ID# 274397

Recruiting

Trois-Rivières, Quebec, Canada, G9A 3X2

Dr. Latha Naik Medical Professional Corporation /ID# 272803

Recruiting

Saskatoon, Saskatchewan, Canada, S7H 0P4

More Information

Sponsor

AbbVie

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2025-12-18.