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NCT06865105 | RECRUITING | Psoriatic Arthritis

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

AbbVie

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.

Condition or disease

Psoriatic Arthritis

Intervention/treatment

Lutikizumab

Risankizumab

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis
Actual Study Start Date : 2025-04-11
Estimated Primary Completion Date : 2028-01
Estimated Study Completion Date : 2028-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis

Location Details

NCT06865105

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Newport Huntington Medical Group /ID# 272764

Huntington Beach, California, United States, 92648-5994

RECRUITING

United States, Florida

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

Avon Park, Florida, United States, 33825

RECRUITING

United States, Florida

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

Clearwater, Florida, United States, 33765

RECRUITING

United States, Florida

HMD Research LLC /ID# 273086

Orlando, Florida, United States, 32819

RECRUITING

United States, Florida

West Broward Rheumatology Associates /ID# 272892

Tamarac, Florida, United States, 33321

RECRUITING

United States, Florida

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

Tampa, Florida, United States, 33606

RECRUITING

United States, Maryland

Klein And Associates /ID# 272829

Hagerstown, Maryland, United States, 21740

RECRUITING

United States, Ohio

Paramount Medical Research and Consulting /ID# 272757

Middleburg Heights, Ohio, United States, 44130

RECRUITING

United States, Pennsylvania

Altoona Center For Clinical Research /ID# 272593

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, Tennessee

Dr. Ramesh Gupta /ID# 272897

Memphis, Tennessee, United States, 38119

RECRUITING

United States, Texas

Tekton Research - West Gate /ID# 272765

Austin, Texas, United States, 78745

RECRUITING

United States, Texas

Accurate Clinical Research - Houston /ID# 272754

Houston, Texas, United States, 77089-6142

RECRUITING

United States, Texas

Tekton Research, LLC /ID#

San Antonio, Texas, United States, 78251

RECRUITING

United States, Texas

Dynamed Clinical Research - Tomball /ID# 272760

Tomball, Texas, United States, 77375

RECRUITING

Canada, Saskatchewan

Dr. Latha Naik Medical Professional Corporation /ID# 272803

Saskatoon, Saskatchewan, Canada, S7H 0P4