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

Conditions

• Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lutikizumab — DRUG
  Subcutaneous (SC) Injection
• Risankizumab — DRUG
  Subcutaneous (SC) Injection

Study Details

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.

Key Dates

Start date

Apr 11, 2025

Status verified

Dec 2025

Primary completion

Dec 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (16)

Find similar trials in Huntington Beach, CA

Related Studies

• Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
  Recruiting · University of California, San Diego · La Jolla, California
• Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
  PHASE1 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
  PHASE3 · Recruiting · University of Pennsylvania · Loxahatchee Groves, Florida