Authorised Therapeutic exploratory (Phase II) Psoriatic Arthritis

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

EU CTIS ID: 2024-519291-11-00

What this study is testing

- To evaluate the efficacy of lutikizumab and risankizumab combination therapy and the respective monotherapies for the treatment of active psoriatic arthritis - To assess the safety and tolerability of lutikizumab and risankizumab combination therapy and the respective monotherapies for the treatment of active psoriatic arthritis

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Subject is willing and able to comply with procedures required in the Master Protocol and substudies.
  • Subject 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.
  • Subject has active disease defined as ≥ 3 tender joints (based on 68 joint count) and ≥ 3 swollen joints (based on 66 joint count) at both the Screening Visit and Baseline.
  • Subject has active plaque PsO and/or a documented history of plaque PsO.

You likely can't join if

  • Subjects 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).
  • Subjects 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 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 PsA (including but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).

The study team makes the final eligibility decision.

Where it's taking place

  • Canada
  • United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Canada; United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.