RightFit
RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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 sites (16)

CA

FL

IL

MD

OH

PA

TN

TX