A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Newport Huntington Medical Group /ID# 272764
RECRUITING
Huntington Beach
Florida
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085
RECRUITING
Avon Park
Clinical Research Of West Florida - Phase I Unit /ID# 273198
RECRUITING
Clearwater
HMD Research LLC /ID# 273086
RECRUITING
Orlando
West Broward Rheumatology Associates /ID# 272892
RECRUITING
Tamarac
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199
RECRUITING
Tampa
Illinois
Willow Rheumatology and Wellness, PLLC /ID# 277354
RECRUITING
Willowbrook
Maryland
Klein And Associates /ID# 272829
RECRUITING
Hagerstown
Ohio
Paramount Medical Research and Consulting /ID# 272757
RECRUITING
Middleburg Heights
Pennsylvania
Altoona Center For Clinical Research /ID# 272593
RECRUITING
Duncansville
Tennessee
Dr. Ramesh Gupta /ID# 272897
RECRUITING
Memphis
Texas
Tekton Research - West Gate /ID# 272765
RECRUITING
Austin
Accurate Clinical Research - Houston /ID# 272754
RECRUITING
Houston
Tekton Research, LLC /ID# 272901
RECRUITING
San Antonio
Dynamed Clinical Research - Tomball /ID# 272760
RECRUITING
Tomball
Other Locations
Canada
Dr. Latha Naik Medical Professional Corporation /ID# 272803
RECRUITING
Saskatoon
Centre de Recherche Musculo-Squelettique /ID# 274397
RECRUITING
Trois-rivières
France
CHU Bordeaux - Hopital Pellegrin /ID# 273390
RECRUITING
Bordeaux
Infirmerie Protestante De Lyon /ID# 273731
RECRUITING
Caluire-et-cuire
Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762
RECRUITING
Chambray-lès-tours
Centre Hospitalier Universitaire de Nice - Hôpital Pasteur /ID# 272771
RECRUITING
Nice
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877