Clinical trial NCT06865105: Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
Official title: A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Psoriatic Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
timeFrame: At Week 16
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving Minimal Disease Activity (MDA) Response
timeFrame: At Week 16
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
timeFrame: At Week 16
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
timeFrame: At Week 16
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response (in the subset of participants with a PsO BSA ≥ 3% at Baseline)
timeFrame: At Week 16
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group /ID# 272764
state: California
city: Avon Park
country: United States
facility: Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates /ID# 272892
state: Florida
city: Tampa
country: United States
facility: Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199
state: Florida
city: Hagerstown
country: United States
facility: Klein And Associates /ID# 272829
state: Maryland
city: Middleburg Heights
country: United States
facility: Paramount Medical Research and Consulting /ID# 272757
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research /ID# 272593
state: Pennsylvania
city: Memphis
country: United States
facility: Dr. Ramesh Gupta /ID# 272897
state: Tennessee
city: Austin
country: United States
facility: Tekton Research - West Gate /ID# 272765
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research - Houston /ID# 272754
state: Texas
city: San Antonio
country: United States
facility: Tekton Research, LLC /ID# 272901
state: Texas
city: Tomball
country: United States
facility: Dynamed Clinical Research - Tomball /ID# 272760
state: Texas
city: Saskatoon
country: Canada
facility: Dr. Latha Naik Medical Professional Corporation /ID# 272803
state: Saskatchewan
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: