Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

Purpose

This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Condition

  • Arthritis, Psoriatic

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Participants must be ≥18 years of age . 2. Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit. 3. Participants have active disease (defined by a 68 tender joint count [TJC68] of ≥3 and a 66 swollen joint count [SJC66] of ≥3). 4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO. 5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit. 6. Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor.

Exclusion Criteria

  1. Participants with a known hypersensitivity to sonelokimab or any of its excipients. 2. Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container. 3. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA. 4. Participants with a diagnosis of inflammatory bowel disease. 5. Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit. 6. Participants who have an established diagnosis of arthritis mutilans. 7. Previous exposure to sonelokimab. 8. Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
sonelokimab dose 1 with an induction regimen 		Subjects randomized to this arm will receive sonelokimab dose 1 subcutaneously (SC) as an induction regimen of 4 doses , followed by sonelokimab SC every 4 weeks (Q4W) maintenance dosing starting at Week 8.
  • Drug: Sonelokimab
    Sonelokimab
Experimental
sonelokimab dose 2 with an induction regimen 		Subjects randomized to this arm will receive sonelokimab dose 2 SC as an induction regimen of 4 doses, followed by sonelokimab SC Q4W maintenance dosing starting at Week 8.
  • Drug: Sonelokimab
    Sonelokimab
Placebo Comparator
Placebo 		Subjects randomized to this arm will receive placebo SC
  • Drug: Placebo
    Placebo
Active Comparator
risankizumab 		Subjects randomized to this arm will receive risankizumab SC
  • Drug: Risankizumab
    Active comparator

Recruiting Locations

Clinical Site
Avondale, Arizona 85392

Clinical Site
Chandler, Arizona 85225

Clinical Site
Flagstaff, Arizona 86001

Clinical Site
Mesa, Arizona 85210

Clinical Site
Phoenix, Arizona 85032

Clinical Site
Scottsdale, Arizona 85260

Clinical Site
Tucson, Arizona 85748

Clinical Site
Jonesboro, Arkansas 72401

Clinical Site
La Jolla, California 92037

Clinical Site
Pomona, California 91767

Clinical Site
San Diego, California 92108

Clinical Site
Santa Monica, California 90404

Clinical Site
Thousand Oaks, California 91360

Clinical Site
Upland, California 91786

Clinical Site
Avon Park, Florida 33825

Clinical Site
Clearwater, Florida 33765

Clinical Site
Hialeah, Florida 33016

Clinical Site
Miami Gardens, Florida 33014

Clinical Site
Tampa, Florida 33607

Clinical Site
Zephyrhills, Florida 33542

Clinical Site
Gainesville, Georgia 30501

Clinical Site
Springfield, Illinois 62702

Clinical Site
Lake Charles, Louisiana 70605

Clinical Site
Baltimore, Maryland 21224-6821

Clinical Site
Grand Blanc, Michigan 48439-2451

Clinical Site
Brooklyn, New York 11201

Clinical Site
Rochester, New York 14642

Clinical Site
Charlotte, North Carolina 28262

Clinical Site
Leland, North Carolina 28451

Clinical Site
Middleburg Heights, Ohio 44130

Clinical Site
Portland, Oregon 97239

Clinical Site
Duncansville, Pennsylvania 16635

Clinical Site
Jackson, Tennessee 38305

Clinical Site
Memphis, Tennessee 38119

Clinical Site
Murfreesboro, Tennessee 37128

Clinical Site
Allen, Texas 75013

Clinical Site
Austin, Texas 78745

Clinical Site
Baytown, Texas 77521

Clinical Site
Colleyville, Texas 76034

Clinical Site
Houston, Texas 77089

Clinical Site
Lubbock, Texas 79424

Clinical Site
Plano, Texas 75024

Clinical Site
Seattle, Washington 98122

Clinical Site
Beckley, West Virginia 25801

More Details

Status
Recruiting
Sponsor
MoonLake Immunotherapeutics AG

Study Contact

Moonlake Clinical Trial Helpdesk
+41 41 510 8022
ClinicalTrials@moonlaketx.com

Detailed Description

M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.