Evaluation of Sonelokimab in Patients with Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

Description

This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

Conditions

Arthritis, Psoriatic

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Study Overview

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Study Details

Study overview

This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.

A Phase 3, Parallel-group, Randomized, Double-blind, 3-arm, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over with Active Psoriatic Arthritis Who Are Naive to Biologic DMARDs

Evaluation of Sonelokimab in Patients with Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

Condition
Arthritis, Psoriatic
Intervention / Treatment

-

Contacts and Locations

Upland

Clinical Site, Upland, California, United States, 91786

Grapevine

Clinical Site, Grapevine, Texas, United States, 76051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MoonLake Immunotherapeutics AG,

Study Record Dates

2027-01-15