RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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 Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over with Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors

Quick Facts

Study Start:2024-10-15

Study Completion:2027-01-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06641089

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 6. Participants must have received 1 or 2 TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with the 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.	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. 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 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

Inclusion Criteria

Exclusion 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.
6. Participants must have received 1 or 2 TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with the 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.

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.
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 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

Contacts and Locations

Study Contact

Moonlake Clinical Trial Helpdesk

CONTACT

+41 41 510 8022

ClinicalTrials@moonlaketx.com

Study Locations (Sites)

Clinical Site

Upland, California, 91786

United States

Clinical Site

Duncansville, Pennsylvania, 16635

United States

Clinical Site

Grapevine, Texas, 76051

United States

Collaborators and Investigators

Sponsor: MoonLake Immunotherapeutics AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-15

Study Completion Date2027-01-15

Study Record Updates

Study Start Date2024-10-15

Study Completion Date2027-01-15

Terms related to this study

Additional Relevant MeSH Terms

Arthritis, Psoriatic