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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: MoonLake Immunotherapeutics AG · Participants: 600 · Started: Oct 15, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06641089

Locations in the U.S.

ArizonaClinical Site, Avondale
Clinical Site, Mesa
Clinical Site, Phoenix
Clinical Site, Scottsdale
Clinical Site, Tucson
ArkansasClinical Site, Jonesboro
CaliforniaClinical Site, La Jolla
Clinical Site, Pomona
Clinical Site, Santa Monica
Clinical Site, Thousand Oaks
Clinical Site, Upland
FloridaClinical Site, Avon Park
Clinical Site, Clearwater
Clinical Site, Hialeah
Clinical Site, Miami Gardens
Clinical Site, Tampa
Clinical Site, Zephyrhills
GeorgiaClinical Site, Gainesville
IllinoisClinical Site, Springfield
LouisianaClinical Site, Lake Charles
MarylandClinical Site, Baltimore
New YorkClinical Site, Brooklyn
Clinical Site, Rochester
North CarolinaClinical Site, Charlotte
Clinical Site, Leland
OhioClinical Site, Middleburg Heights
OregonClinical Site, Portland
PennsylvaniaClinical Site, Duncansville
TennesseeClinical Site, Jackson
Clinical Site, Memphis
TexasClinical Site, Austin
Clinical Site, Baytown
Clinical Site, Colleyville
Clinical Site, Lubbock
WashingtonClinical Site, Seattle
West VirginiaClinical Site, Beckley

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.