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

Recruiting · NCT06641089 · Interventional (participants receive a specific treatment) · Lead sponsor: MoonLake Immunotherapeutics AG

View the official record on ClinicalTrials.gov →

Psoriasis

Interventions studied

PlaceboRisankizumabSonelokimab

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

Participants must be ≥18 years of age .
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.
Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).
Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
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

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

Where it is running

60 locations listed across 18 US states.

Clinical Site - Avondale, Arizona, United States
Clinical Site - Chandler, Arizona, United States
Clinical Site - Flagstaff, Arizona, United States
Clinical Site - Mesa, Arizona, United States
Clinical Site - Phoenix, Arizona, United States
Clinical Site - Scottsdale, Arizona, United States
Clinical Site - Tucson, Arizona, United States
Clinical Site - Jonesboro, Arkansas, United States
Clinical Site - La Jolla, California, United States
Clinical Site - Pomona, California, United States
Clinical Site - San Diego, California, United States
Clinical Site - Santa Monica, California, United States
Clinical Site - Thousand Oaks, California, United States
Clinical Site - Upland, California, United States
Clinical Site - Avon Park, Florida, United States
Clinical Site - Clearwater, Florida, United States
Clinical Site - Hialeah, Florida, United States
Clinical Site - Miami Gardens, Florida, United States
Clinical Site - Tampa, Florida, United States
Clinical Site - Zephyrhills, Florida, United States
Clinical Site - Gainesville, Georgia, United States
Clinical Site - Springfield, Illinois, United States
Clinical Site - Lake Charles, Louisiana, United States
Clinical Site - Baltimore, Maryland, United States
Clinical Site - Grand Blanc, Michigan, United States
Clinical Site - Brooklyn, New York, United States
Clinical Site - Rochester, New York, United States
Clinical Site - Charlotte, North Carolina, United States
Clinical Site - Leland, North Carolina, United States
Clinical Site - Middleburg Heights, Ohio, United States
Clinical Site - Portland, Oregon, United States
Clinical Site - Duncansville, Pennsylvania, United States
Clinical Site - Jackson, Tennessee, United States
Clinical Site - Memphis, Tennessee, United States
Clinical Site - Murfreesboro, Tennessee, United States
Clinical Site - Allen, Texas, United States
Clinical Site - Austin, Texas, United States
Clinical Site - Baytown, Texas, United States
Clinical Site - Colleyville, Texas, United States
Clinical Site - Houston, Texas, United States
Clinical Site - Lubbock, Texas, United States
Clinical Site - Plano, Texas, United States
Clinical Site - Seattle, Washington, United States
Clinical Site - Beckley, West Virginia, United States
Clinical Site - A Coruña, Spain
Clinical Site - Alcobendas, Spain
Clinical Site - Barnet, United Kingdom
Clinical Site - Berlin, Germany
Clinical Site - Berlin, Germany
Clinical Site - Berlin, Germany
Clinical Site - Bialystok, Poland
Clinical Site - Bilbao, Spain
Clinical Site - Brno, Czechia
Clinical Site - Budapest, Hungary
Clinical Site - Budapest, Hungary
Clinical Site - Bydgoszcz, Poland
Clinical Site - Calgary, Canada
Clinical Site - Caluire-et-Cuire, France
Clinical Site - Castellon, Spain
Clinical Site - Częstochowa, Poland

Showing 60 of 143 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →