NCT06641089Active, not recruitingPhase 3
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
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
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 11 Oct 2024
- Start date
- 15 Oct 2024
- Primary completion date
- 4 Jan 2027
- Lead sponsor
- MoonLake Immunotherapeutics AG
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT06641089
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 600
- From 15 Oct 2024 to the primary completion date, 4 Jan 2027
- 111 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
- 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
Other illness
- 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.
Other
- Participants who have an established diagnosis of arthritis mutilans.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (111)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Site Coordinator of this site? Confirm its status | Pazardzhik | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Pleven | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Rousse | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Waterloo | Canada | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Ostrava | Czechia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Studénka | Czechia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Zlín | Czechia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Herne | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Alcobendas | Spain | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Bilbao | Spain | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Castellon | Spain | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Clinical SIte Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Caluire-et-Cuire | France | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Narbonne | France | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Barnet | United Kingdom | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Westcliff-on-Sea | United Kingdom | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Clinical SIte Coordinator of this site? Confirm its status | Gyula | Hungary | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Hódmezővásárhely | Hungary | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Szolnok | Hungary | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Veszprém | Hungary | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Częstochowa | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Elblag | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Gdynia | Poland | Unknown status |
| Clinical site Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Nadarzyn | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Sochaczew | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Swidnica | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Wołomin | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Allen | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Avondale | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Avon Park | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Baytown | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Beckley | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Colleyville | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Duncansville | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Flagstaff | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Grand Blanc | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Jonesboro | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Lake Charles | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Leland | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Mesa | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Miami Gardens | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Middleburg Heights | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Murfreesboro | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Pomona | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Thousand Oaks | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Upland | United States | Unknown status |
| Clinical Site Coordinator of this site? Confirm its status | Zephyrhills | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.