NCT05640245CompletedPhase 2
Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis
Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 207 (actual)
- First submitted
- 28 Nov 2022
- Start date
- 13 Dec 2022
- Primary completion date
- 5 Sept 2023
- Lead sponsor
- MoonLake Immunotherapeutics AG
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT05640245
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 207
- From 13 Dec 2022 to the primary completion date, 5 Sept 2023
- 35 sites in 8 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
- Participant who has previously failed on anti-interleukin (IL)-17 therapy;
- Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy;
- Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit;
Other illness
- Participant with known hypersensitivity to sonelokimab or any of its excipients;
- Participant with known hypersensitivity to adalimumab or any of its excipients;
- Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA;
Other
- Participant who has a diagnosis of arthritis mutilans
Who the study is looking for
- Participant is ≥18 years of age;
- Participant has a confirmed diagnosis of PsA per the 2006 Classification criteria for Psoriatic Arthritis (CASPAR) with symptoms for ≥6 months prior to the Screening Visit;
- Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3);
- Participant has either current active PsO or a dermatologist confirmed history of PsO;
- Participant tests negative for rheumatoid factor (RF) at the Screening Visit;
- Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit;
- Participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.