Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

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.

Key facts

Study ID

NCT05640245

Run by

MoonLake Immunotherapeutics AG

People needed

207

Starts

2022-12-13

Expected to finish

2024-01-15

Last updated by the study team

2024-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 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;
• Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA;
• Participant who has a diagnosis of arthritis mutilans

Where it is running

• Clinical Site — Sochaczew, Poland
• Clinical Site — Swidnica, Poland
• Clinical Site — Warsaw, Poland
• Clinical SIte — Wroclaw, Poland
• Clinical Site — Madrid, Spain
• Clinical Site — Sabadell, Spain
• Clinical Site — Santiago de Compostela, Spain
• Clinical Site — Seville, Spain
• Clinical Site — Nadarzyn, Poland
• Clinical Site — Nowa Sól, Poland
• Clinical Site — Rancho Mirage, California, United States
• Clinical Site — Duncansville, Pennsylvania, United States
• Clinical Site — Pleven, Bulgaria
• Clinical Site — Pleven, Bulgaria
• Clinical Site — Plovdiv, Bulgaria
• Clinical Site — Plovdiv, Bulgaria
• Clinical Site — Rousse, Bulgaria
• Clinical Site — Sofia, Bulgaria
• Clinical Site — Stara Zagora, Bulgaria
• Clinical Site — Varna, Bulgaria
• Clinical Site — Ostrava, Czechia
• Clinical Site — Tallinn, Estonia
• Clinical Site — Tartu, Estonia
• Clinical Site — Hamburg, Germany
• Clinical Site — Herne, Germany

Full record on ClinicalTrials.gov

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