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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MoonLake Immunotherapeutics AG
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

1. Participant is ≥18 years of age;

2. 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;

3. Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3);

4. Participant has either current active PsO or a dermatologist confirmed history of PsO;

5. Participant tests negative for rheumatoid factor (RF) at the Screening Visit;

6. Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit;

7. Participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information.

Exclusion Criteria:

1. Participant with known hypersensitivity to sonelokimab or any of its excipients;

2. Participant with known hypersensitivity to adalimumab or any of its excipients;

3. Participant who has previously failed on anti-interleukin (IL)-17 therapy;

4. Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy;

5. Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit;

6. Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA;

7. Participant who has a diagnosis of arthritis mutilans