NCT05640245

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: MoonLake Immunotherapeutics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will be randomized to receive one of three sonelokimab treatment regimes, adalimumab or placebo. Primary efficacy evaluation will take place at Week 12. Patients will be allocated to a further 12 weeks of treatment with sonelokimab or adalimumab based on response assessment at week 12. In certain countries, treatment will end at week 12.

Conditions

• Arthritis, Psoriatic

Interventions

Type	Name	Description
DRUG	Sonelokimab	randomized treatment; parallel group
DRUG	Placebo	randomized treatment; parallel-group
DRUG	Adalimumab	randomized treatment; parallel-group

Timeline

• Start date: 2022-12-13
• Primary completion: 2023-09-05
• Completion: 2024-01-15
• First posted: 2022-12-07
• Last updated: 2024-09-05

Locations

42 sites across 8 countries: United States, Bulgaria, Czechia, Estonia, Germany, Hungary, Poland, Spain

Regulatory

• FDA-regulated drug study