Psoriasis Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

207

Study ID:

NCT05640245

Recruitment Status:

Completed

Sponsor:

MoonLake Immunotherapeutics AG

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 42 Locations for this study

See Locations Near You

Clinical Site
Rancho Mirage California, 92260, United States
Clinical Site
Duncansville Pennsylvania, 16635, United States
Clinical Site
Pleven , 5800, Bulgaria
Clinical Site
Pleven , 5803, Bulgaria
Clinical Site
Plovdiv , 4002, Bulgaria
Clinical Site
Plovdiv , 4003, Bulgaria
Clinical Site
Ruse , 7002, Bulgaria
Clinical Site
Sofia , 1336, Bulgaria
Clinical Site
Stara Zagora , 6000, Bulgaria
Clinical Site
Varna , 9000, Bulgaria
Clinical Site
Ostrava , 702 0, Czechia
Clinical Site
Tallinn , 10128, Estonia
Clinical Site
Tartu , 20708, Estonia
Clinical Site
Hamburg , 20095, Germany
Clinical Site
Herne , 44649, Germany
Clinical Site
Budapest , 1023, Hungary
Clinical Site
Budapest , 1027, Hungary
Clinical Site
Budapest , 1036, Hungary
Clinical Site
Szekesfehervar , 8000, Hungary
Clinical Site
Szentes , 6600, Hungary
Clinical Site
Veszprém , 8200, Hungary
Clinical Site
Białystok , 15-07, Poland
Clinical Site
Białystok , 15-35, Poland
Clinical Site
Białystok , 15-87, Poland
Clinical Site
Bydgoszcz , 85-06, Poland
Clinical Site
Bydgoszcz , 85-16, Poland
Clinical Site
Elbląg , 82-30, Poland
Clinical Site
Gdynia , 81-33, Poland
Clinical Site
Kraków , 30-72, Poland
Clinical Site
Nadarzyn , 05-83, Poland
Clinical Site
Nowa Sól , 67-10, Poland
Clinical Site
Olsztyn , 10-11, Poland
Clinical Site
Poznan , 61-11, Poland
Clinical Site
Sochaczew , 96-50, Poland
Clinical Site
Swidnica , 58-10, Poland
Clinical Site
Warsaw , 02-66, Poland
Clinical SIte
Wrocław , 52-41, Poland
Clinical Site
Łódź , 90-24, Poland
Clinical Site
Madrid , 28100, Spain
Clinical Site
Sabadell , 8208, Spain
Clinical Site
Santiago De Compostela , 15702, Spain
Clinical Site
Sevilla , 41010, Spain

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

207

Study ID:

NCT05640245

Recruitment Status:

Completed

Sponsor:


MoonLake Immunotherapeutics AG

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.