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.
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.
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
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There are 42 Locations for this study
Rancho Mirage California, 92260, United States
Duncansville Pennsylvania, 16635, United States
Pleven , 5800, Bulgaria
Pleven , 5803, Bulgaria
Plovdiv , 4002, Bulgaria
Plovdiv , 4003, Bulgaria
Ruse , 7002, Bulgaria
Sofia , 1336, Bulgaria
Stara Zagora , 6000, Bulgaria
Varna , 9000, Bulgaria
Ostrava , 702 0, Czechia
Tallinn , 10128, Estonia
Tartu , 20708, Estonia
Hamburg , 20095, Germany
Herne , 44649, Germany
Budapest , 1023, Hungary
Budapest , 1027, Hungary
Budapest , 1036, Hungary
Szekesfehervar , 8000, Hungary
Szentes , 6600, Hungary
Veszprém , 8200, Hungary
Białystok , 15-07, Poland
Białystok , 15-35, Poland
Białystok , 15-87, Poland
Bydgoszcz , 85-06, Poland
Bydgoszcz , 85-16, Poland
Elbląg , 82-30, Poland
Gdynia , 81-33, Poland
Kraków , 30-72, Poland
Nadarzyn , 05-83, Poland
Nowa Sól , 67-10, Poland
Olsztyn , 10-11, Poland
Poznan , 61-11, Poland
Sochaczew , 96-50, Poland
Swidnica , 58-10, Poland
Warsaw , 02-66, Poland
Wrocław , 52-41, Poland
Łódź , 90-24, Poland
Madrid , 28100, Spain
Sabadell , 8208, Spain
Santiago De Compostela , 15702, Spain
Sevilla , 41010, Spain
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