Oral CBP-0276 or Placebo in Adults With Active Psoriatic Arthritis (PsA)

Randomized trial aimed to assess in adults with PsA the effect of oral CBP-0276 administrated at a dose of 200mg QD, or 800mg QD vs. Placebo for CBP-0276 for 24 weeks. Primary outcome is the change at least 20% on severity of symptoms eat week 24, using the American College Rheumatologic Score (ACR) and key secondary outcomes are the change on ACR20% at week 16 and ACR50/70% at at week 24. Additional secondary outcome include a) ACR50/70% at week 4, 8, 12, 16 and 20; b) changes on Disease Activity at week 4, 8, 12, 16, 20 and 24; c) Changes on disability index at week 4, 8, 12, 16, 20 and 24; d) Changes on dactilitis and enthesitis severity; d) Changes on Quality of Life and e) Changes on plaque psoriatic activity. Exploratory outcomes include changes at week 4,8,12,16 and 24 on a) tender joint count; b) global patient evaluation and c) patient level of fatigue and imapct on daily life. Elegible patients are 18-75 years, BMI between 18 and 39 kg/m2, fulfill the classification criteria for PsA, had symptoms for at least 6 months and less than 12 months before screening, had active disease at baseline (3 of 68 or more tender joints and 3 of 66 or more swollen joints), had at least one active plaque psoriatic lesion or documented history of plaque psoriasis and failed to respond or stabilize on NSAIDs and/or csDMARDs will be included. Enrolled patients will be randomly assigned (1:1:1) to receive oral CBP-0276 200mg QD, 800mg QD or placebo for CBP-0276 for 24 weeks