Oral CBP-0276 or Placebo in Adults With Active Psoriatic Arthritis (PsA)
ConditionArthritic Psoriasis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorClarent Biopharma, Inc.
About this trial
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 week 24. Eligible 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
Eligibility criteria
Qualifiers
Subject must voluntarily sign the informed consent form before any study-related procedures, understand and communicate with the investigator smoothly during the trial, and understand and voluntarily strictly abide by the provisions of this clinical study protocol;
Age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form, male or female;
Body Mass Index (BMI) ≥ 18 and ≤ 39 kg/m2 at screening;
Fulfilled the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR) and had symptoms of psoriatic arthritis for more than 6 months but less than 12 months of evolution at screening
Disqualifiers
History of Drug-induced psoriasis (including, but not limited to, psoriasis induced by beta-blockers, calcium channel inhibitors, or lithium);
Had other active inflammatory diseases or autoimmune diseases other than psoriatic arthritis, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, inflammatory bowel disease arthritis, etc.;
History of organ transplantation (except for corneal transplantation within 3 months prior to screening;
History of lymphoproliferative disorders, including symptoms and signs of lymphoma or underlying lymphoproliferative disorders;
Trial design
Treatments tested in this trial
- CBP-0276 capsules 100mg
- Placebo
Treatment groups
240 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov