1. to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis (PsA).
2. to determine the dose-response relationship of DDY391 in participants with PsA to support dose selection for Phase 3.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Key Inclusion Criteria:
* Female or male participants at least 18 years of age.
* Diagnosis of PsA and meeting classification criteria for Psoriatic arthritis (CASPAR) at screening.
* Moderate to severe PsA at screening and baseline.
Key Exclusion Criteria:
* Presence of inflammatory conditions other than psoriasis or PsA including but not limited to those associated with arthralgia or arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, scleroderma, sarcoidosis) or presence of fibromyalgia or osteoarthritis with articular symptoms.
* Use of bDMARD treatment within 4 weeks or 5 half-lives of randomization, whichever is longer
* Prior use of JAK inhibitors or TYK2 inhibitors (e.g., deucravacitinib). Prior use of apremilast is allowed but must not be taken within 4 weeks of baseline.
* Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to baseline.
* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
* Any active viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infections.
Other protocol-defined inclusion/exclusion criteria may apply.
Primary outcome measure(s)
Part A: Number of participants achieving American College of Rheumatology 50 (ACR50) response — Week 12 To evaluate the efficacy of DDY391 versus placebo through achievement of ACR 50. ACR 50 is a validated tool for assessing RA disease activity.
Part A and B: Number of participants achieving American College of Rheumatology 50 (ACR50) response — Week 12 To demonstrate the dose-response relationship of DDY391 compared to placebo in bDMARD-IR participants.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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