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A Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2a/b Study Assessing the Efficacy, Safety and Tolerability of DDY391 in Participants With Active Moderate to Severe Psoriatic Arthritis
Who can join
Ages 18 to 100 · All sexes
Full eligibility criteria
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.
About the study
The purpose of this Phase 2a/b study is:
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.
What is being tested
- DDY391 (drug)
- Placebo (drug)
Sponsor: Novartis Pharmaceuticals · Participants: 220 · Started: Oct 14, 2026
Contact the study team
- Novartis Pharmaceuticals · Phone: 1-888-669-6682
- Novartis Pharmaceuticals · Phone: +41613241111
Official record on ClinicalTrials.gov — NCT07801495
Locations in the U.S.
| Texas | Precision Comprehensive Research, Colleyville Rheumatology Associates of South Texas, San Antonio |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.