Tests DDY391 in adults with moderate to severe psoriatic arthritis
Tests DDY391 against a placebo in adults with active psoriatic arthritis.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis
Key facts
- Where
- Colleyville, Corpus Christi, Duncansville, Huntington Beach, Katy, Memphis, Philadelphia, and San Antonio, United StatesSee the 8 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT07801495, who can take part
Where in United States
- Precision Comprehensive ResearchColleyville, United StatesTaking people
- Arthritis Care of TexasCorpus Christi, United StatesTaking people
- Altoona Center for Clin ResDuncansville, United StatesTaking people
- Newport Huntington Medical GroupHuntington Beach, United StatesTaking people
- Biopharma Informatic, LLCKaty, United StatesTaking people
- Shelby Research LLCMemphis, United StatesTaking people
- WCG CR Philadelphia LLCPhiladelphia, United StatesTaking people
- Rheumatology Associates of South TexasSan Antonio, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07801495
- Record updated
- 9 November 2026
- Original description
The purpose of this Phase 2a/b study is:Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; 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; 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; Use of bDMARD treatment within 4 weeks or 5 half-lives of randomization, whichever is longer.