A Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis
- NCT ID
- NCT07801495
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Phase 2
- Sponsor
- Novartis Pharmaceuticals
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 220 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following 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.
Study locations
1 study location is listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: United States
- Texas, United States: 1
Sample of listed locations
- Rheumatology Associates of South Texas — San Antonio, Texas, 78251, United States — Site recruitment status not specified in the registry data
Study details
- Start date
- October 14, 2026
- Primary completion date
- December 13, 2028
- First posted
- September 3, 2026
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT07801495
- Registry last updated
- September 17, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT07801495 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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