A Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis
Novartis Pharmaceuticals · NCT07801495
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–100 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 220
- US sites recruiting
- 3
- Study start
- October 14, 2026
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of this Phase 2a/b study is:
- to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis (PsA).
- to determine the dose-response relationship of DDY391 in participants with PsA to support dose selection for Phase 3.
Being studied: DDY391; Placebo
Conditions: Moderate to Severe Psoriatic Arthritis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Shelby Research LLC
Memphis, TN 38119
Site contact: Pavan Macharla · +1 901 681 9670 · shelbyres8686@outlook.com
Precision Comprehensive Research
Colleyville, TX 76034
Site contact: Mohammad Sohail · +1 972 299 8399 · mohammadsohail@pccrsolutions.com
Rheumatology Associates of South Texas
San Antonio, TX 78251
Site contact: Veronica Gonzales · VGonzales@biopharmainfo.net
Study contacts (from the official record)
- Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
- Novartis Pharmaceuticals · +41613241111
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