DDY391 in psoriatic arthritis: a mid-stage test in adults with active disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial is conducted at multiple centers to evaluate the efficacy, safety, tolerability, and dose-response of DDY391 in adults with active moderate to severe psoriatic arthritis. The study has two parts: Part A compares DDY391 to placebo to assess initial efficacy and safety, and Part B explores different DDY391 doses to establish the dose-response relationship for Phase 3 planning. Participants are assigned to DDY391 at various dose levels or placebo, with ongoing monitoring for adverse events and clinical response. Eligible patients must have CASPAR-confirmed PsA and meet moderate to severe disease criteria, while certain prior therapies and comorbid conditions are exclusionary to minimize confounding factors.

Why it matters

Who can join: the full rules

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.

Where it's running

• Newport Huntington Medical Group
  Huntington Beach, California, United States Recruiting
• Altoona Center for Clin Res
  Duncansville, Pennsylvania, United States Recruiting
• WCG CR Philadelphia LLC
  Philadelphia, Pennsylvania, United States Recruiting
• Shelby Research LLC
  Memphis, Tennessee, United States Recruiting
• Precision Comprehensive Research
  Colleyville, Texas, United States Recruiting
• Arthritis Care of Texas
  Corpus Christi, Texas, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.