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RecruitingPhase 2

A Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis

Novartis Pharmaceuticals · NCT07801495

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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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A Study to Assess the Efficacy, Safety and Tolerability of DDY391… (NCT07801495) | Bored Studies