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NCT07801495From ClinicalTrials.govRecruiting

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

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

  • Moderate to Severe Psoriatic Arthritis

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Novartis Pharmaceuticals
Enrolment target
220
Started
14 October 2026
Main results due
13 December 2028
Study sites
2
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 100 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(2)

  • Precision Comprehensive Research

    Colleyville, Texas, United States

    Recruiting

  • Rheumatology Associates of South Texas

    San Antonio, Texas, United States

    Recruiting

Showing 2 of 2 sites. 2 of the 2 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07801495. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psor | Trialion