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Clinical Trials in the USA / NCT07801495
Recruiting Phase 2

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

NCT07801495 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2026-10-14
Last updated
2026-09-17

Condition(s) studied

Moderate to Severe Psoriatic Arthritis

Investigational drug(s) / intervention(s)

DDY391Placebo

DDY391: DDY391

Placebo: Matching placebo

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Rheumatology Associates of South Texas San Antonio Texas Recruiting

More Novartis Pharmaceuticals trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07801495 on ClinicalTrials.gov ↗ ← All trials in the USA