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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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well DDY391 works and how safe and easy it is to tolerate. It is for adults with moderate to severe psoriatic arthritis, a disease that causes joint pain and swelling. The study also compares doses to help choose doses for a later study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You have psoriatic arthritis and meet the study’s rules for this diagnosis at screening.
  • Your psoriatic arthritis is moderate to severe at screening and at the start of the study.

Who can't join

  • You have another disease that causes inflammation, other than psoriasis or psoriatic arthritis. You also cannot have fibromyalgia or osteoarthritis that causes joint symptoms.
  • You recently used a biologic DMARD, a medicine that targets the immune system. You must wait at least 4 weeks, or longer depending on how long the drug stays in your body, before being assigned to a study group.
  • You have ever used a JAK or TYK2 inhibitor, types of medicines that block signals involved in inflammation. Past apremilast use is allowed, but you must stop it at least 4 weeks before the study starts.
  • You had treatment that removes certain immune cells, such as anti-CD20 treatment, less than 12 months before the study starts.
  • You have a history of a disease that causes too many lymph cells, or current cancer or cancer within the past 5 years. Exceptions include treated basal cell skin cancer or actinic keratosis with no return in the past 3 months, or removed early cervical cancer or non-invasive cancerous colon polyps.
  • You have an active infection at screening or when assigned to a study group, or a history of repeated serious infections or repeated bacterial infections.
  • Other study rules may affect whether you can join.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (3)

TN

TX