Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults with moderate to severe psoriatic arthritis. Participants will take a medication called DDY391 to see how well it works and if it's safe.
Are You a Good Fit for This Trial?
Rules you outRheumatoid arthritisSystemic lupus erythematosusSclerodermaSarcoidosisFibromyalgiaOsteoarthritis
You may be able to join if
I am at least 18 years old.
I have been diagnosed with psoriatic arthritis.
I have moderate to severe psoriatic arthritis.
You may not be able to join if
I have inflammatory conditions other than psoriasis or psoriatic arthritis.
I have used certain treatments for psoriatic arthritis in the last few weeks.
I have a history of certain cancers in the past 5 years.
I currently have any active infections.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 o…
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.
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