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Clinical trials
NCT07801495

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

ClinicalTrials.gov identifier NCT07801495

Novartis reference CDDY391A12201

Show study information as

Condition Moderate to Severe Psoriatic Arthritis

Study status Recruiting

Phase 2

Number of participants 220

Gender All

Age 18 to 100 years

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Study details

This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy, safety, tolerability and dose-response relationship of DDY391 in participants with active moderate to severe PsA.

The study is composed of two sequential parts:

Part A to evaluate efficacy, safety and tolerability of DDY391 compared with placebo.
Part B to determine the dose-response relationship of multiple doses of DDY391 compared with placebo.

Interventions

DRUG: DDY391|DRUG: Placebo

Official title

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

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Who can take part?

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.

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.

Home
Clinical trials
NCT07801495

Study of an Investigational Treatment for Moderate to Severe Psoriatic Arthritis

ClinicalTrials.gov identifier NCT07801495

Novartis reference CDDY391A12201

Show study information as

Condition Moderate to Severe Psoriatic Arthritis

Study status Recruiting

Phase 2

Number of participants 220

Gender All

Age 18 to 100 years

Learn More

Study details

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

The purpose of this research study is to learn about the effects and safety of an investigational treatment in adults with active moderate to severe psoriatic arthritis.

Participants will receive either the investigational treatment at different dose levels or a placebo. A placebo looks like the investigational treatment but does not contain active medication. The study has 2 parts. In the first part, the investigational treatment is compared with placebo. In the second part, multiple doses of the investigational treatment are compared with placebo to understand how the dose relates to effects and safety.

This study may be an option for
Adults with psoriatic arthritis may be able to participate if they:

Are age 18 or older
Have psoriatic arthritis that meets standard classification criteria
Have moderate to severe psoriatic arthritis

Interventions

DRUG: DDY391|DRUG: Placebo

Official title

Who can take part?

This text was simplified by AI to make it easier to read. It may contain mistakes. Switch to Original information for the official version.

You might be able to join if

Are female or male and age 18 or older
Have psoriatic arthritis and meet standard classification criteria for psoriatic arthritis at screening
Have moderate to severe psoriatic arthritis at screening and at the start of the study

You might not be able to join if

Have an inflammatory condition other than psoriasis or psoriatic arthritis that can cause joint pain or arthritis (for example, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or sarcoidosis), or have fibromyalgia, or have osteoarthritis with joint symptoms
Have used a biologic disease-modifying antirheumatic drug (bDMARD) too recently (within 4 weeks before assignment to study treatment, or within 5 drug half-lives, whichever is longer)
Have used JAK inhibitors or TYK2 inhibitors in the past (prior use of apremilast is allowed, but it must not be taken within 4 weeks before the start of the study)
Have been treated before with any cell-depleting therapy (for example, anti-CD20), unless it was at least 12 months before the start of the study
Have a history of lymphoproliferative disease, or have any known cancer, or have had cancer in the past 5 years (except certain treated skin conditions with no return in the past 3 months, carcinoma in situ of the cervix, or non-invasive cancerous colon polyps that have been removed)
Have an active viral, bacterial, or other infection at screening or at assignment to study treatment, or have a history of repeated serious infections or repeated bacterial infections

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