DDY391 for Psoriatic Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who have been diagnosed with moderate to severe psoriatic arthritis. Participants must meet specific criteria confirming their diagnosis at the start of the study.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- DDY391
Trial Overview
The study is testing a new drug called DDY391 compared to a placebo (inactive treatment) in people with psoriatic arthritis, aiming to find out how well it works and what dose is best. Participants are randomly assigned to receive either DDY391 or placebo.
How Is the Trial Designed?
8
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive matching placebo Schedule 2. Based on treatment response, participants will then either switch to DDY391 Schedule 1 Dose A or receive local SOC.
Participants will receive matching placebo Schedule 1. Based on treatment response, participants will then either switch to DDY391 Schedule 1 Dose A or receive local SOC.
Participants will receive DDY391 Schedule 2 Dose C. Based on treatment response, participants will then either switch to DDY391 Schedule 1 Dose A or receive local SOC.
Participants will receive DDY391 Schedule 1 Dose C. Based on treatment response, participants will then either continue receiving DDY391 or switch to local SOC.
Participants will receive DDY391 Schedule 1 Dose B. Based on treatment response, participants will then either continue receiving DDY391 or switch to local SOC.
Participants will receive DDY391 Schedule 1 Dose A. Based on treatment response, participants will then either continue receiving DDY391 or switch to local standard of care (SOC).
Participants will receive DDY391 Schedule 1 Dose A.
Participants will receive matching placebo Schedule 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.