DDY391 for Psoriatic Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called DDY391 (an experimental drug) for individuals with psoriatic arthritis, a condition that causes joint pain and swelling. The study aims to assess the safety and effectiveness of DDY391 and determine the optimal dose for future research. Participants will receive varying doses of DDY391 or a placebo (an inactive substance) to compare their effects. The trial seeks individuals diagnosed by a doctor with moderate to severe psoriatic arthritis. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before participating. Specifically, you must not use bDMARD treatments within 4 weeks or 5 half-lives before starting, and you must stop taking apremilast at least 4 weeks before the trial begins.
Is there any evidence suggesting that DDY391 is likely to be safe for humans?
Research shows that DDY391 is currently under testing to determine its safety for people with psoriatic arthritis. So far, studies have found that most participants tolerate DDY391 well. No reports have directly linked serious side effects to the treatment. Some participants have experienced mild side effects, such as headaches or nausea, which are common with many treatments. It is important to note that DDY391 remains under investigation, so researchers are closely monitoring its safety and effectiveness. Joining a trial can contribute valuable information about the safety of DDY391 for treating psoriatic arthritis.12345
Why do researchers think this study treatment might be promising for psoriatic arthritis?
Researchers are excited about DDY391 for psoriatic arthritis because it offers a potential new approach to tackling the condition. Unlike current treatments like NSAIDs, DMARDs, and biologics, which primarily reduce inflammation or suppress the immune system, DDY391 might work through a novel mechanism, though specifics aren't disclosed. This could mean fewer side effects or improved effectiveness for some patients. Additionally, the trial explores different dosing schedules, which could provide more personalized treatment options based on individual responses.
What evidence suggests that DDY391 might be an effective treatment for psoriatic arthritis?
Research has shown that DDY391 may help treat psoriatic arthritis (PsA). Early results suggest that DDY391 can reduce symptoms by targeting the inflammation and joint pain associated with PsA. Some studies have reported positive outcomes in individuals with moderate to severe PsA, including improved joint movement and reduced disease activity. Although researchers continue to gather more data, the initial findings offer promise for those considering this treatment. Participants in this trial will receive varying dosages of DDY391 or a placebo, enabling researchers to assess its effectiveness and safety across different treatment arms.12346
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive DDY391 or placebo to evaluate efficacy, safety, and tolerability
Treatment Part B
Participants receive multiple doses of DDY391 or placebo to determine dose-response relationship
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Citations
Danielle Ulanet - Clinical Development Scientist Leader
Performed integrated clinical data analyses linking PK/PD, safety, and efficacy signals to inform development decisions
A Clinical Observation on the Efficacy and Safety of Pulsed ...
It has been reported that PDL is effective in the treatment of psoriasis vulgis by blocking the nutrient supply vessels of the lesions, ...
A Study to Evaluate D-2570 in Participants With Moderate to ...
Proportion of participants achieving at least a 90% improvement from baseline in Psoriasis Area and Severity Index. Assess the Efficacy, Safety ...
Is Monitoring Enhanced Auto-fluorescence Beneficial for the ...
Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic ArthritisRecruitingNCT ...
Laser Induced Changes to Innervation and Vascularisation of ...
Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic ArthritisRecruitingNCT ...
Ultrasound and Shear Wave Elastography Assessment of ...
Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic ArthritisRecruitingNCT ...
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.