220 Participants NeededMy employer runs this trial

DDY391 for Psoriatic Arthritis

Recruiting at 2 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Novartis Pharmaceuticals
Prior Safety DataThis treatment has passed at least one previous human trial

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

I meet the main requirements for this study.
I am at least 18 years old.
I have moderate to severe psoriatic arthritis now.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive DDY391 or placebo to evaluate efficacy, safety, and tolerability

12 weeks

Treatment Part B

Participants receive multiple doses of DDY391 or placebo to determine dose-response relationship

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Part B: Placebo Schedule 2Experimental Treatment1 Intervention
Group II: Part B: Placebo Schedule 1Experimental Treatment1 Intervention
Group III: Part B: DDY391- Schedule 2 Dose CExperimental Treatment1 Intervention
Group IV: Part B: DDY391- Schedule 1 Dose CExperimental Treatment1 Intervention
Group V: Part B: DDY391- Schedule 1 Dose BExperimental Treatment1 Intervention
Group VI: Part B: DDY391- Schedule 1 Dose AExperimental Treatment1 Intervention
Group VII: Part A: DDY391-Schedule 1 Dose AExperimental Treatment1 Intervention
Group VIII: Part A: Placebo Schedule 1Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

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