IRX4204 for Plaque Psoriasis

(IRX4204-Psoria Trial)

Overseen By Michelle Wawrzyniak

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Io Therapeutics

Must not be taking: Biologics, Immunosuppressives, Anticoagulants, others

Disqualifiers: Severe psoriasis, Non-plaque psoriasis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, IRX4204, to determine its effectiveness for plaque psoriasis, a skin condition that causes scaly, itchy patches. The study compares IRX4204 to a placebo (a substance with no active drug) and monitors for any side effects. Suitable candidates for this trial have had plaque psoriasis for at least six months and struggle to manage it with current treatments. Participants will take the study medication daily for 28 days and visit the clinic weekly for checkups and tests. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires participants to stop certain medications before starting. You must stop biologics 12 weeks before, systemic immunosuppressives 4 weeks before, and topical medications 2 weeks before the trial begins.

Is there any evidence suggesting that IRX4204 is likely to be safe for humans?

Research shows that IRX4204 is being tested for safety in treating plaque psoriasis, a common skin condition. In earlier studies, researchers administered this treatment to assess patient tolerance. Most participants managed the treatment without experiencing many serious side effects. Some mild to moderate side effects occurred, but they were uncommon.

Since IRX4204 is now in a phase 2 trial, earlier tests have already demonstrated some safety. These early tests suggest that serious side effects are rare. This phase focuses on understanding the treatment's effectiveness and checking for any additional safety concerns. Prospective participants should know that the treatment is still under study, but previous results have been promising in terms of safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

IRX4204 is unique because it targets the retinoid X receptor (RXR), which is a different approach compared to standard treatments for plaque psoriasis like TNF inhibitors and interleukin blockers. Most treatments for this condition focus on suppressing the immune response to reduce inflammation. However, IRX4204 works by modulating gene expression through RXR, potentially offering a novel way to manage psoriasis. Researchers are excited about this treatment because it could provide an alternative for patients who do not respond well to existing therapies, and it might have a different side effect profile.

What evidence suggests that IRX4204 might be an effective treatment for plaque psoriasis?

Research has shown that IRX4204 has been investigated for treating plaque psoriasis. While specific data on its effectiveness for psoriasis in humans is limited, IRX4204 affects certain cell processes related to inflammation, potentially reducing the skin plaques seen in psoriasis. Early results from studies on other conditions suggest that IRX4204 can enhance certain treatment effects, offering hope for its use in psoriasis. However, further research is necessary to confirm its benefits for this condition. Participants in this trial will receive either IRX4204 or a placebo to evaluate its effectiveness for plaque psoriasis. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate plaque psoriasis. Participants must be willing to take a daily dose of the study medication or placebo for 28 days and visit the clinic weekly for checkups and tests. The specific eligibility criteria are not provided, but typically participants should not have other serious health issues that could interfere with the study.

Inclusion Criteria

I have been diagnosed with plaque psoriasis for at least 6 months.

I am eligible for light therapy or medication for my psoriasis.

My doctor thinks RXR agonist therapy is right for me.

Exclusion Criteria

I haven't taken any experimental drugs in the last 4 weeks.

My psoriasis is not in the form of plaques.

I have heart problems that are not well-controlled.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take IRX4204 every day for 28 days and visit the clinic once every week for checkups and tests

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IRX4204

Trial Overview The trial is testing IRX4204's effectiveness in treating symptoms of plaque psoriasis compared to a placebo (a substance with no active drug). It's double-blind, meaning neither researchers nor participants know who gets the real drug versus placebo, ensuring unbiased results.

How Is the Trial Designed?

Group I: Treatment Active Control 1 Intervention

IRX4204

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Io Therapeutics

Lead Sponsor

Trials

5

Recruited

100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06723171

Study Details | NCT06723171 | Evaluation of Safety and ... The goal of this clinical trial is to learn if IRX4204 works to treat plaque psoriasis in adults. It will also learn about the safety of IRX4204.

2. withpower.com withpower.com/trial/phase-2-psoriasis-2-2025-f7fb6

IRX4204 for Plaque Psoriasis · Info for Participants The goal of this clinical trial is to learn if IRX4204 works to treat plaque psoriasis in adults. It will also learn about the safety of IRX4204.

3. ctv.veeva.com ctv.veeva.com/study/a-multicenter-double-blind-placebo-controlled-study-evaluating-safety-and-efficacy-of-irx4204-in-p

Evaluation of Safety and Efficacy of IRX4204 in Mild to ... The goal of this clinical trial is to learn if IRX4204 works to treat plaque psoriasis in adults. It will also learn about the safety of ...

4. delta.larvol.com delta.larvol.com/Products/?ProductId=4250a7be-2a3e-4335-bac8-1444d9b87a91

IRX4204 / Io Therap IRX4204-Psoria: A Study Evaluating Safety and Efficacy of IRX4204 in Plaque Psoriasis ... These data demonstrate that IRX4204 can enhance the anti-cancer ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11604970/

Efficacy and Safety of Risankizumab in Patients with Psoriasis ... Risankizumab has demonstrated superior efficacy compared to other psoriasis treatments, including secukinumab, adalimumab, and ustekinumab.

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06723171/

Trial | NCT06723171 The goal of this clinical trial is to learn if IRX4204 works to treat plaque psoriasis in adults. It will also learn about the safety of IRX4204.

7. medchemexpress.com medchemexpress.com/agn194204.html?srsltid=AfmBOopae1uVOaUosBi7XgIJroU_RSoriOyKaXWgzClQqzZojRrflyvi

AGN194204 (IRX4204) | Selective RXR Agonist Psoriasis|Plaque Type Psorisis|Plaque Psoriasis. 2025-06, PHASE2. NCT02991651 ... SAFETY DATA SHEET (SDS). English - EN (252 KB) Français - FR (252 KB) ...