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Evaluation of Safety and Efficacy of IRX4204 in Mild to Moderate Plaque Psoriasis | Clinical Trials | Clareo Health

SUSPENDEDPHASE2

Evaluation of Safety and Efficacy of IRX4204 in Mild to Moderate Plaque Psoriasis

A 4-Week, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of the RXR Agonist Compound IRX4204 for the Treatment of Mild to Moderate Plaque Psoriasis

NCT06723171•Io Therapeutics

View on ClinicalTrials.gov

Summary

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. The main questions it aims to answer are: * Does IRX4204 treat plaque psoriasis symptoms? * Does IRX4204 treat plaque psoriasis symptoms better than someone who is not being treated? * What medical problems do participants have when taking IRX4204? Researchers will compare IRX4204 to a placebo (a look-alike substance that contains no drug) to see if the drug works to treat mild to moderate plaque psoriasis. Participants will: * Take IRX4204 every day for 28 days * Visit the clinic once every week for checkups and tests * Complete specific assessments about plaque psoriasis and changes to plaques

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. At least 18 years of age
•2. Have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study treatment
•3. Meet the following disease severity criteria for moderate to severe plaque psoriasis at Screening and Baseline visits:
•1. IGA Score of 3 or 4 AND
•2. Total affected body surface area of \>3 to 10% for moderate and 10% to 15% for severe psoriasis
•3. Excludes participants with scalp only plaques
•4. Be inadequately controlled with or intolerant of at least one prior topical therapy including but not limited to: corticosteroids, retinoids, vitamin D, vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast for the treatment of psoriasis at both Screening and Baseline visits
•5. In the opinion of the Investigator, be a candidate for phototherapy or systemic treatment for psoriasis
•6. Completed appropriate washouts for prior treatments for psoriasis
•7. Be considered, in the opinion of the Investigator, suitable candidates for RXR agonist therapy
+6 more criteria

Exclusion Criteria

•1. Has more than 15% of total body surface area affected by psoriasis plaques
•2. Has a non-plaque form of psoriasis (e.g., erythrodermic, guttate, or pustular) at Screening or at time of randomization
•3. Has current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium channel blockers, or lithium)
•4. Has confounding diagnoses including but not limited to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma
•5. Has received within 12 weeks of the first dose (Day 1) any prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis, or any other indications that could impact the assessment of psoriasis. Prior biologic therapy includes but is not limited to TNF-inhibitors, IL-17 inhibitors, IL-12/23 inhibitors, IL-23 inhibitors
•6. Has received within 4 weeks of the first dose (Day 1) any systemic immunosuppressives for the treatment of psoriasis or psoriatic arthritis, or any other indications that could impact the assessment of psoriasis, Phototherapy or narrow band laser (e.g., Excimer or XTRAC), lithium, antimalarials, or intramuscular (IM) gold. Systemic immunosuppressive therapy includes but is not limited to methotrexate, azathioprine, cyclosporine, JAK/TYK pathway inhibitors, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus, acitretin, or anakinra
•7. Has received within 2 weeks of the first dose (Day 1) any topical medications for psoriasis or other conditions that could impact assessment of psoriasis, including but not limited to topical corticosteroids, retinoids, vitamin D analogs, combinations of calcipotriene and topical corticosteroids, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, PDE4 inhibitors (e.g. crisaborole), or other topicals used for the treatment of psoriasis (tapinarof, roflumilast etc.)
•8. Has received within 12 weeks or 5 half-lives (whichever is longer) of the first dose (Day 1) other biologic therapy or experimental antibody, any agent that modulates T-cells (e.g., natalizumab, abatacept etc.)
•9. Has received within 4 weeks or 5 half-lives (whichever is longer) of the first dose (Day 1) any other experimental systemic therapy for any indication
•10. Is currently enrolled in another study using an investigational agent or procedure
+22 more criteria

Locations (1)

Not posted

Webster, Texas, United States

Key Dates

Start Date

March 1, 2026

Primary Completion Date

March 1, 2026

Completion Date

April 1, 2026

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

PsoriasisPlaque Type PsorisisPlaque Psoriasis

Interventions

IRX4204

DRUG

Placebo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Safety and Efficacy of IRX4204 in Mild to Moderate Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments