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Nuclear Receptor Agonist

IRX4204 for Plaque Psoriasis (IRX4204-Psoria Trial)

Phase 2

Waitlist Available

Research Sponsored by Io Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Meet disease severity criteria for mild to moderate plaque psoriasis at Screening and Baseline visits: IGA Score of 1 or 2 AND affected BSA of > 1% (does not include scalp only plaques)

Must not have

Has confounding diagnoses such as palmoplantar pustulosis, eczematous dermatitis, or contact/irritant dermatitis

Received systemic immunosuppressives for psoriasis within 4 weeks of Baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (day 1) to end of study (day 42)

Summary

This trial aims to see if a new drug, IRX4204, can effectively treat plaque psoriasis in adults. It will also assess the safety of IRX4204. Participants will take IR

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with new treatments can include skin reactions at application sites, headaches, nausea, or other potential allergic reactions. Safety will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My psoriasis is mild to moderate, not just on my scalp, and covers more than 1% of my body.

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I agree not to breastfeed during the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have skin conditions like palmoplantar pustulosis or eczema.

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I have taken medication to suppress my immune system for psoriasis within the last month.

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My psoriasis is not in the form of plaques.

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I have heart problems that are not well-controlled.

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I have skin conditions that might affect psoriasis evaluations.

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I have psoriasis caused by medication.

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I have received biologic therapy for psoriasis within the last 3 months.

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I have or had cancer within the last 5 years.

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I have received an organ transplant.

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I had major surgery less than 8 weeks ago or plan to have surgery soon.

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I am being treated for a thyroid condition or have abnormal thyroid tests.

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I have severe health conditions that are not under control.

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I have a history of diseases related to lymphocyte growth.

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I cannot avoid long periods in the sun or using tanning beds.

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I was hospitalized for a serious infection within the last 2 months.

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I have an active tuberculosis infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day 1) to end of study (day 42)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (day 1) to end of study (day 42)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) to end of study (day 42) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate if participants receiving IRX4204 achieve greater improvement from baseline in disease and symptom severity as measured by the Psoriasis Area and Severity Index (PASI).

Secondary study objectives

To evaluate if a greater proportion of participants receiving IRX4204 achieve PASI50, PASI75 and PASI90 when compared to participants receiving placebo

To evaluate if participants receiving IRX4204 achieve greater reduction in IGA scores when compared to participants receiving placebo

To evaluate if participants receiving IRX4204 experience a greater reduction in affected Body Surface Area when compared to participants receiving placebo

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Other study objectives

Incidence of Treatment Emergent and Serious Adverse Events