Evaluation of Safety and Efficacy of IRX4204 in Mild to Moderate Plaque Psoriasis (NCT06723171) | Clinical Trial Compass
SuspendedPhase 2
Evaluation of Safety and Efficacy of IRX4204 in Mild to Moderate Plaque Psoriasis
Stopped: Sponsor request for study hold
United States20 participantsStarted 2026-03-01
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 18 years of age
✓. Have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study treatment
✓. Meet the following disease severity criteria for moderate to severe plaque psoriasis at Screening and Baseline visits:
✓. IGA Score of 3 or 4 AND
✓. Total affected body surface area of \>3 to 10% for moderate and 10% to 15% for severe psoriasis
✓. Excludes participants with scalp only plaques
✓. 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
✓. In the opinion of the Investigator, be a candidate for phototherapy or systemic treatment for psoriasis
Exclusion criteria
What they're measuring
1
To evaluate if participants receiving IRX4204 achieve greater reduction in IGA scores when compared to participants receiving placebo
✕. Has more than 15% of total body surface area affected by psoriasis plaques
✕. Has a non-plaque form of psoriasis (e.g., erythrodermic, guttate, or pustular) at Screening or at time of randomization
✕. 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)
✕. Has confounding diagnoses including but not limited to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma
✕. 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
✕. 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
✕. 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.)
✕. 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.)