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

Exclusion criteria

• . 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.)