Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis

This is a phase 2a, Randomized, Multi-center, Blinded, Paired Psoriasis Lesion, Comparative Placebo-Controlled study to evaluate the safety, preliminary efficacy and pharmacokinetics of MOL4239 in 30 adult subjects with mild to moderate plaque psoriasis. Eligible subject will have a diagnosis of mild to moderate plaque psoriasis affecting 9.9% body surface area (BSA) or less, and two designated similar target lesions with a Psoriasis Severity Score of at least 6 or higher. Each subject will apply 10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days.

Inclusion criteria

• Adults, males or females, 18 to 72 years of age (both inclusive.)
• Mild to moderate plaque psoriasis with lesions that in total are no more than 9.9% BSA and with a baseline Psoriasis Severity Score (PSS) of 6 or more.
• Identification of bilaterally symmetrical or approximately equivalent target lesions of at least 2.5 x 2.5 cm (~6 cm2) on the trunk, arms or legs to mid calf with a Psoriasis Severity Score (PSS) of 6 or greater.
• Willing to avoid tanning devices or exposure of the treated skin to the sun.
• Willing to not use cosmetics, including lotions, creams, and moisturizers on the treated lesions.
• Use of Eucerin® is allowed on all non-test site areas.
• Willing to forgo systemic and other topical treatments for psoriasis during the course of the study.
• Willing to avoid bathing or swimming for two hours after study drug treatment.
• Negative urine pregnancy test at Screening and baseline for women of childbearing potential (WOCP).
• Sexually active WOCP participating in the study must agree to use a medically acceptable method of contraception while on study.
• Must have recovered from the effects of any surgery, other than minor office surgical procedures, and a minimum of 3 months must have elapsed from the day of surgery to the day of screening.

Exclusion criteria

• Presence of significant abnormalities of liver or renal functions.
• Presence of any clinically significant lab abnormalities at screening.
• Any significant uncontrolled medical disease.
• Use of the anti-tumor necrosis factor (TNF) biologic agents 4 months prior to randomization or use of Stelara 6 months prior to randomization.
• Use, within one month prior to baseline or during the study, of: 1) systemic immunosuppressive drugs (e.g., tacrolimus), or 2) oral meds (e.g. methotrexate, retinoids, etc.).
• Use within one month prior to baseline or during the study of: 1) Systemic corticosteroids, 2) Systemic antibiotics, 3) other systemic antipsoriatic treatment, 4) oral psoralen with ultraviolet A (PUVA) therapy, or 5) ultraviolet B (UVB) therapy.
• Use within two weeks prior to baseline or during the study of: 1) topical anti-psoriatic drugs, 2) topical corticosteroids, 3) other topical retinoids, or 4) topical immunosuppressive agents.
• Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis.
• Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris.
• Females who are pregnant, breast feeding, or planning a pregnancy.