Comparison of Otezla to SFA-002 to Placebo in Plaque Psoriasis Patients

Launched by SFA THERAPEUTICS · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two treatments, SFA002 and Otezla (also known as apremilast), to see which one works better for people with plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin. The study will involve adults and children who have mild to severe forms of this condition. Researchers want to find out how effective each treatment is over a period of 52 weeks, with check-ins at 12, 24, and 52 weeks to see how much improvement participants experience. They will also include a placebo group, which is a look-alike treatment that contains no active medication, to compare the results.

To join the trial, participants must have chronic plaque psoriasis that has lasted at least six months, with specific severity levels. Those who qualify will be randomly assigned to receive either SFA002, Otezla, or the placebo. Participants can expect regular visits for medical assessments, where their skin condition will be checked, and they will answer questionnaires about their experience. If someone does not see improvement after 12 weeks on either Otezla or the placebo, they will be given the option to switch to SFA002 for the rest of the study. It's important to note that there may be more visits and evaluations than usual compared to standard care.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria:-
• 1. Candidates for systemic therapy with mild to moderate chronic plaque psoriasis (PsO) (with or without psoriatic arthritis) at Screening and Baseline for at least 6 months prior to Baseline defined as:
• • 2. Body Surface Area (BSA) \>= 10% and \<= 15%; and Psoriasis Area and Severity Index (PASI) \>= 12; and Static Physician Global Assessment (sPGA) = 3 (moderate) based on a 5-point scale (0 to 4) -
• Exclusion Criteria:
• • 1. Participant has any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
• • 2. History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
• • 3. History of active ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).
• • 4. Prior exposure to SFA002 or apremilast. -