drugset / Trial / NCT06863493

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

NCT06863493

Phase 2/3 Not yet recruiting 125 enrolled SFA Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial\] is to learn if SFA002 can treat mild, moderate and severe plaque psoriasis as good or better than Otezla, compared to placebo in adult and pediatric patients. The main questions it aims to answer are: How much does oral SFA002 treatment improve plaque psoriasis measured at different timepoints, 12 weeks, 24 weeks and 52 weeks of treatment. How much does Oral Otezla (Apremilast) improve plaque psoriasis measured at different timepoints, 12 weeks, 24 weeks and 52 weeks of treatment. These treatments will be compared to placebo, a look-alike substance that contains no drug. Participants will be randomly placed into 3 groups to receive either SFA002, or oral apremilast or placebo for the duration of the trial. Patients that do not respond to apremilast or placebo treatment in 12 weeks will be offered the opportunity to take SFA002 for the remainder of the study. There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

Timeline

Start
2025-06-01
Primary completion
2026-06-01
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Apremilast Small molecule 30 mg Oral
Subject SFA002 Unknown 760 mg Oral

Indications