NCT06863493

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

Study of the Safety and Effectiveness of Oral SFA-002 Compared to Oral Apremilast (Otezla) Tablets and Placebo in Mild to Severe Plaque Psoriasis

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: SFA Therapeutics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis (PsO)

Interventions

Type	Name	Description
DRUG	SFA002	SFA002 760mg
DRUG	Otezla	Oral Otezla 30mg
DRUG	Placebo	Placebo will be matched to whichever drug is assigned when randomized

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2025-03-07
• Last updated: 2025-03-11

Regulatory

• FDA-regulated drug study