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

Last updated: March 6, 2025
Sponsor: SFA Therapeutics
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Warts

Skin Wounds

Scalp Disorders

Treatment

Placebo

SFA002

Otezla

Clinical Study ID

NCT06863493
SFA-002-04
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 6months 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 ona 5-point scale (0 to 4) -

Exclusion

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 guttatePsO).

  2. History of current drug-induced PsO or a drug-induced exacerbation of pre-existingpsoriasis.

  3. History of active ongoing inflammatory skin diseases other than PsO and psoriaticarthritis that could interfere with the assessment of PsO (e.g., hyperkeratoticeczema).

  4. Prior exposure to SFA002 or apremilast. -

Study Design

Total Participants: 125
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
June 01, 2025
Estimated Completion Date:
September 01, 2026