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

SFA Therapeutics

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Psoriasis (PsO)

Treatments: Drug: SFA002; Drug: Otezla; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06863493

SFA-002-04

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 3 patient groups, including a placebo group

SFA002

Experimental group

Description:

SFA002 750mg 2 times daily

Treatment:

Drug: Placebo

Drug: SFA002

Otezla (apremilast)

Experimental group

Description:

30mg 2 times daily

Matched Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: SFA002