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

NCT ID: NCT06863493

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-09-01

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SFA002

SFA002 750mg 2 times daily

Group Type: EXPERIMENTAL

SFA002

Intervention Type: DRUG

SFA002 760mg

Placebo

Intervention Type: DRUG

Placebo will be matched to whichever drug is assigned when randomized

Otezla (apremilast)

30mg 2 times daily

Group Type: EXPERIMENTAL

No interventions assigned to this group

Matched Placebo

Group Type: PLACEBO_COMPARATOR

SFA002

Intervention Type: DRUG

SFA002 760mg

Placebo

Intervention Type: DRUG

Placebo will be matched to whichever drug is assigned when randomized

Interventions

SFA002

SFA002 760mg

Intervention Type: DRUG

Otezla

Oral Otezla 30mg

Intervention Type: DRUG

Placebo

Placebo will be matched to whichever drug is assigned when randomized

Intervention Type: DRUG

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SFA Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Head, Drug development

Role: CONTACT

info@sfatherapeutics.com

6105004665

Other Identifiers

SFA-002-04

Identifier Type: -

Identifier Source: org_study_id