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

NCT06863493 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: SFA-002-04
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Otezla; apremilast; Mild psoriasis

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 (Defined as at Least 90% Improvement in PASI From Baseline) in Intent to Treat Population at Week 12 (ITT_A)

  The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.

  Week 12

• Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population at Week 12 (ITT_A)

  The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. Scores range from 0 (clear) to 4 (severe).

  12 weeks

• Percentage of Participants Achieving PASI 90 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)

  The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with higher scores indicating more severe disease.

  week 52

Secondary Outcomes (3)

• Percentage of Participants Achieving PASI 75 (Defined as at Least 75% Improvement in PASI From Baseline) in Intent to Treat Population at Week 12 (ITT_A)

  Week 12

• Percentage of Participants Achieving PASI 75 in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)

  week 52

• Percentage of Participants Achieving Static Physician Global Assessment (sPGA) 0 or 1 With at Least 2-grade Improvement From Baseline in Intent to Treat Population for Apremilast Non-Responders at Week 52 (ITT_B_NR)

  Week 52

Study Arms (3)

SFA002

EXPERIMENTAL

SFA002 750mg 2 times daily

Drug: SFA002; Drug: Placebo

Otezla (apremilast)

EXPERIMENTAL

30mg 2 times daily

Matched Placebo

PLACEBO COMPARATOR

Drug: SFA002; Drug: Placebo

Interventions

SFA002 DRUG

SFA002 760mg

Matched Placebo; SFA002

Otezla DRUG

Oral Otezla 30mg

Placebo DRUG

Placebo will be matched to whichever drug is assigned when randomized

Matched Placebo; SFA002

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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) -

You may not qualify if:

• Participant has any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
• History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
• 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).
• Prior exposure to SFA002 or apremilast. -

Sponsors & Collaborators

• SFA Therapeutics: lead

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Head, Drug development

CONTACT

6105004665; info@sfatherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03