A Phase 2 Placebo Controlled, Clinical Trial Designed to Assess the Efficacy, Safety and Dose Response Characterisation of STS01 for the Treatment of Mild-moderate Alopecia Areata (AA) (SOT01)

Soterios Ltd

Status and phase: Completed; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: Placebo; Drug: STS01

Study type: Interventional

Funder types: Industry

Identifiers

NCT06402630

2021-004145-20 (EudraCT Number)

SOT01

Details and patient eligibility

About

A Phase 2 double-blind, multi-site, placebo-controlled, parallel-group design to assess the efficacy, safety and dose-response characterisation of STS-01 for the treatment of mild- moderate alopecia areata.

Full description

STS-01 is being developed to address the need for an effective, safe and convenient non-steroidal topical treatment for mild-moderate alopecia areata. The product builds on a mechanism with a well-established safety profile in dermatology, and existing evidence of its effectiveness in this condition through targeting key relevant cytokines. STS-01 has been modified to maximise the effectiveness of this mechanism and offer a cosmetically elegant topical cream. The study aims to assess the effectiveness, safety and dose-response characteristics of STS-01 for the treatment of mild-moderate alopecia areata.

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Active alopecia areata (less than 50% SALT score, present for at least 6 months)
2. Not currently receiving treatment for hair loss
3. Eighteen years of age or more
4. Affected skin with normal appearance and no grossly evident epidermal alteration such as scaling or follicular abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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158 participants in 5 patient groups, including a placebo group

0.25% Dose

Experimental group

Description:

Once daily, STS-01 topical cream applied to affected area of the head

Treatment:

Drug: STS01

0.5% Dose

Experimental group

Description:

Once daily, STS-01 topical cream applied to affected area of the head

Treatment:

Drug: STS01

1% Dose

Experimental group

Description:

Once daily, STS-01 topical cream applied to affected area of the head

Treatment:

Drug: STS01

2% Dose

Experimental group

Description:

Once daily, STS-01 topical cream applied to affected area of the head

Treatment:

Drug: STS01

Placebo

Placebo Comparator group

Description:

Once daily, topical cream applied to affected area of the head (without API)

Treatment:

Drug: Placebo