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)

NCT06402630 | Completed Phase 2

• 2 other identifiers: SOT012021-004145-20
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Alopecia Areata

Keywords

alopecia areata; alopecia; areata; aa; autoimmune; hair loss; hair; autoimmune hair; follicle

Outcome Measures

Primary Outcomes (1)

• Relative change from baseline in Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months

  Alopecia areata severity measured using the Severity of Alopecia Tool (SALT) at 6 months. Targeting patients with \<50 SALT (less than 50% hair loss).

  6 Months

Secondary Outcomes (4)

• Regrowth area measured by graphical measuring of the size of the patch

  6 months

• Global assessment using the Clinical Global Impression (CGI) score

  6 Months

• AA quality of life measured using Subject Alopecia Areata Symptom Impact Scale (AASIS)

  6 Months

• AA quality of life measured using Alopecia Areata Quality of Life Index (AAQLI) 0-25

  6 months

Study Arms (5)

0.25% Dose

EXPERIMENTAL

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

Drug: STS01

0.5% Dose

EXPERIMENTAL

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

Drug: STS01

1% Dose

EXPERIMENTAL

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

Drug: STS01

2% Dose

EXPERIMENTAL

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

Drug: STS01

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

STS01 DRUG

Participants are block randomised to be treated with 0.25%, 0.5%, 1.0%, 2% STS-01 or a matching placebo control topically once daily for 6 months with a 2-month follow up.

0.25% Dose; 0.5% Dose; 1% Dose; 2% Dose

Placebo DRUG

Participants are block randomised to be treated with 0.25%, 0.5%, 1.0%, 2% STS-01 or a matching placebo control topically once daily for 6 months with a 2-month follow up.

Placebo

Eligibility Criteria

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

You may qualify if:

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

Sponsors & Collaborators

• Soterios Ltd: lead

Study Sites (9)

Queen Margaret Hospital

Glasgow, Dunfirmline, KY12 0SU, United Kingdom

Location

St Lukes Hospital

Bradford, Little Horton Lane, BD5 0NA, United Kingdom

Location

Royal Alexandra Children's Hospital

Brighton, BN2 5BE, United Kingdom

Location

University Hospital Coventry & Warwickshire

Coventry, CV2 2DX, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, GL1 3NN, United Kingdom

Location

Queen Anne Street Medical Centre Limited

London, W1G 8HU, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

Salford Royal Hospital

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Alopecia Areata; Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

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: April 26, 2024
• First Posted: May 7, 2024
• Study Start: March 23, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (9)