NCT05589610

Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata

An Open-label, Phase 2 Study to Assess the Safety and Efficacy of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Equillium · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, PK, and PD of EQ101 as well as measure the efficacy of EQ101 at Week 24 compared to Baseline in adult subjects with moderate to severe AA. The study consists of 3 phases: a screening phase of up to 5 weeks, a treatment phase of 24 weeks, and a follow-up phase of 4 weeks. Study drug will be administered via intravenous (IV) push weekly.

Detailed description

This is a multicentre, Phase 2, open-label PoC study of EQ101 in adult subjects with at least 35% scalp hair loss due to AA. Approximately, 30 subjects will be enrolled in the study. During the 24-week treatment period, subjects will be dosed once weekly with EQ101 2 mg/kg IV. Subjects then will be followed up for an additional 4 weeks. The maximum duration of study participation will be approximately 33 weeks. Eligible subjects must be between the ages of 18 and 60 years, have a clinical diagnosis of AA with a scalp hair loss of ≥ 35% at Screening and Baseline. Approximately 25% of subjects with 35% to \< 50% scalp hair loss and approximately 25% may have AT and/or AU. In addition, each subject's current hair loss episode must have lasted at least 6 months but not more than 7 years and there can be no appreciable improvement in terminal hair regrowth within 6 months of Baseline. Safety, efficacy, PK, and PD assessments will be made during the study. Safety assessments will include AEs (i.e., type, severity, frequency, seriousness, causality) and clinical safety lab results. Efficacy measurements will include Clinical Investigator assessments (e.g., SALT, ClinRO for eyebrows (EB), eyelashes (EL), and body hair changes) and assessments made by study subjects (e.g., Scalp Hair Assessment PRO, and PRO measures for EB, EL, and body hair changes).

Conditions

• Alopecia Areata
• Alopecia
• Alopecia Totalis
• Alopecia Universalis

Interventions

Type	Name	Description
DRUG	EQ101	EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses

Timeline

• Start date: 2022-12-19
• Primary completion: 2024-03-26
• Completion: 2024-04-30
• First posted: 2022-10-21
• Last updated: 2025-04-10
• Results posted: 2025-04-10

Locations

5 sites across 2 countries: Australia, New Zealand