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
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Subjects have AA, meeting all of the following criteria:

⁃ Clinical diagnosis of AA with no other aetiology of hair loss ;

⁃ At least 35% scalp hair loss, as defined by a SALT score ≥ 35, at Screening and Baseline. Approximately 25% of subjects with 35% to \<50% scalp hair loss and 25% may have AT/AU.

⁃ Current episode of hair loss lasting \> 6 months to \< 7 yrs at time of Screening; and

⁃ No appreciable change in terminal hair regrowth within 6 months of the baseline visit.

Locations
Other Locations
Australia
Sinclair Dermatology
East Melbourne
Fremantle Dermatology
Fremantle
Premier Specialists
Kogarah
Veracity Clinical Research
Woolloongabba
New Zealand
Optimal Clinical Trials Limited
Auckland
Time Frame
Start Date: 2022-12-19
Completion Date: 2024-04-30
Participants
Target number of participants: 36
Treatments
Experimental: EQ101
EQ101 weekly
Sponsors
Leads: Equillium
Collaborators: Equillium AUS Pty Ltd

This content was sourced from clinicaltrials.gov

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