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

NCT05589610 | Completed Phase 2 Results

• 1 other identifier: EQ101-104-01
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Alopecia Areata; Alopecia; Alopecia Totalis; Alopecia Universalis

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Emergent Adverse Events

  Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE)

  Week 28

Secondary Outcomes (3)

• The Efficacy of EQ101 in Adult Subjects With Moderate to Severe Alopecia

  Week 24

• To Characterize the Pharmacokinetics (PK) of EQ101

  Week 24

• To Characterize the Pharmacodynamics (PD) of EQ101

  Week 24

Study Arms (1)

EQ101

EXPERIMENTAL

EQ101 weekly

Drug: EQ101

Interventions

EQ101 DRUG

EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses

EQ101

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Known history of, or currently experiencing, male pattern androgenetic alopecia or female pattern hair loss
• History of scalp hair transplantation.
• Other scalp disease that may impact AA assessment or require topical treatment
• Unwilling to maintain a consistent hair style, including shampoo and hair products, and to refrain from weaves or extensions throughout the course of the study, or shaving of scalp.
• Use of adhesive or difficult to remove hairpiece or wigs during the study
• Have undergone significant trauma or major surgery within 8 weeks of the first dose of study drug or considered in imminent need for surgery or with elective surgery scheduled to occur during the study.
• Participation in other clinical studies involving investigational drug(s) within 4 weeks prior to the baseline visit.
• Treatment with an oral JAK inhibitor within 6 months prior to the baseline visit.
• Have previously been treated with an oral JAK inhibitor for AA for at least 12 weeks without achieving at least a 25% improvement in SALT score.
• Have been treated with any cell-depleting agents including but not limited to rituximab: within 6 months of the baseline visit, or 5 half-lives (if known), or until lymphocyte count returns to normal, whichever is longer.
• Have been treated with any biologics within 12 weeks or 5 half-lives of the baseline visit, whichever is longer.
• Have been treated with any oral immune suppressants within 8 weeks of the baseline visit.
• Have received intralesional injections of corticosteroid or platelet-rich plasma (PRP) in the scalp within 6 weeks of the baseline visit.
• Have used phototherapy, contact sensitisers, contact irritants, or cryotherapy within 4 weeks of the baseline visit.
• Have used topical treatments applied to the scalp, eyebrows, or eyelashes (e.g., corticosteroid cream; JAK inhibitors; medicated shampoo; minoxidil (Rogaine); or herbal hair care that could affect AA) within 4 weeks of the baseline visit.

Sponsors & Collaborators

• Equillium: lead
• Equillium AUS Pty Ltd: collaborator

Study Sites (5)

Sinclair Dermatology

East Melbourne, Australia

Location

Fremantle Dermatology

Fremantle, Australia

Location

Premier Specialists

Kogarah, Australia

Location

Veracity Clinical Research

Woolloongabba, Australia

Location

Optimal Clinical Trials Limited

Auckland, New Zealand

Location

Related Links

• Company website

MeSH Terms

Conditions

Alopecia Areata; Alopecia; Alopecia universalis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Equillium, Inc.

clinicaltrials@equilliumbio.com

8582401200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 21, 2022
• Study Start: December 19, 2022
• Primary Completion: March 26, 2024
• Study Completion: April 30, 2024
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-04

Locations

NZ (1); AU (4)