Phase 2
N=36
Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata
Alopecia Areata · Alopecia · Alopecia Totalis · Alopecia Universalis
Bottom Line
View on ClinicalTrials.gov: NCT05589610 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Number of Treatment Emergent Adverse Events — 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EQ101 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Equillium
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Emergent Adverse Events |
27 | — |
| SECONDARY The Efficacy of EQ101 in Adult Subjects With Moderate to Severe Alopecia |
— | — |
| SECONDARY To Characterize the Pharmacokinetics (PK) of EQ101 |
— | — |
| SECONDARY To Characterize the Pharmacodynamics (PD) of EQ101 |
— | — |
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 Criteria
Key Inclusion Criteria
1.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 6 months to 3 x ULN.
- Total bilirubin >1.5 times ULN (unless isolated Gilbert's syndrome)
- Serum creatinine >1.5 ULN.
Data sourced from ClinicalTrials.gov (NCT05589610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.