Trial Outcomes & Findings for Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata (NCT NCT05589610)

NCT ID: NCT05589610

Last Updated: 2025-04-10

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: Week 28
• Results posted on: 2025-04-10

Participant Flow

Participant milestones

Measure	EQ101 EQ101 weekly EQ101: EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses
Overall Study STARTED	36
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	EQ101 n=36 Participants EQ101 weekly EQ101: EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses
Age, Continuous	38.2 years STANDARD_DEVIATION 13.45 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment New Zealand	12 participants n=5 Participants
Region of Enrollment Australia	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 28

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

Outcome measures

Measure	EQ101 n=36 Participants EQ101 weekly EQ101: EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses
Number of Treatment Emergent Adverse Events	27 Participants

SECONDARY outcome

Timeframe: Week 24

Percent change in SALT score

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

To characterize the pharmacokinetics (PK) of EQ101 by plasma concentrations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24

Percent change in target engagement

Outcome measures

Outcome data not reported

Adverse Events

EQ101

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	EQ101 n=36 participants at risk EQ101 weekly EQ101: EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses
Skin and subcutaneous tissue disorders Urticaria	5.6% 2/36 • Number of events 2 • From the time of signing the ICF through week 28 (final follow-up visit) for a total of approximately 33 weeks (5 week screening period starting with the signing of the ICF, 24 week treatment period, and 4 week follow up period), all SAEs and nonserious AEs will be recorded on the SAE/AE eCRF.
General disorders Fatigue	11.1% 4/36 • Number of events 26 • From the time of signing the ICF through week 28 (final follow-up visit) for a total of approximately 33 weeks (5 week screening period starting with the signing of the ICF, 24 week treatment period, and 4 week follow up period), all SAEs and nonserious AEs will be recorded on the SAE/AE eCRF.
Nervous system disorders Headache	5.6% 2/36 • Number of events 3 • From the time of signing the ICF through week 28 (final follow-up visit) for a total of approximately 33 weeks (5 week screening period starting with the signing of the ICF, 24 week treatment period, and 4 week follow up period), all SAEs and nonserious AEs will be recorded on the SAE/AE eCRF.
Nervous system disorders Dizziness	5.6% 2/36 • Number of events 2 • From the time of signing the ICF through week 28 (final follow-up visit) for a total of approximately 33 weeks (5 week screening period starting with the signing of the ICF, 24 week treatment period, and 4 week follow up period), all SAEs and nonserious AEs will be recorded on the SAE/AE eCRF.
Metabolism and nutrition disorders Decreased appetite	5.6% 2/36 • Number of events 2 • From the time of signing the ICF through week 28 (final follow-up visit) for a total of approximately 33 weeks (5 week screening period starting with the signing of the ICF, 24 week treatment period, and 4 week follow up period), all SAEs and nonserious AEs will be recorded on the SAE/AE eCRF.

Additional Information

Clinical Trial Manager

Equillium, Inc.

Phone: 8582401200

Email: clinicaltrials@equilliumbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60