Alopecia AreataPhase 2NCT05589610
Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata
A Phase 2 study testing EQ101 in people with Alopecia Areata and Alopecia, run by Equillium at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alopecia Areata, Alopecia, Alopecia Totalis
- What is being tested?
- EQ101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 19 Dec 2022to 30 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 <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.
Who cannot join
- 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.
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- 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.
- Have current or recent history of clinically significant severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality
- Have a known immunodeficiency disorder.
- History of solid organ or haematological transplantation.
- History of a lymphoproliferative disease or malignancy, other than adequately treated non-melanoma skin cancer or cervical carcinoma with no evidence of recurrence.
- Have active acute or chronic infection
- Abnormalities in clinical laboratory tests at Screening:
- Absolute neutrophil count (ANC) <1.0 × 109/L.
- Liver function tests ( ALT and AST) >3 x ULN.
- Total bilirubin >1.5 times ULN (unless isolated Gilbert's syndrome)
- Serum creatinine >1.5 ULN.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia4 sites
Sinclair Dermatology
East Melbourne
Fremantle Dermatology
Fremantle
Premier Specialists
Kogarah
Veracity Clinical Research
Woolloongabba
About this study
Official title: An Open-label, Phase 2 Study to Assess the Safety and Efficacy of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata
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.
Read the 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
- Being tested
- EQ101
- Medical subject headings
- Alopecia Areata, Alopecia, Alopecia universalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQ101Drug
EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses
| Study group | Role | What they receive |
|---|---|---|
| EQ101 | Experimental | EQ101 weekly Receives: Drug: EQ101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 28
Secondary outcomes (3)
The Efficacy of EQ101 in Adult Subjects With Moderate to Severe Alopecia
Percent change in SALT score
Measured: Week 24
To Characterize the Pharmacokinetics (PK) of EQ101
To characterize the pharmacokinetics (PK) of EQ101 by plasma concentrations
Measured: Week 24
To Characterize the Pharmacodynamics (PD) of EQ101
Percent change in target engagement
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start19 Dec 2022
- Primary completion26 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Equillium
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Equillium AUS Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589610
- Sponsor's protocol ID
- EQ101-104-01
- Status last verified
- Apr 2025
- First submitted
- 13 Oct 2022
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 2 Study to Assess the Safety and Efficacy of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata
- ClinicalTrials.gov ID
- NCT05589610
- Acronym / sponsor ID
- EQ101-104-01
- Conditions
- Alopecia Areata, Alopecia, Alopecia Totalis, Alopecia Universalis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- EquilliumIndustry (pharma, biotech, devices)
- Collaborators
- Equillium AUS Pty Ltd
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Posted 10 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EQ101 | Experimental | Drug: EQ101EQ101 weekly |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EQ101EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses | Drug | EQ101 |
Primary outcome
Number of Treatment Emergent Adverse Events
Time frame: Week 28
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
3 secondary outcomes
The Efficacy of EQ101 in Adult Subjects With Moderate to Severe Alopecia
Time frame: Week 24
To Characterize the Pharmacokinetics (PK) of EQ101
Time frame: Week 24
To Characterize the Pharmacodynamics (PD) of EQ101
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Company websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EQ101 in people with Alopecia Areata and Alopecia, run by Equillium at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Emergent Adverse Events (time frame: Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.