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| Name | Class |
|---|---|
| Equillium AUS Pty Ltd | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EQ101 | Experimental | EQ101 weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EQ101 | Drug | EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Efficacy of EQ101 in Adult Subjects With Moderate to Severe Alopecia | Percent change in SALT score | Week 24 |
| To Characterize the Pharmacokinetics (PK) of EQ101 | To characterize the pharmacokinetics (PK) of EQ101 by plasma concentrations |
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Key Inclusion Criteria:
1.Subjects have AA, meeting all of the following criteria:
Key Exclusion Criteria:
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.
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinclair Dermatology | East Melbourne | Australia | ||||
| Fremantle Dermatology |
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| Label | URL |
|---|---|
| Company website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | EQ101 | EQ101 weekly EQ101: EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EQ101 | EQ101 weekly EQ101: EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Count of Participants | Participants | Week 28 |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EQ101 | EQ101 weekly EQ101: EQ101, 2 mg/kg, once weekly dosing, for a total of 24 doses |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Equillium, Inc. | 8582401200 | clinicaltrials@equilliumbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 23, 2022 | Mar 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2024 | Mar 10, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| D000505 | Alopecia |
| C537055 | Alopecia universalis |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Week 24 |
| To Characterize the Pharmacodynamics (PD) of EQ101 | Percent change in target engagement | Week 24 |
| Fremantle |
| Australia |
| Premier Specialists | Kogarah | Australia |
| Veracity Clinical Research | Woolloongabba | Australia |
| Optimal Clinical Trials Limited | Auckland | New Zealand |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | The Efficacy of EQ101 in Adult Subjects With Moderate to Severe Alopecia | Percent change in SALT score | Not Posted | Week 24 | Participants |
| Secondary | To Characterize the Pharmacokinetics (PK) of EQ101 | To characterize the pharmacokinetics (PK) of EQ101 by plasma concentrations | Not Posted | Week 24 | Participants |
| Secondary | To Characterize the Pharmacodynamics (PD) of EQ101 | Percent change in target engagement | Not Posted | Week 24 | Participants |
| 0 |
| 36 |
| 0 |
| 36 |
| 11 |
| 36 |
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |