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The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.
This is a phase 1b/2a, open label study to assess the safety, PK, and efficacy of IMG-007 in adult AA participants with 50% or greater scalp hair loss. The study will consist of two cohorts with three periods: a screening period of up to 5 -weeks, a 16-week treatment period and a 20-week follow- up period. Approximately 6 and 24 participants will be sequentially enrolled into cohort 1 and cohort 2, respectively, to receive three intravenous infusions of IMG-007 over 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMG-007 Dose 1 (300 mg) | Experimental | IMG-007 Dose 1 (300 mg) will be administered intravenously 3 times over 4 weeks |
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| IMG-007 Dose 2 (600 mg) | Experimental | IMG-007 Dose 2 (600 mg) will be administered intravenously 3 times over 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMG-007 | Drug | Intravenous Infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Adverse Events in Participants | To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA. | Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Severity of Alopecia Tool (SALT) | To evaluate the efficacy of multiple doses of IMG-007 in AA participants as measured by the Severity of Alopecia Tool (SALT). The Severity of Alopecia Tool (SALT) is a quantitative assessment of AA severity by the investigator based on scalp terminal hair loss. To evaluate the efficacy of multiple doses of IMG-007 in AA participants as measured by Severity of Alopecia Tool (SALT) on a scale of 0 for no hair loss, and 100 is complete hair loss (higher scores attributes to worse outcomes). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A. | Rogers | Arkansas | 72758 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | IMG-007 300 mg | IMG-007 300 mg will be administered intravenously 3 times over 4 weeks IMG-007: Intravenous Infusion |
| FG001 | IMG-007 600 mg | IMG-007 600 mg will be administered intravenously 3 times over 4 weeks IMG-007: Intravenous Infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 2, 2024 | Dec 18, 2025 |
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| Mean percent change from baseline in Severity of ALopecia Tool (SALT) at week 24. |
| Torrance Clinical Research Institute Inc. |
| Lomita |
| California |
| 90717 |
| United States |
| Alliance Clinical Research of Tampa | Tampa | Florida | 33615 | United States |
| Dawes Fretzin Clinical Resarch Group, LLC | Indianapolis | Indiana | 47906 | United States |
| Options Research Group | West Lafayette | Indiana | 47906 | United States |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01803 | United States |
| Great Lakes Research Group Inc. | Bay City | Michigan | 48706 | United States |
| Skin Cancer and Dermatology Institute | Reno | Nevada | 89509 | United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| Stride Clinical Research LLC | Sugar Land | Texas | 77479 | United States |
| Dermatology Specialists of Spokane | Spokane | Washington | 99202 | United States |
| SimcoMed Health Ltd. | Barrie | Ontario | L4M7G1 | Canada |
| Skin Health | Cobourg | Ontario | K9A0Z4 | Canada |
| Guelph Dermatology Research | Guelph | Ontario | N1L0B7 | Canada |
| Research Toronto | Toronto | Ontario | M2W2N4 | Canada |
| Centre de Recherche Saint-Louis | Québec | Quebec | G1W4R4 | Canada |
| Innovaderm Research Inc. | Montreal | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | IMG-007 300 mg | IMG-007 300 mg will be administered intravenously 3 times over 4 weeks IMG-007: Intravenous Infusion |
| BG001 | IMG-007 600 mg | IMG-007 600 mg will be administered intravenously 3 times over 4 weeks IMG-007: Intravenous Infusion |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Age, Continuous | The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007. | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007. | Count of Participants | Participants | No |
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| Severity of ALopecia Tool (SALT) Score | The Severity of Alopecia Tool (SALT) is a quantitative assessment of AA severity by the investigator based on scalp terminal hair loss. To evaluate the efficacy of multiple doses of IMG-007 in AA participants as measured by Severity of Alopecia Tool (SALT) on a scale of 0 for no hair loss, and 100 is complete hair loss (higher scores attributes to worse outcomes). | The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007. | Mean | Standard Deviation | units on a scale |
|
| 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 | Evaluation of Adverse Events in Participants | To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA. | Posted | Count of Participants | Participants | No | Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks. |
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| Secondary | Evaluation of Severity of Alopecia Tool (SALT) | To evaluate the efficacy of multiple doses of IMG-007 in AA participants as measured by the Severity of Alopecia Tool (SALT). The Severity of Alopecia Tool (SALT) is a quantitative assessment of AA severity by the investigator based on scalp terminal hair loss. To evaluate the efficacy of multiple doses of IMG-007 in AA participants as measured by Severity of Alopecia Tool (SALT) on a scale of 0 for no hair loss, and 100 is complete hair loss (higher scores attributes to worse outcomes). | Posted | Least Squares Mean | Standard Error | percentage of change | Mean percent change from baseline in Severity of ALopecia Tool (SALT) at week 24. |
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Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
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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 | IMG-007 300 mg | IMG-007 300 mg will be administered intravenously 3 times over 4 weeks IMG-007: Intravenous Infusion | 0 | 6 | 0 | 6 | 2 | 6 |
| EG001 | IMG-007 600 mg | IMG-007 600 mg will be administered intravenously 3 times over 4 weeks IMG-007: Intravenous Infusion | 0 | 23 | 0 | 23 | 8 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Streptococcal infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Lead | Inmagene LLC | (858) 345-6927 | ClinicalTrials@imagenebio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2024 | Dec 18, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| D000505 | Alopecia |
| D012871 | Skin Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| TEAE that was an infusion-related reaction |
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| TEAE leading to 4-week dosing period discontinuation |
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| TEAE with outcome of death |
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