Alopecia Areata (AA)Phase 1/2NCT06060977
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants
A Phase 1/2 study testing IMG-007 in people with Alopecia Areata (AA), run by Inmagene LLC at 17 sites in 2 countries.
Trial summary
The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata (AA)
- What is being tested?
- IMG-007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 25 Sep 2023to 14 Jan 2025
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 and ≤ 65 years
- AA with current episode of hair loss of > 6 months but < 8 years
- AA with ≥ 50% scalp involvement as defined as SALT score ≥ 50
Who cannot join
- Known hepatitis B, hepatitis C, or human immunodeficiency virus infection
- Evidence of active or latent tuberculosis (TB)
- History of untreated or inadequately treated TB infection.
- Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening visit
- Concurrent hair loss due to other etiologies
- Primary "diffuse" type of AA
Show all 10Show fewer
- Active inflammatory diseases on the scalp that would interfere with the assessment of AA
- History or presence of hair transplants or micropigmentation of the scalp
- Active systemic diseases that may cause hair loss
- Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States11 sites
Great Lakes Research Group Inc.
Bay City, Michigan, 48706
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01803
Dawes Fretzin Clinical Resarch Group, LLC
Indianapolis, Indiana, 47906
Torrance Clinical Research Institute Inc.
Lomita, California, 90717
Skin Cancer and Dermatology Institute
Reno, Nevada, 89509
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Northwest Arkansas Clinical Trials Center, PLLC/ Hull Dermatology P.A.
Rogers, Arkansas, 72758
Dermatology Specialists of Spokane
Spokane, Washington, 99202
Stride Clinical Research LLC
Sugar Land, Texas, 77479
Alliance Clinical Research of Tampa
Tampa, Florida, 33615
Options Research Group
West Lafayette, Indiana, 47906
Canada6 sites
SimcoMed Health Ltd.
Barrie, Ontario, L4M7G1
Skin Health
Cobourg, Ontario, K9A0Z4
Guelph Dermatology Research
Guelph, Ontario, N1L0B7
Innovaderm Research Inc.
Montreal
Centre de Recherche Saint-Louis
Québec, Quebec, G1W4R4
Research Toronto
Toronto, Ontario, M2W2N4
About this study
Official title: A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants With 50% or Greater Scalp Hair Loss
The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.
Read the detailed description
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.
- Conditions
- Alopecia Areata (AA)
- Being tested
- IMG-007
- Keywords
- IMG-007, Alopecia Areata, Alopecia, Hair Loss, Skin Disease, Immune System Disorder, Dermatologic Agents
- Medical subject headings
- Alopecia Areata, Alopecia, Skin Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMG-007Drug
Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| IMG-007 Dose 1 (300 mg) | Experimental | IMG-007 Dose 1 (300 mg) will be administered intravenously 3 times over 4 weeks Receives: Drug: IMG-007 |
| IMG-007 Dose 2 (600 mg) | Experimental | IMG-007 Dose 2 (600 mg) will be administered intravenously 3 times over 4 weeks Receives: Drug: IMG-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Adverse Events in Participants
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.
Measured: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
Secondary outcomes (1)
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).
Measured: Mean percent change from baseline in Severity of ALopecia Tool (SALT) at week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start25 Sep 2023
- Primary completion14 Jan 2025
- Study completion14 Jan 2025
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 Areata (AA)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmagene LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060977
- Sponsor's protocol ID
- IMG-007-202
- Status last verified
- Jan 2026
- First submitted
- 21 Sep 2023
- Last updated
- 9 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants With 50% or Greater Scalp Hair Loss
- ClinicalTrials.gov ID
- NCT06060977
- Acronym / sponsor ID
- IMG-007-202
- Conditions
- Alopecia Areata (AA)
- Keywords
- IMG-007, Alopecia Areata, Alopecia, Hair Loss, Skin Disease, Immune System Disorder, Dermatologic Agents
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Inmagene LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 14 Jan 2025 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Posted 9 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMG-007 Dose 1 (300 mg) | Experimental | Drug: IMG-007IMG-007 Dose 1 (300 mg) will be administered intravenously 3 times over 4 weeks |
| IMG-007 Dose 2 (600 mg) | Experimental | Drug: IMG-007IMG-007 Dose 2 (600 mg) will be administered intravenously 3 times over 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged ≥ 18 and ≤ 65 years
- AA with current episode of hair loss of > 6 months but < 8 years
- AA with ≥ 50% scalp involvement as defined as SALT score ≥ 50
Key exclusion criteria (10 listed)
- Known hepatitis B, hepatitis C, or human immunodeficiency virus infection
- Evidence of active or latent tuberculosis (TB)
- History of untreated or inadequately treated TB infection.
- Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening visit
- Concurrent hair loss due to other etiologies
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 |
|---|---|---|
| IMG-007Intravenous Infusion | Drug | IMG-007 Dose 1 (300 mg), IMG-007 Dose 2 (600 mg) |
Primary outcome
Evaluation of Adverse Events in Participants
Time frame: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.
1 secondary outcome
Evaluation of Severity of Alopecia Tool (SALT)
Time frame: Mean percent change from baseline in Severity of ALopecia Tool (SALT) at week 24.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMG-007 in people with Alopecia Areata (AA), run by Inmagene LLC at 17 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 3 inclusion and 10 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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 9 Feb 2026). 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?
Evaluation of Adverse Events in Participants (time frame: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.). 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 9 Feb 2026.