Alopecia Areata(AA)Phase 1IL-2NCT07049328
HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata
A Phase 1 study testing HCW9302, an IL-2 fusion protein in people with Alopecia Areata(AA), run by HCW Biologics at 3 sites in United States.
Trial summary
This is a Phase 1, open-label, multi-center, competitive enrollment, and dose-escalation study of HCW9302 in subjects with Alopecia Areata (AA) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alopecia Areata(AA)
- What is being tested?
- HCW9302, an IL-2 fusion protein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Aug 2025to 15 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women who are 18 to 70 years of age, or adult males who are 18 to 60 years of age at the time of informed consent.
- Clinical diagnosis of Alopecia Areata (AA) (including ophiasis, totalis or universalis forms) at Screening.
- Negative serum pregnancy test within 14 days of treatment start if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
- Female subjects of childbearing potential must adhere to using a highly effective medically accepted method of birth control (defined as those with failure less than 1%; see Appendix 2) prior to screening and agree to continue its use for at least 28 days after the last dose of HCW9302 or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use a barrier method of birth control and agree to continue its use for at least 28 days after the last dose of HCW9302.
- Laboratory tests performed within 28 days of treatment start:
- Absolute neutrophil count (AGC/ANC) ≥ 1,500/μL (≥1.5 × 109/L)
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- Platelets ≥ 100,000/μL (≥ 100 × 109/L)
- Hemoglobin ≥ 10 g/dL (>100g/L)
- Calculated glomerular filtration rate (GFR)* >40 mL/min OR serum creatinine ≤ 1.5 × ULN
- Total bilirubin ≤ 2.0 × ULN or ≤ 3.0 × ULN for subjects with Gilbert's syndrome
- AST, ALT, ALP ≤ 2.0 × ULN
- Able and willing to comply with requested study visits and procedures.
- Able and willing to provide written informed consent and HIPAA authorization
Who cannot join
- Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding
- Patient has primarily "diffuse" type AA (characterized by diffuse hair shedding)
- Presence of another form of alopecia
- Prior use of any of the following treatments: a. Aldesleukin b. Investigational IL-2 analog
- Concurrent use of oral or topical treatments targeting hair growth or hair restoration (including but not limited to finasteride, dutasteride, topical minoxidil or oral minoxidil) if discontinuation or dosage change is planned during the study period.
- Prior use of phototherapy and any systemic immunosuppressant (systemic steroids, cyclosporin, methotrexate or any other immunosuppressive therapy) or immunomodulating biologic therapy (including but not limited to dupilumab, tralokinumab, lebrikizumab, nemolizumab, rocatinlimab, or daxdilimab, whether marketed or investigational) within 3 months prior to Screening.
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- Prior use of any B-cell depleting agents, whether marketed or investigational, including but not limited to rituximab, ocrelizumab, ofatumumab, or belimumab, within 6 months prior to Screening.
- Known hypersensitivity or history of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study.
- History of diabetes mellitus, regardless of whether it is controlled or not.
- History of myocardial infarction, congestive heart failure, uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months prior to Screening.
- Significant organ dysfunction that is unstable or inadequately treated within 6 months prior to Screening.
- History of cancer or lymphoproliferative disease, except for the following: adequately treated basal cell or squamous cell skin cancer without current evidence of disease.
- Currently receiving any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).
- Active tuberculosis (TB) (based on TB blood test or a TB skin test) or a history of inadequately treated TB.
- Herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months prior to Screening. Subjects with a history of frequent outbreaks of Herpes Simplex Virus (defined as 4 or more outbreaks a year).
- Major surgery within 3 months prior to Screening visit or has a major surgery planned during the study.
- Active systemic infection requiring parenteral antibiotic/antiviral therapy. All prior infections must have resolved following optimal therapy.
- Prior organ allograft or allogeneic transplantation.
- Positive based on serological screening for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening.
- Any ongoing toxicity from prior therapies that, in the judgment of the Investigator, may interfere with study treatment. All toxicities attributed to prior therapy must resolve to grade 1 or baseline before administration of the study treatment.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Other skin conditions that would interfere with study assessments of AA.
- Other illness or a medical issue that in the opinion of the Investigator would exclude the subject from participating in this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Alison Wandling, B.S. CCRC, 614-685-0251, Alison.Wandling@osumc.edu
Benjamin Kaffenberger, MD
- Recruiting
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46250
Kenneth Dawes, MD, (317) 516-5030, awallace@ecommunity.com
Kenneth Dawes, MD
- Recruiting
James A. Haley Veterans' Hospital
Tampa, Florida, 33612
Adam Zoble, MS, 813-972-2000 ext. 106939, Adam.Zoble@va.gov
Thomas Beachkofsky, MD
About this study
Official title: A Phase 1 Study of HCW9302, an IL-2 Fusion Protein, for Alopecia Areata
This is a Phase 1, open-label, multi-center, competitive enrollment, and dose-escalation study of HCW9302 in subjects with Alopecia Areata (AA)
Read the detailed description
The study involves dose escalation to determine the toxicity profile of HCW9302 and to designate a dose level for the Phase 2 expansion phase (RP2D).
Up to five HCW9302 dose levels will be evaluated. A step-down dose level (level -1) will be provided in the event that unacceptable toxicity is encountered at the planned initial dose level. In the first stage of the study, HCW9302 will be administered subcutaneously as a single dose. Depending on the results of the single ascending dose stage, a multidose study of HCW9302 administered subcutaneously every 28 days for 4 consecutive treatments will be considered.
- Conditions
- Alopecia Areata(AA)
- Being tested
- HCW9302, an IL-2 fusion protein
- Keywords
- Alopecia, Interleukin-2 (IL-2), T-Reg
- Medical subject headings
- Alopecia Areata, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCW9302, an IL-2 fusion proteinDrug
Injection
| Study group | Role | What they receive |
|---|---|---|
| Study of HCW9302, an IL-2 fusion protein, for alopecia areata | Experimental | Single dose subcutaneous injection of HCW9302. Receives: Drug: HCW9302, an IL-2 fusion protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs) in Subjects Receiving HCW9302 Monotherapy
Evaluate the safety profile of HCW9302 monotherapy in subjects with Alopecia Areata (AA), based on the incidence, type, and severity of adverse events (AEs) classified according to MedDRA.
Measured: 9 Weeks
Designate the recommended Phase 2 dose level (RP2D) for Phase 2 study of HCW9302 in subjects with AA
Measured: 9 Weeks
Secondary outcomes (2)
Determine the percent change from baseline of Severity of Alopecia Tool (SALT) score (0-100) at Day 29 and Week 9 in AA subjects receiving HCW9302
A SALT score of 0 indicates no hair loss, while a score of 100 signifies complete hair loss.
Measured: 9 Weeks
Determine the change from baseline of Alopecia Areata-Investigator Global Assessment (AA-IGA) score at Day 29 and Week 9 in AA subjects receiving HCW9302
The AA-IGA contains 5 categories: 0 = None (SALT score of 0%); 1 = Limited (SALT score of 1% - 20%); 2 = Moderate (SALT score of 21% - 49%); 3 = Severe (SALT score of 50% - 94%); and 4 = Very Severe (SALT score of 95% - 100%).
Measured: 9 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start16 Aug 2025
- Primary completion16 Jul 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HCW Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049328
- Sponsor's protocol ID
- HCWALO101
- Acronym
- IL-2
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of HCW9302, an IL-2 Fusion Protein, for Alopecia Areata
- ClinicalTrials.gov ID
- NCT07049328
- Acronym / sponsor ID
- IL-2 / HCWALO101
- Conditions
- Alopecia Areata(AA)
- Keywords
- Alopecia, Interleukin-2 (IL-2), T-Reg
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HCW BiologicsIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2025 (actual)
- Primary completion
- 16 Jul 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, multi-center, competitive enrollment, and dose-escalation study of HCW9302 in subjects with Alopecia Areata (AA)
Detailed description
The study involves dose escalation to determine the toxicity profile of HCW9302 and to designate a dose level for the Phase 2 expansion phase (RP2D).
Up to five HCW9302 dose levels will be evaluated. A step-down dose level (level -1) will be provided in the event that unacceptable toxicity is encountered at the planned initial dose level. In the first stage of the study, HCW9302 will be administered subcutaneously as a single dose. Depending on the results of the single ascending dose stage, a multidose study of HCW9302 administered subcutaneously every 28 days for 4 consecutive treatments will be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study of HCW9302, an IL-2 fusion protein, for alopecia areata | Experimental | Drug: HCW9302, an IL-2 fusion proteinSingle dose subcutaneous injection of HCW9302. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult women who are 18 to 70 years of age, or adult males who are 18 to 60 years of age at the time of informed consent.
- Clinical diagnosis of Alopecia Areata (AA) (including ophiasis, totalis or universalis forms) at Screening.
- Negative serum pregnancy test within 14 days of treatment start if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized).
- Female subjects of childbearing potential must adhere to using a highly effective medically accepted method of birth control (defined as those with failure less than 1%; see Appendix 2) prior to screening and agree to continue its use for at least 28 days after the last dose of HCW9302 or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use a barrier method of birth control and agree to continue its use for at least 28 days after the last dose of HCW9302.
- Laboratory tests performed within 28 days of treatment start:
Key exclusion criteria (23 listed)
- Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding
- Patient has primarily "diffuse" type AA (characterized by diffuse hair shedding)
- Presence of another form of alopecia
- Prior use of any of the following treatments: a. Aldesleukin b. Investigational IL-2 analog
- Concurrent use of oral or topical treatments targeting hair growth or hair restoration (including but not limited to finasteride, dutasteride, topical minoxidil or oral minoxidil) if discontinuation or dosage change is planned during the study period.
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 |
|---|---|---|
| HCW9302, an IL-2 fusion proteinInjection | Drug | Study of HCW9302, an IL-2 fusion protein, for alopecia areata |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs) in Subjects Receiving HCW9302 Monotherapy
Time frame: 9 Weeks
Evaluate the safety profile of HCW9302 monotherapy in subjects with Alopecia Areata (AA), based on the incidence, type, and severity of adverse events (AEs) classified according to MedDRA.
Designate the recommended Phase 2 dose level (RP2D) for Phase 2 study of HCW9302 in subjects with AA
Time frame: 9 Weeks
2 secondary outcomes
Determine the percent change from baseline of Severity of Alopecia Tool (SALT) score (0-100) at Day 29 and Week 9 in AA subjects receiving HCW9302
Time frame: 9 Weeks
Determine the change from baseline of Alopecia Areata-Investigator Global Assessment (AA-IGA) score at Day 29 and Week 9 in AA subjects receiving HCW9302
Time frame: 9 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HCW9302, an IL-2 fusion protein in people with Alopecia Areata(AA), run by HCW Biologics at 3 sites in United States.
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 13 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pallavi Chaturvedi, PhD. (19548422024, clinical@hcwbiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) in Subjects Receiving HCW9302 Monotherapy (time frame: 9 Weeks). The study lists 2 primary outcomes in all. 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 15 Sep 2026.