BridgeMD
New treatment option for Alopecia Areata(AA)
Official title HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata
ClinicalTrials.gov ID: NCT07049328
What this study is testing
What is HCW9302, an IL-2 fusion protein?
HCW9302, an IL-2 fusion protein is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for alopecia areata(aa).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1, open-label, multi-center, competitive enrollment, and dose-escalation study of HCW9302 in subjects with Alopecia Areata (AA)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Female people of childbearing potential must adhere to using a highly effective medically accepted method of birth control (defined as those with...
- Laboratory tests performed within 28 days of treatment start:
You likely can't join if
- 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...
- Prior use of phototherapy and any systemic immunosuppressant (systemic steroids, cyclosporin, methotrexate or any other immunosuppressive therapy) or...
See the full eligibility criteria
- 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 people 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...
- Laboratory tests performed within 28 days of treatment start:
- Absolute neutrophil count (AGC/ANC) ≥ 1,500/μL (≥1.5 × 109/L)
- 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 people 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
- 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...
- 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...
- 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. people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.