HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata
ConditionAlopecia Areata(AA)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHCW Biologics
About this trial
This is a Phase 1, open-label, multi-center, competitive enrollment, and dose-escalation study of HCW9302 in subjects with Alopecia Areata (AA)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
HCW9302, an IL-2 fusion protein
DrugInjection
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Study of HCW9302, an IL-2 fusion protein, for alopecia areataExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
9 Weeks2
Designate the recommended Phase 2 dose level (RP2D) for Phase 2 study of HCW9302 in subjects with AA
Time frame
9 WeeksSecondary outcomes
1
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.
Time frame
9 Weeks2
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%).
Time frame
9 WeeksSponsors and contacts
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Source ClinicalTrials.gov