HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata

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

Qualifiers

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

Treatments tested in this trial

  • HCW9302, an IL-2 fusion protein

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators