STAR-0215 for Hereditary Angioedema

Recruiting at 20 trial locations

Overseen By Christopher Morabito, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Astria Therapeutics, Inc.

Must not be taking: ACE inhibitors, Estrogens, Androgens, others

Disqualifiers: Chronic angioedema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 months

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to test the drug STAR-0215 in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of STAR-0215, and two other groups will get 2 doses of STAR-0215. Researchers will study the effects of STAR-0215 in participants with HAE as this is the first time that the drug has been given to participants with HAE.

Are You a Good Fit for This Trial?

This trial is for people with hereditary angioedema (HAE) types I or II who have had at least two HAE attacks during the run-in period. Participants must not have used certain medications like ACE inhibitors, estrogen, androgens, or preventive HAE therapies within specified time frames before screening.

Inclusion Criteria

I have been diagnosed with HAE and have a history of swelling episodes without hives.

You had at least 2 HAE attacks confirmed by a doctor during the initial period of the study.

Exclusion Criteria

I haven't taken ACE inhibitors or estrogen medications in the last 28 days.

I haven't taken HAE prevention drugs like lanadelumab, berotralstat, or others recently.

I have not taken any androgen medications in the last 7 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive STAR-0215 in different dosing regimens: Cohort 1 receives 1 dose, Cohort 2 receives 2 doses 3 months apart, and Cohort 3 receives 2 doses 1 month apart

6-8 months

Follow-up

Participants are monitored for safety, tolerability, and clinical activity after treatment

24-36 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term in the STAR-0215-202, ALPHA-SOLAR study

What Are the Treatments Tested in This Trial?

Interventions

• STAR-0215

Trial Overview The study tests STAR-0215 in individuals with hereditary angioedema. It involves one group receiving a single dose of STAR-0215 and two other groups getting two doses to evaluate the drug's effects on HAE patients.

How Is the Trial Designed?

Group I: Cohort 3 - Multiple Dose Experimental Treatment 1 Intervention

Participants will receive 2 doses of STAR-0215 administered 1 month apart.

Group II: Cohort 2 - Multiple Dose Experimental Treatment 1 Intervention

Participants will receive 2 doses of STAR-0215 administered 3 months apart.

Group III: Cohort 1 - Single Dose Experimental Treatment 1 Intervention

Participants will receive 1 dose of STAR-0215.

Who Is Running the Clinical Trial?

Astria Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

310+