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Monoclonal Antibodies

STAR-0215 for Hereditary Angioedema

Phase 2
Waitlist Available
Research Sponsored by Astria Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months for first 2 years, every 6 months for next 3 years
Awards & highlights

Study Summary

This trial will test a drug for long-term safety and effectiveness in treating hereditary angioedema (HAE). Patients will take the drug over 5 years.

Who is the study for?
This trial is for people with hereditary angioedema who participated in a previous STAR-0215 study and met certain conditions. They shouldn't have used ACE inhibitors, estrogen medications, or androgens recently, nor should they have other chronic angioedema types or be on preventive HAE therapies without consulting the medical monitor.Check my eligibility
What is being tested?
The trial tests the long-term safety and effectiveness of repeated doses of STAR-0215 in individuals with hereditary angioedema. It's designed to last up to five years, gathering extensive data on how well this treatment works over time.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to long-term use of STAR-0215. This may include new or worsening symptoms related to their condition or unexpected health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months for first 2 years, every 6 months for next 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months for first 2 years, every 6 months for next 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Experiencing Treatment-emergent Adverse Events
Secondary outcome measures
Change From Baseline in Monthly HAE Attack Rate
Duration of HAE Attacks
Number of HAE Attack-free Days
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Regimen 2: STAR-0215Experimental Treatment1 Intervention
Participants will receive STAR-0215 every 6 months.
Group II: Dose Regimen 1: STAR-0215Experimental Treatment1 Intervention
Participants will receive STAR-0215 every 3 months.

Find a Location

Who is running the clinical trial?

Astria Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
69 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the Dose Regimen 1: STAR-0215 protocol authorized by the FDA?

"Our team rates Dose Regimen 1: STAR-0215's safety a 2 on the scale of 1 to 3, as this is still in Phase 2 and there are no efficacy data yet but some evidence backing its safety."

Answered by AI

Is enrollment for this experiment still open?

"Per the information provided by clinicaltrials.gov, this particular trial posted on September 26th 2023 is not actively seeking participants at present time. However, 23 other medical studies are still recruiting volunteers to join their trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
2023. "A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06007677.
All > Hereditary Angioedema
~37 spots leftby Aug 2030
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