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Monoclonal Antibodies
STAR-0215 for Hereditary Angioedema
Phase 1 & 2
Recruiting
Research Sponsored by Astria Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented diagnosis of HAE (type I or II) with documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohort 1: day 1 (pre-dose); days 14, 28, 56, 84, 112, 140, and 168; cohort 2: days 1 and 84 (pre-dose); days 14, 28, 56, 111, 167, and 251; cohort 3: days 1 and 28 (pre-dose); days 14, 55, 111, and 195
Awards & highlights
Study Summary
This trial will study the effects of a new drug, STAR-0215, on people with hereditary angioedema. Some will get 1 dose, some 2, to see which works best.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is the first time STAR-0215 is being given to participants with HAE, specific side effects are unknown but may be similar to those of other treatments for HAE which can include reactions at injection site, headache, fatigue, nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with HAE and have a history of swelling episodes without hives.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cohort 1: day 1 (pre-dose); days 14, 28, 56, 84, 112, 140, and 168; cohort 2: days 1 and 84 (pre-dose); days 14, 28, 56, 111, 167, and 251; cohort 3: days 1 and 28 (pre-dose); days 14, 55, 111, and 195
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort 1: day 1 (pre-dose); days 14, 28, 56, 84, 112, 140, and 168; cohort 2: days 1 and 84 (pre-dose); days 14, 28, 56, 111, 167, and 251; cohort 3: days 1 and 28 (pre-dose); days 14, 55, 111, and 195
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 Participants Experiencing HAE Attacks Requiring On-demand Therapy
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3 - Multiple DoseExperimental Treatment1 Intervention
Participants will receive 2 doses of STAR-0215 administered 1 month apart.
Group II: Cohort 2 - Multiple DoseExperimental Treatment1 Intervention
Participants will receive 2 doses of STAR-0215 administered 3 months apart.
Group III: Cohort 1 - Single DoseExperimental Treatment1 Intervention
Participants will receive 1 dose of STAR-0215.
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Who is running the clinical trial?
Astria Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
97 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HAE and have a history of swelling episodes without hives.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.You had at least 2 HAE attacks confirmed by a doctor during the initial period of the study.I have been diagnosed with a form of chronic angioedema other than hereditary.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 - Single Dose
- Group 2: Cohort 2 - Multiple Dose
- Group 3: Cohort 3 - Multiple Dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project currently seeking participants?
"Affirmative. Clinicaltrials.gov shows that this clinical trial is currently recruiting, with the initial posting being made on February 1st 2023 and its last update taking place on February 9th 2023. 18 patients are required for participation from a single medical site."
Answered by AI
How many individuals can potentially participate in this research experiment?
"Verified. Clinicaltrials.gov reveals that this trial is actively recruiting with an initial post date of February 1st 2023 and a recent update on the 9th of February, 2023. Currently, 18 individuals need to be sourced from one medical facility."
Answered by AI
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