The ALPHA-SOLAR Trial

• Research type

  Research Study

• Full title

  A Phase 2 Long-Term Open-Label Trial to Assess the Safety and Efficacy of Repeat Dosing of STAR-0215 in Adult Patients with Hereditary Angioedema (The ALPHA-SOLAR Trial)

• IRAS ID

  1009099

• Contact name

  Clinical Trial Inquiries

• Contact email

  AstriaClinicalOperations@astriatx.com

• Sponsor organisation

  Astria Therapeutics, Inc.

• Clinicaltrials.gov Identifier

  NCT06007677

• Research summary

  STAR-0215-202 is a long-term, open-label trial to assess the safety and efficacy of repeat dosing of STAR-0215 for the prevention of acute attacks in adult patients with Type I or Type II HAE enrolling from the Phase 1b/2 STAR 0215 201 (ALPHA-STAR) trial.

  The primary objective of this study is to assess long-term safety and tolerability of STAR 0215 in participants with Type I or Type II hereditary angioedema (HAE).

  STAR-0215 drug product is supplied as a sterile, preservative-free solution for subcutaneous injection.

  The duration of treatment is approximately 5 years or until marketing authorization and the duration of the trial is approximately 6 years and 4 months or until marketing authorization, whichever comes first.

  All participants will receive STAR 0215 and will be assigned to receive 1 of 2 dosing regimens:

  Dosing Regimen 1: Day 1 dose of 600mg, then starting at Month 4, 300mg every 3 months
  Dosing Regimen 2: Day 1 dose of 600mg, then starting at Month 2, 600mg every 6 months

  The dosing regimen to which they are assigned will depend on the cohort they were in while participating in the STAR 0215-201 study: If they were in cohorts 1 or 2, they will be in Dosing Regimen 1 and if they were in cohort 3, they will be in Dosing Regimen 2.
  If they did not receive a cohort assignment during the STAR 0215-201 study, they will be assigned to a dosing regimen sequentially in relation to other participants without previous cohort assignment.

  Participants will have a total of approximately 23 study site visits and 6 remote contact visits if in Dosing Regimen 1 and approximately 18 study site visits and 11 remote contact visits if in Dosing Regimen 2. Following the last dose of STAR-0215 they will be monitored for 16 months to check for any safety concerns, regardless of dosing regimen. This follow-up period consists of 2 study site visits and 6 remote contact visits.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  24/EM/0017

• Date of REC Opinion

  6 Mar 2024

• REC opinion

  Further Information Favourable Opinion