A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema

Astria Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Hereditary Angioedema

Treatments: Drug: STAR-0215

Study type: Interventional

Funder types: Industry

Identifiers

NCT06007677

2023-506540-16 (EudraCT Number)

STAR-0215-202

Details and patient eligibility

About

The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive repeat doses of STAR-0215 for up to 5 years.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions:

  • Completed STAR-0215-201 (follow up through 6 months after their last dose);
  • Eligible for STAR-0215-201 and entered the Run-In period but did not qualify for the Treatment Period because they did not meet the criterion for the minimum number of HAE attacks;
  • Eligible for STAR-0215-201 and entered the Run-In period but did not complete it for reasons other than not meeting the criterion for the minimum number of HAE attacks (eligibility requires consultation with the Medical Monitor); or
  • Discontinued STAR-0215-201 (for reasons other than safety) after having completed at least 84 days of trial follow-up since their last dose of STAR-0215 (eligibility requires consultation with the Medical Monitor).

• Open to participants who are STAR-0215 naïve and were not enrolled in STAR-0215-201 (NCT05695248), have a documented diagnosis of HAE (Type 1 or Type 2).

Exclusion criteria

• Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria.

• Any exposure to angiotensin-converting enzyme inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening

• Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.

• Use of therapies prescribed for the prevention of HAE attacks prior to Screening:

  • lanadelumab within 90 days
  • berotralstat within 21 days
  • all other prophylactic therapies, discuss with the Medical Monitor

Note: Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 4 patient groups

Dose Regimen 1 (Arm A): STAR-0215

Experimental group

Description:

Participants will receive STAR-0215 every 3 months.

Treatment:

Drug: STAR-0215

Dose Regimen 2 (Arm B): STAR-0215

Experimental group

Description:

Participants will receive STAR-0215 every 6 months.

Treatment:

Drug: STAR-0215

Dose Regimen 1 (Arm C): STAR-0215

Experimental group

Description:

STAR-0215 will be administered as a subcutaneous injection.

Treatment:

Drug: STAR-0215

Dose Regimen 3 (Arm D): STAR-0215

Experimental group

Description:

STAR-0215 will be administered as a subcutaneous injection.

Treatment:

Drug: STAR-0215