A Study of Navenibart in Participants With Hereditary Angioedema (ALPHA-ORBIT)

Astria Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Hereditary Angioedema (HAE)

Treatments: Drug: navenibart; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06842823

STAR-0215-301

Details and patient eligibility

About

This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (HAE). The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.

Enrollment: 145 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented diagnosis of HAE (Type 1 or 2). The following must be met:

  1. Documented clinical history consistent with HAE
  2. Lab findings consistent with HAE Type 1 or 2

• Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.

Exclusion criteria

• Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathic angioedema, or angioedema associated with urticaria.

• Use of therapies prescribed for the prevention of HAE attacks may not be used during the trial or within the below time frames prior to the Run-In Period (adult participants may be on these medications at the time of the Screening Visit, but will need to washout prior to entering the Run-In Period).

  1. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In
  2. Plasma-derived C1INH for LTP within 14 days prior to Run-In
  3. Berotralstat within 21 days prior to Run-In
  4. Lanadelumab within 70 days prior to Run-In
  5. Garadacimab within 90 days prior to Run-In

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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145 participants in 5 patient groups, including a placebo group

Adult Navenibart Dosing Regimen 1

Experimental group

Description:

Participants will receive 600 mg of navenibart every 3 months.

Treatment:

Drug: navenibart

Adult Navenibart Dosing Regimen 2

Experimental group

Description:

Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.

Treatment:

Drug: navenibart

Adult Navenibart Dosing Regimen 3

Experimental group

Description:

Participants will receive 600 mg of navenibart every 6 months.

Treatment:

Drug: navenibart

Placebo (adult)

Placebo Comparator group

Description:

Participants will receive placebo every 3 months.

Treatment:

Drug: Placebo

Adolescent Navenibart Dosing Regimen 1

Experimental group

Description:

Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.

Treatment:

Drug: navenibart