The trial is taking place at:
M

Medical Research of Arizona | Scottsdale, AZ

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Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks

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CSL Behring

Status and phase

Active, not recruiting
Phase 3

Conditions

Hereditary Angioedema

Treatments

Biological: CSL312

Study type

Interventional

Funder types

Industry

Identifiers

NCT04739059
2020-003918-12 (EudraCT Number)
CSL312_3002

Details and patient eligibility

About

This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)

Enrollment

171 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males and females aged ≥ 12 years
  • Diagnosed with clinically confirmed C1-INH HAE
  • Experienced ≥ 3 HAE attacks during the 3 months before Screening
  • Participated in the Run-in Period for at least 1 month (CSL312-naïve subjects only)
  • Experienced at least an average of 1 HAE attack per month during the Run-in Period

Exclusion criteria

  • Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria
  • Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period
  • Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
  • Female subjects use estrogen-containing oral contraceptives or hormone replacement therapy within 4 weeks prior to screening
  • Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 30 days after receipt of the last dose of CSL312
  • Pregnant, breastfeeding, or not willing to cease breastfeeding

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

171 participants in 1 patient group

CSL312
Experimental group
Description:
Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously
Treatment:
Biological: CSL312

Trial contacts and locations

44

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Data sourced from clinicaltrials.gov

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