The trial is taking place at:
M

Medical Research of Arizona | Scottsdale, AZ

Veeva-enabled site

CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema

CSL Behring logo

CSL Behring

Status and phase

Enrolling
Phase 3

Conditions

Hereditary Angioedema (HAE)

Treatments

Biological: CSL312

Study type

Interventional

Funder types

Industry

Identifiers

NCT05819775
2022-502386-13-00
CSL312_3003

Details and patient eligibility

About

The purpose of this study is to investigate the safety, PK / PD, and efficacy of SC CSL312 for prophylactic treatment of pediatric subjects with HAE.

Enrollment

20 estimated patients

Sex

All

Ages

2 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female
  • Aged 2 to 11 years, inclusive, with body weight ≥ 10th percentile based on age
  • Diagnosed with clinically confirmed C1-INH HAE
  • Experienced ≥ 2 HAE attacks during the 6 months before Screening

Exclusion criteria

  • Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria, or HAE type 3
  • Use of C1-INH products, androgens, antifibrinolytics, approved or future approved medications, or other small molecule medications for routine prophylaxis against HAE attacks within a minimum of 2 weeks before the Treatment Period
  • Participation in another interventional clinical study during the 30 days before the Treatment Period or within 5 half-lives of the final dose of the investigational product administered during the previous interventional study, whichever is longer
  • Having laboratory clinical abnormalities assessed as clinically significant by the investigator in results of hematology or chemistry assessments performed during Screening
  • Currently receiving a therapy not permitted during the study
  • Being pregnant or breastfeeding.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

CSL312
Experimental group
Description:
Ages 2-5 years and 6-11 years will have specific subcutaneous dosing schedules
Treatment:
Biological: CSL312

Trial contacts and locations

7

Loading...

Central trial contact

Trial Registration Coordinator

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems