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Monoclonal Antibodies

CSL312 for Hereditary Angioedema

Phase 3
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, first 3-months and second 3-months of treatment period
Awards & highlights

Summary

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.

Eligible Conditions
  • Hereditary Angioedema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, first 3-months and second 3-months of treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, first 3-months and second 3-months of treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period
Secondary outcome measures
Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as Treatment Emergent Adverse Events (TEAEs)
Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), and AEs of Special Interest (AESI)
Percentage Change in the Time-normalized Number of HAE Attacks Per Month During the Treatment Period Compared to the Run-in Period
+7 more

Side effects data

From 2022 Phase 3 trial • 64 Patients • NCT04656418
10%
Upper respiratory tract infection
8%
Nasopharyngitis
8%
Headache
5%
Gastrointestinal infection
5%
Conjunctivitis
5%
Sinusitis
5%
Urinary tract infection
5%
Diarrhoea
5%
Abdominal pain
5%
Back pain
5%
Oropharyngeal pain
5%
Visual impairment
3%
Hereditary angioedema
3%
Injection site erythema
3%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
CSL312
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CSL312Experimental Treatment1 Intervention
Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg subcutaneous (SC) injections, once monthly from Months 2 to 6.
Group II: PlaceboPlacebo Group1 Intervention
Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CSL312
2022
Completed Phase 3
~320

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor
197 Previous Clinical Trials
1,211,302 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring LLC
1,252 Previous Clinical Trials
504,315 Total Patients Enrolled
~14 spots leftby Sep 2025
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