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Monoclonal Antibodies

CSL312 for Hereditary Angioedema

Phase 3
Recruiting
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 2 to 11 years, inclusive, with body weight ≥ 10th percentile based on age
Diagnosed with clinically confirmed C1-INH HAE
Must not have
Use of C1-INH products, androgens, antifibrinolytics, approved or future approved medications, or other small molecule medications for routine prophylaxis against HAE attacks
Any preplanned major surgeries or procedures during the clinical study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at least 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial examines how safe and effective a medication is for preventing a rare disease in children.

Who is the study for?
This trial is for boys and girls aged 2 to 11 with Hereditary Angioedema (HAE), weighing at least in the 10th percentile for their age. They must have had at least two HAE attacks in the past six months. Kids can't join if they're in another study, have other types of angioedema, are taking certain HAE medications, or plan to have major surgery.
What is being tested?
The trial is testing CSL312 given under the skin as a preventive treatment for kids with HAE. It aims to check how safe it is, how the body processes it (pharmacokinetics/PK), and how well it works (pharmacodynamics/PD).
What are the potential side effects?
Possible side effects of CSL312 may include reactions at the injection site, allergic responses, headaches, stomach pain or issues related to immune system activation since it's designed to modify disease pathways.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 2 and 11 years old and my weight is in the healthy range for my age.
Select...
I have been diagnosed with hereditary angioedema.
Select...
I have had 2 or more HAE attacks in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I use medication to prevent swelling attacks due to HAE.
Select...
I do not have any major surgeries planned during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at least 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at least 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
FXIIa-mediated kallikrein activity

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
Placebo
CSL312

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CSL312Experimental Treatment1 Intervention
Ages 2-5 years and 6-11 years will have specific subcutaneous dosing schedules
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
198 Previous Clinical Trials
1,204,801 Total Patients Enrolled
12 Trials studying Angioedema
1,100 Patients Enrolled for Angioedema
Study DirectorStudy DirectorCSL Behring
1,276 Previous Clinical Trials
499,258 Total Patients Enrolled
66 Trials studying Angioedema
6,611 Patients Enrolled for Angioedema
~11 spots leftby Nov 2026
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