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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at least 14 months

Awards & highlights

Study 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.Check my eligibility

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).See study design

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

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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.

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I have had 2 or more HAE attacks in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at least 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at least 14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at least 14 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum concentration (Cmax) of CSL312 at steady-state

Number of TEAEs

Number of subjects with treatment emergent adverse events (TEAEs)

+5 more

Secondary outcome measures

FXIIa-mediated kallikrein activity

Number of subjects experiencing death

Number of subjects with Anti-CSL312 antibodies

+19 more

Side effects data

From 2022 Phase 3 trial • 64 Patients • NCT04656418

10%

Upper respiratory tract infection

Headache

Nasopharyngitis

Visual impairment

Diarrhoea

Conjunctivitis

Sinusitis

Urinary tract infection

Abdominal pain

Back pain

Oropharyngeal pain

Gastrointestinal infection

Pyrexia

Injection site erythema

Hereditary angioedema

100%

80%

60%

40%

20%

Study treatment Arm

CSL312

Placebo

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor

194 Previous Clinical Trials

1,211,046 Total Patients Enrolled

Study DirectorStudy DirectorCSL Behring

1,211 Previous Clinical Trials

489,252 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare centers are conducting this investigation?

"At present, this experiment is active at 4 distinct sites. These are located in Litchfield Park, Santa Monica and Ashkelon with other locations also being considered. It may be beneficial to select the most proximal clinic when signing up for the trial in order to minimize transport demands."

Answered by AI

Who is eligible to join this medical experiment?

"Patients eligible for this research project must have hereditary angioedema and should be between 2 and 11 years of age. The investigators are ultimately searching for a cohort of 12 individuals in total."

Answered by AI

How many participants has been allotted for this exploratory initiative?

"Correct. Information retrieved from clinicaltrials.gov reveals that this medical trial is actively enrolling participants, with 12 patients to be recruited across 4 sites since its launch on May 24th 2023 and subsequent edits made in November 29th 2023."

Answered by AI

To what extent could CSL312 detrimentally affect patients?

"Based on available data, CSL312 has been assigned a rating of 3 as the drug is being evaluated in Phase 3 trials which implies established efficacy and consistent safety."

Answered by AI

Are individuals currently able to register for this experiment?

"The details shared on clinicaltrials.gov confirm that this trial is actively accepting new participants. It was initially published in May of 2023 and underwent its most recent revision at the end of November in the same year."

Answered by AI