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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
Males and females aged ≥ 12 years
Experienced ≥ 3 HAE attacks during the 3 months before Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 45 months
Awards & highlights

Study Summary

This trial will study the long-term safety and effectiveness of CSL312 given as a shot under the skin.

Who is the study for?
This trial is for males and females aged 12 or older with hereditary angioedema (HAE), who've had at least three HAE attacks in the past three months. Participants must not be pregnant, breastfeeding, or unwilling to use contraception. They can't have other forms of angioedema or have used certain medications like monoclonal antibodies within specific time frames before the study.Check my eligibility
What is being tested?
The trial is testing CSL312 (Garadacimab) given under the skin to see how safe and effective it is over a long period for preventing swelling attacks in people with hereditary angioedema—a condition causing repeated episodes of severe swelling.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to CSL312 since it's being studied for its long-term safety profile as part of this phase 3b clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 12 years old or older.
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I have had 3 or more HAE attacks in the last 3 months.
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I have been diagnosed with hereditary angioedema.
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I have had at least 1 HAE attack per month recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 45 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 45 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
Number of subjects with treatment emergent adverse events (TEAEs)
Percentage of subjects with TEAEs
TEAEs rates per injection
+1 more
Secondary outcome measures
Number and percentage of subjects rating their response to therapy as good or excellent
The number and percentage of subjects experiencing CSL312 induced anti-CSL312 antibodies
The number and percentage of subjects experiencing TEAEs
+6 more

Side effects data

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: CSL312Experimental Treatment1 Intervention
Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously
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
194 Previous Clinical Trials
1,211,051 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,202 Previous Clinical Trials
489,461 Total Patients Enrolled

Media Library

CSL312 (Garadacimab) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04739059 — Phase 3
Hereditary Angioedema Research Study Groups: CSL312
Hereditary Angioedema Clinical Trial 2023: CSL312 (Garadacimab) Highlights & Side Effects. Trial Name: NCT04739059 — Phase 3
CSL312 (Garadacimab) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04739059 — Phase 3

Frequently Asked Questions

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

How many test subjects are being given lenalidomide in this clinical trial?

"This study is not enrolling patients at the moment. The listing for this clinical trial was first posted on 29 March 2021 and updated on 2 November 2022. There are presently 23 other studies actively enrolling participants with angioedemas, hereditary and 2 studies for CSL312 that are recruiting patients."

Answered by AI

Are we still looking for more people to participate in this clinical trial?

"The most recent information on clinicaltrials.gov shows that this study is not presently enrolling patients. The trial was initially posted on 3/29/2021 and was most recently edited on 11/2/2022. However, there are 25 other trials that are actively recruiting patients."

Answered by AI

At how many hospitals or research facilities is this study taking place?

"The trial sites for this clinical study are PennState Health Milton S. Hershey Medical Center in Hershey, Pennsylvania, Little Rock Allergy & Asthma Clinic in Little Rock, Arkansas, Bernstein Clinical Research Center, LLC in Cincinnati, Ohio, and 5 other medical facilities."

Answered by AI

If CSL312 has been studied before, where can I find those papers?

"The first clinical trial for CSL312 was conducted in 2021 at Queen Mary Hospital, which is part of The University of Hong Kong. As of now, there have been a total of 5 completed clinical trials. Out of the 2 that are currently ongoing, a large number are based in Hershey, Pennsylvania."

Answered by AI

Does this medical research break new ground?

"CSL312 has been under investigation since early 2021. The first clinical trial, which was sponsored by CSL Behring, took place that year. After the successful Phase 1 study with 171 patients, CSL312 was approved for Phase 3 clinical trials. Now, there are 2 ongoing studies involving CSL312 in 51 cities and 18 countries."

Answered by AI

Has CSL312 undergone evaluation by the FDA?

"CSL312 is a Phase 3 trial drug, so it has received a 3 for safety. This is due to the presence of data supporting both efficacy and multiple rounds of safety data."

Answered by AI
~59 spots leftby Nov 2025