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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
Experienced ≥ 3 HAE attacks during the 3 months before Screening
Diagnosed with clinically confirmed C1-INH HAE
Must not have
Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria
Pregnant, breastfeeding, or not willing to cease breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
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.
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.
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 belowSelect...
I have had 3 or more HAE attacks in the last 3 months.
Select...
I have been diagnosed with hereditary angioedema.
Select...
I have had at least 1 HAE attack per month recently.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with another type of swelling condition besides HAE.
Select...
I am pregnant, breastfeeding, or not willing to stop breastfeeding.
Select...
I haven't used monoclonal antibodies like Takhzyro® in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2022 Phase 3 trial • 64 Patients • NCT0465641810%
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
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
199 Previous Clinical Trials
1,204,910 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,281 Previous Clinical Trials
500,331 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with another type of swelling condition besides HAE.You have not taken the study drug CSL312 for at least 1 month before joining the trial.I am 12 years old or older.I am pregnant, breastfeeding, or not willing to stop breastfeeding.I am fertile, sexually active, and not using or unwilling to use birth control during and 30 days after the study.I have had 3 or more HAE attacks in the last 3 months.I have used estrogen-based birth control or hormone therapy in the last 4 weeks.I haven't used certain medications for HAE prevention for at least 2 weeks.I haven't used monoclonal antibodies like Takhzyro® in the last 3 months.I have been diagnosed with hereditary angioedema.I have had at least 1 HAE attack per month recently.
Research Study Groups:
This trial has the following groups:- Group 1: CSL312
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.