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Monoclonal Antibodies

Lanadelumab for Angioedema

Cincinnati, OH
Phase 4
Recruiting
Led By Jonathan Bernstein, MD
Research Sponsored by Bernstein Clinical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Historical attack rate of >= one attack per month prior to starting tranexamic acid (TAA)
Be older than 18 years old
Must not have
Women who are pregnant or breast feeding
HAE Type 1 or 2 and normal complement HAE
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial investigates the effectiveness of lanadelumab in patients with acquired angioedema.

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Who is the study for?
This trial is for patients with acquired angioedema who experience at least one attack per month and have specific lab findings like decreased C1INH, C4, and C1q levels. It's not open to pregnant or breastfeeding women, those with hereditary angioedema types 1 or 2, people allergic to biologics, or anyone with uncontrolled systemic diseases.Check my eligibility
What is being tested?
The study tests Lanadelumab (300 mg), a medication intended for long-term prevention of swelling attacks in acquired angioedema. Participants will receive this treatment to see how effective it is in reducing the frequency of their symptoms.See study design
What are the potential side effects?
While the side effects are not detailed here, similar medications can cause reactions at the injection site, respiratory symptoms, headaches, and potentially serious allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had at least one attack per month before starting TAA.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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Select...
I have Hereditary Angioedema Type 1 or 2.
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Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Objective

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: open-label administrationExperimental Treatment1 Intervention
all subjects receive open-label lanadelumab

Find a Location

Closest Location:Bernstein Clinical Research Center, LLC· Cincinnati, OH

Who is running the clinical trial?

Bernstein Clinical Research CenterLead Sponsor
3 Previous Clinical Trials
88 Total Patients Enrolled
1 Trials studying Angioedema
5 Patients Enrolled for Angioedema
Jonathan Bernstein, MDPrincipal Investigator5139314181
3 Previous Clinical Trials
126 Total Patients Enrolled
1 Trials studying Angioedema
5 Patients Enrolled for Angioedema
~3 spots leftby Sep 2027
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