ClinicalTrials.gg
RecruitingNCT06818474Updated Feb 25, 2025

Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

A Phase 4 interventional study of Lanadelumab 300 mg in Angioedema, sponsored by Bernstein Clinical Research Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-25.

Sponsored by Bernstein Clinical Research Center · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jun 2024, registered Feb 2025).
  • Started Jun 2024; still recruiting 2 years 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

use of lanadelumab in patients with acquired angioedema

02

Conditions studied

  • Angioedema

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03

In context

Angioedema

69 studies on the registry are indexed under Angioedema; 16 are open to participants now.

This study's planned enrollment of 5 is below the median of 45 across 44 interventional studies indexed under Angioedema.

Browse Angioedema studies →

Lead sponsor

Bernstein Clinical Research Center is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A diagnosis of AAE with recurrent attacks without urticaria (decreased C1INH functional, quantitative levels, decreased C4 and decreased C1q levels, no family history of angioedema), presence of anti-C1INH antibody and/or paraproteinemia (e.g. monoclonal gammopathy of unknown significance)
  • historical attack rate of >= on attack per month prior to starting tranexamic acid (TAA)

Exclusion criteria

Exclusion Criteria:

  • History of anaphylaxis or to biologics
  • History of major systemic disease not well controlled in opinion of the PI
  • Women who are pregnant or breast feeding
  • Concurrent participation in other clinical trials
  • HAE Type 1 or 2 and normal complement HAE
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Other
    open-label administration

    all subjects receive open-label lanadelumab

    Biological: Lanadelumab 300 mg

Interventions

06

What researchers measure

Primary outcomes

  1. Primary Objective

    Rate of investigator confirmed AAE attacks during study period, as measured by the ACT. AAE attack will be defined as a unique event during which the study subject will progress from no angioedema to symptoms of angioedema and no further angioedema for 24 hours after resolution of the event with rescu therapy

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Bernstein Clinical Research Center, LLC
    Cincinnati, Ohio 45236, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2024 (actual). Primary completion is estimated for Sep 2027, 39 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2025
First posted
Feb 10, 2025
StartActual
Jun 1, 2024
Primary completionEst.
Sep 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Feb 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06818474
Lead sponsor
Bernstein Clinical Research Center
Responsible party
Jonathan A. Bernstein, MD (PI/ Owner, Bernstein Clinical Research Center) — Principal investigator
First posted
Feb 10, 2025
Start date
Jun 1, 2024
Primary completion
Sep 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Feb 25, 2025

Study contacts

Karen Berendts
Contact
kberendts@bernsteincrc.com
513-354-1746
Jonathan Bernstein, MD
Contact
bernstja@ucmail.uc.edu
Jonathan Bernstein, MD
principal investigator · 5139314181

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Lanadelumab

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