Lanadelumab in Long-term Prophylaxis of Acquired Angioedema | NCT06818474

Studies
Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

NCT06818474

Sponsor

Bernstein Clinical Research Center

Status

Recruiting

Last Update Posted

Feb 25, 2025Actual

Enrollment

5Estimated

Phase

Phase 4

Conditions

Angioedema

Interventions

Lanadelumab 300 mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

Sep 1, 2027Estimated

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Feb 5, 2025

First Submission Date that Met QC Criteria

Feb 5, 2025

First Posted Date

Feb 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2025

Last Update Posted Date

Feb 25, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jonathan A. Bernstein, MD, PI/ Owner, Bernstein Clinical Research CenterPrincipal Investigator

Lead Sponsor

Bernstein Clinical Research CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
open-label administration	Other	all subjects receive open-label lanadelumab	Biological: Lanadelumab 300 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lanadelumab 300 mg	Biological	no other intervention	open-label administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

History of anaphylaxis or hypersensitivity 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Karen Berendts	Contact	513-354-1746		kberendts@bernsteincrc.com
Jonathan Bernstein, MD	Contact			bernstja@ucmail.uc.edu

Overall Officials

Name	Affiliation	Role
Jonathan Bernstein, MD	5139314181	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bernstein Clinical Research Center, LLC	Recruiting	Cincinnati	Ohio	45236	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000799	Angioedema

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D014581	Urticaria
D017445	Skin Diseases, Vascular

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000596550	lanadelumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided