A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor

NCT ID: NCT04444895

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-05
• Study Completion Date: 2023-05-05

Brief Summary

The purpose of this study is to evaluate the long-term safety and efficacy of repeated subcutaneous (SC) administration of lanadelumab in adolescents and adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303 (NCT04206605).

Detailed Description

This study consists of 26-week treatment period (Day 0 to Day 182) and a 2-week follow-up period. Participants who completed the double-blind treatment period at Day 182 of Study SHP643-303 (NCT04206605) will enroll into this extension study.

Conditions

Angioedema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lanadelumab 300 mg Every 2 Weeks

Participants received 300 milligrams (mg) lanadelumab subcutaneous (SC) injection, every 2 weeks (Q2W) for up to 26 weeks with an option to switch to lanadelumab 300 mg every 4 weeks (Q4W) if attacks were well-controlled based on the investigator's discretion and consultation with the sponsor's medical monitor.

Group Type: EXPERIMENTAL

Lanadelumab

Intervention Type: DRUG

Lanadelumab SC injection

Interventions

Lanadelumab

Lanadelumab SC injection

Intervention Type: DRUG

Other Intervention Names

DX-2930; SHP643; TAK-743

Eligibility Criteria

Inclusion Criteria

• Males and females, 12 years of age and older diagnosed with non-histaminergic normal C1-INH angioedema at the time of enrollment into the antecedent Study SHP643-303 (NCT04206605).
• Participants must have completed the treatment period (through Visit 26/Day 182) of Study SHP643-303 (NCT04206605) without reporting a clinically significant TEAE that would preclude subsequent exposure to lanadelumab.
• Agree to adhere to the protocol-defined schedule of treatments, assessments, and procedures.
• Males, or non-pregnant, non-lactating females who are of child-bearing potential and who agree to be abstinent or agree to comply with the applicable contraceptive requirements of this protocol for the duration of the study; or females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months.
• The participant (or the participant's parent/legal guardian, if applicable) has provided written informed consent approved by the institutional review board/research ethics board/ethics committee (IRB/REB/EC) at any time prior to study start. If the participant is a minor (i.e. lesser then (<) 18 years of age), have a parent/legal guardian who is informed of the nature of the study provide written informed consent (i.e. permission) for the minor to participate in the study before any study-specific procedures are performed. Assent will be obtained from minor participants.

Exclusion Criteria

• Discontinued from Study SHP643-303 (NCT04206605) after enrollment but before Visit 26 for any reason.
• Presence of important safety concerns identified in Study SHP643-303 (NCT04206605) that would preclude participation in this study.
• Dosing with an investigational product (IP, not including IP defined in antecedent Study SHP643-303 [NCT04206605]) or exposure to an investigational device within 4 weeks prior to Day 0.
• Participants has a known hypersensitivity to the investigational product or its components.
• Have any condition (surgical or medical) that, in the opinion of the investigator or sponsor, may compromise their safety or compliance, preclude the successful conduct of the study, or interfere with interpretation of the results (e.g. significant pre-existing illness or other major comorbidities that the investigator considers may confound the interpretation of study results).

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Development Center Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda Development Center Americas

Locations

Clinical Research Center of Alabama

Birmingham, Alabama, United States

Medical Research of Arizona

Scottsdale, Arizona, United States

UCSD Angioedema Center

San Diego, California, United States

Allergy and Asthma Clinical Research Inc

Walnut Creek, California, United States

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, United States

Rush University Medical Center

Chicago, Illinois, United States

Kanarek Allergy, Asthma and Immunology

Overland Park, Kansas, United States

Institute for Asthma & Allergy, P.C.

Chevy Chase, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

Optimed Research, LTD

Columbus, Ohio, United States

Seattle Allergy & Asthma Research Institute

Seattle, Washington, United States

Ottawa Allergy Research Corporation

Ottawa, Ontario, Canada

Clinique Specialisee en Allergie de la Capitale

Québec, Quebec, Canada

Hôpital Saint-Antoine

Paris, , France

Klinikum rechts der Isar der TU

Munich, Bavaria, Germany

Klinikum der Johann Wolfgang Goethe-Universitaet pt

Frankfurt am Main, Hesse, Germany

Semmelweis Egyetem

Budapest, , Hungary

A.O. Ospedali riuniti Villa Sofia - Cervello,

Palermo, Palermo Palermo, Italy

Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

Milan, , Italy

Azienda Ospedaliera Universitaria "Federico II"

Napoli, , Italy

Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

Salerno, , Italy

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Clover Hospital

Fujisawa-shi, Kanagawa, Japan

Amsterdam UMC

Amsterdam, , Netherlands

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

UMC Utrecht

Utrecht, , Netherlands

NZOZ Homeo Medicus, Poradnia Alergologiczna

Bialystok, , Poland

"ALL-MED" Specjalistyczna Opieka Medyczna Filia

Wroclaw, , Poland

Hospital Universitario Cruces

Barakaldo, Vizcaya, Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Countries

United States; Canada; France; Germany; Hungary; Italy; Japan; Netherlands; Poland; Spain

References

Riedl MA, Staubach P, Farkas H, Zanichelli A, Ren H, Nurse C, Andresen I, Juethner S, Yu M, Zhang J. Lanadelumab for prevention of attacks of non-histaminergic normal C1 inhibitor angioedema: results from the randomized, double-blind CASPIAN Study and CASPIAN open-label extension. Front Immunol. 2025 May 21;16:1502325. doi: 10.3389/fimmu.2025.1502325. eCollection 2025.

Reference Type: DERIVED

PMID: 40469312 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b600d4db2bf003ab48cf1?idFilter=%5B%22TAK-743-3001%22%5D

To obtain more information on the study, click here/on this link

Other Identifiers

2019-004823-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

jRCT2051220001

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-743-3001

Identifier Type: -

Identifier Source: org_study_id