A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

IDENTIFIERS
Trial Protocol: SHP643-303
Clinicaltrials.gov: NCT04206605
EudraCT: 2019-001703-20
JapicCTI: jRCT2061210013
PURPOSE

The main aim of this study is to check if repeated subcutaneous (SC) injections of lanadelumab can prevent angioedema attacks in teenagers and adults with non-histaminergic angioedema with normal C1-INH. Another aim is to check if they tolerate the repeated SC injections. Participants will receive a SC injection of lanadelumab every two weeks for 26 weeks. The first two doses of lanadelumab will be given at the study clinic. Once a participant (and/or parent/caregiver) has been appropriately trained, lanadelumab can be self-injected. Visits to the study clinic are planned for the first, third and fourth week and then every 4 weeks.

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Trial at a glance

What medical condition is being studied?   Angioedema
What is the trial testing?   Lanadelumab, Placebo
Are placebos part of the trial?   Yes
How many participants are being enrolled?   75
When is the trial being conducted?    - 
How long is participation in the trial?   Participants will be in the study for about 40 weeks.

Key requirements

Sex   
All
Age   
From 12 Years
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Phase:   Phase 3
Trial Type:   Interventional
Trial Arms/Groups or Cohorts:   
Lanadelumab: Participants will receive 300 milligrams (mg) of lanadelumab solution in a prefilled syringe (PFS) as subcutaneous (SC) injection once every 2 weeks (q2w) for 26 weeks.
Placebo: Participants will receive placebo matched to lanadelumab SC injection once q2w for 26 weeks.
Intervention:   Lanadelumab, Placebo
Primary Outcome Measure(s):
Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 [Time Frame: Day 0 through Day 182]
Secondary Outcome Measure(s):   
Number of Participants Achieving Attack-Free Status During the Treatment Period of Day 0 Through Day 182 [Time Frame: Day 0 through Day 182]
Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 [Time Frame: Day 0 Through Day 182]
Number of Investigator-Confirmed Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 [Time Frame: Day 70 through Day 182]
Number of Participants Achieving Attack-Free Status During the Presumed Steady State Period of Day 70 Through Day 182 [Time Frame: Day 70 through Day 182]
Number of Investigator-Confirmed Moderate or Severe Angioedema Attacks During the Presumed Steady State Period of Day 70 Through Day 182 [Time Frame: Day 70 through Day 182]
Number of Participants with Maximum Attack Severity During Presumed Steady State Period of Day 70 Through Day 182 [Time Frame: Day 70 through Day 182]
Number of Participants with Maximum Attack Severity During Treatment Period of Day 0 Through Day 182 [Time Frame: Day 0 through Day 182]
Time to First Angioedema Attack After Day 0 Through Day 182 [Time Frame: Day 0 Through Day 182]
Time to First Angioedema Attack After Day 70 Through Day 182 [Time Frame: Day 70 through Day 182]
Number of Participants Achieving at Least 50 %, 70%, 90% and 100% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) per 4 Weeks during each of the Efficacy Evaluation Periods Relative to the Observation Period NNA [Time Frame: Day 0 Through Day 182]
Number of Participants Achieving Normalized Number of Attacks (NNA) Less than (<)1.0 per 4 weeks During Each of the Efficacy Evaluation Periods [Time Frame: Day 0 Through Day 182, Day 70 through Day 182]
Number of Participants with Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) [Time Frame: From start of the study up to follow up (Day 196)]
Plasma Concentrations of Lanadelumab [Time Frame: Day 0, 14, 28, 56, 84, 112, 140, 168 and 182]
Plasma Kallikrein (pKal) Activity [Time Frame: Day 0, 14, 28, 56, 84, 112, 140, 168 and 182]
Number of Participants With Neutralizing or Non-neutralizing Antidrug Antibodies (ADA) in Plasma [Time Frame: Day 0, 28, 56, 84, 112, 140, 168 and 182]
Change in Total Angioedema Quality of life (AE-QoL) Questionnaire Score During the Treatment Period of Day 0 Through Day 182 [Time Frame: Day 0 through Day 182]
Entry Criteria:
- Can be boys or girls or men and women, - Must be 12 years or older for people with non-histaminergic normal C1-INH angioedema at the time of signing of the informed consent form (ICF) - Must have an investigator-confirmed diagnosis of non-histaminergic bradykinin-mediated angioedema with nonhistaminergic angioedema with normal C1-INH - Must have a history of recurrent angioedema with at least an average of 1 angioedema attack per 4 weeks prior to study start Additional entry criteria will be discussed with the study doctor.

Trial Locations

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Clinical Research Center of Alabama

504 Brookwood Blvd #250, Birmingham, AL 35209, USA

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Medical Research of Arizona

7514 E Monterey Way, Scottsdale, AZ 85251, USA

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University of California San Diego

9500 Gilman Dr, La Jolla, CA 92093, USA

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Allergy and Asthma Clinical Research Inc

370 N Wiget Ln #210, Walnut Creek, CA 94598, USA

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Asthma and Allergy Associates, PC

2709 N Tejon St, Colorado Springs, CO 80907, USA

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University of South Florida Asthma, Allergy & Immunology

4503 N Armenia Ave, Tampa, FL 33603, USA

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Rush University Medical Center

1620 W Harrison St, Chicago, IL 60612, USA

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Kanarek Allergy, Asthma and Immunology

4601 W 109th St Suite 350, Overland Park, KS 66211, USA

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Institute for Asthma & Allergy - Chevy Chase

2 Wisconsin Cir #250, Chevy Chase, MD 20815, USA

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Massachusetts General Hospital

55 Fruit St, Boston, MA 02114, USA

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University of Michigan

500 S State St, Ann Arbor, MI 48109, USA

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Mayo Clinic - Rochester

200 1st St SW, Rochester, MN 55905, USA

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Washington University

1 Brookings Dr, St. Louis, MO 63130, USA

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Jay M Kashkin, MD Allergy, Asthma and Immunology

23-00 NJ-208, Fair Lawn, NJ 07410, USA

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Bernstein Clinical Research Center, LLC

8444 Winton Rd, Cincinnati, OH 45231, USA

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Optimed Research, LTD

8080 Ravines Edge Ct Suite 200, Columbus, OH 43235, USA

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Tanner Clinic

2121 N 1700 W, Layton, UT 84041, USA

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Seattle Allergy & Asthma Research Institute

9725 3rd Ave NE #500, Seattle, WA 98115, USA

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Ottawa Allergy Research Corporation

1081 Carling Ave Suit 800, Ottawa, ON K1Y 4K4, Canada

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Clinique Specialisee en Allergie de la Capitale

2600 Boulevard Laurier #880, Québec, QC G1V 4W1, Canada

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Klinikum der Johann Wolfgang Goethe-Universitaet

Theodor-Stern-Kai 7, 60596 Frankfurt am Main, Germany

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Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Langenbeckstraße 1, 55131 Mainz, Germany

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Universitaetsklinikum Leipzig AoeR

Johannisallee 32a, 04103 Leipzig, Germany

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Semmelweis Egyetem

Budapest, Mikszáth Kálmán tér 5, 1088 Hungary

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Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

Via Giovanni Battista Grassi, 74, 20157 Milano MI, Italy

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

Via San Leonardo, 1, 84131 Salerno SA, Italy

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Amsterdam UMC

Meibergdreef 9, 1105 AZ Amsterdam, Netherlands

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Universitair Medisch Centrum Groningen

Hanzeplein 1, 9713 GZ Groningen, Netherlands

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UMC Utrecht

Heidelberglaan 100, 3584 CX Utrecht, Netherlands

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NZOZ Homeo Medicus, Poradnia Alergologiczna

Komisji Edukacji Narodowej 3b/lok 1, 15-687 Białystok, Poland

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"ALL-MED" Specjalistyczna Opieka Medyczna Medyczny Instytut Badawczy

aleja Hallera 95, 53-201 Wrocław, Poland

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Hospital Universitari de Bellvitge

Carrer de la Feixa Llarga, s/n, 08907 L'Hospitalet de Llobregat, Barcelona, Spain

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Complexo Hospitalario Universitario de Vigo

Estrada de Clara Campoamor, 341, 36213 Vigo, Pontevedra, Spain

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Hospital Universitario Cruces

Cruces Plaza, S/N, 48903 Barakaldo, Bizkaia, Spain

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Hospital Universitari Vall d'Hebron

Passeig de la Vall d'Hebron, 119, 08035 Barcelona, Spain

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Hospital Universitario La Paz

Paseo de la Castellana, 261, 28046 Madrid, Spain

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Hospital Universitari i Politecnic La Fe

Avinguda de Fernando Abril Martorell, 106, 46026 València, Valencia, Spain

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AIRE Medical of Los Angeles

1301 20th St #380, Santa Monica, CA 90404, USA

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Clinical Research of Charlotte

8045 Providence Rd #300, Charlotte, NC 28277, USA

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Trial Protocol ID: SHP643-303
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