Lanadelumab in Participants Hospitalized With COVID-19 Pneumonia

NCT ID: NCT04460105

Last Updated: 2020-10-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2021-01-27

Brief Summary

The purpose of this study is to evaluate the safety, pharmacokinetic and pharmacodynamics of lanadelumab administered by intravenous (IV) infusion when added to standard-of-care (SoC) in adults hospitalized with COVID-19 pneumonia.

Detailed Description

This study consists of two cohorts (Cohort 1 [Single-dose Cohort], and Cohort 2 [Repeat-dose Cohort]). Up to approximately 24 participants will be enrolled in this study, in which up to 12 participants may be enrolled into Cohort 1. However, Cohort 1 will be closed upon implementation of Amendment 2. Approximately 12 participants will be enrolled in Cohort 2. Participants will be randomized in 3:1 ratio (9 lanadelumab: 3 placebo) in each Cohort.

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lanadelumab

Participants receive 300 milligram (mg) of lanadelumab intravenous (IV) infusion on Day 1 during Cohort 1 (single dose cohort) and on Day 1 and Day 4 during Cohort 2 (repeat-dose cohort).

Group Type: EXPERIMENTAL

Lanadelumab

Intervention Type: DRUG

Participants will receive 300 mg of lanadelumab IV infusion on Day 1 and Day 4.

Placebo

Participants will receive placebo matching IV infusion on Day 1 during Cohort 1 (single dose cohort) and on Day 1 and Day 4 during Cohort 2 (repeat-dose cohort).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants will receive placebo matching IV infusion on Day 1 and Day 4.

Interventions

Lanadelumab

Participants will receive 300 mg of lanadelumab IV infusion on Day 1 and Day 4.

Intervention Type: DRUG

Placebo

Participants will receive placebo matching IV infusion on Day 1 and Day 4.

Intervention Type: OTHER

Other Intervention Names

SHP643; TAK-743; DX-2930

Eligibility Criteria

Inclusion Criteria

• Males and females 18 years of age or older at the time of signing of the informed consent form (ICF).
• Hospitalized with evidence of COVID-19 pneumonia defined as:

1. Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection documented with polymerase chain reaction (PCR) of any specimen; e.g. respiratory, blood, urine, stool, other body fluid

2. Presence of respiratory distress as indicated by peripheral capillary oxygen saturation (SpO2) lesser than or equal to (=<) 93 percent (%) on room air or respiratory rate greater than or equal to (>=) 30 breaths per minute (breaths/min).

• The participant (or a legally acceptable representative) has provided written informed consent approved by the institutional review board (IRB)/ independent ethics committee (IEC) before any study-specific procedures are performed.
• Agree to adhere to the protocol-defined schedule of treatments, assessments, and procedures.

Exclusion Criteria

• Invasive mechanical ventilation (IMV) extracorporeal membrane oxygenation (ECMO) or with evidence of severe respiratory distress such that IMV/ECMO is imminent within 12 hours of randomization.
• Where, in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
• Requiring vasopressor support (use of fluid support is not exclusionary)
• Known or suspected venous thromboembolism.
• Known or suspected hypersensitivity to lanadelumab or any of its excipients.
• Dosing with an investigational drug or exposure to an investigational device within 4 weeks prior to screening.
• Previous (within 3 months of screening) or current use of immunomodulators (e.g. methotrexate, azathioprine, 6-mercaptopurine, tumor necrosis factor [TNF] alpha inhibitor, Janus kinase [JAK] inhibitor, alpha-integrin).
• Previous (within 3 months of screening) or current use of plasma kallikrein inhibitor or bradykinin receptor blocker.
• Use of supplemental oxygen for a medical condition prior to receiving COVID-19 diagnosis.
• Previously diagnosed with acquired immunodeficiency syndrome (AIDS).
• Active tuberculosis or clinical suspicion of latent tuberculosis.
• Any of the following laboratory abnormalities at screening:

1. Hemoglobin <= 8 grams per deciliter (g/dL)

2. White blood cells <= 3000/ microliters (μL)

3. Platelets <= 75,000/μL

4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3×upper limit of normal (ULN); alkaline phosphatase (ALP) >= 3×ULN; or total bilirubin greater than (>) 2×ULN (unless the bilirubin elevation is a result of Gilbert's syndrome)

5. Creatinine >= 2×ULN

• Pregnant or breastfeeding.
• Any significant condition (any surgical or medical condition) 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: 18 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, Inc.

Other Identifiers

TAK-743-1002

Identifier Type: -

Identifier Source: org_study_id