Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2024-12-31

Brief Summary

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Phase 1 study investigating safety of lanadelumab administration to patients with lung injury

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Detailed Description

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This study will investigate the safety of inhibition of plasma kallikrein by lanadelumab administration in patients with lung injury.

Conditions

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Lung Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Open-label placebo-controlled dose-escalation Phase 1 study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Saline control

Group Type PLACEBO_COMPARATOR

Saline control

Intervention Type OTHER

Saline control

Lanadelumab 30 mg

Group Type EXPERIMENTAL

Lanadelumab

Intervention Type DRUG

Monoclonal antibody that targets active plasma kallikrein

Lanadelumab 100 mg

Group Type EXPERIMENTAL

Lanadelumab

Intervention Type DRUG

Monoclonal antibody that targets active plasma kallikrein

Lanadelumab 300 mg

Group Type EXPERIMENTAL

Lanadelumab

Intervention Type DRUG

Monoclonal antibody that targets active plasma kallikrein

Interventions

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Lanadelumab

Monoclonal antibody that targets active plasma kallikrein

Intervention Type DRUG

Saline control

Intervention Type OTHER

Other Intervention Names

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Takhzyro

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years admitted to the ICU with primary diagnosis of lung injury. The criteria for the diagnosis of lung injury include five principal elements: hypoxemia (blood oxygen saturation (PaO2) ≤92% when breathing ambient air, ratio of PaO2 to the fraction of inspired oxygen (FiO2) ≤300), diffuse pulmonary infiltrates on chest radiographs, decreased lung compliance, and the absence of congestive heart failure.
* Both males and females will be recruited in the proportion in which they are admitted to the ICU with lung injury.
* Arterial cannula in place as part of usual care for the measurement of blood gases.
* Patients may or may not be intubated and mechanically ventilated.
* Able to provide informed consent, or if unable to do so, a responsible person:

medical treatment decision maker is available (by telephone if necessary) who can be approached to seek consent.

Exclusion Criteria

* Other causes of lung infiltrates: pulmonary oedema, alveolar haemorrhage, adverse drug reactions, radiation injury and the idiopathic pneumonitis syndrome.
* Significant dysfunction of non-pulmonary organs in the opinion of the treating ICU consultant.
* Death is deemed imminent or inevitable or there is underlying disease with a life expectancy of less than 90 days.
* Previously enrolled in this study.
* Enrolled in another study.
* Usually receives home oxygen.
* Usually receives any type of assisted ventilation at home. e.g. continuous positive airway pressure for obstructive sleep apnoea.
* Pregnant or might be pregnant. Women aged 18 to 49 are excluded unless there is documented menopause, hysterectomy or surgical sterilisation, or a pregnancy test is negative.
* Objection from the treating clinician.
* Consent refused by the patient or substitute decision maker.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No