A clinical trial of Tocilizumab in participants with asthma

Phase 1

Completed

• Conditions: Asthma; Respiratory - Asthma; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12614000123640
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-03
• Study Completion: 2017-07-19
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

For Part 1 of the study:

1.Male/female volunteers 18-65 years of age.
2.General good health.
3.Mild to moderate, stable, allergic asthma.
4.History of episodic wheeze and shortness of breath.
5.FEV(1) at baseline at least 70percent of the predicted value.
6.Positive skin-prick test to common allergens.
7.Able to comprehend and follow all required study procedures
8.Willing and able to sign an informed consent form.

For Part 2 of the study:

1. Positive histamine challenge test.
2. Positive allergen-induced early and late airway bronchoconstriction.
3. rs4129267 genotype TT or CT

Exclusion Criteria

General:

1.History or symptoms of clinically significant autoimmune disease;
2.Lung disease other than mild to moderate allergic asthma;
3.Recent history of alcohol dependency;
4.Use of tobacco products of any kind currently or within the previous 12 months, or smoking history greater than 10 pack years;
5.Unwillingness or inability to comply with the study protocol for any other reason;

Previous or concomitant therapy:

6.Use of corticosteroids, immunosuppressives, anticoagulants or any medications that may interact with drug within 28 days prior to treatment randomization;
7.Have chronic use of any other medication for treatment of allergic lung disease other than short- and intermediate-acting Beta2-agonists or ipratropium bromide;
8.Participation in any other investigational drug treatment protocol within the preceding 30 days or 5 half lives of the drug;

Exclusions for general safety:

9.A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry;
10.History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness;
11.History or symptoms of cardiovascular disease;
12.History or symptoms of significant neurologic disease;
13.History of serious adverse reaction or hypersensitivity to any drug;
14.Abnormal chest X-ray;
15.Abnormal electrocardiogram;
16.History of clinically significant hematologic abnormality;
17.History of intestinal ulceration or diverticulitis.
18.Clinically significant abnormalities in laboratory test results;
19.Women not using adequate contraception, actively seeking pregnancy, pregnant or lactating or have positive serum pregnancy test at screening or positive urine pregnancy test during the study;
20.History of, or known currently active, recurrent bacterial, viral, fungal, mycobacterial or other infections.
21.Primary or secondary immunodeficiency.
22.Patients with lack of peripheral venous access.
23.Concomitant disease or condition which could interfere with the conduct of the study or pose an unacceptable risk to the subject.
24.Development of severe asthma reaction during the screening allergen challenge that could not be rescued by bronchodilator alone.

Laboratory exclusion criteria (at visits 1 to 4):

25.Serum aspartate transaminase or alanine transaminase greater than 1.5x ULN
26.Absolute neutrophil count less than 2 x 10e9/L
27.Platelet count less than 100 x 10e9/L.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The primary objective of this study is to evaluate the impact of Tocilizumab (TCZ) on the Late Asthmatic Response (LAR) triggered by allergen inhalation in asthma patients, compared with placebo. [As such, the primary efficacy outcome measure is the LAR, taken to be the largest fall in Forced Expiratory Volume in 1 second FEV(1) between 3 hours and 7 hours after allergen inhalation. An allergen inhalation challenge test will be performed at visits 3 (screening) and 7 (after treatment).];2. A primary objective is to evaluate the safety of TCZ in patients with asthma.[As such the primary safety outcomes will be measured by the following safety laboratory tests that will be performed at visits 1, 3, 5, 7, 9 and 10 (unless otherwise noted):<br><br>-Hematology (all visits)<br><br>-Blood biochemistry<br><br>-Urinalysis<br><br>-Serology (visit 1 only)<br>]