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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02443298 |
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Date of registration:
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11/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma
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Scientific title:
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Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Subcutaneously Administered BI 655066/ABBV-066 (Risankizumab) as add-on Therapy Over 24 Weeks in Patients With Severe Persistent Asthma. |
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Date of first enrolment:
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June 23, 2015 |
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Target sample size:
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214 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02443298 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Canada
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France
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Germany
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Hungary
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Ireland
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Italy
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Korea, Republic of
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Netherlands
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Poland
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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Boehringer Ingelheim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Pre-bronchodilator clinic measured forced expiratory volume (FEV1) of =40% and =85% of
predicted normal.
2. One year history of asthma diagnosed by a physician, and have FEV1 reversibility of
=12% and an absolute change of at least 200 mL after administration of 400 µg
salbutamol.
3. Must be on at least medium dose inhaled corticosteroids and at least one other asthma
controller medication for at least one year.
4. Must have documented history of two or more severe asthma exacerbations in the last 12
months.
Exclusion criteria:
1. Patients with a significant disease other than asthma.
2. Patients who are not able to produce sputum or sputum samples of sufficient quality.
3. Patients who had clinically relevant history of intubation for asthma exacerbation in
the past year.
4. Patients diagnosed with any concurrent respiratory disease.
5. Recent history (within 6 months) of myocardial infarction or hospitalized for cardiac
failure in the past year.
6. Patients who have undergone thoracotomy with pulmonary resection.
7. Patients who have undergone bronchial thermoplasty or radiotherapy procedure in the
past year or have planned procedures during the study.
8. Patients taking oral corticosteroids with a total daily dose of more than 20 mg
prednisone (or equivalent) in the past 6 weeks.
9. Pregnant or nursing women.
10. Women of childbearing potential that, if sexually active, is unwilling to use a highly
effective method of birth control.
11. Clinically relevant acute infections or chronic infections.
12. Have received any live bacterial or live viral vaccination in the last12 weeks.
13. Have received Bacille Calmette-Guerin (BCG) vaccination in the last 12 months.
14. Have received treatment with ustekinumab (Stelara®).
15. Have received treatment with any other biologics in the last 3 months or within 6
times the half-life of the compound.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: placebo
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Drug: risankizumab
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Primary Outcome(s)
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Time to First Asthma Worsening During the Planned 24 Week Treatment Period
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period
[Time Frame: 24 weeks]
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Weekly Asthma Control Questionaire Score at Week 24
[Time Frame: 24 weeks]
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Time to First Severe Asthma Exacerbation During the Planned 24 Week Treatment Period
[Time Frame: 24 weeks]
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Annualized Rate of Severe Asthma Exacerbation During the Planned 24-week Treatment Period
[Time Frame: 24 weeks]
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Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
[Time Frame: Baseline and 24 weeks]
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Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition
[Time Frame: 24 weeks]
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Trough Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
[Time Frame: Baseline and 24 weeks]
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Secondary ID(s)
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2014-004932-20
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1311.14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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