Phase 2
Completed N=214
Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma
Source: ClinicalTrials.gov NCT02443298 ↗Enrolled (actual)
214
Serious AEs
16.4%
Results posted
Apr 2019
Primary outcomePrimary: Time to First Asthma Worsening During the Planned 24 Week Treatment Period — 40.00; 85.50 Days — p=0.0255
Summary
The objectives of this trial are primarily to evaluate the efficacy and safety of BI 655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with BI 655066/ABBV-066 (risankizumab).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Asthma Worsening During the Planned 24 Week Treatment Period |
40.00; 85.50 | 0.0255 sig |
| SECONDARY Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition |
20.00; 37.00 | 0.0131 sig |
| SECONDARY Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period |
4.8412; 3.2410 | 0.0065 sig |
| SECONDARY Time to First Severe Asthma Exacerbation During the Planned 24 Week Treatment Period |
NA; NA | 0.4619 |
| SECONDARY Annualized Rate of Severe Asthma Exacerbation During the Planned 24-week Treatment Period |
1.5901; 1.4051 | 0.5550 |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24 |
-0.052; -0.013 | 0.4423 |
| SECONDARY Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24 |
-0.097; -0.030 | 0.1377 |
| SECONDARY Weekly Asthma Control Questionaire Score at Week 24 |
1.857; 1.708 | 0.1985 |
Eligibility Criteria
Inclusion criteria
- Pre-bronchodilator clinic measured forced expiratory volume (FEV1) of =40% and =85% of predicted normal.
- 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.
- Must be on at least medium dose inhaled corticosteroids and at least one other asthma controller medication for at least one year.
- Must have documented history of two or more severe asthma exacerbations in the last 12 months.
Exclusion criteria
- Patients with a significant disease other than asthma.
- Patients who are not able to produce sputum or sputum samples of sufficient quality.
- Patients who had clinically relevant history of intubation for asthma exacerbation in the past year.
- Patients diagnosed with any concurrent respiratory disease.
- Recent history (within 6 months) of myocardial infarction or hospitalized for cardiac failure in the past year.
- Patients who have undergone thoracotomy with pulmonary resection.
- Patients who have undergone bronchial thermoplasty or radiotherapy procedure in the past year or have planned procedures during the study.
- Patients taking oral corticosteroids with a total daily dose of more than 20 mg prednisone (or equivalent) in the past 6 weeks.
- Pregnant or nursing women.
- Women of childbearing potential that, if sexually active, is unwilling to use a highly effective method of birth control.
- Clinically relevant acute infections or chronic infections.
- Have received any live bacterial or live viral vaccination in the last12 weeks.
- Have received Bacille Calmette-Guerin (BCG) vaccination in the last 12 months.
- Have received treatment with ustekinumab (Stelara®).
- Have received treatment with any other biologics in the last 3 months or within 6 times the half-life of the compound.
Data sourced from ClinicalTrials.gov (NCT02443298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.