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Trial record 1 of 1 for:    risankizumab asthma
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Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02443298
First received: May 11, 2015
Last updated: July 6, 2017
Last verified: July 2017
  Purpose
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).

Condition Intervention Phase
Asthma Drug: ABBV-066 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 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.

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Time to first asthma worsening during the planned 24 week treatment period [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Annualized rate of asthma worsening during the planned 24 week treatment period [ Time Frame: 24 weeks ]
  • Annualized rate of severe asthma exacerbation during the planned 24-week treatment period [ Time Frame: 24 weeks ]
  • Weekly Asthma Control Questionaire score at week 24 [ Time Frame: 24 weeks ]
  • Trough FEV1 in-clinic change from baseline at week 24 [ Time Frame: 24 weeks ]
  • Post-bronchodilator FEV1 in-clinic change from baseline at week 24 [ Time Frame: 24 weeks ]
  • Time to first severe asthma exacerbation during the planned 24 week treatment period [ Time Frame: 24 weeks ]

Enrollment: 214
Actual Study Start Date: June 2015
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABBV-066
Single dose
Drug: ABBV-066
Monoclonal IgG Antibody
Other Names:
  • BI 655066
  • risankizumab
Placebo Comparator: Placebo Drug: Placebo
Matching placebo for ABBV-066

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Pre-bronchodilator clinic measured 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02443298

  Show 73 Study Locations
Sponsors and Collaborators
AbbVie
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02443298     History of Changes
Other Study ID Numbers: 1311.14
2014-004932-20 ( EudraCT Number )
Study First Received: May 11, 2015
Last Updated: July 6, 2017

Keywords provided by AbbVie:
ABBV-066
BI 655066
risankizumab

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 22, 2017