AsthmaPhase 2NCT02443298
Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma
A Phase 2 study testing risankizumab in people with Asthma, run by AbbVie at 65 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 65 sitesin 10 countries
- Study dates
- 23 Jun 2015to 2 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
65 sites in 10 countries.
65 sites in 10 countries
United States20 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21224
Brigham and Women's Hospital
Boston, Massachusetts, 02115
VA WNY Healthcare System
Buffalo, New York, 14215
IMMUNOe Research Centers
Centennial, Colorado, 80112
American Health Research, Inc.
Charlotte, North Carolina, 28207
Northwestern University
Chicago, Illinois, 60611
MedTrial, LLC
Columbia, South Carolina, 29204
WCCT Global, LLC
Costa Mesa, California, 92626
O and O Alpan, LLC
Fairfax, Virginia, 22030
VitaLink Research
Greenville, South Carolina, 29615
El Camino Hospital
Mountain View, California, 94040
Coastal Carolina Health Care, P.A.
New Bern, North Carolina, 28562
Yale New Haven Hospital
New Haven, Connecticut, 06504
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Research Protocol Mgmt Spc
Pittsburgh, Pennsylvania, 15243
Washington University School of Medicine
St Louis, Missouri, 63110
Clinical Research Trials of Florida, Inc.
Tampa, Florida, 33607
Respiratory and Sleep Disorders Specialists
The Woodlands, Texas, 77380
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27104
Germany15 sites
Praxis Dr. Linnhoff, Berlin
Berlin, 10717
MECS Research GmbH, Berlin
Berlin, 12203
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
Bochum, 44789
Praxis Dr. med. Claus Keller
Frankfurt, 60389
IKF Pneumologie GmbH & Co. KG
Frankfurt, 60596
Medaimun GmbH
Frankfurt, 60596
Hamburger Institut für Therapieforschung GmbH (HIT)
Hamburg, 20354
Praxis Dr. Hoffmann, Hannover
Hanover, 30173
Universitätsklinikum des Saarlandes
Homburg/Saar, 66421
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
KPPK GmbH, Studienzentrum
Koblenz, 56068
KLB Gesundheitsforschung Lübeck GmbH
Lübeck, 23552
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Institut für klinische Forschung GmbH
Neu-Isenburg, 63263
IFG Institut für Gesundheitsförderung GmbH
Rüdersdorf, 15562
France5 sites
HOP CHU de Grenoble
Grenoble, 38043
HOP Nord
Marseille, 13915
HOP Arnaud de Villeneuve
Montpellier, 34295
HOP Nord Laënnec
Nantes, 44093
HOP Bichat
Paris, 75018
Poland5 sites
Gibinski Univ.Clin.Cnter of Silesian Med.Uni.Katowice,Outpat
Katowice, 40-752
Specjalistyczny Osrodek Alergologiczno-Intern. ALL-MED
Krakow, 30033
Univ. Hospital in Krakow,Pulmonology Clinical Dept
Krakow, 31066
Barlicki University Hospital No. 1
Lodz, 90 141
Barlicki University Hospital No. 1
Lodz, 90141
United Kingdom5 sites
Celerion Inc
Belfast, BT9 6AD
Bradford Royal Infirmary
Bradford, BD9 6RJ
Glenfield Hospital
Leicester, LE3 9QP
The Medicines Evaluation Unit
Manchester, M23 9QZ
Wishaw General Hospital
Wishaw, ML2 0DP
Belgium4 sites
ULB Hopital Erasme
Brussels, 1070
Brussels - UNIV St-Luc
Brussels, 1200
UZ Leuven
Leuven, 3000
Centre Hospitalier Universitaire de Liège
Liège, 4000
South Korea4 sites
Chungbuk National University Hospital
Cheongju-si, 361-771
Chonnam National University Hospital
Gwangju, 501-757
Korea University Guro Hospital
Seoul, 08308
The Catholic University of Korea, St.Paul's Hospital
Seoul, 130-709
Canada3 sites
Burlington Lung Clinic
Burlington, Ontario, L7N 3V2
Airway Inflammometry Laboratory
Hamilton, Ontario, L8N 4A6
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Netherlands2 sites
Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333 ZA
HagaZiekenhuis
The Hague, 2545 CH
Taiwan2 sites
Chang Gung Memorial Hospital Keelung
Keelung, 20401
China Medical University Hospital
Taichung, 40447
About this study
Official title: 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.
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).
- Conditions
- Asthma
- Being tested
- placebo, risankizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Matching placebo for risankizumab
risankizumabDrug
Also called ABBV-066, BI 655066
Monoclonal IgG antibody
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab | Experimental | Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe with 90 milligram/ milliliter (mg/mL) risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20). Receives: Drug: risankizumab |
| Placebo | Placebo comparator | Patients received subcutaneous injection of 1 milliliter (mL) prefilled syringe consisting of matching placebo to risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20). Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Asthma Worsening During the Planned 24 Week Treatment Period
Time to first asthma worsening during the planned 24 week treatment period:
Asthma worsening was defined as the occurrence of any one of the following four criteria:
- Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.75 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.
Measured: 24 weeks
Secondary outcomes (7)
Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition
Time to first asthma worsening during the planned 24 week treatment period according to alternative definition:
Asthma worsening was defined as the occurrence of any one of the following four criteria:
- Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.5 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.
Measured: 24 weeks
Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period
Annualized rate of asthma worsening during the planned 24 week treatment period.
Asthma worsening was defined as the occurrence of any one of the following four criteria:
- Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.75 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.
Mean is Annualized rate.
Measured: 24 weeks
Time to First Severe Asthma Exacerbation During the Planned 24 Week Treatment Period
Time to first severe asthma exacerbation during the planned 24 week treatment period. Severe asthma exacerbation was defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.
Measured: 24 weeks
Annualized Rate of Severe Asthma Exacerbation During the Planned 24-week Treatment Period
Annualized rate of severe asthma exacerbation during the planned 24-week treatment period.
Severe asthma exacerbation was defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.
Mean is Annualized rate.
Measured: 24 weeks
Trough Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
Trough forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.
Measured: Baseline and 24 weeks
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
Post-bronchodilator forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.
Measured: Baseline and 24 weeks
Weekly Asthma Control Questionaire Score at Week 24
The score at week 24 is the average of the responses to the five ACQ5 questions for the week preceding the Week 24 visit. The ACQ5 asks patients to rate the severity of their asthma symptoms and the degree to which asthma affected their sleep and other daily activities. The scale for all five ACQ5 questions range from the best possible answer of 0 (No symptoms, None, Never) to the worst possible answer of 6 (very severe, unable to sleep, totally limited). The ACQ5 score can range from 0.0 (best) to 6.0 (worst).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study start23 Jun 2015
- Primary completion13 Oct 2017
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443298
- Sponsor's protocol ID
- 1311.14
- Other IDs
- 2014-004932-20, 2014
- Status last verified
- Mar 2019
- First submitted
- 11 May 2015
- Last updated
- 10 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Publications
Brightling CE, Nair P, Cousins DJ, Louis R, Singh D. Risankizumab in Severe Asthma - A Phase 2a, Placebo-Controlled Trial. N Engl J Med. 2021 Oct 28;385(18):1669-1679. doi: 10.1056/NEJMoa2030880.
PubMed 34706172
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02443298
- Acronym / sponsor ID
- 1311.14
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- 23 Jun 2015 (actual)
- Primary completion
- 13 Oct 2017 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Posted 10 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risankizumab | Experimental | Drug: risankizumabPatients received subcutaneous injection of 1 milliliter (mL) prefilled syringe with 90 milligram/ milliliter (mg/mL) risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20). |
| Placebo | Placebo comparator | Drug: placeboPatients received subcutaneous injection of 1 milliliter (mL) prefilled syringe consisting of matching placebo to risankizumab once every 4 weeks (weeks 0, 4, 8, 12, 16, 20). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboMatching placebo for risankizumab | Drug | Placebo |
| risankizumabAlso: ABBV-066, BI 655066Monoclonal IgG antibody | Drug | Risankizumab |
Primary outcome
Time to First Asthma Worsening During the Planned 24 Week Treatment Period
Time frame: 24 weeks
Time to first asthma worsening during the planned 24 week treatment period: Asthma worsening was defined as the occurrence of any one of the following four criteria: a) Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.75 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.
7 secondary outcomes
Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition
Time frame: 24 weeks
Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period
Time frame: 24 weeks
Time to First Severe Asthma Exacerbation 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
Trough Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
Time frame: Baseline and 24 weeks
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
Time frame: Baseline and 24 weeks
Weekly Asthma Control Questionaire Score at Week 24
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34706172Brightling CE, Nair P, Cousins DJ, Louis R, Singh D. Risankizumab in Severe Asthma - A Phase 2a, Placebo-Controlled Trial. N Engl J Med. 2021 Oct 28;385(18):1669-1679. doi: 10.1056/NEJMoa2030880.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
65 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing risankizumab in people with Asthma, run by AbbVie at 65 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Germany, France, Poland, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Asthma Worsening During the Planned 24 Week Treatment Period (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02443298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.