Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004932-20 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
Not provided
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Matching placebo for risankizumab |
| |
| risankizumab |
| Measure | Description | Time Frame |
|---|---|---|
| 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: 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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: 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 ≥0.5 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. |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global, LLC | Costa Mesa | California | 92626 | United States | ||
| El Camino Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34706172 | Derived | 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. |
Not provided
Not provided
All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they (the patients) met all strictly implemented inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria was violated.
This was a randomized, double-blind, placebo-controlled, parallel-group multicenter study to assess the efficacy and safety of risankizumab, an IL-23p19 monoclonal antibody, compared to placebo in patients with severe persistent asthma.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Risankizumab | 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) |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 17, 2017 | Feb 26, 2019 |
Not provided
Not provided
Not provided
Not provided
| Drug |
Monoclonal IgG antibody |
|
|
| 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: 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. Mean is Annualized rate. | 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. | 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. | 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. | 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. | 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). | 24 weeks |
| Mountain View |
| California |
| 94040 |
| United States |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06504 | United States |
| Clinical Research Trials of Florida, Inc. | Tampa | Florida | 33607 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| VA WNY Healthcare System | Buffalo | New York | 14215 | United States |
| American Health Research, Inc. | Charlotte | North Carolina | 28207 | United States |
| Coastal Carolina Health Care, P.A. | New Bern | North Carolina | 28562 | United States |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27104 | United States |
| Temple University School of Medicine | Philadelphia | Pennsylvania | 19140 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Research Protocol Mgmt Spc | Pittsburgh | Pennsylvania | 15243 | United States |
| MedTrial, LLC | Columbia | South Carolina | 29204 | United States |
| VitaLink Research | Greenville | South Carolina | 29615 | United States |
| Respiratory and Sleep Disorders Specialists | The Woodlands | Texas | 77380 | United States |
| O and O Alpan, LLC | Fairfax | Virginia | 22030 | United States |
| ULB Hopital Erasme | Brussels | 1070 | Belgium |
| Brussels - UNIV St-Luc | Brussels | 1200 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liège | Liège | 4000 | Belgium |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Burlington Lung Clinic | Burlington | Ontario | L7N 3V2 | Canada |
| Airway Inflammometry Laboratory | Hamilton | Ontario | L8N 4A6 | Canada |
| HOP CHU de Grenoble | Grenoble | 38043 | France |
| HOP Nord | Marseille | 13915 | France |
| HOP Arnaud de Villeneuve | Montpellier | 34295 | France |
| HOP Nord Laënnec | Nantes | 44093 | France |
| HOP Bichat | Paris | 75018 | France |
| Praxis Dr. Linnhoff, Berlin | Berlin | 10717 | Germany |
| MECS Research GmbH, Berlin | Berlin | 12203 | Germany |
| Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH | Bochum | 44789 | Germany |
| Praxis Dr. med. Claus Keller | Frankfurt | 60389 | Germany |
| IKF Pneumologie GmbH & Co. KG | Frankfurt | 60596 | Germany |
| Medaimun GmbH | Frankfurt | 60596 | Germany |
| Hamburger Institut für Therapieforschung GmbH (HIT) | Hamburg | 20354 | Germany |
| Praxis Dr. Hoffmann, Hannover | Hanover | 30173 | Germany |
| Universitätsklinikum des Saarlandes | Homburg/Saar | 66421 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| KPPK GmbH, Studienzentrum | Koblenz | 56068 | Germany |
| KLB Gesundheitsforschung Lübeck GmbH | Lübeck | 23552 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Institut für klinische Forschung GmbH | Neu-Isenburg | 63263 | Germany |
| IFG Institut für Gesundheitsförderung GmbH | Rüdersdorf | 15562 | Germany |
| Leids Universitair Medisch Centrum (LUMC) | Leiden | 2333 ZA | Netherlands |
| HagaZiekenhuis | The Hague | 2545 CH | Netherlands |
| Gibinski Univ.Clin.Cnter of Silesian Med.Uni.Katowice,Outpat | Katowice | 40-752 | Poland |
| Specjalistyczny Osrodek Alergologiczno-Intern. ALL-MED | Krakow | 30033 | Poland |
| Univ. Hospital in Krakow,Pulmonology Clinical Dept | Krakow | 31066 | Poland |
| Barlicki University Hospital No. 1 | Lodz | 90 141 | Poland |
| Barlicki University Hospital No. 1 | Lodz | 90141 | Poland |
| Chungbuk National University Hospital | Cheongju-si | 361-771 | South Korea |
| Chonnam National University Hospital | Gwangju | 501-757 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| The Catholic University of Korea, St.Paul's Hospital | Seoul | 130-709 | South Korea |
| Chang Gung Memorial Hospital Keelung | Keelung | 20401 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Celerion Inc | Belfast | BT9 6AD | United Kingdom |
| Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom |
| Glenfield Hospital | Leicester | LE3 9QP | United Kingdom |
| The Medicines Evaluation Unit | Manchester | M23 9QZ | United Kingdom |
| Wishaw General Hospital | Wishaw | ML2 0DP | United Kingdom |
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)
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized Set (RS): This patient set included all randomized patients, whether treated or not.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Risankizumab | 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) |
| BG001 | Placebo | 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Oral corticosteroid (OCS) use at baseline | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Morning peak expiratory flow (PEF) | Mean | Standard Deviation | Liter/Minute (L/min) |
| |||||||||||||||
| Baseline 24 Hour Rescue Medication Use | Baseline 24 Hour Rescue Medication Use: Average over the 14 days prior to randomization | Mean | Standard Deviation | Puff |
| ||||||||||||||
| Baseline First 5 questions of the Asthma Control Questionnaire (ACQ5) Score | Baseline ACQ5 is the mean of last 2 available measurements in last 2 weeks prior to Visit 2, that is, 14 days prior to the administration of the first dose. Weekly score is average of responses to the five questions. 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 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). ACQ5 score can range from 0.0 (best) to 6.0 (worst). | Mean | Standard Deviation | Unit on scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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: 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. | Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment. | Posted | Median | 80% Confidence Interval | Days | 24 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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: 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 ≥0.5 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. | Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment. | Posted | Median | 80% Confidence Interval | Days | 24 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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: 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. Mean is Annualized rate. | Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment. | Posted | Mean | Standard Error | Events per patient year | 24 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment. NA = not estimable due to an insufficient numbers of patient with an event | Posted | Median | 80% Confidence Interval | Days | 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment. | Posted | Mean | Standard Error | Events per patient year | 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment. One patient not included in the analysis due to missing baseline value. Number of patients with either baseline or on-treatment data at the respective week and does not require having both. | Posted | Least Squares Mean | Standard Error | Liter (L) | Baseline and 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS: All randomized patients who received at least one dose of treatment. One patient not included in the analysis due to missing baseline value and one patient not included in the analysis due to missing on-treatment data. Number of patients with either baseline or on-treatment data at the respective week and does not require having both. | Posted | Least Squares Mean | Standard Error | Liter (L) | Baseline and 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment. Ten patients excluded from the analysis due to missing data at week 24. | Posted | Least Squares Mean | Standard Error | Unit on Scale | 24 weeks |
|
From the administration of first dose of study medication until 16 weeks after last dose of study medication, up to 40 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Risankizumab | 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) | 0 | 105 | 14 | 105 | 84 | 105 |
| EG001 | Placebo | 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) | 0 | 109 | 21 | 109 | 80 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 1-800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2017 | Feb 26, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000601773 | risankizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No |
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|