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Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma

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ClinicalTrials.gov Identifier: NCT02443298
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: placebo
Drug: risankizumab
Enrollment 214
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Risankizumab Placebo
Hide Arm/Group Description 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) 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)
Period Title: Overall Study
Started 105 109
Completed 101 104
Not Completed 4 5
Reason Not Completed
Adverse Event             3             3
Withdrawal by Subject             1             2
Arm/Group Title Risankizumab Placebo Total
Hide Arm/Group Description 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) 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) Total of all reporting groups
Overall Number of Baseline Participants 105 109 214
Hide Baseline Analysis Population Description
Randomized Set (RS): This patient set included all randomized patients, whether treated or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 109 participants 214 participants
54.1  (11.3) 52.3  (12.5) 53.2  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 109 participants 214 participants
Female
69
  65.7%
64
  58.7%
133
  62.1%
Male
36
  34.3%
45
  41.3%
81
  37.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 109 participants 214 participants
Hispanic or Latino
3
   2.9%
3
   2.8%
6
   2.8%
Not Hispanic or Latino
102
  97.1%
106
  97.2%
208
  97.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 109 participants 214 participants
American Indian or Alaska Native
0
   0.0%
1
   0.9%
1
   0.5%
Asian
11
  10.5%
11
  10.1%
22
  10.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
   8.6%
8
   7.3%
17
   7.9%
White
84
  80.0%
88
  80.7%
172
  80.4%
More than one race
1
   1.0%
1
   0.9%
2
   0.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Oral corticosteroid (OCS) use at baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 109 participants 214 participants
Yes
15
  14.3%
17
  15.6%
32
  15.0%
No
90
  85.7%
92
  84.4%
182
  85.0%
Baseline Morning peak expiratory flow (PEF)  
Mean (Standard Deviation)
Unit of measure:  Liter/Minute (L/min)
Number Analyzed 105 participants 109 participants 214 participants
299.34  (110.50) 309.56  (115.34) 304.54  (112.84)
Baseline 24 Hour Rescue Medication Use   [1] 
Mean (Standard Deviation)
Unit of measure:  Puff
Number Analyzed 105 participants 109 participants 214 participants
3.17  (3.81) 3.89  (4.78) 3.53  (4.34)
[1]
Measure Description: Baseline 24 Hour Rescue Medication Use: Average over the 14 days prior to randomization
Baseline First 5 questions of the Asthma Control Questionnaire (ACQ5) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Unit on scale
Number Analyzed 105 participants 109 participants 214 participants
2.15  (1.15) 2.39  (1.17) 2.27  (1.17)
[1]
Measure Description: 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).
1.Primary Outcome
Title Time to First Asthma Worsening During the Planned 24 Week Treatment Period
Hide Description

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.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment.
Arm/Group Title Risankizumab Placebo
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 105 109
Median (80% Confidence Interval)
Unit of Measure: Days
40.00
(30.00 to 52.00)
85.50
(63.00 to 131.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab, Placebo
Comments This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0255
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.46
Confidence Interval (2-Sided) 80%
1.18 to 1.81
Estimation Comments Comparison of Risankizumab to Placebo
2.Secondary Outcome
Title Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition
Hide Description

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.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment.
Arm/Group Title Risankizumab Placebo
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 105 109
Median (80% Confidence Interval)
Unit of Measure: Days
20.00
(16.00 to 25.00)
37.00
(31.00 to 45.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab, Placebo
Comments This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0131
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.47
Confidence Interval (2-Sided) 80%
1.20 to 1.79
Estimation Comments Comparison of Risankizumab to Placebo
3.Secondary Outcome
Title Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period
Hide Description

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.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment.
Arm/Group Title Risankizumab Placebo
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 105 109
Mean (Standard Error)
Unit of Measure: Events per patient year
4.8412  (0.577) 3.2410  (0.401)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab, Placebo
Comments Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0065
Comments [Not Specified]
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.4937
Confidence Interval (2-Sided) 80%
1.2366 to 1.8044
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.220
Estimation Comments Comparison of Risankizumab to Placebo
4.Secondary Outcome
Title Time to First Severe Asthma Exacerbation During the Planned 24 Week Treatment Period
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Risankizumab Placebo
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 105 109
Median (80% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Not estimable due to an insufficient numbers of patient with an event
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab, Placebo
Comments Time to first event is obtained from fitting a Cox proportional-hazards model including treatment, and OCS use at baseline as covariate
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4619
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.18
Confidence Interval (2-Sided) 80%
0.88 to 1.57
Estimation Comments Comparison of Risankizumab to Placebo
5.Secondary Outcome
Title Annualized Rate of Severe Asthma Exacerbation During the Planned 24-week Treatment Period
Hide Description

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.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment.
Arm/Group Title Risankizumab Placebo
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 105 109
Mean (Standard Error)
Unit of Measure: Events per patient year
1.5901  (0.257) 1.4051  (0.228)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab, Placebo
Comments Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5550
Comments [Not Specified]
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 1.1317
Confidence Interval (2-Sided) 80%
0.8652 to 1.4803
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.237
Estimation Comments Comparison of Risankizumab to Placebo
6.Secondary Outcome
Title Trough Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
Hide Description Trough forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Risankizumab Placebo
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 105 109
Least Squares Mean (Standard Error)
Unit of Measure: Liter (L)
-0.052  (0.036) -0.013  (0.035)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab, Placebo
Comments The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment-by-test day interaction, baseline, and baseline-by-test day interaction as covariates patient as a random effect.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4423
Comments [Not Specified]
Method Mixed Models Analysis
Comments Unstructured covariance structure for within-patient variation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.039
Confidence Interval (2-Sided) 80%
-0.104 to 0.026
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.051
Estimation Comments Comparison of Risankizumab to Placebo
7.Secondary Outcome
Title Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24
Hide Description Post-bronchodilator forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Risankizumab Placebo
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 105 109
Least Squares Mean (Standard Error)
Unit of Measure: Liter (L)
-0.097  (0.032) -0.030  (0.032)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab, Placebo
Comments The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment-by-test day interaction, baseline, and baseline-by-test day interaction as covariates patient as a random effect.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1377
Comments [Not Specified]
Method Mixed Models Analysis
Comments Unstructured covariance structure for within-patient variation
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.068
Confidence Interval (2-Sided) 80%
-0.126 to -0.009
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.045
Estimation Comments Comparison of Risankizumab to Placebo
8.Secondary Outcome
Title Weekly Asthma Control Questionaire Score at Week 24
Hide Description 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).
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Risankizumab Placebo
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 105 109
Least Squares Mean (Standard Error)
Unit of Measure: Unit on Scale
1.857  (0.099) 1.708  (0.099)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risankizumab, Placebo
Comments The adjusted mean (SE) are obtained from fitting an analysis of covariance (ANCOVA) model separately for each week including treatment, OCS use at baseline, and baseline as covariates. The weekly averages of daily measurements are calculated before fitting the model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1985
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.149
Confidence Interval (2-Sided) 80%
0.000 to 0.297
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.115
Estimation Comments Comparison of Risankizumab to Placebo
Time Frame From the administration of first dose of study medication until 16 weeks after last dose of study medication, up to 40 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Risankizumab Placebo
Hide Arm/Group Description 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) 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)
All-Cause Mortality
Risankizumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/105 (0.00%)   0/109 (0.00%) 
Hide Serious Adverse Events
Risankizumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   14/105 (13.33%)   21/109 (19.27%) 
Ear and labyrinth disorders     
Sudden hearing loss  1  1/105 (0.95%)  0/109 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  0/105 (0.00%)  1/109 (0.92%) 
Immune system disorders     
Anaphylactic reaction  1  0/105 (0.00%)  1/109 (0.92%) 
Infections and infestations     
Appendicitis  1  0/105 (0.00%)  1/109 (0.92%) 
Arthritis bacterial  1  0/105 (0.00%)  1/109 (0.92%) 
Chronic sinusitis  1  0/105 (0.00%)  1/109 (0.92%) 
Epstein-Barr virus infection  1  1/105 (0.95%)  0/109 (0.00%) 
Localised infection  1  0/105 (0.00%)  1/109 (0.92%) 
Pneumonia  1  1/105 (0.95%)  2/109 (1.83%) 
Respiratory syncytial virus infection  1  1/105 (0.95%)  0/109 (0.00%) 
Urosepsis  1  0/105 (0.00%)  1/109 (0.92%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/105 (0.00%)  1/109 (0.92%) 
Radius fracture  1  0/105 (0.00%)  1/109 (0.92%) 
Investigations     
Electrocardiogram T wave abnormal  1  0/105 (0.00%)  1/109 (0.92%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/105 (0.00%)  1/109 (0.92%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/105 (0.95%)  1/109 (0.92%) 
Lumbar spinal stenosis  1  0/105 (0.00%)  1/109 (0.92%) 
Rhabdomyolysis  1  0/105 (0.00%)  1/109 (0.92%) 
Rotator cuff syndrome  1  1/105 (0.95%)  0/109 (0.00%) 
Nervous system disorders     
Dyskinesia  1  0/105 (0.00%)  1/109 (0.92%) 
Multiple sclerosis  1  1/105 (0.95%)  0/109 (0.00%) 
Transient ischaemic attack  1  0/105 (0.00%)  1/109 (0.92%) 
Psychiatric disorders     
Anxiety  1  1/105 (0.95%)  0/109 (0.00%) 
Depression  1  0/105 (0.00%)  1/109 (0.92%) 
Renal and urinary disorders     
Hydronephrosis  1  0/105 (0.00%)  1/109 (0.92%) 
Nephrolithiasis  1  0/105 (0.00%)  1/109 (0.92%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  6/105 (5.71%)  5/109 (4.59%) 
Asthmatic crisis  1  1/105 (0.95%)  1/109 (0.92%) 
Dyspnoea  1  1/105 (0.95%)  0/109 (0.00%) 
Nasal polyps  1  0/105 (0.00%)  1/109 (0.92%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Risankizumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   84/105 (80.00%)   80/109 (73.39%) 
Infections and infestations     
Bronchitis  1  11/105 (10.48%)  9/109 (8.26%) 
Nasopharyngitis  1  11/105 (10.48%)  22/109 (20.18%) 
Sinusitis  1  6/105 (5.71%)  3/109 (2.75%) 
Upper respiratory tract infection  1  9/105 (8.57%)  10/109 (9.17%) 
Urinary tract infection  1  5/105 (4.76%)  6/109 (5.50%) 
Investigations     
Blood creatine phosphokinase increased  1  9/105 (8.57%)  3/109 (2.75%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/105 (0.00%)  6/109 (5.50%) 
Nervous system disorders     
Headache  1  7/105 (6.67%)  6/109 (5.50%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  65/105 (61.90%)  58/109 (53.21%) 
Dyspnoea  1  6/105 (5.71%)  7/109 (6.42%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 1-800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02443298    
Other Study ID Numbers: 1311.14
2014-004932-20 ( EudraCT Number )
First Submitted: May 11, 2015
First Posted: May 13, 2015
Results First Submitted: February 1, 2019
Results First Posted: April 10, 2019
Last Update Posted: April 10, 2019