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Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE

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ClinicalTrials.gov Identifier: NCT02586805
Recruitment Status : Completed
First Posted : October 26, 2015
Results First Posted : April 24, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Dyax Corp.
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Hereditary Angioedema (HAE)
Interventions Drug: DX-2930 - 300mg/2wk
Drug: DX-2930 - 300mg/4wk
Drug: DX-2930 - 150mg/4wk
Drug: Placebo
Enrollment 125
Recruitment Details The study was conducted at 41 sites in the United States, United Kingdom, Italy, Germany, Canada and Jordan between 03 March 2016 (first participant first visit) and 13 April 2017 (last participant last visit).
Pre-assignment Details A total of 159 participants were screened and 126 participants were randomized in the ratio of 3:2:2:2 to the placebo versus DX-2930-03 arms. Of them, 125 participants were assigned to study treatment and one participant determined to be screen failure after randomization.
Arm/Group Title Placebo Lanadelumab (DX-2930) 150 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Hide Arm/Group Description Participants received placebo matched to DX-2930 subcutaneously (SC) once in every 2 weeks (q2wks) for 26 weeks. Participants received 150 milligram (mg) dose of DX-2930 SC once in every 4 weeks (q4wks) and matched placebo SC q2wks between DX-2930 doses for 26 weeks. Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks. Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
Period Title: Overall Study
Started 41 28 29 27
Completed 35 27 26 25
Not Completed 6 1 3 2
Reason Not Completed
Withdrawal by Subject             3             1             1             2
Adverse Event             2             0             1             0
Lost to Follow-up             0             0             1             0
Physician Decision             1             0             0             0
Arm/Group Title Placebo Lanadelumab (DX-2930) 150 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 2 Weeks Total
Hide Arm/Group Description Participants received placebo matched to DX-2930 SC q2wks for 26 weeks. Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks. Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks. Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks. Total of all reporting groups
Overall Number of Baseline Participants 41 28 29 27 125
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants who received any exposure to the investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 28 participants 29 participants 27 participants 125 participants
40.1  (16.75) 43.4  (14.91) 39.5  (12.85) 40.3  (13.35) 40.7  (14.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 28 participants 29 participants 27 participants 125 participants
Female
34
  82.9%
20
  71.4%
19
  65.5%
15
  55.6%
88
  70.4%
Male
7
  17.1%
8
  28.6%
10
  34.5%
12
  44.4%
37
  29.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 28 participants 29 participants 27 participants 125 participants
Hispanic or Latino
3
   7.3%
1
   3.6%
2
   6.9%
3
  11.1%
9
   7.2%
Not Hispanic or Latino
38
  92.7%
27
  96.4%
27
  93.1%
23
  85.2%
115
  92.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.7%
1
   0.8%
1.Primary Outcome
Title Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period
Hide Description HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks was analyzed using a generalized linear model (GLM) for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
Time Frame From Day 0 to Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received any exposure to the investigational product.
Arm/Group Title Placebo Lanadelumab (DX-2930) 150 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Hide Arm/Group Description:
Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
Overall Number of Participants Analyzed 41 28 29 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Attacks per 4 weeks
1.967
(1.640 to 2.358)
0.480
(0.313 to 0.735)
0.526
(0.358 to 0.771)
0.257
(0.145 to 0.458)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lanadelumab (DX-2930) 150 mg Every 4 Weeks
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are adjusted for multiple testing.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % change in mean rate (vs placebo)
Estimated Value -75.609
Confidence Interval (2-Sided) 95%
-84.650 to -61.243
Estimation Comments % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1).
Other Statistical Analysis Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lanadelumab (DX-2930) 300 mg Every 4 Weeks
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are adjusted for multiple testing.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % change in mean rate (vs placebo)
Estimated Value -73.271
Confidence Interval (2-Sided) 95%
-82.379 to -59.456
Estimation Comments % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)
Other Statistical Analysis Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are adjusted for multiple testing.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % change in mean rate (vs placebo)
Estimated Value -86.921
Confidence Interval (2-Sided) 95%
-92.828 to -76.150
Estimation Comments % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)
Other Statistical Analysis Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
2.Secondary Outcome
Title Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment
Hide Description HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attack was analyzed using the GLM for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
Time Frame From Day 0 to Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received any exposure to the investigational product.
Arm/Group Title Placebo Lanadelumab (DX-2930) 150 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Hide Arm/Group Description:
Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
Overall Number of Participants Analyzed 41 28 29 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Attacks per 4 weeks
1.637
(1.337 to 2.005)
0.314
(0.184 to 0.535)
0.423
(0.276 to 0.648)
0.208
(0.109 to 0.396)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lanadelumab (DX-2930) 150 mg Every 4 Weeks
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are adjusted for multiple testing.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % change in mean rate (vs placebo)
Estimated Value -80.842
Confidence Interval (2-Sided) 95%
-89.169 to -66.114
Estimation Comments % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1).
Other Statistical Analysis Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lanadelumab (DX-2930) 300 mg Every 4 Weeks
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are adjusted for multiple testing.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % change in mean rate (vs placebo)
Estimated Value -74.169
Confidence Interval (2-Sided) 95%
-83.733 to -58.983
Estimation Comments % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)
Other Statistical Analysis Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are adjusted for multiple testing.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % change in mean rate (vs placebo)
Estimated Value -87.299
Confidence Interval (2-Sided) 95%
-93.494 to -75.204
Estimation Comments % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)
Other Statistical Analysis Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
3.Secondary Outcome
Title Rate of Moderate or Severe Investigator Confirmed Hereditary Angioedema (HAE) Attacks
Hide Description HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Moderate and severe investigator-confirmed HAE attacks were the attacks that were moderate or severe as per the HAE attack assessment and reporting procedures (HAARP) defined severity. The overall severity of attack was determined by the investigator using following definitions: mild (transient or mild discomfort), moderate (mild to moderate limitation in activity), severe (marked limitation in activity). Rate of moderate or severe investigator confirmed HAE attack was analyzed using the GLM for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
Time Frame From Day 0 to Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received any exposure to the investigational product.
Arm/Group Title Placebo Lanadelumab (DX-2930) 150 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Hide Arm/Group Description:
Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
Overall Number of Participants Analyzed 41 28 29 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Attacks per 4 weeks
1.216
(0.971 to 1.522)
0.359
(0.221 to 0.581)
0.325
(0.199 to 0.529)
0.202
(0.106 to 0.386)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lanadelumab (DX-2930) 150 mg Every 4 Weeks
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are adjusted for multiple testing.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % change in mean rate (vs placebo)
Estimated Value -70.497
Confidence Interval (2-Sided) 95%
-82.696 to -49.699
Estimation Comments % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)
Other Statistical Analysis Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lanadelumab (DX-2930) 300 mg Every 4 Weeks
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are adjusted for multiple testing.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % change in mean rate (vs placebo)
Estimated Value -73.285
Confidence Interval (2-Sided) 95%
-84.316 to -54.496
Estimation Comments % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)
Other Statistical Analysis Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are adjusted for multiple testing.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % change in mean rate (vs placebo)
Estimated Value -83.394
Confidence Interval (2-Sided) 95%
-91.618 to -67.099
Estimation Comments % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)
Other Statistical Analysis Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
4.Secondary Outcome
Title Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Day 14 Through Day 182
Hide Description HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks during day 14 after study drug administration through day 182 was analyzed by the same poisson regression model as in the primary endpoint analysis.
Time Frame From Day 14 to Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants who received any exposure to the investigational product.
Arm/Group Title Placebo Lanadelumab (DX-2930) 150 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Hide Arm/Group Description:
Participants received placebo matched to DX-2930 SC q2wks for 26 weeks.
Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks.
Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
Overall Number of Participants Analyzed 41 28 29 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Attacks per 4 weeks
1.988
(1.652 to 2.391)
0.445
(0.283 to 0.698)
0.489
(0.326 to 0.734)
0.218
(0.115 to 0.414)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lanadelumab (DX-2930) 150 mg Every 4 Weeks
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are adjusted for multiple testing.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % change in mean rate (vs placebo)
Estimated Value -77.622
Confidence Interval (2-Sided) 95%
-86.253 to -63.572
Estimation Comments % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1).
Other Statistical Analysis Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lanadelumab (DX-2930) 300 mg Every 4 Weeks
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are adjusted for multiple testing.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % change in mean rate (vs placebo)
Estimated Value -75.377
Confidence Interval (2-Sided) 95%
-84.115 to -61.833
Estimation Comments % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1).
Other Statistical Analysis Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are adjusted for multiple testing.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % change in mean rate (vs placebo)
Estimated Value -89.008
Confidence Interval (2-Sided) 95%
-94.325 to -78.707
Estimation Comments % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1).
Other Statistical Analysis Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
Time Frame From start of study drug administration up to Day 182
Adverse Event Reporting Description Adverse events were collected over the entire treatment period and were assigned to the treatment group without regard to the type of injection (that is placebo or active drug in the 150 mg q4wk and 300 mg q4wk groups). Number of adverse events were calculated as unique events per System Organ Class (SOC), preferred term (PT), participant and adverse event start date.
 
Arm/Group Title Placebo Lanadelumab (DX-2930) 150 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Hide Arm/Group Description Participants received placebo matched to DX-2930 SC q2wks for 26 weeks. Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks. Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks. Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks.
All-Cause Mortality
Placebo Lanadelumab (DX-2930) 150 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)      0/28 (0.00%)      0/29 (0.00%)      0/27 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Lanadelumab (DX-2930) 150 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/41 (2.44%)      0/28 (0.00%)      3/29 (10.34%)      2/27 (7.41%)    
Congenital, familial and genetic disorders         
Hereditary angioedema * 1  1/41 (2.44%)  1 0/28 (0.00%)  0 0/29 (0.00%)  0 1/27 (3.70%)  1
Infections and infestations         
Catheter site infection * 1  0/41 (0.00%)  0 0/28 (0.00%)  0 0/29 (0.00%)  0 1/27 (3.70%)  1
Pyelonephritis * 1  0/41 (0.00%)  0 0/28 (0.00%)  0 1/29 (3.45%)  1 0/27 (0.00%)  0
Injury, poisoning and procedural complications         
Meniscus injury * 1  0/41 (0.00%)  0 0/28 (0.00%)  0 1/29 (3.45%)  1 0/27 (0.00%)  0
Psychiatric disorders         
Bipolar ii disorder * 1  0/41 (0.00%)  0 0/28 (0.00%)  0 1/29 (3.45%)  1 0/27 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Lanadelumab (DX-2930) 150 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 4 Weeks Lanadelumab (DX-2930) 300 mg Every 2 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/41 (97.56%)      25/28 (89.29%)      26/29 (89.66%)      23/27 (85.19%)    
Congenital, familial and genetic disorders         
Hereditary angioedema * 1  40/41 (97.56%)  577 17/28 (60.71%)  84 20/29 (68.97%)  108 15/27 (55.56%)  45
Gastrointestinal disorders         
Abdominal discomfort * 1  1/41 (2.44%)  1 2/28 (7.14%)  3 0/29 (0.00%)  0 0/27 (0.00%)  0
Abdominal pain * 1  2/41 (4.88%)  2 1/28 (3.57%)  1 2/29 (6.90%)  3 0/27 (0.00%)  0
Abdominal pain upper * 1  4/41 (9.76%)  4 2/28 (7.14%)  2 0/29 (0.00%)  0 0/27 (0.00%)  0
Diarrhoea * 1  2/41 (4.88%)  2 3/28 (10.71%)  3 0/29 (0.00%)  0 1/27 (3.70%)  2
Nausea * 1  0/41 (0.00%)  0 1/28 (3.57%)  1 0/29 (0.00%)  0 2/27 (7.41%)  2
Paraesthesia oral * 1  0/41 (0.00%)  0 0/28 (0.00%)  0 0/29 (0.00%)  0 2/27 (7.41%)  2
Toothache * 1  0/41 (0.00%)  0 2/28 (7.14%)  4 1/29 (3.45%)  1 1/27 (3.70%)  1
Vomiting * 1  1/41 (2.44%)  1 2/28 (7.14%)  2 0/29 (0.00%)  0 0/27 (0.00%)  0
General disorders         
Fatigue * 1  1/41 (2.44%)  1 0/28 (0.00%)  0 0/29 (0.00%)  0 2/27 (7.41%)  2
Injection site bruising * 1  0/41 (0.00%)  0 3/28 (10.71%)  5 2/29 (6.90%)  2 1/27 (3.70%)  1
Injection site discomfort * 1  0/41 (0.00%)  0 0/28 (0.00%)  0 2/29 (6.90%)  13 1/27 (3.70%)  10
Injection site erythema * 1  1/41 (2.44%)  1 4/28 (14.29%)  23 2/29 (6.90%)  6 2/27 (7.41%)  7
Injection site haematoma * 1  3/41 (7.32%)  3 1/28 (3.57%)  1 1/29 (3.45%)  2 1/27 (3.70%)  1
Injection site haemorrhage * 1  1/41 (2.44%)  7 1/28 (3.57%)  2 0/29 (0.00%)  0 2/27 (7.41%)  11
Injection site pain * 1  12/41 (29.27%)  71 13/28 (46.43%)  123 9/29 (31.03%)  68 14/27 (51.85%)  67
Injection site paraesthesia * 1  0/41 (0.00%)  0 2/28 (7.14%)  2 0/29 (0.00%)  0 0/27 (0.00%)  0
Injection site pruritus * 1  0/41 (0.00%)  0 1/28 (3.57%)  1 2/29 (6.90%)  2 0/27 (0.00%)  0
Infections and infestations         
Gastroenteritis * 1  3/41 (7.32%)  3 1/28 (3.57%)  1 0/29 (0.00%)  0 0/27 (0.00%)  0
Hordeolum * 1  0/41 (0.00%)  0 0/28 (0.00%)  0 0/29 (0.00%)  0 2/27 (7.41%)  2
Otitis externa * 1  0/41 (0.00%)  0 2/28 (7.14%)  2 0/29 (0.00%)  0 0/27 (0.00%)  0
Rhinitis * 1  2/41 (4.88%)  2 0/28 (0.00%)  0 2/29 (6.90%)  3 0/27 (0.00%)  0
Sinusitis * 1  1/41 (2.44%)  1 1/28 (3.57%)  1 0/29 (0.00%)  0 2/27 (7.41%)  2
Upper respiratory tract infection * 1  2/41 (4.88%)  3 0/28 (0.00%)  0 2/29 (6.90%)  2 2/27 (7.41%)  2
Urinary tract infection * 1  1/41 (2.44%)  1 2/28 (7.14%)  2 1/29 (3.45%)  1 1/27 (3.70%)  1
Viral upper respiratory tract infection * 1  11/41 (26.83%)  16 3/28 (10.71%)  5 7/29 (24.14%)  10 10/27 (37.04%)  12
Injury, poisoning and procedural complications         
Procedural pain * 1  4/41 (9.76%)  4 0/28 (0.00%)  0 1/29 (3.45%)  1 1/27 (3.70%)  1
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  1/41 (2.44%)  2 0/28 (0.00%)  0 2/29 (6.90%)  2 0/27 (0.00%)  0
Back pain * 1  4/41 (9.76%)  7 1/28 (3.57%)  1 0/29 (0.00%)  0 1/27 (3.70%)  1
Musculoskeletal pain * 1  0/41 (0.00%)  0 2/28 (7.14%)  2 1/29 (3.45%)  1 0/27 (0.00%)  0
Myalgia * 1  0/41 (0.00%)  0 1/28 (3.57%)  1 0/29 (0.00%)  0 3/27 (11.11%)  3
Neck pain * 1  1/41 (2.44%)  1 1/28 (3.57%)  1 0/29 (0.00%)  0 2/27 (7.41%)  3
Pain in extremity * 1  1/41 (2.44%)  1 2/28 (7.14%)  2 0/29 (0.00%)  0 1/27 (3.70%)  1
Nervous system disorders         
Dizziness * 1  0/41 (0.00%)  0 1/28 (3.57%)  2 3/29 (10.34%)  5 1/27 (3.70%)  1
Headache * 1  8/41 (19.51%)  10 3/28 (10.71%)  10 5/29 (17.24%)  8 9/27 (33.33%)  18
Migraine * 1  4/41 (9.76%)  4 2/28 (7.14%)  5 0/29 (0.00%)  0 0/27 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain * 1  3/41 (7.32%)  3 0/28 (0.00%)  0 0/29 (0.00%)  0 1/27 (3.70%)  1
Skin and subcutaneous tissue disorders         
Dermatitis contact * 1  0/41 (0.00%)  0 1/28 (3.57%)  1 2/29 (6.90%)  2 0/27 (0.00%)  0
Pruritus * 1  0/41 (0.00%)  0 0/28 (0.00%)  0 0/29 (0.00%)  0 2/27 (7.41%)  2
Rash * 1  2/41 (4.88%)  2 1/28 (3.57%)  2 3/29 (10.34%)  3 0/27 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Physician
Organization: Shire
Phone: 1 866 842 5335
EMail: ClinicalTransparency@shire.com
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02586805     History of Changes
Other Study ID Numbers: DX-2930-03
2015-003943-20 ( EudraCT Number )
First Submitted: October 23, 2015
First Posted: October 26, 2015
Results First Submitted: March 20, 2018
Results First Posted: April 24, 2018
Last Update Posted: April 16, 2019