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Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT02446899
Recruitment Status : Completed
First Posted : May 18, 2015
Results First Posted : March 18, 2020
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Active Systemic Lupus Erythematosus
Interventions Biological: Anifrolumab
Drug: Placebo
Enrollment 373
Recruitment Details Participants took part in the trial at 119 sites in 15 countries worldwide.
Pre-assignment Details 8 participants were assigned study drug, but due to non-compliance were analyzed separately (not included in the participant flow). 3 additional participants were assigned study drug & included in the participant flow, but did not receive study drug due to an adverse event (1 Anifrolumab 300mg) & failure to meet randomization criteria (2 Placebo).
Arm/Group Title Anifrolumab 300 mg Placebo
Hide Arm/Group Description Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Period Title: Overall Study
Started 181 184
Received Study Drug 180 182
Completed 156 136
Not Completed 25 48
Reason Not Completed
Adverse Event             4             7
Condition Under Investigation Worsened             1             4
Study Specific Withdrawal Criteria             1             0
Lack of Efficacy             2             8
Lost to Follow-up             1             3
Severe Non-Compliance to Protocol             0             1
Withdrawal by Subject             11             19
Miscellaneous             5             4
Failure to Meet Randomization Criteria             0             2
Arm/Group Title Anifrolumab 300 mg Placebo Total
Hide Arm/Group Description Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Total of all reporting groups
Overall Number of Baseline Participants 180 182 362
Hide Baseline Analysis Population Description
Full analysis set: All participants who were randomized and received at least one dose of the study drug. 3 participants discontinued the study prior to receiving the study drug and are not included in the full analysis set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
175
  97.2%
181
  99.5%
356
  98.3%
>=65 years
5
   2.8%
1
   0.5%
6
   1.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants 182 participants 362 participants
43.1  (11.95) 41.1  (11.47) 42.1  (11.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
Female
168
  93.3%
170
  93.4%
338
  93.4%
Male
12
   6.7%
12
   6.6%
24
   6.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
Hispanic or Latino
54
  30.0%
54
  29.7%
108
  29.8%
Not Hispanic or Latino
118
  65.6%
120
  65.9%
238
  65.7%
Unknown or Not Reported
8
   4.4%
8
   4.4%
16
   4.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
White
110
  61.1%
107
  58.8%
217
  59.9%
Black or African American
17
   9.4%
25
  13.7%
42
  11.6%
Asian
30
  16.7%
30
  16.5%
60
  16.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
American Indian or Alaska Native
4
   2.2%
1
   0.5%
5
   1.4%
Other
11
   6.1%
11
   6.0%
22
   6.1%
Missing
8
   4.4%
8
   4.4%
16
   4.4%
Geographic region  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
Asia Pacific
27
  15.0%
26
  14.3%
53
  14.6%
Europe
51
  28.3%
46
  25.3%
97
  26.8%
Latin America
35
  19.4%
32
  17.6%
67
  18.5%
United States/Canada
64
  35.6%
68
  37.4%
132
  36.5%
Rest of World (South Africa)
3
   1.7%
10
   5.5%
13
   3.6%
1.Primary Outcome
Title Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52
Hide Description

Composite endpoint BICLA was defined by meeting all of the following criteria:

  • Reduction of all baseline British Isles Lupus Assessment Group (BILAG)-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B
  • No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), where worsening is defined as an increase from baseline of >0 points in SLEDAI-2K
  • No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS)
  • No discontinuation of investigational product
  • No use of restricted medications beyond the protocol allowed threshold before assessment
Time Frame Baseline; Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All participants who were randomized and received at least one dose of study drug.
Arm/Group Title Anifrolumab 300 mg Placebo
Hide Arm/Group Description:
Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Overall Number of Participants Analyzed 180 182
Measure Type: Count of Participants
Unit of Measure: Participants
86
  47.8%
57
  31.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anifrolumab 300 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
Statistical Test of Hypothesis P-Value 0.0013
Comments Nominal p-value.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.3
Confidence Interval (2-Sided) 95%
6.3 to 26.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 in the IFN Test-High Sub-group
Hide Description

Defined by meeting all of the following criteria:

  • Reduction of all baseline British Isles Lupus Assessment Group (BILAG)-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B
  • No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), where worsening is defined as an increase from baseline to >0 points in SLEDAI-2K
  • No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS)
  • No discontinuation of investigational product
  • No use of restricted medications beyond the protocol allowed threshold before assessment
Time Frame Baseline; Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All participants who were randomized and received at least one dose of study drug, with a high interferon (IFN) test result at baseline.
Arm/Group Title Anifrolumab 300 mg Placebo
Hide Arm/Group Description:
Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Overall Number of Participants Analyzed 150 151
Measure Type: Count of Participants
Unit of Measure: Participants
72
  48.0%
46
  30.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anifrolumab 300 mg, Placebo
Comments The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments Adjusted p-value.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 17.3
Confidence Interval (2-Sided) 95%
6.5 to 28.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants Who Achieved and Maintained an Oral Corticosteroids (OCS) Dose of ≤7.5 mg/Day at Week 52 in the Sub-Group of Participants With Baseline OCS ≥10 mg/Day
Hide Description

Maintained OCS reduction was defined by meeting all of the following criteria:

  • Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40
  • Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52
  • No discontinuation of investigational product
  • No use of restricted medications beyond the protocol allowed threshold before assessment
Time Frame Week 40; Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All participants who were randomized and received at least one dose of study drug, who had a baseline OCS dose of ≥10 mg/day.
Arm/Group Title Anifrolumab 300 mg Placebo
Hide Arm/Group Description:
Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Overall Number of Participants Analyzed 87 83
Measure Type: Count of Participants
Unit of Measure: Participants
45
  51.7%
25
  30.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anifrolumab 300 mg, Placebo
Comments The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0135
Comments Adjusted p-value.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 21.2
Confidence Interval (2-Sided) 95%
6.8 to 35.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10
Hide Description

50% reduction in CLASI activity score compared to baseline was defined by meeting all of the following criteria:

  • Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline
  • No discontinuation of investigational product
  • No use of restricted medications beyond the protocol allowed threshold before assessment
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All participants who were randomized and received at least one dose of study drug, and who had a CLASI activity score of ≥10 at baseline.
Arm/Group Title Anifrolumab 300 mg Placebo
Hide Arm/Group Description:
Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Overall Number of Participants Analyzed 49 40
Measure Type: Count of Participants
Unit of Measure: Participants
24
  49.0%
10
  25.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anifrolumab 300 mg, Placebo
Comments The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0392
Comments Adjusted p-value.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 24.0
Confidence Interval (2-Sided) 95%
4.3 to 43.6
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With ≥50% Reduction in Joint Counts at Week 52 in The Sub-group of Participants With ≥6 Swollen and ≥6 Tender Joints at Baseline
Hide Description

50% reduction in the number of swollen and tender joints compared to baseline was defined by meeting all of the following criteria:

  • Achieve ≥50% reduction from baseline in the number of swollen and tender joints, separately
  • No discontinuation of investigational product
  • No use of restricted medications beyond the protocol allowed threshold before assessment
Time Frame Baseline; Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All participants who were randomized and received at least one dose of study drug, and who had ≥6 swollen and ≥6 tender joints at baseline.
Arm/Group Title Anifrolumab 300 mg Placebo
Hide Arm/Group Description:
Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Overall Number of Participants Analyzed 71 90
Measure Type: Count of Participants
Unit of Measure: Participants
30
  42.3%
34
  37.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anifrolumab 300 mg, Placebo
Comments The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5469
Comments Adjusted p-value
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
-10.6 to 20.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Annualised Flare Rate Through 52 Weeks
Hide Description A flare was defined as either 1 or more new British Isle Lupus Assessment Group (BILAG-2004) A or 2 or more new BILAG-2004 B items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG-2004 assessment.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All participants who were randomized and received at least one dose of study drug.
Arm/Group Title Anifrolumab 300 mg Placebo
Hide Arm/Group Description:
Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Overall Number of Participants Analyzed 180 182
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Annualized flare rate ratio
0.43
(0.31 to 0.59)
0.64
(0.47 to 0.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anifrolumab 300 mg, Placebo
Comments Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening [<10 points vs >=10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]). The logarithm of the follow-up time is used as an offset variable.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0809
Comments Adjusted p-value.
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.48 to 0.94
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With One or More Adverse Events (AEs)
Hide Description An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). The reported value is inclusive of serious and non-serious AEs.
Time Frame Baseline to end of study (Maximum of 60 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All participants who were randomized and received at least one dose of study drug.
Arm/Group Title Anifrolumab 300 mg Placebo
Hide Arm/Group Description:
Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Overall Number of Participants Analyzed 180 182
Measure Type: Count of Participants
Unit of Measure: Participants
162
  90.0%
154
  84.6%
8.Secondary Outcome
Title Number of Participants With One or More Adverse Events of Special Interest (AESIs)
Hide Description

An AESI is an adverse event (AE) of scientific and medical concern specific to understanding biologics. An AESI may be serious or non-serious. AESI are serious infections, including non-opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, tuberculosis (TB) (including latent TB), influenza, vasculitis (non-systemic lupus erythematosus [SLE]), and major adverse cardiovascular events (MACE) (including stroke, myocardial infarction [MI], or cardiovascular death).

AESIs were collected throughout the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).

Time Frame Baseline to end of study (Maximum of 60 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All participants who were randomized and received at least one dose of study drug.
Arm/Group Title Anifrolumab 300 mg Placebo
Hide Arm/Group Description:
Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Overall Number of Participants Analyzed 180 182
Measure Type: Count of Participants
Unit of Measure: Participants
29
  16.1%
20
  11.0%
9.Secondary Outcome
Title Number of Participants With a Potentially Clinically Important Change From Baseline in Vital Sign Measurements
Hide Description

Vital sign measurements included oral temperature, blood pressure (BP), pulse rate, and respiratory rate.

Vital signs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).

Time Frame Baseline to end of study (Maximum of 60 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All participants who were randomized and received at least one dose of study drug.
Arm/Group Title Anifrolumab 300 mg Placebo
Hide Arm/Group Description:
Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Overall Number of Participants Analyzed 180 182
Measure Type: Count of Participants
Unit of Measure: Participants
45
  25.0%
45
  24.7%
10.Secondary Outcome
Title Number of Participants With a Potentially Clinically Important Change From Baseline in Clinical Laboratory Tests
Hide Description

Clinical laboratory tests were analyzed in a central clinical laboratory and included hematology, serum chemistry and urinalysis tests.

Laboratory values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).

Time Frame Baseline to end of study (Maximum of 60 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: All participants who were randomized and received at least one dose of study drug.
Arm/Group Title Anifrolumab 300 mg Placebo
Hide Arm/Group Description:
Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
Overall Number of Participants Analyzed 180 182
Measure Type: Count of Participants
Unit of Measure: Participants
72
  40.0%
87
  47.8%
Time Frame Day 1 to end of study (Maximum of 60 weeks)
Adverse Event Reporting Description

AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met serious adverse event (SAE) criteria or led to study drug discontinuation. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug.

Full analysis set: All participants who had received at least one dose of study drug.

 
Arm/Group Title Anifrolumab 300 mg Placebo
Hide Arm/Group Description Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses). Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses).
All-Cause Mortality
Anifrolumab 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/180 (0.56%)      0/182 (0.00%)    
Hide Serious Adverse Events
Anifrolumab 300 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/180 (8.89%)      34/182 (18.68%)    
Blood and lymphatic system disorders     
Anaemia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Cardiac disorders     
Acute coronary syndrome  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Atrial flutter  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Cardiac failure congestive  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Gastrointestinal disorders     
Chilaiditi's syndrome  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Haematemesis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Intra-abdominal haematoma  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Oesophageal stenosis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
General disorders     
Influenza like illness  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Hepatobiliary disorders     
Cholecystitis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Immune system disorders     
Hypersensitivity  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Infections and infestations     
Abscess  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Appendicitis  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Diverticulitis  1  1/180 (0.56%)  2 0/182 (0.00%)  0
Gastroenteritis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Gastroenteritis viral  1  2/180 (1.11%)  2 0/182 (0.00%)  0
Herpes zoster  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Influenza  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Periodontitis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Pneumonia  1  3/180 (1.67%)  3 7/182 (3.85%)  7
Sepsis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Sialoadenitis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Upper respiratory tract infection  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Fall  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Radius fracture  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Traumatic fracture  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Investigations     
Blood creatinine increased  1  1/180 (0.56%)  1 0/182 (0.00%)  0
International normalised ratio increased  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Liver function test increased  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Musculoskeletal and connective tissue disorders     
Osteonecrosis  1  1/180 (0.56%)  1 1/182 (0.55%)  1
Systemic lupus erythematosus  1  1/180 (0.56%)  1 6/182 (3.30%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lip squamous cell carcinoma  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Uterine cancer  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Nervous system disorders     
Hypoaesthesia  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Psychiatric disorders     
Panic attack  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Psychotic disorder  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Lupus nephritis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Nephrolithiasis  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Reproductive system and breast disorders     
Cervical dysplasia  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Vaginal ulceration  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Pulmonary alveolar haemorrhage  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Skin and subcutaneous tissue disorders     
Angioedema  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Drug eruption  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Vascular disorders     
Haematoma  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Hypotension  1  0/180 (0.00%)  0 1/182 (0.55%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Anifrolumab 300 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   125/180 (69.44%)      99/182 (54.40%)    
Gastrointestinal disorders     
Nausea  1  7/180 (3.89%)  7 10/182 (5.49%)  11
Infections and infestations     
Bronchitis  1  23/180 (12.78%)  31 8/182 (4.40%)  8
Herpes zoster  1  12/180 (6.67%)  12 3/182 (1.65%)  3
Nasopharyngitis  1  28/180 (15.56%)  42 23/182 (12.64%)  31
Sinusitis  1  13/180 (7.22%)  21 9/182 (4.95%)  10
Upper respiratory tract infection  1  42/180 (23.33%)  57 19/182 (10.44%)  24
Urinary tract infection  1  21/180 (11.67%)  27 26/182 (14.29%)  40
Injury, poisoning and procedural complications     
Infusion related reaction  1  25/180 (13.89%)  42 14/182 (7.69%)  27
Musculoskeletal and connective tissue disorders     
Arthralgia  1  10/180 (5.56%)  11 6/182 (3.30%)  6
Back pain  1  11/180 (6.11%)  12 3/182 (1.65%)  3
Nervous system disorders     
Headache  1  11/180 (6.11%)  13 18/182 (9.89%)  23
Respiratory, thoracic and mediastinal disorders     
Cough  1  10/180 (5.56%)  11 7/182 (3.85%)  7
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Lead
Organization: AstraZeneca AB
Phone: +46317761000
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02446899    
Other Study ID Numbers: D3461C00004
First Submitted: May 14, 2015
First Posted: May 18, 2015
Results First Submitted: March 5, 2020
Results First Posted: March 18, 2020
Last Update Posted: April 21, 2020