Trial Outcomes & Findings for FAsenra Safety Trial in India (NCT NCT05384938)
NCT ID: NCT05384938
Last Updated: 2024-12-11
Results Overview
The number and percentage of participants who experienced at least one adverse event (AE), serious AE, or treatment-emergent AE experienced are presented
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
139 participants
Primary outcome timeframe
From study treatment to follow-up (up to 24 weeks)
Results posted on
2024-12-11
Participant Flow
Participant milestones
| Measure |
Benralizumab
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
Overall Study
STARTED
|
139
|
|
Overall Study
COMPLETED
|
124
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Benralizumab
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
One participant included in study but not included in analysis as did not meet eligibility criteria
|
1
|
Baseline Characteristics
Only female participants were analyzed
Baseline characteristics by cohort
| Measure |
Benralizumab
n=138 Participants
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
Age, Continuous
|
47.7 Years
STANDARD_DEVIATION 14.3 • n=138 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=138 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
138 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
0 Participants
n=138 Participants
|
|
Female, Indicate childbearing potential
Premenarchal
|
0 Participants
n=71 Participants • Only female participants were analyzed
|
|
Female, Indicate childbearing potential
Premenopausal female
|
6 Participants
n=71 Participants • Only female participants were analyzed
|
|
Female, Indicate childbearing potential
Postmenopausal female
|
30 Participants
n=71 Participants • Only female participants were analyzed
|
|
Female, Indicate childbearing potential
Potentially able to bear children
|
35 Participants
n=71 Participants • Only female participants were analyzed
|
PRIMARY outcome
Timeframe: From study treatment to follow-up (up to 24 weeks)Population: Safety analysis set
The number and percentage of participants who experienced at least one adverse event (AE), serious AE, or treatment-emergent AE experienced are presented
Outcome measures
| Measure |
Benralizumab
n=138 Participants
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs
Participants with at least one AE (including SAEs)
|
44 Participants
|
|
Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs
Participants with at least one serious AE
|
5 Participants
|
|
Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs
Participants with at least one treatment-emergent AE (including SAEs)
|
43 Participants
|
|
Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs
Participants with at least one non-treatment-emergent and non-serious AE
|
1 Participants
|
PRIMARY outcome
Timeframe: From study treatment to follow-up (up to 24 weeks)Population: Safety analysis set
Severity of adverse events (AEs) by intensity grade
Outcome measures
| Measure |
Benralizumab
n=138 Participants
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
Severity of AEs
Participants with at least one mild AE
|
33 Participants
|
|
Severity of AEs
Participants with at least one moderate AE
|
16 Participants
|
|
Severity of AEs
Participants with at least one severe AE
|
1 Participants
|
PRIMARY outcome
Timeframe: From study treatment to follow-up (up to 24 weeks)Population: Safety analysis set
Participants with adverse events (AEs) that led to study treatment discontinuations or modifications
Outcome measures
| Measure |
Benralizumab
n=138 Participants
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
Participants With AEs That Led to Study Treatment Discontinuations or Modifications
|
0 Participants
|
SECONDARY outcome
Timeframe: From study treatment to follow-up (up to 24 weeks)Population: Evaluable Analysis Set
Time to first asthma exacerbation in days in participants with asthma exacerbation
Outcome measures
| Measure |
Benralizumab
n=19 Participants
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
Time to First Asthma Exacerbation
|
112.6 days
Standard Deviation 50.45
|
SECONDARY outcome
Timeframe: From study treatment to follow-up (up to 24 weeks)Population: Evaluable Analysis Set
The annual exacerbation rate for each participant was calculated by dividing the total number of exacerbations by the number of days participated in the study and multiplying by 365.
Outcome measures
| Measure |
Benralizumab
n=138 Participants
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
Exacerbation Rate: Before and After Treatment
Exacerbation before study
|
2.0 exacerbations events/year
Standard Deviation 0.00
|
|
Exacerbation Rate: Before and After Treatment
Exacerbation at end of study
|
0.2 exacerbations events/year
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: From study treatment to follow-up (up to 24 weeks)Population: Evaluable Analysis Set
Overall annualized exacerbation rate. The annual exacerbation rate for each participant was calculated by dividing the total number of exacerbations by the number of days participated in the study and multiplying by 365.
Outcome measures
| Measure |
Benralizumab
n=138 Participants
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
Annualized Exacerbation Rate: Overall
|
0.36 exacerbation events/year
|
SECONDARY outcome
Timeframe: From study treatment to follow-up (up to 24 weeks)Population: Evaluable Analysis Set
Overall investigator's assessment on the outcome of the treatment: "well controlled", "partly controlled", and "uncontrolled."
Outcome measures
| Measure |
Benralizumab
n=135 Participants
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
Overall Investigators Assessment
Well controlled
|
83 Participants
Interval 52.72 to 69.72
|
|
Overall Investigators Assessment
Partly controlled
|
45 Participants
Interval 25.46 to 41.96
|
|
Overall Investigators Assessment
Uncontrolled
|
7 Participants
Interval 2.11 to 10.39
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 16, and 24Population: Evaluable Analysis Set
Mean change in blood eosinophil levels from baseline at Weeks 4, 16, and 24
Outcome measures
| Measure |
Benralizumab
n=138 Participants
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
Change in Blood Eosinophil Levels From Baseline at Weeks 4, 16, and 24
Week 4 (Visit 2)
|
-511 cells/mm^3
Standard Deviation 779.13
|
|
Change in Blood Eosinophil Levels From Baseline at Weeks 4, 16, and 24
Week 16 (Visit 4)
|
-546 cells/mm^3
Standard Deviation 867.79
|
|
Change in Blood Eosinophil Levels From Baseline at Weeks 4, 16, and 24
Week 24 (Visit 5)
|
-541 cells/mm^3
Standard Deviation 893.62
|
Adverse Events
Benralizumab
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Benralizumab
n=138 participants at risk
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
Infections and infestations
H1n1 influenza
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Gastrointestinal disorders
Constipation
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
4/138 • Number of events 4 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.9%
4/138 • Number of events 4 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
General disorders
Pyrexia
|
2.2%
3/138 • Number of events 3 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
Other adverse events
| Measure |
Benralizumab
n=138 participants at risk
30 mg/mL subcutaneous benralizumab once every 4 weeks for the first 3 doses, followed by a maintenance dosage of 30 mg/mL once every 8 weeks thereafter
|
|---|---|
|
General disorders
Ulcer
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Infections and infestations
Covid-19
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
3/138 • Number of events 3 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Infections and infestations
Urinary tract infection
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Investigations
Sars-cov-2 test positive
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Nervous system disorders
Burning sensation
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Gastrointestinal disorders
Constipation
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Nervous system disorders
Headache
|
1.4%
2/138 • Number of events 2 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Nervous system disorders
Paraesthesia
|
1.4%
2/138 • Number of events 2 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Nervous system disorders
Restless legs syndrome
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Renal and urinary disorders
Dysuria
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
4/138 • Number of events 4 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
3/138 • Number of events 3 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
2/138 • Number of events 2 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.4%
2/138 • Number of events 2 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
2/138 • Number of events 3 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
Gastrointestinal disorders
Nausea
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
General disorders
Asthenia
|
1.4%
2/138 • Number of events 2 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
General disorders
Chest pain
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
General disorders
Non-cardiac chest pain
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
General disorders
Pain
|
0.72%
1/138 • Number of events 1 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
|
General disorders
Pyrexia
|
14.5%
20/138 • Number of events 37 • From screening to follow-up (up to 27 weeks)
Adverse events were reported by the participant (or when appropriate by a caregiver, surrogate, or the participant's legally authorised representative). Participants were provided a patient diary to record any undesirable health-related experience or adverse events occurring during the study. Adverse events and serious adverse events mentioned both in the patient diary and verbally communicated by the participant were recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years after completion of the Study shall require the Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER