Trial Outcomes & Findings for A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO) (NCT NCT03766685)
NCT ID: NCT03766685
Last Updated: 2025-07-14
Results Overview
Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) which shows that the investigational medicinal product (IMP) was delivered completely (ie, container is empty), and - No Adverse Device Effects (ADEs) that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
172 participants
Primary outcome timeframe
Week 8
Results posted on
2025-07-14
Participant Flow
The study started to enroll study participants in December 2018 and concluded in September 2020. This study is a substudy to PS0014 (NCT03598790).
Participant flow refers to Enrolled Set.
Participant milestones
| Measure |
Bimekizumab-SS-1mL 320 mg
Participants self-injected bimekizumab (BKZ) 320 milligrams (mg) solution as a subcutaneous (sc) injection with bimekizumab-Safety Syringe-1 milliliter (mL) (BKZ-SS-1mL) device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on every 4 weeks (Q4W) and every 8 weeks (Q8W) dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml prefilled syringe (PFS) at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16.
|
Bimekizumab-AI-1mL 320 mg
Participants self-injected BKZ 320 mg solution as a sc injection with bimekizumab-Auto-Injector-1mL (BKZ-AI-1mL) device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16.
|
Bimekizumab-SS-2mL 320 mg
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16.
|
Bimekizumab-AI-2mL 320 mg
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
68
|
19
|
19
|
|
Overall Study
COMPLETED
|
65
|
61
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
0
|
1
|
Reasons for withdrawal
| Measure |
Bimekizumab-SS-1mL 320 mg
Participants self-injected bimekizumab (BKZ) 320 milligrams (mg) solution as a subcutaneous (sc) injection with bimekizumab-Safety Syringe-1 milliliter (mL) (BKZ-SS-1mL) device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on every 4 weeks (Q4W) and every 8 weeks (Q8W) dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml prefilled syringe (PFS) at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16.
|
Bimekizumab-AI-1mL 320 mg
Participants self-injected BKZ 320 mg solution as a sc injection with bimekizumab-Auto-Injector-1mL (BKZ-AI-1mL) device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16.
|
Bimekizumab-SS-2mL 320 mg
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16.
|
Bimekizumab-AI-2mL 320 mg
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Overall Study
Adverse Event, not fatal
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Non-compliance
|
0
|
2
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO)
Baseline characteristics by cohort
| Measure |
Bimekizumab-SS-1mL 320 mg (SS-s-1mL)
n=65 Participants
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the Safety Set (SS) for the 1mL safety syringe (s) device presentation (SS-s-1mL).
|
Bimekizumab AI-1mL 320 mg (SS-a-1mL)
n=68 Participants
Participants self-injected BKZ 320 mg solution as a sc injection with bimekizumab-Auto-Injector-1mL (BKZ-AI-1mL) device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the SS for the 1mL auto-injector (a) device presentation (SS-a-1mL).
|
Bimekizumab-SS-2mL 320 mg (SS-s-2mL)
n=19 Participants
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the SS for the 2mL safety syringe (s) device presentation (SS-s-2mL).
|
Bimekizumab-AI-2mL 320 mg (SS-a-2mL)
n=19 Participants
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the SS for the 2mL auto-injector (a) device presentation (SS-a-2mL).
|
Total Title
n=171 Participants
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
150 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 14.0 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
47.9 years
STANDARD_DEVIATION 13.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
60 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
153 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other or Mixed
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: The Full Analysis Set for device presentation bimekizumab-SS-1mL (FAS-s-1mL) and bimekizumab-AI-1mL (FAS-a-1mL) consisted of all study participants in the SS-s-1mL and SS-a-1mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection. Here, number of participants were included who were evaluable for the assessment.
Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) which shows that the investigational medicinal product (IMP) was delivered completely (ie, container is empty), and - No Adverse Device Effects (ADEs) that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).
Outcome measures
| Measure |
Bimekizumab-SS-1mL 320 mg (FAS-s-1mL)
n=63 Participants
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the Full Analysis Set (FAS) for the 1mL safety syringe (s) device presentation (FAS-s-1mL).
|
Bimekizumab -AI-1mL 320 mg (FAS-a-1mL)
n=62 Participants
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the FAS for the 1mL auto-injector (a) device presentation (FAS-a-1mL).
|
|---|---|---|
|
Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique
|
100 percentage of participants
Interval 95.4 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
PRIMARY outcome
Timeframe: Week 8Population: The Full Analysis Set for device presentation bimekizumab-SS-2mL (FAS-s-2mL) and bimekizumab-AI-2mL (FAS-a-2mL) consisted of all study participants in the SS-s-2mL and SS-a-2mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection.
Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal).
Outcome measures
| Measure |
Bimekizumab-SS-1mL 320 mg (FAS-s-1mL)
n=19 Participants
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the Full Analysis Set (FAS) for the 1mL safety syringe (s) device presentation (FAS-s-1mL).
|
Bimekizumab -AI-1mL 320 mg (FAS-a-1mL)
n=19 Participants
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the FAS for the 1mL auto-injector (a) device presentation (FAS-a-1mL).
|
|---|---|---|
|
Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Week 8, After Training in Self-injection Technique
|
100 percentage of participants
Interval 85.4 to 100.0
|
94.7 percentage of participants
Interval 77.4 to 99.7
|
SECONDARY outcome
Timeframe: Baseline (the first self-injection visit)Population: The Full Analysis Set for device presentation bimekizumab-SS-1mL (FAS-s-1mL) and bimekizumab-AI-1mL (FAS-a-1mL) consisted of all study participants in the SS-s-1mL and SS-a-1mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection. Here, number of participants were included who were evaluable for the assessment.
Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which showed that the IMP was delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).
Outcome measures
| Measure |
Bimekizumab-SS-1mL 320 mg (FAS-s-1mL)
n=64 Participants
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the Full Analysis Set (FAS) for the 1mL safety syringe (s) device presentation (FAS-s-1mL).
|
Bimekizumab -AI-1mL 320 mg (FAS-a-1mL)
n=68 Participants
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the FAS for the 1mL auto-injector (a) device presentation (FAS-a-1mL).
|
|---|---|---|
|
Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-1mL or the Bimekizumab-AI-1mL at Baseline, After Training in Self-injection Technique
|
100 percentage of participants
Interval 95.4 to 100.0
|
97.1 percentage of participants
Interval 91.0 to 99.5
|
SECONDARY outcome
Timeframe: Baseline (the first self-injection visit)Population: The Full Analysis Set for device presentation bimekizumab-SS-2mL (FAS-s-2mL) and bimekizumab-AI-2mL (FAS-a-2mL) consisted of all study participants in the SS-s-2mL and SS-a-2mL who self-injected at least 1 dose of bimekizumab using the given device presentation and who had an assessment of self-injection.
Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal).
Outcome measures
| Measure |
Bimekizumab-SS-1mL 320 mg (FAS-s-1mL)
n=19 Participants
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the Full Analysis Set (FAS) for the 1mL safety syringe (s) device presentation (FAS-s-1mL).
|
Bimekizumab -AI-1mL 320 mg (FAS-a-1mL)
n=19 Participants
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the FAS for the 1mL auto-injector (a) device presentation (FAS-a-1mL).
|
|---|---|---|
|
Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Baseline, After Training in Self-injection Technique
|
100 percentage of participants
Interval 85.4 to 100.0
|
100 percentage of participants
Interval 85.4 to 100.0
|
Adverse Events
Bimekizumab-SS-1mL 320 mg (SS-s-1mL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bimekizumab AI-1mL 320 mg (SS-a-1mL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bimekizumab-SS-2mL 320 mg (SS-s-2mL)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Bimekizumab-AI-2mL 320 mg (SS-a-2mL)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bimekizumab-SS-1mL 320 mg (SS-s-1mL)
n=65 participants at risk
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the SS for the 1mL safety syringe (s) device presentation (SS-s-1mL).
|
Bimekizumab AI-1mL 320 mg (SS-a-1mL)
n=68 participants at risk
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 1ml PFS at Week 16. Participants formed the SS for the 1mL auto-injector (a) device presentation (SS-a-1mL).
|
Bimekizumab-SS-2mL 320 mg (SS-s-2mL)
n=19 participants at risk
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-SS-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the SS for the 2mL safety syringe (s) device presentation (SS-s-2mL).
|
Bimekizumab-AI-2mL 320 mg (SS-a-2mL)
n=19 participants at risk
Participants self-injected BKZ 320 mg solution as a sc injection with BKZ-AI-2mL device presentation (ie. 1 self-injection) at Baseline and at Week 8 for participants on Q4W and Q8W dosing. For Q4W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 4, 12 and 16. For Q8W dosing, participants were injected by study personnel with 320 mg BKZ using the 2ml PFS at Week 16. Participants formed the SS for the 2mL auto-injector (a) device presentation (SS-a-2mL).
|
|---|---|---|---|---|
|
General disorders
Injection site reaction
|
0.00%
0/65 • From Baseline up to Week 16
As pre-specified in protocol and SAP, this sub-study collected only specific Adverse Events (AEs) indicated as injection site reactions during selfinjection and investigational device-related AEs - i.e., adverse device effects (ADEs) and serious ADEs, which are reported.Treatment-Emergent (TE)ADEs were defined as AEs related to study device that have a start date on or following the first self-administration of study treatment through the final self-administration of study treatment plus 7 days.
|
0.00%
0/68 • From Baseline up to Week 16
As pre-specified in protocol and SAP, this sub-study collected only specific Adverse Events (AEs) indicated as injection site reactions during selfinjection and investigational device-related AEs - i.e., adverse device effects (ADEs) and serious ADEs, which are reported.Treatment-Emergent (TE)ADEs were defined as AEs related to study device that have a start date on or following the first self-administration of study treatment through the final self-administration of study treatment plus 7 days.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 16
As pre-specified in protocol and SAP, this sub-study collected only specific Adverse Events (AEs) indicated as injection site reactions during selfinjection and investigational device-related AEs - i.e., adverse device effects (ADEs) and serious ADEs, which are reported.Treatment-Emergent (TE)ADEs were defined as AEs related to study device that have a start date on or following the first self-administration of study treatment through the final self-administration of study treatment plus 7 days.
|
0.00%
0/19 • From Baseline up to Week 16
As pre-specified in protocol and SAP, this sub-study collected only specific Adverse Events (AEs) indicated as injection site reactions during selfinjection and investigational device-related AEs - i.e., adverse device effects (ADEs) and serious ADEs, which are reported.Treatment-Emergent (TE)ADEs were defined as AEs related to study device that have a start date on or following the first self-administration of study treatment through the final self-administration of study treatment plus 7 days.
|
|
General disorders
Injection site pain
|
0.00%
0/65 • From Baseline up to Week 16
As pre-specified in protocol and SAP, this sub-study collected only specific Adverse Events (AEs) indicated as injection site reactions during selfinjection and investigational device-related AEs - i.e., adverse device effects (ADEs) and serious ADEs, which are reported.Treatment-Emergent (TE)ADEs were defined as AEs related to study device that have a start date on or following the first self-administration of study treatment through the final self-administration of study treatment plus 7 days.
|
0.00%
0/68 • From Baseline up to Week 16
As pre-specified in protocol and SAP, this sub-study collected only specific Adverse Events (AEs) indicated as injection site reactions during selfinjection and investigational device-related AEs - i.e., adverse device effects (ADEs) and serious ADEs, which are reported.Treatment-Emergent (TE)ADEs were defined as AEs related to study device that have a start date on or following the first self-administration of study treatment through the final self-administration of study treatment plus 7 days.
|
0.00%
0/19 • From Baseline up to Week 16
As pre-specified in protocol and SAP, this sub-study collected only specific Adverse Events (AEs) indicated as injection site reactions during selfinjection and investigational device-related AEs - i.e., adverse device effects (ADEs) and serious ADEs, which are reported.Treatment-Emergent (TE)ADEs were defined as AEs related to study device that have a start date on or following the first self-administration of study treatment through the final self-administration of study treatment plus 7 days.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 16
As pre-specified in protocol and SAP, this sub-study collected only specific Adverse Events (AEs) indicated as injection site reactions during selfinjection and investigational device-related AEs - i.e., adverse device effects (ADEs) and serious ADEs, which are reported.Treatment-Emergent (TE)ADEs were defined as AEs related to study device that have a start date on or following the first self-administration of study treatment through the final self-administration of study treatment plus 7 days.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60