Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis
Conditions
Keywords
Bimekizumab, PSO, Psoriasis, Auto-Injector
Brief summary
The purpose of the study is to evaluate the ability of subjects with moderate to severe chronic plaque psoriasis (PSO) to safely and effectively self-inject bimekizumab at study start and 8 weeks after training in self-injection technique using a prefilled safety syringe or an auto-injector.
Interventions
DRUGBimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject fulfills all inclusion criteria for the PS0014 \[NCT03598790\] study * Subject is considered reliable and capable of adhering to the DV0002 protocol (eg, able to understand and complete questionnaires, willing to self-inject, able to use investigational device according to the instructions for use (IFU), and able to adhere to the visit schedule) according to the judgment of the Investigator
Exclusion criteria
* Subjects are not permitted to enroll in DV0002 if any of the PS0014 \[NCT03598790\] study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 8 | 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). |
| 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 | Week 8 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (the first self-injection visit) | 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). |
| 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 | Baseline (the first self-injection visit) | 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). |
Countries
Canada, United States
Participant flow
Recruitment details
The study started to enroll study participants in December 2018 and concluded in September 2020. This study is a substudy to PS0014 (NCT03598790).
Pre-assignment details
Participant flow refers to Enrolled Set.
Participants by arm
| Arm | Count |
|---|---|
| Bimekizumab-SS-1mL 320 mg (SS-s-1mL) 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). | 65 |
| Bimekizumab AI-1mL 320 mg (SS-a-1mL) 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). | 68 |
| Bimekizumab-SS-2mL 320 mg (SS-s-2mL) 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). | 19 |
| Bimekizumab-AI-2mL 320 mg (SS-a-2mL) 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). | 19 |
| Total Title | 171 |
| Total | 342 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event, not fatal | 0 | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 0 |
| Overall Study | Non-compliance | 0 | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Bimekizumab-SS-1mL 320 mg (SS-s-1mL) | Bimekizumab AI-1mL 320 mg (SS-a-1mL) | Bimekizumab-SS-2mL 320 mg (SS-s-2mL) | Bimekizumab-AI-2mL 320 mg (SS-a-2mL) | Total Title |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Age, Categorical >=65 years | 7 Participants | 8 Participants | 3 Participants | 1 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 59 Participants | 16 Participants | 18 Participants | 150 Participants |
| Age, Continuous | 49.7 years STANDARD_DEVIATION 13.4 | 46.8 years STANDARD_DEVIATION 14 | 50.3 years STANDARD_DEVIATION 15.8 | 43.0 years STANDARD_DEVIATION 12.4 | 47.9 years STANDARD_DEVIATION 13.9 |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other or Mixed | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 60 Participants | 61 Participants | 16 Participants | 16 Participants | 153 Participants |
| Sex: Female, Male Female | 22 Participants | 19 Participants | 9 Participants | 9 Participants | 59 Participants |
| Sex: Female, Male Male | 43 Participants | 49 Participants | 10 Participants | 10 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 68 | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 65 | 0 / 68 | 1 / 19 | 1 / 19 |
| serious Total, serious adverse events | 0 / 65 | 0 / 68 | 0 / 19 | 0 / 19 |
Outcome results
Primary
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
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).
Time frame: Week 8
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimekizumab-SS-1mL 320 mg (FAS-s-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 |
| Bimekizumab -AI-1mL 320 mg (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 |
Primary
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
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).
Time frame: Week 8
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimekizumab-SS-1mL 320 mg (FAS-s-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 |
| Bimekizumab -AI-1mL 320 mg (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 | 94.7 percentage of participants |
Secondary
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
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimekizumab-SS-1mL 320 mg (FAS-s-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 |
| Bimekizumab -AI-1mL 320 mg (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 | 97.1 percentage of participants |
Secondary
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
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimekizumab-SS-1mL 320 mg (FAS-s-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 |
| Bimekizumab -AI-1mL 320 mg (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 |