Psoriatic Arthritis
Conditions
Keywords
Psoriatic Arthritis, PsA, Auto-Injector, Bimekizumab
Brief summary
The purpose of the study is to evaluate for each self-injecting device presentation the ability of subjects with psoriatic arthritis (PsA) to safely and effectively self-inject bimekizumab at study start and 4 weeks after training in self-injection technique using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI).
Interventions
DRUGBimekizumab
Study participants 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 PA0012 \[NCT04009499\] study * Subject is considered reliable and capable of adhering to the DV0004 protocol (eg, able to understand and complete questionnaires, able to use investigational self-injecting device presentations according to the instructions for use (IFU), and able to adhere to the visit schedule) according to the judgment of the Investigator * Subject is willing to self-inject
Exclusion criteria
-Subjects are not permitted to enroll in DV0004 if any of the PA0012 \[NCT04009499\] study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Week 4 | Week 4 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Baseline | Baseline | 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
Czechia, Germany, Hungary, Poland, Russia, United States
Participant flow
Recruitment details
The study started to enroll study participants in Aug 2019 and concluded in Nov 2020. This study is a substudy to PA0012 (NCT04009499).
Pre-assignment details
Participant Flow refers to the Enrolled Set.
Participants by arm
| Arm | Count |
|---|---|
| BKZ-SS-1mL 160 mg Q4W Participants self-injected BKZ 160 mg solution Q4W as a sc injection with BKZ-SS-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 4. | 107 |
| BKZ-AI-1mL 160 mg Q4W Participants self-injected BKZ 160 mg solution Q4W as a sc injection with BKZ-AI-1mL device presentation (ie. 2 self-injections) at Baseline and at Week 4. | 107 |
| Total | 214 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | BKZ-SS-1mL 160 mg Q4W | BKZ-AI-1mL 160 mg Q4W | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 16 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 94 Participants | 91 Participants | 185 Participants |
| Age, Continuous | 48.3 years STANDARD_DEVIATION 13.2 | 51.5 years STANDARD_DEVIATION 11.9 | 49.9 years STANDARD_DEVIATION 12.6 |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 106 Participants | 107 Participants | 213 Participants |
| Race/Ethnicity, Customized Other/Mixed | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 106 Participants | 107 Participants | 213 Participants |
| Sex: Female, Male Female | 54 Participants | 54 Participants | 108 Participants |
| Sex: Female, Male Male | 53 Participants | 53 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 107 | 0 / 107 |
| other Total, other adverse events | 0 / 107 | 0 / 107 |
| serious Total, serious adverse events | 0 / 107 | 0 / 107 |
Outcome results
Primary
Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Week 4
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 4
Population: The Full Analysis Set for device presentation bimekizumab-SS-1mL (FAS-s) and bimekizumab-AI-1mL (FAS-a) consisted of all study participants in the SS-s and SS-a 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 analyzed signifies participants who were evaluable for the assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BKZ-SS-1mL 160 mg Q4W | Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Week 4 | 100 percentage of participants |
| BKZ-AI-1mL 160 mg Q4W | Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Week 4 | 100 percentage of participants |
Secondary
Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Baseline
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
Population: The Full Analysis Set for device presentation bimekizumab-SS-1mL (FAS-s) and bimekizumab-AI-1mL (FAS-a) consisted of all study participants in the SS-s and SS-a 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 analyzed signifies participants who were evaluable for the assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BKZ-SS-1mL 160 mg Q4W | Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Baseline | 100 percentage of participants |
| BKZ-AI-1mL 160 mg Q4W | Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Baseline | 100 percentage of participants |