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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004725-86 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimekizumab-SS | Experimental | Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the prefilled safety syringe (SS). |
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| Bimekizumab-AI | Experimental | Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the auto-injector (AI). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | Study participants will receive bimekizumab at pre-specified time points. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
-Subjects are not permitted to enroll in DV0004 if any of the PA0012 [NCT04009499] study exclusion criteria are met
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dv0004 50024 | Boise | Idaho | 83702 | United States | ||
| Dv0004 50028 |
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| Label | URL |
|---|---|
| Product Information | View source |
| FDA Safety Alerts and Recalls | View source |
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Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.
Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.clinicalstudydatarequest.com and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Participant Flow refers to the Enrolled Set.
The study started to enroll study participants in Aug 2019 and concluded in Nov 2020. This study is a substudy to PA0012 (NCT04009499).
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| ID | Title | Description |
|---|---|---|
| FG000 | BKZ-SS-1mL 160 mg Q4W | Participants self-injected bimekizumab (BKZ) 160 milligrams (mg) solution every 4 weeks (Q4W) 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 4. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2020 | Nov 2, 2023 |
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| Baseline |
| Lexington |
| Kentucky |
| 40504 |
| United States |
| Dv0004 50023 | Baton Rouge | Louisiana | 70836 | United States |
| Dv0004 50015 | Hagerstown | Maryland | 21742 | United States |
| Dv0004 50026 | Wheaton | Maryland | 20902 | United States |
| Dv0004 50019 | Lansing | Michigan | 48910 | United States |
| Dv0004 50016 | St Louis | Missouri | 63141 | United States |
| Dv0004 50005 | Freehold | New Jersey | 07728 | United States |
| Dv0004 50029 | Albuquerque | New Mexico | 87102 | United States |
| Dv0004 50010 | Brooklyn | New York | 11201 | United States |
| Dv0004 50125 | Charlotte | North Carolina | 28210 | United States |
| Dv0004 50031 | Salisbury | North Carolina | 28144 | United States |
| Dv0004 50040 | Dayton | Ohio | 45417 | United States |
| Dv0004 50020 | Duncansville | Pennsylvania | 16635 | United States |
| Dv0004 50006 | Wyomissing | Pennsylvania | 19610 | United States |
| Dv0004 50008 | Johnston | Rhode Island | 02919 | United States |
| Dv0004 50001 | Jackson | Tennessee | 38305 | United States |
| Dv0004 50036 | Mesquite | Texas | 75150 | United States |
| Dv0004 50009 | Waco | Texas | 76710 | United States |
| Dv0004 50050 | Beckley | West Virginia | 25801 | United States |
| Dv0004 40061 | Brno | Czechia |
| Dv0004 40009 | Pardubice | Czechia |
| Dv0004 40063 | Prague | Czechia |
| Dv0004 40066 | Prague | Czechia |
| Dv0004 40010 | Uherské Hradiště | Czechia |
| Dv0004 40012 | Zlín | Czechia |
| Dv0004 40029 | Hamburg | Germany |
| Dv0004 40079 | Szentes | Hungary |
| Dv0004 40038 | Elblag | Poland |
| Dv0004 40088 | Elblag | Poland |
| Dv0004 40096 | Gdynia | Poland |
| Dv0004 40042 | Krakow | Poland |
| Dv0004 40092 | Krakow | Poland |
| Dv0004 40037 | Lublin | Poland |
| Dv0004 40091 | Nowa Sól | Poland |
| Dv0004 40044 | Poznan | Poland |
| Dv0004 40118 | Torun | Poland |
| Dv0004 40041 | Warsaw | Poland |
| Dv0004 40097 | Warsaw | Poland |
| Dv0004 40098 | Warsaw | Poland |
| Dv0004 40039 | Wroclaw | Poland |
| Dv0004 40043 | Wroclaw | Poland |
| Dv0004 20005 | Moscow | Russia |
| Dv0004 20013 | Petrozavodsk | Russia |
| Dv0004 20004 | Saint Petersburg | Russia |
| Dv0004 20014 | Ulyanovsk | Russia |
| Dv0004 20015 | Yaroslavl | Russia |
| BKZ-AI-1mL 160 mg Q4W |
Participants self-injected BKZ 160 mg solution Q4W as a sc injection with bimekizumab-Auto-Injector-1mL (BKZ-AI-1mL) device presentation (ie. 2 self-injections) at Baseline and at Week 4. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Safety Set (SS) consisted of all study participants who received at least 1 dose of bimekizumab by the indicated self-injection investigational device presentation (bimekizumab-SS-1mL [SS-s] and bimekizumab-AI-1mL [SS-a]).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 4 |
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| 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). | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline |
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From Baseline up to Week 5
Treatment emergent adverse device events (TEADEs) were defined as adverse event 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. As Pre-specified in SAP, only those AEs related to the use of the investigational medical devices BKZ-SS or BKZ-AI (based on the Investigator's judgment) were assessed and have been reported in this section.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 107 | 0 | 107 | 0 | 107 |
| EG001 | 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. | 0 | 107 | 0 | 107 | 0 | 107 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001-844-599-2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2021 | Nov 2, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000625981 | bimekizumab |
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| >=65 years |
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| Male |
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| Other/Mixed |
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| Hispanic or Latino |
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