Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimekizumab-SS | Experimental | Subjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS). |
|
| Bimekizumab-AI | Experimental | Subjects will receive assigned bimekizumab dose regimen using an auto-injector (AI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | Subjects will receive bimekizumab at pre-specified time-points. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 8 |
| 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). | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dv0002 946 | Phoenix | Arizona | 85032 | United States | ||
| Dv0002 910 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40156698 | Result | Sebastian M, Bagel J, Hoepken B, Knapp B, Bicer C, MacPherson M, Langley RG. Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector. Dermatol Ther (Heidelb). 2025 May;15(5):1113-1134. doi: 10.1007/s13555-025-01366-6. Epub 2025 Mar 29. | |
| 35133113 | Derived |
| Label | URL |
|---|---|
| Product Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participant flow refers to Enrolled Set.
The study started to enroll study participants in December 2018 and concluded in September 2020. This study is a substudy to PS0014 (NCT03598790).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2019 | Jun 12, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline (the first self-injection visit) |
| 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). | Baseline (the first self-injection visit) |
| Bakersfield |
| California |
| 93309 |
| United States |
| Dv0002 955 | San Diego | California | 92123 | United States |
| Dv0002 943 | San Luis Obispo | California | 93405 | United States |
| Dv0002 967 | Santa Monica | California | 90404 | United States |
| Dv0002 906 | Boca Raton | Florida | 33486 | United States |
| Dv0002 907 | Miami | Florida | 33144 | United States |
| Dv0002 903 | Ocala | Florida | 34471 | United States |
| Dv0002 936 | Tampa | Florida | 33624 | United States |
| Dv0002 941 | Alpharetta | Georgia | 30022 | United States |
| Dv0002 954 | Skokie | Illinois | 60077 | United States |
| Dv0002 900 | West Des Moines | Iowa | 50265 | United States |
| Dv0002 905 | Overland Park | Kansas | 66215 | United States |
| Dv0002 962 | Owensboro | Kentucky | 42301 | United States |
| Dv0002 922 | Baton Rouge | Louisiana | 70809 | United States |
| Dv0002 925 | Brighton | Massachusetts | 02135 | United States |
| Dv0002 917 | Troy | Michigan | 48084 | United States |
| Dv0002 915 | St Louis | Missouri | 63117 | United States |
| Dv0002 901 | Portsmouth | New Hampshire | 03801 | United States |
| Dv0002 908 | East Windsor | New Jersey | 08520 | United States |
| Dv0002 913 | New York | New York | 10029 | United States |
| Dv0002 963 | Rochester | New York | 14623 | United States |
| Dv0002 920 | Portland | Oregon | 97210 | United States |
| Dv0002 929 | Portland | Oregon | 97223 | United States |
| Dv0002 937 | Johnston | Rhode Island | 02919 | United States |
| Dv0002 951 | Houston | Texas | 77598 | United States |
| Dv0002 914 | San Antonio | Texas | 78213 | United States |
| Dv0002 672 | Edmonton | Canada |
| Dv0002 673 | Halifax | Canada |
| Dv0002 671 | Hamilton | Canada |
| Dv0002 675 | Markham | Canada |
| Dv0002 663 | Mississauga | Canada |
| Dv0002 660 | Montreal | Canada |
| Dv0002 665 | Québec | Canada |
| Dv0002 651 | Richmond Hill | Canada |
| Dv0002 653 | Toronto | Canada |
| Dv0002 662 | Toronto | Canada |
| Dv0002 657 | Waterloo | Canada |
| Dv0002 670 | Windsor | Canada |
| Bagel J, Tatla D, Hellot S, Knapp B, Murphy C, Peterson L, Sebastian M. Bimekizumab Self-Injection Devices: Two Multicenter, Randomized, Open-Label Studies on Self-Administration by Patients With Psoriasis. J Drugs Dermatol. 2022 Feb 1;21(2):162-171. doi: 10.36849/jdd.6274. |
| FDA Safety Alerts and Recalls | View source |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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 [SS-s], bimekizumab-AI-1mL SS [SS-a], bimekizumab-SS-2mL SS [SS-s] and bimekizumab-AI-2mL SS [SS-a]). One study participant included in the Enrolled Set did not self-inject at any time during the study and is therefore not included in the Safety Set (SS-s-1mL).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | 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). |
| BG004 | Total Title |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 (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). | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 8 |
|
|
| ||||||||||||||||||||||||||||
| 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). | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | Week 8 |
| ||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline (the first self-injection visit) |
| ||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline (the first self-injection visit) |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 SS for the 1mL safety syringe (s) device presentation (SS-s-1mL). | 0 | 65 | 0 | 65 | 0 | 65 |
| EG001 | Bimekizumab AI-1mL 320 mg (SS-a-1mL) | 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). | 0 | 68 | 0 | 68 | 0 | 68 |
| EG002 | 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). | 0 | 19 | 0 | 19 | 1 | 19 |
| EG003 | 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). | 0 | 19 | 0 | 19 | 1 | 19 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA19.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2020 | Jun 12, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625981 | bimekizumab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other or Mixed |
|
| OG001 |
| Bimekizumab-AI-2mL 320 mg (FAS-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 FAS for the 2mL auto-injector (a) device presentation (FAS-a-2mL). |
|
|
| OG001 | Bimekizumab -AI-1mL 320 mg (FAS-a-1mL) | 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). |
|
|
| OG001 |
| Bimekizumab-AI-2mL 320 mg (FAS-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 FAS for the 2mL auto-injector (a) device presentation (FAS-a-2mL). |
|
|