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 Active Psoriatic Arthritis (NCT NCT04109976)

Last Updated: 2023-11-30

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

214 participants

Primary outcome timeframe

Week 4

Results posted on

2023-11-30

Participant Flow

The study started to enroll study participants in Aug 2019 and concluded in Nov 2020. This study is a substudy to PA0012 (NCT04009499).

Participant Flow refers to the Enrolled Set.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	107	107
Overall Study COMPLETED	106	107
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	1	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 Active Psoriatic Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BKZ-SS-1mL 160 mg Q4W n=107 Participants 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.	BKZ-AI-1mL 160 mg Q4W n=107 Participants 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.	Total n=214 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	94 Participants n=5 Participants	91 Participants n=7 Participants	185 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Age, Continuous	48.3 years STANDARD_DEVIATION 13.2 • n=5 Participants	51.5 years STANDARD_DEVIATION 11.9 • n=7 Participants	49.9 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Race/Ethnicity, Customized White	106 Participants n=5 Participants	107 Participants n=7 Participants	213 Participants n=5 Participants
Race/Ethnicity, Customized Other/Mixed	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	106 Participants n=5 Participants	107 Participants n=7 Participants	213 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BKZ-SS-1mL 160 mg Q4W n=105 Participants 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.	BKZ-AI-1mL 160 mg Q4W n=104 Participants 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.
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 Interval 97.2 to 100.0	100 percentage of participants Interval 97.2 to 100.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	BKZ-SS-1mL 160 mg Q4W n=106 Participants 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.	BKZ-AI-1mL 160 mg Q4W n=106 Participants 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.
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 Interval 97.2 to 100.0	100 percentage of participants Interval 97.2 to 100.0

Adverse Events

BKZ-SS-1mL 160 mg Q4W

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BKZ-AI-1mL 160 mg Q4W

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

UCB

Cares

Phone: 001-844-599-2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60