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Trial record 1 of 1 for:    DV0004
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04109976
Recruitment Status : Completed
First Posted : October 1, 2019
Results First Posted : November 30, 2023
Last Update Posted : November 30, 2023
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriatic Arthritis
Intervention Drug: Bimekizumab
Enrollment 214
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.
Arm/Group Title BKZ-SS-1mL 160 mg Q4W BKZ-AI-1mL 160 mg Q4W
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 107 107
Completed 106 107
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title BKZ-SS-1mL 160 mg Q4W BKZ-AI-1mL 160 mg Q4W Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 107 107 214
Hide Baseline Analysis Population Description
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]).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 107 participants 214 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
94
  87.9%
91
  85.0%
185
  86.4%
>=65 years
13
  12.1%
16
  15.0%
29
  13.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 107 participants 214 participants
48.3  (13.2) 51.5  (11.9) 49.9  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 107 participants 214 participants
Female
54
  50.5%
54
  50.5%
108
  50.5%
Male
53
  49.5%
53
  49.5%
106
  49.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 107 participants 214 participants
White
106
  99.1%
107
 100.0%
213
  99.5%
Other/Mixed
1
   0.9%
0
   0.0%
1
   0.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 107 participants 214 participants
Not Hispanic or Latino
106
  99.1%
107
 100.0%
213
  99.5%
Hispanic or Latino
1
   0.9%
0
   0.0%
1
   0.5%
1.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title BKZ-SS-1mL 160 mg Q4W BKZ-AI-1mL 160 mg Q4W
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 105 104
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
100
(97.2 to 100)
100
(97.2 to 100)
2.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title BKZ-SS-1mL 160 mg Q4W BKZ-AI-1mL 160 mg Q4W
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 106 106
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
100
(97.2 to 100)
100
(97.2 to 100)
Time Frame From Baseline up to Week 5
Adverse Event Reporting Description 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.
 
Arm/Group Title BKZ-SS-1mL 160 mg Q4W BKZ-AI-1mL 160 mg Q4W
Hide Arm/Group Description 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. 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.
All-Cause Mortality
BKZ-SS-1mL 160 mg Q4W BKZ-AI-1mL 160 mg Q4W
Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)   0/107 (0.00%) 
Hide Serious Adverse Events
BKZ-SS-1mL 160 mg Q4W BKZ-AI-1mL 160 mg Q4W
Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)   0/107 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BKZ-SS-1mL 160 mg Q4W BKZ-AI-1mL 160 mg Q4W
Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)   0/107 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: 001-844-599-2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT04109976    
Other Study ID Numbers: DV0004
2018-004725-86 ( EudraCT Number )
First Submitted: September 27, 2019
First Posted: October 1, 2019
Results First Submitted: November 2, 2023
Results First Posted: November 30, 2023
Last Update Posted: November 30, 2023