Trial Outcomes & Findings for A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants (NCT NCT05292131)
NCT ID: NCT05292131
Last Updated: 2025-04-10
Results Overview
AUC is the area under the plasma concentration-time curve from time 0 (Day 1 predose) to infinity.
COMPLETED
PHASE1
121 participants
Baseline (Day 1 predose) at predefined time points (up to Day 140)
2025-04-10
Participant Flow
The study started to enroll participants in March 2022 and concluded in January 2023.
The Participant Flow refers to the Safety Set (SS). The SS consisted of all study participants who randomized and received full or partial investigational medicinal product (IMP) according to the treatment the study participants actually received.
Participant milestones
| Measure |
Bimekizumab-AI-2mL (Test)
Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference)
Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
|
Overall Study
COMPLETED
|
59
|
59
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Bimekizumab-AI-2mL (Test)
Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference)
Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants
Baseline characteristics by cohort
| Measure |
Bimekizumab-AI-2mL (Test)
n=60 Participants
Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference)
n=61 Participants
Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.6 Years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
44.8 Years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
45.2 Years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
|
Age, Customized
18 - <65 yrs
|
60 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Age, Customized
65 - <85 yrs
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other or Mixed
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
48 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1 predose) at predefined time points (up to Day 140)Population: The Pharmacokinetic Set (PKS) was a subset of the SS, consisted of those study participants that received at least 1 total dose of IMP and had at least 1 observable pharmacokinetic measurement and who had no important protocol deviations affecting pharmacokinetics (PK) during the whole study phase. Number of participants analyzed included those participants who were evaluable for the assessment.
AUC is the area under the plasma concentration-time curve from time 0 (Day 1 predose) to infinity.
Outcome measures
| Measure |
Bimekizumab-AI-2mL (Test)
n=60 Participants
Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference)
n=59 Participants
Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ)
|
1223 days*micrograms/milliliter (days*ug/mL)
Interval 1146.1 to 1306.1
|
1255 days*micrograms/milliliter (days*ug/mL)
Interval 1174.2 to 1341.1
|
PRIMARY outcome
Timeframe: From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140)Population: The PKS was a subset of the SS, consisted of those study participants that received at least 1 total dose of IMP and had at least 1 observable pharmacokinetic measurement and who had no important protocol deviations affecting PK during the whole study phase. Number of participants analyzed included those participants who were evaluable for the assessment.
AUC0-t is the area under the plasma concentration-time curve from time zero (Day 1 predose) to the last quantifiable concentration.
Outcome measures
| Measure |
Bimekizumab-AI-2mL (Test)
n=60 Participants
Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference)
n=59 Participants
Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for a Single Dose Bimekizumab (BKZ)
|
1186 day*ug/mL
Interval 1114.7 to 1262.9
|
1223 day*ug/mL
Interval 1147.3 to 1302.6
|
PRIMARY outcome
Timeframe: From Baseline (Day 1 predose) at predefined time points (up to Day 140)Population: The PKS was a subset of the SS, consisted of those study participants that received at least 1 total dose of IMP and had at least 1 observable pharmacokinetic measurement and who had no important protocol deviations affecting PK during the whole study phase. Number of participants analyzed included those participants who were evaluable for the assessment.
Cmax is a maximum observed plasma concentration.
Outcome measures
| Measure |
Bimekizumab-AI-2mL (Test)
n=60 Participants
Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference)
n=60 Participants
Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) for a Single Dose Bimekizumab (BKZ)
|
35.17 micrograms/milliliter (ug/mL)
Interval 32.8 to 37.7
|
36.55 micrograms/milliliter (ug/mL)
Interval 34.1 to 39.2
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)Population: The SS consisted of all study participants who randomized and received full or partial IMP according to the treatment the study participants actually received.
An AE is any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are defined as AEs not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment.
Outcome measures
| Measure |
Bimekizumab-AI-2mL (Test)
n=60 Participants
Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference)
n=61 Participants
Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|
|
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Baseline to End of Safety Follow-Up
|
43.3 percentage of participants
|
49.2 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)Population: The SS consisted of all study participants who randomized and received full or partial IMP according to the treatment the study participants actually received.
A SAE is defined as any untoward medical occurrence that at any dose: a. Results in death, b. Is life-threatening, c. Requires inpatient hospitalization or prolongation of existing hospitalization, d. Results in persistent disability/incapacity, e. Is a congenital anomaly/ birth defect, f. Is an important medical event which based on appropriate medical judgment, jeopardized the study participant and required medical or surgical intervention to prevent any of the above.
Outcome measures
| Measure |
Bimekizumab-AI-2mL (Test)
n=60 Participants
Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference)
n=61 Participants
Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|
|
Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) From Baseline to End of Safety Follow-Up
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Day 1 predose) at predefined time points (up to Day 140)Population: The PKS was a subset of the SS, consisted of those study participants that received at least 1 total dose of IMP and had at least 1 observable pharmacokinetic measurement and who had no important protocol deviations affecting PK during the whole study phase. Number of participants analyzed included those participants who were evaluable for the assessment.
Apparent terminal half-life as determined via linear regression (slope=-lamdbaz) of the natural log (ln) concentration versus time, for data points in the terminal phase of the concentration time curve (ln2/lambdaz).
Outcome measures
| Measure |
Bimekizumab-AI-2mL (Test)
n=60 Participants
Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference)
n=59 Participants
Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|
|
Apparent Terminal Half-life (t1/2)
|
24.65 days
Interval 23.2 to 26.2
|
24.38 days
Interval 22.9 to 25.9
|
SECONDARY outcome
Timeframe: From Baseline (Day 1 predose) at predefined time points (up to Day 140)Population: The PKS was a subset of the SS, consisted of those study participants that received at least 1 total dose of IMP and had at least 1 observable pharmacokinetic measurement and who had no important protocol deviations affecting PK during the whole study phase. Number of participants analyzed included those participants who were evaluable for the assessment.
tmax is the time to reach maximum plasma concentration.
Outcome measures
| Measure |
Bimekizumab-AI-2mL (Test)
n=60 Participants
Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference)
n=60 Participants
Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|
|
Time of Occurrence of the Maximum Observed Concentration (Tmax) of a Single Dose Bimekizumab (BKZ)
|
6.962 day
Interval 2.96 to 12.0
|
5.979 day
Interval 2.0 to 21.0
|
Adverse Events
Bimekizumab-AI-2mL (Test)
Bimekizumab-AI-2x1mL (Reference)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bimekizumab-AI-2mL (Test)
n=60 participants at risk
Participants received a single dose of bimekizumab 320 mg (1x320 mg) administered as a subcutaneous injection using a 2 mL auto-injector (AI) on Day 1 of the study.
|
Bimekizumab-AI-2x1mL (Reference)
n=61 participants at risk
Participants received a single dose of bimekizumab 320 mg (2x160 mg) administered as a subcutaneous injection using 2x1 mL AI on Day 1 of the study.
|
|---|---|---|
|
General disorders
Fatigue
|
1.7%
1/60 • Number of events 2 • From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
TEAEs are defined as AEs not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. The SS consisted of all study participants who randomized and received full or partial IMP according to the treatment the study participants actually received.
|
6.6%
4/61 • Number of events 4 • From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
TEAEs are defined as AEs not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. The SS consisted of all study participants who randomized and received full or partial IMP according to the treatment the study participants actually received.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
4/60 • Number of events 4 • From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
TEAEs are defined as AEs not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. The SS consisted of all study participants who randomized and received full or partial IMP according to the treatment the study participants actually received.
|
11.5%
7/61 • Number of events 8 • From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
TEAEs are defined as AEs not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. The SS consisted of all study participants who randomized and received full or partial IMP according to the treatment the study participants actually received.
|
|
Nervous system disorders
Headache
|
13.3%
8/60 • Number of events 14 • From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
TEAEs are defined as AEs not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. The SS consisted of all study participants who randomized and received full or partial IMP according to the treatment the study participants actually received.
|
13.1%
8/61 • Number of events 11 • From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)
TEAEs are defined as AEs not present prior to the administration of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to study treatment. The SS consisted of all study participants who randomized and received full or partial IMP according to the treatment the study participants actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60