Trial Outcomes & Findings for A Study of Mirikizumab in Healthy Participants (NCT NCT04607733)
NCT ID: NCT04607733
Last Updated: 2024-02-20
Results Overview
PK: Cmax of Mirikizumab
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
240 participants
Primary outcome timeframe
Predose up to 85 days postdose
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
AI (Test) Abdomen
AI (Test) Abdomen:
2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
AI (Test) Arm
AI (Test) Arm:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
AI (Test) Thigh
AI (Test) Thigh:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
PFS (Reference) Abdomen
PFS (Reference) Abdomen:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
PFS (Reference) Arm
PFS (Reference) Arm:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
PFS (Reference) Thigh
PFS (Reference) Thigh:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
39
|
41
|
40
|
41
|
39
|
|
Overall Study
Received at Least One Dose of Drug
|
40
|
39
|
41
|
40
|
41
|
39
|
|
Overall Study
COMPLETED
|
39
|
39
|
41
|
39
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
AI (Test) Abdomen
AI (Test) Abdomen:
2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
AI (Test) Arm
AI (Test) Arm:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
AI (Test) Thigh
AI (Test) Thigh:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
PFS (Reference) Abdomen
PFS (Reference) Abdomen:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
PFS (Reference) Arm
PFS (Reference) Arm:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
PFS (Reference) Thigh
PFS (Reference) Thigh:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Mirikizumab in Healthy Participants
Baseline characteristics by cohort
| Measure |
AI (Test)
n=120 Participants
AI (Test):
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
PFS (Reference)
n=120 Participants
PFS (Reference):
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
40.1 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
41.7 years
STANDARD_DEVIATION 12.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
101 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=93 Participants
|
100 Participants
n=4 Participants
|
199 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
180 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
120 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
240 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Predose up to 85 days postdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data for this outcome.
PK: Cmax of Mirikizumab
Outcome measures
| Measure |
PFS (Reference)
n=120 Participants
PFS (Reference):
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
AI (Test)
n=120 Participants
AI (Test):
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
|
14.3 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 44
|
15.2 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 40
|
PRIMARY outcome
Timeframe: Predose up to 85 days postdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data for this outcome.
PK: AUC\[0-∞\] of Mirikizumab
Outcome measures
| Measure |
PFS (Reference)
n=120 Participants
PFS (Reference):
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
AI (Test)
n=120 Participants
AI (Test):
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab
|
246 micrograms*day/milliliter (µg*day/mL)
Geometric Coefficient of Variation 44
|
262 micrograms*day/milliliter (µg*day/mL)
Geometric Coefficient of Variation 39
|
PRIMARY outcome
Timeframe: Predose up to 85 days postdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data for this outcome.
PK: AUC\[0-tlast\] of Mirikizumab
Outcome measures
| Measure |
PFS (Reference)
n=116 Participants
PFS (Reference):
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
AI (Test)
n=119 Participants
AI (Test):
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab
|
244 micrograms*day/milliliter (µg*day/mL)
Geometric Coefficient of Variation 44
|
257 micrograms*day/milliliter (µg*day/mL)
Geometric Coefficient of Variation 39
|
Adverse Events
AI (Test) Abdomen
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
AI (Test) Arm
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AI (Test) Thigh
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PFS (Reference) Abdomen
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PFS (Reference) Arm
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PFS (Reference) Thigh
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AI (Test) Abdomen
n=40 participants at risk
AI (Test) Abdomen:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
AI (Test) Arm
n=39 participants at risk
AI (Test) Arm:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
AI (Test) Thigh
n=41 participants at risk
AI (Test) Thigh:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI).
|
PFS (Reference) Abdomen
n=40 participants at risk
PFS (Reference) Abdomen:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
PFS (Reference) Arm
n=41 participants at risk
PFS (Reference) Arm:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
PFS (Reference) Thigh
n=39 participants at risk
PFS (Reference) Thigh:
2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS).
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site reaction
|
7.5%
3/40 • Number of events 6 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
7.7%
3/39 • Number of events 5 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 8 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 4 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 8 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
7.7%
3/39 • Number of events 5 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Covid-19
|
0.00%
0/40 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/41 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 2 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
12.5%
5/40 • Number of events 5 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
10.3%
4/39 • Number of events 5 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 3 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 4 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
7.7%
3/39 • Number of events 3 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60