Trial Outcomes & Findings for A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants (NCT NCT05644353)
NCT ID: NCT05644353
Last Updated: 2025-03-28
Results Overview
PK: Cmax of Mirikizumab
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
450 participants
Primary outcome timeframe
Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose
Results posted on
2025-03-28
Participant Flow
Participant milestones
| Measure |
Mirikizumab - Abdomen
Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via Pre-filled Syringe (PFS) in the abdomen on Day 1.
|
Mirikizumab - Arm
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms on Day 1.
|
Mirikizumab - Thigh
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs on Day 1.
|
Citrate-Free Mirikizumab - Abdomen
Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to the abdomen on Day 1.
|
Citrate-Free Mirikizumab - Arm
Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms on Day 1.
|
Citrate-Free Mirikizumab - Thigh
Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
74
|
76
|
76
|
75
|
75
|
74
|
|
Overall Study
Received At Least One Dose of Study Drug
|
74
|
76
|
76
|
75
|
75
|
74
|
|
Overall Study
COMPLETED
|
72
|
74
|
75
|
75
|
74
|
74
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Mirikizumab - Abdomen
Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via Pre-filled Syringe (PFS) in the abdomen on Day 1.
|
Mirikizumab - Arm
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms on Day 1.
|
Mirikizumab - Thigh
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs on Day 1.
|
Citrate-Free Mirikizumab - Abdomen
Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to the abdomen on Day 1.
|
Citrate-Free Mirikizumab - Arm
Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms on Day 1.
|
Citrate-Free Mirikizumab - Thigh
Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
Baseline characteristics by cohort
| Measure |
Mirikizumab - Abdomen
n=74 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS in the abdomen on Day 1.
|
Mirikizumab - Arm
n=76 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms on Day 1.
|
Mirikizumab - Thigh
n=76 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs on Day 1.
|
Citrate-Free Mirikizumab - Abdomen
n=75 Participants
Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to the abdomen on Day 1.
|
Citrate-Free Mirikizumab - Arm
n=75 Participants
Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms on Day 1.
|
Citrate-Free Mirikizumab - Thigh
n=74 Participants
Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs on Day 1.
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
41.4 years
STANDARD_DEVIATION 12.5 • n=21 Participants
|
40.8 years
STANDARD_DEVIATION 12.5 • n=8 Participants
|
40.9 years
STANDARD_DEVIATION 12.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
238 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
212 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
271 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
178 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
67 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
53 Participants
n=8 Participants
|
353 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
74 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
74 Participants
n=8 Participants
|
450 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data for this outcome. Per protocol, PK analysis was performed to compare all mirikizumab participants together versus all citrate-free mirikizumab participants together.
PK: Cmax of Mirikizumab
Outcome measures
| Measure |
Mirikizumab
n=207 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to abdomen or arms or thighs on Day 1.
|
Citrate-Free Mirikizumab
n=208 Participants
Participants received 3 mL citrate- free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to abdomen or arms or thighs on Day 1.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation
|
20.9 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 43
|
20.9 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 39
|
PRIMARY outcome
Timeframe: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data for this outcome. Per protocol, PK analysis was performed to compare all mirikizumab participants together versus all citrate-free mirikizumab participants together.
PK: AUC\[0-∞\] of Mirikizumab
Outcome measures
| Measure |
Mirikizumab
n=205 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to abdomen or arms or thighs on Day 1.
|
Citrate-Free Mirikizumab
n=208 Participants
Participants received 3 mL citrate- free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to abdomen or arms or thighs on Day 1.
|
|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation
|
331 microgram*day per milliliter (μg*day/ mL
Geometric Coefficient of Variation 39
|
325 microgram*day per milliliter (μg*day/ mL
Geometric Coefficient of Variation 36
|
PRIMARY outcome
Timeframe: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data for this outcome. Per protocol, PK analysis was performed to compare all mirikizumab participants together versus all citrate-free mirikizumab participants together.
PK: AUC\[0-tlast\] of Mirikizumab
Outcome measures
| Measure |
Mirikizumab
n=205 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to abdomen or arms or thighs on Day 1.
|
Citrate-Free Mirikizumab
n=208 Participants
Participants received 3 mL citrate- free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to abdomen or arms or thighs on Day 1.
|
|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation
|
327 microgram*day per milliliter (μg*day/ mL
Geometric Coefficient of Variation 39
|
320 microgram*day per milliliter (μg*day/ mL
Geometric Coefficient of Variation 36
|
Adverse Events
Mirikizumab - Abdomen
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Mirikizumab - Arm
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Mirikizumab - Thigh
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Citrate-Free Mirikizumab - Abdomen
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Citrate-Free Mirikizumab - Arm
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Citrate-Free Mirikizumab - Thigh
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mirikizumab - Abdomen
n=74 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS in the abdomen on Day 1.
|
Mirikizumab - Arm
n=76 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms on Day 1.
|
Mirikizumab - Thigh
n=76 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs on Day 1.
|
Citrate-Free Mirikizumab - Abdomen
n=75 participants at risk
Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to the abdomen on Day 1.
|
Citrate-Free Mirikizumab - Arm
n=75 participants at risk
Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms on Day 1.
|
Citrate-Free Mirikizumab - Thigh
n=74 participants at risk
Participants received 3 mL citrate-free mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs on Day 1.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site reaction
|
25.7%
19/74 • Number of events 30 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
40.8%
31/76 • Number of events 57 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
40.8%
31/76 • Number of events 56 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
8.0%
6/75 • Number of events 10 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
16.0%
12/75 • Number of events 20 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
16.2%
12/74 • Number of events 21 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Medication error
|
8.1%
6/74 • Number of events 12 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
7.9%
6/76 • Number of events 12 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
6.6%
5/76 • Number of events 10 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
6.7%
5/75 • Number of events 10 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
6.7%
5/75 • Number of events 10 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
5.4%
4/74 • Number of events 8 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
4.1%
3/74 • Number of events 7 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
2.6%
2/76 • Number of events 2 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
5.3%
4/76 • Number of events 5 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
1.3%
1/75 • Number of events 1 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
2.7%
2/75 • Number of events 2 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have received at least one dose of study drug.
|
1.4%
1/74 • Number of events 1 • Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have 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