Trial Outcomes & Findings for A Study to Compare Two Formulations of Mirikizumab (LY3074828) in Healthy Participants (NCT NCT05069896)
NCT ID: NCT05069896
Last Updated: 2025-03-04
Results Overview
PK: Cmax of Mirikizumab administered by PFS and AI.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
237 participants
Primary outcome timeframe
Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose
Results posted on
2025-03-04
Participant Flow
Participant milestones
| Measure |
Mirikizumab Pre-filled Syringe (PFS) - Abdomen
Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via PFS in the abdomen.
|
Mirikizumab PFS - Arm
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms.
|
Mirikizumab PFS - Thigh
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs.
|
Mirikizumab Autoinjector (AI) - Abdomen
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to the abdomen.
|
Mirikizumab AI - Arm
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to arms.
|
Mirikizumab AI - Thigh
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to thighs.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
39
|
40
|
40
|
40
|
|
Overall Study
Received At Least One Dose of Study Drug
|
39
|
39
|
39
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
39
|
38
|
37
|
40
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Mirikizumab Pre-filled Syringe (PFS) - Abdomen
Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via PFS in the abdomen.
|
Mirikizumab PFS - Arm
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms.
|
Mirikizumab PFS - Thigh
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs.
|
Mirikizumab Autoinjector (AI) - Abdomen
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to the abdomen.
|
Mirikizumab AI - Arm
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to arms.
|
Mirikizumab AI - Thigh
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to thighs.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
2
|
Baseline Characteristics
A Study to Compare Two Formulations of Mirikizumab (LY3074828) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Mirikizumab PFS - Abdomen
n=39 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS in the abdomen.
|
Mirikizumab PFS - Arm
n=39 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms.
|
Mirikizumab PFS - Thigh
n=39 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs.
|
Mirikizumab AI - Abdomen
n=40 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to the abdomen.
|
Mirikizumab AI - Arm
n=40 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to arms.
|
Mirikizumab AI - Thigh
n=40 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to thighs.
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
198 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
United States
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
237 Participants
n=8 Participants
|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 14.4 • n=4 Participants
|
42.6 years
STANDARD_DEVIATION 13.0 • n=21 Participants
|
39.1 years
STANDARD_DEVIATION 12.8 • n=8 Participants
|
41.3 years
STANDARD_DEVIATION 12.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
138 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
99 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
189 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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)
American Indian or Alaska Native
|
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)
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
|
1 Participants
n=8 Participants
|
7 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dosePopulation: All participants who received at least one dose of mirikizumab and had evaluable PK data. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together.
PK: Cmax of Mirikizumab administered by PFS and AI.
Outcome measures
| Measure |
Mirikizumab PFS
n=114 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.
|
Mirikizumab AI
n=119 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to abdomen or arms or thighs.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab Administered by PFS and AI
|
20.0 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 44
|
23.5 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 40
|
PRIMARY outcome
Timeframe: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dosePopulation: All participants who received at least one dose of mirikizumab and had evaluable PK data. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together.
PK: AUC\[0-∞\] of Mirikizumab administered by PFS and AI.
Outcome measures
| Measure |
Mirikizumab PFS
n=116 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.
|
Mirikizumab AI
n=120 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to abdomen or arms or thighs.
|
|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI
|
359 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 44
|
412 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 39
|
PRIMARY outcome
Timeframe: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dosePopulation: All participants who received at least one dose of mirikizumab and had evaluable PK data. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together.
PK: AUC\[0-tlast\] of Mirikizumab administered by PFS and AI.
Outcome measures
| Measure |
Mirikizumab PFS
n=111 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.
|
Mirikizumab AI
n=117 Participants
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to abdomen or arms or thighs.
|
|---|---|---|
|
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab Administered by PFS and AI
|
355 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 44
|
411 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 38
|
Adverse Events
Mirikizumab PFS - Abdomen
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Mirikizumab PFS - Arm
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Mirikizumab PFS - Thigh
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Mirikizumab AI - Abdomen
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Mirikizumab AI - Arm
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Mirikizumab AI - Thigh
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mirikizumab PFS - Abdomen
n=39 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS in the abdomen.
|
Mirikizumab PFS - Arm
n=39 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms.
|
Mirikizumab PFS - Thigh
n=39 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs.
|
Mirikizumab AI - Abdomen
n=40 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to the abdomen.
|
Mirikizumab AI - Arm
n=40 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to arms.
|
Mirikizumab AI - Thigh
n=40 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to thighs.
|
|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/19 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/25 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.8%
1/21 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/29 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/22 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
Mirikizumab PFS - Abdomen
n=39 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS in the abdomen.
|
Mirikizumab PFS - Arm
n=39 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms.
|
Mirikizumab PFS - Thigh
n=39 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs.
|
Mirikizumab AI - Abdomen
n=40 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to the abdomen.
|
Mirikizumab AI - Arm
n=40 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to arms.
|
Mirikizumab AI - Thigh
n=40 participants at risk
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to thighs.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/39 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
2/40 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 3 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.0%
6/40 • Number of events 11 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.5%
5/40 • Number of events 8 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pain
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
COVID-19
|
2.6%
1/39 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
3/39 • Number of events 3 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
3/39 • Number of events 3 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
4/40 • Number of events 4 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
4/40 • Number of events 4 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
2/40 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
5.1%
2/39 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
2/40 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
10.3%
4/39 • Number of events 4 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.4%
6/39 • Number of events 7 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.5%
3/40 • Number of events 5 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
4/40 • Number of events 4 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
3/39 • Number of events 3 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
2/40 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.5%
3/40 • Number of events 3 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
2/39 • Number of events 3 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.1%
2/39 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.0%
2/40 • Number of events 2 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.7%
3/39 • Number of events 3 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/39 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.5%
1/40 • Number of events 1 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/40 • Baseline up to 88 days.
All participants who received at least one dose of mirikizumab. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60