Trial Outcomes & Findings for A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants (NCT NCT04548219)

NCT ID: NCT04548219

Last Updated: 2024-01-25

Results Overview

PK: Cmax of mirikizumab was evaluated.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose

Results posted on

2024-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	200 Milligram (mg) Mirikizumab (Reference): Arm Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a subcutaneous (SC) injection into the arm on day 1.	200 mg Mirikizumab (Reference): Thigh Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the thigh on day 1.	200 mg Mirikizumab (Reference): Abdomen Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the abdomen on day 1.	200 mg Mirikizumab (Test): Arm Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm on day 1.	200 mg Mirikizumab (Test): Thigh Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the thigh on day 1.	200 mg Mirikizumab (Test): Abdomen Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the abdomen on day 1.
Overall Study STARTED	10	10	10	10	10	10
Overall Study Received at Least 1 Dose of Study Drug	10	10	10	10	10	10
Overall Study COMPLETED	10	10	10	10	10	10
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	200 mg Mirikizumab (Reference) n=30 Participants Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1.	200 mg Mirikizumab (Test) n=30 Participants Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose

Population: All participants who received at least 1 dose of study drug (mirikizumab) and had evaluable PK data.

PK: Cmax of mirikizumab was evaluated.

Outcome measures

Outcome measures
Measure	200 mg Mirikizumab (Reference) n=30 Participants Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1.	200 mg Mirikizumab (Test) n=30 Participants Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab	12.7 micrograms per milliliter (ug/mL) Geometric Coefficient of Variation 48	11.6 micrograms per milliliter (ug/mL) Geometric Coefficient of Variation 45

PRIMARY outcome

Timeframe: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose

Population: All participants who received at least 1 dose of study drug (mirikizumab) and had evaluable PK data.

PK: AUC(0-inf) of mirikizumab was evaluated.

Outcome measures

Outcome measures
Measure	200 mg Mirikizumab (Reference) n=30 Participants Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1.	200 mg Mirikizumab (Test) n=30 Participants Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Mirikizumab	229 ug*day/mL Geometric Coefficient of Variation 56	209 ug*day/mL Geometric Coefficient of Variation 45

PRIMARY outcome

Timeframe: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose

Population: All participants who received at least 1 dose of study drug (mirikizumab) and had evaluable PK data.

PK: (AUC\[0-tlast\]) of mirikizumab was evaluated.