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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMBW | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated.
Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 17 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirikizumab - Prefilled Syringe | Experimental | 2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS) |
|
| Mirikizumab - Autoinjector | Experimental | 2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab Prefilled Syringe | Drug | Administered SC by prefilled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | PK: Cmax of Mirikizumab | Predose up to 85 days postdose |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab | PK: AUC[0-∞] of Mirikizumab | Predose up to 85 days postdose |
| PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab | PK: AUC[0-tlast] of Mirikizumab | Predose up to 85 days postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States | ||
| QPS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40900263 | Derived | Zhang X, Otani Y, Payne CD, Morris NJ, Chua L, Escobar R, Wang S, Shi G. Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants. Adv Ther. 2025 Nov;42(11):5529-5546. doi: 10.1007/s12325-025-03335-z. Epub 2025 Sep 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AI (Test) Abdomen | AI (Test) Abdomen: 2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI). |
| FG001 | AI (Test) Arm | AI (Test) Arm: 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI). |
| FG002 | AI (Test) Thigh | AI (Test) Thigh: 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI). |
| FG003 | PFS (Reference) Abdomen | PFS (Reference) Abdomen: 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS). |
| FG004 | PFS (Reference) Arm | PFS (Reference) Arm: 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS). |
| FG005 | PFS (Reference) Thigh | PFS (Reference) Thigh: 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | AI (Test) | AI (Test): 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI). |
| BG001 | PFS (Reference) | PFS (Reference): 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | PK: Cmax of Mirikizumab | All participants who received at least one dose of study drug and had evaluable PK data for this outcome. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | micrograms/milliliter (µg/mL) | Predose up to 85 days postdose |
|
Baseline Up To 85 Days
All participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AI (Test) Abdomen | AI (Test) Abdomen: 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2020 | May 5, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2020 | May 5, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Mirikizumab Autoinjector | Drug | Administered SC by autoinjector |
|
|
| Springfield |
| Missouri |
| 65802 |
| United States |
| Covance Dallas | Dallas | Texas | 75247 | United States |
| Covance Clinical Research Inc | Madison | Wisconsin | 53704 | United States |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab | PK: AUC[0-∞] of Mirikizumab | All participants who received at least one dose of study drug and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*day/milliliter (µg*day/mL) | Predose up to 85 days postdose |
|
|
|
| Primary | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab | PK: AUC[0-tlast] of Mirikizumab | All participants who received at least one dose of study drug and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*day/milliliter (µg*day/mL) | Predose up to 85 days postdose |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 7 |
| 40 |
| EG001 | AI (Test) Arm | AI (Test) Arm: 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI). | 0 | 39 | 0 | 39 | 6 | 39 |
| EG002 | AI (Test) Thigh | AI (Test) Thigh: 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI). | 0 | 41 | 0 | 41 | 8 | 41 |
| EG003 | PFS (Reference) Abdomen | PFS (Reference) Abdomen: 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS). | 0 | 40 | 0 | 40 | 6 | 40 |
| EG004 | PFS (Reference) Arm | PFS (Reference) Arm: 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS). | 0 | 41 | 0 | 41 | 5 | 41 |
| EG005 | PFS (Reference) Thigh | PFS (Reference) Thigh: 2× 1mL (total 200 mg mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS). | 0 | 39 | 0 | 39 | 6 | 39 |
| Covid-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
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