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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMBY | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via pre-filled syringe compared to mirikizumab (reference) solution given via pre-filled syringe. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated.
Screening is required within 35 days prior to enrolment. 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 | Experimental | Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via Pre-filled Syringe (PFS) to abdomen or arms or thighs on Day 1. |
|
| Citrate-Free Mirikizumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab | Drug | Administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation | PK: Cmax of Mirikizumab | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose |
| 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 | PK: AUC[0-∞] of Mirikizumab | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose |
| 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 | PK: AUC[0-tlast] of Mirikizumab | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose |
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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 |
|---|---|---|---|---|---|---|
| Altasciences Clinical Los Angeles, Inc | Cypress | California | 90630 | United States | ||
| LabCorp CRU, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40117091 | Derived | Otani Y, Feagan BG, D'Haens GR, Escobar R, Morris NJ, Payne CD, Ugolini Lopes M, Zhang X. Pharmacokinetic Comparability and Safety Between Original and Citrate-Free Mirikizumab Formulations for Subcutaneous Injections: Results from Three Clinical Trials. Adv Ther. 2025 May;42(5):2369-2384. doi: 10.1007/s12325-025-03158-y. Epub 2025 Mar 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirikizumab - Abdomen | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS in the abdomen on Day 1. |
| BG001 | 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. |
| 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 in a Citrate-free Solution Formulation Compared to the Solution Formulation | PK: Cmax of Mirikizumab | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose |
|
Baseline Through Follow-Up (Up To 13 Weeks)
All participants who have 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 | Mirikizumab - Abdomen | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS in the abdomen on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 25.1 | 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 | Feb 1, 2023 | Feb 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 7, 2023 | Feb 4, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Daytona Beach |
| Florida |
| 32117 |
| United States |
| Clinical Pharmacology of Miami | Miami | Florida | 33014 | United States |
| Qps-Mra, Llc | Miami | Florida | 33143 | United States |
| Axis | Dilworth | Minnesota | 56529 | United States |
| Labcorp Clinical Research LP | Dallas | Texas | 75247 | United States |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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 |
|
| Citrate-Free Mirikizumab |
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. |
|
|
| Primary | 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 | PK: AUC[0-∞] of Mirikizumab | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day per milliliter (μg*day/ mL | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose |
|
|
|
| Primary | 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 | 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. Per protocol, PK analysis was performed to compare all mirikizumab participants together versus all citrate-free mirikizumab participants together. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day per milliliter (μg*day/ mL | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose |
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|
| 0 |
| 74 |
| 0 |
| 74 |
| 27 |
| 74 |
| EG001 | 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. | 0 | 76 | 0 | 76 | 38 | 76 |
| EG002 | 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. | 0 | 76 | 0 | 76 | 36 | 76 |
| EG003 | 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. | 0 | 75 | 0 | 75 | 11 | 75 |
| EG004 | 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. | 0 | 75 | 0 | 75 | 17 | 75 |
| EG005 | 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. | 0 | 74 | 0 | 74 | 17 | 74 |
| Medication error | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
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