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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMBT | 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 autoinjector compared to mirikizumab (reference) solution given via autoinjector. 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 (Reference) | Experimental | 200 milligram (mg) of mirikizumab as reference formulation [100 mg/milliliter (mL)], 2 × 1-mL autoinjector administered as a subcutaneous (SC) injection into the arm/thigh/abdomen on day 1. |
|
| Mirikizumab (Test) | Experimental | 200 mg of mirikizumab as test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen 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 | PK: Cmax of mirikizumab was evaluated. | 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 |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab | PK: AUC[0-∞] of Mirikizumab was evaluated. | 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 |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab | PK: AUC[0-tlast] of Mirikizumab was evaluated. | 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 |
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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 | 200 Milligram (mg) Mirikizumab (Reference): Abdomen | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL (milliliter) autoinjector administered as a subcutaneous (SC) injection into the abdomen on day 1. |
| FG001 | 200 mg Mirikizumab (Reference): Arm | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm on day 1. |
| FG002 | 200 mg Mirikizumab (Reference): Thigh | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the thigh on day 1. |
| FG003 | 200 mg Mirikizumab (Test): Abdomen | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the abdomen on day 1. |
| FG004 | 200 mg Mirikizumab (Test): Arm | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm on day 1. |
| FG005 | 200 mg Mirikizumab (Test): Thigh | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the thigh on day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 200 mg Mirikizumab (Reference) | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1. |
| BG001 | 200 mg Mirikizumab (Test) |
| 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 was evaluated. | All participants who received at least one dose of study drug (mirikizumab) and had evaluable PK data. Participants were excluded from the PK analysis set in the event of 1) a device malfunction, 2) administration of only 1 of the 2 x 1-mL autoinjector doses, or 3) administration of an incorrect or incomplete dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | 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 |
|
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 | 200 mg Mirikizumab (Reference): Abdomen | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into 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 25.0 | 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 | Jun 10, 2022 | Jan 18, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 22, 2022 | Jan 18, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Daytona Beach |
| Florida |
| 32117 |
| United States |
| Axis | Dilworth | Minnesota | 56529 | United States |
| QPS | Springfield | Missouri | 65802 | United States |
| Labcorp Clinical Research LP | Dallas | Texas | 75247 | United States |
| LabCorp CRU, Inc. | Madison | Wisconsin | 53704 | United States |
| Lost to Follow-up |
|
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.
| 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 |
|
| OG001 | 200 mg Mirikizumab (Test) | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1. |
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab | PK: AUC[0-∞] of Mirikizumab was evaluated. | All participants who received at least one dose of study drug (mirikizumab) and had evaluable PK data. Participants were excluded from the PK analysis set in the event of 1) a device malfunction, 2) administration of only 1 of the 2 x 1-mL autoinjector doses, or 3) administration of an incorrect or incomplete dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day per milliliter (μg*day/mL) | 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 |
|
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab | PK: AUC[0-tlast] of Mirikizumab was evaluated. | All participants who received at least one dose of study drug (mirikizumab) and had evaluable PK data. Participants were excluded from the PK analysis set in the event of 1) a device malfunction, 2) administration of only 1 of the 2 x 1-mL autoinjector doses, or 3) administration of an incorrect or incomplete dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*day/mL | 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 |
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|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 11 |
| 63 |
| EG001 | 200 mg Mirikizumab (Reference): Arm | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm on day 1. | 0 | 69 | 0 | 69 | 12 | 69 |
| EG002 | 200 mg Mirikizumab (Reference): Thigh | Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the thigh on day 1. | 0 | 67 | 0 | 67 | 13 | 67 |
| EG003 | 200 mg Mirikizumab (Test): Abdomen | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the abdomen on day 1. | 0 | 66 | 0 | 66 | 7 | 66 |
| EG004 | 200 mg Mirikizumab (Test): Arm | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm on day 1. | 0 | 66 | 0 | 66 | 11 | 66 |
| EG005 | 200 mg Mirikizumab (Test): Thigh | Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the thigh on day 1. | 0 | 65 | 0 | 65 | 12 | 65 |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
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