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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMBX | 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 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 - Prefilled Syringe | Experimental | Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via a prefilled syringe (PFS) to abdomen or arms or thighs. |
|
| Mirikizumab - Autoinjector | Experimental | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered an autoinjector (AI) to abdomen or arms or thighs. |
|
| 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 Administered by PFS and AI | PK: Cmax of Mirikizumab administered by PFS and AI. | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI | PK: AUC[0-∞] of Mirikizumab administered by PFS and AI. | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 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 Administered by PFS and AI | PK: AUC[0-tlast] of Mirikizumab administered by PFS and AI. | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 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 |
|---|---|---|---|---|---|---|
| LabCorp CRU, 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 | 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. |
| FG001 | Mirikizumab PFS - Arm | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms. |
| FG002 | Mirikizumab PFS - Thigh | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs. |
| FG003 | 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. |
| FG004 | Mirikizumab AI - Arm | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to arms. |
| FG005 | Mirikizumab AI - Thigh | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to thighs. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of mirikizumab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirikizumab PFS - Abdomen | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS in the abdomen. |
| BG001 | Mirikizumab PFS - Arm | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms. |
| 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 Administered by PFS and AI | PK: Cmax of Mirikizumab administered by PFS and AI. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose |
|
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.
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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 PFS - Abdomen | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS in the abdomen. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | 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 11, 2021 | Jun 16, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 28, 2021 | Jun 16, 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 |
| Lost to Follow-up |
|
| BG002 | Mirikizumab PFS - Thigh | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs. |
| BG003 | Mirikizumab AI - Abdomen | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to the abdomen. |
| BG004 | Mirikizumab AI - Arm | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to arms. |
| BG005 | Mirikizumab AI - Thigh | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to thighs. |
| 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 |
|
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to abdomen or arms or thighs. |
|
|
| Primary | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI | PK: AUC[0-∞] of Mirikizumab administered by PFS and AI. | 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. | 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, 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 Administered by PFS and AI | PK: AUC[0-tlast] of Mirikizumab administered by PFS and AI. | 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. | 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, 2040 hours post day 1 dose |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 8 |
| 39 |
| EG001 | Mirikizumab PFS - Arm | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to arms. | 0 | 39 | 0 | 39 | 13 | 39 |
| EG002 | Mirikizumab PFS - Thigh | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via PFS to thighs. | 0 | 39 | 0 | 39 | 8 | 39 |
| EG003 | Mirikizumab AI - Abdomen | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to the abdomen. | 0 | 40 | 1 | 40 | 13 | 40 |
| EG004 | Mirikizumab AI - Arm | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to arms. | 0 | 40 | 0 | 40 | 9 | 40 |
| EG005 | Mirikizumab AI - Thigh | Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered via AI to thighs. | 0 | 40 | 0 | 40 | 9 | 40 |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
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