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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-JE-AMAD | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to explore the safety and tolerability of mirikizumab in healthy Japanese and Caucasian participants. The study will also estimate how much mirikizumab gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 16 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirikizumab IV | Experimental | Participants received 200mg Mirikizumab by intravenously. |
|
| Mirikizumab SC | Experimental | Participants received single dose of either 60mgor 200mg 0r 600mg or 1200mg or 2400mg Mirikizumab by subcutaneously. |
|
| Placebo IV | Placebo Comparator | Participants received placebo by intravenously. |
|
| Placebo SC | Placebo Comparator | Participants received placebo by subcutaneously. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab - IV | Drug | Administered IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | SAE is any adverse event (AE) from this study that results in one of the following outcomes:
| Baseline through Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab. | Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration |
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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 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global | Cypress | California | 90630 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Subcutaneous (SC) | Participants received placebo subcutaneously (SC). |
| FG001 | Placebo IV | Participants received placebo by IV. |
| FG002 | 60mg Mirikizumab IV | Participants received 60mg Mirikizumab by IV. |
| FG003 | 200mg Mirikizumab SC | Participants received 200mg Mirikizumab by SC. |
| FG004 | 200mg Mirikizumab IV | Participants received 200mg Mirikizumab by IV. |
| FG005 | 600mg Mirikizumab IV | Participants received 600mg Mirikizumab by IV. |
| FG006 | 1200mg Mirikizumab IV | Participants received 1200mg Mirikizumab by IV. |
| FG007 | 2400mg Mirikizumab IV | Participants received 2400mg Mirikizumab by IV. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo SC | Participants received placebo by SC. |
| BG001 | Placebo IV | Participants received placebo by IV. |
| 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 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | SAE is any adverse event (AE) from this study that results in one of the following outcomes:
| All randomized participants. | Posted | Count of Participants | Participants | No | Baseline through Day 85 |
|
Up to 88 days
All randomized 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 | Placebo SC | Participants received placebo by SC. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus arrhythmia | Cardiac disorders | MedDRA 18.0 | 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 | Jan 23, 2018 | May 17, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2018 | May 17, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Mirikizumab - SC | Drug | Administered SC |
|
|
| Placebo - IV | Drug | Administered IV |
|
| Placebo - SC | Drug | Administered SC |
|
| Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab | Pharmacokinetics: Area Under the Concentration (AUC) Curve from Time Zero to Infinity of Mirikizumab. | Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration |
| Physician Decision |
|
| BG002 |
| 60mg Mirikizumab IV |
Participants received 60mg Mirikizumab by IV. |
| BG003 | 200mg Mirikizumab SC | Participants received 200mg Mirikizumab by SC. |
| BG004 | 200mg Mirikizumab IV | Participants received 200mg Mirikizumab by IV. |
| BG005 | 600mg Mirikizumab IV | Participants received 600mg Mirikizumab by IV. |
| BG006 | 1200mg Mirikizumab IV | Participants received 1200mg Mirikizumab by IV. |
| BG007 | 2400mg Mirikizumab IV | Participants received 2400mg Mirikizumab by IV. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received placebo by IV. |
| OG002 | 60mg Mirikizumab IV | Participants received 60mg Mirikizumab by IV. |
| OG003 | 200mg Mirikizumab IV | Participants received 200mg Mirikizumab b IV. |
| OG004 | 200mg Mirikizumab SC | Participants received 200mg Mirikizumab by SC. |
| OG005 | 600mg Mirikizumab IV | Participants received 600mg Mirikizumab by IV. |
| OG006 | 1200mg Mirikizumab IV | Participants received 1200mg Mirikizumab by IV. |
| OG007 | 2400mg Mirikizumab IV | Participants received 2400mg Mirikizumab by IV. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab. | All randomized participants who received at least one dose of Mirikizumab and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per Milliliter (μg/mL) | Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab | Pharmacokinetics: Area Under the Concentration (AUC) Curve from Time Zero to Infinity of Mirikizumab. | All randomized participants who received at least one dose of Mirikizumab and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram day per milliliter (μg*day/mL) | Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration |
|
|
|
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Placebo IV | Participants received placebo by IV. | 0 | 10 | 0 | 10 | 5 | 10 |
| EG002 | 60mg Mirikizumab IV | Participants received 60mg Mirikizumab by IV. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | 200mg Mirikizumab SC | Participants received 200mg Mirikizumab by SC. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | 200mg Mirikizumab IV | Participants received 200mg Mirikizumab by IV. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | 600mg Mirikizumab IV | Participants received 600mg Mirikizumab by IV. | 0 | 9 | 0 | 9 | 1 | 9 |
| EG006 | 1200mg Mirikizumab IV | Participants received 1200mg Mirikizumab by IV. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG007 | 2400mg Mirikizumab IV | Participants received 2400mg Mirikizumab by IV. | 0 | 6 | 0 | 6 | 1 | 6 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Infusion site extravasation | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
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