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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMBD | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety of the study drug known as mirikizumab. The study will investigate how the body processes the study drug. It will last up to about 4 months for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirikizumab - Intravenous (IV) | Experimental | Participants received a single dose of 300 milligram (mg), 600 mg and 1200 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes, 60 minutes and 2 hours. |
|
| Placebo - IV | Placebo Comparator | Participants received a single dose of placebo administered IV using a forearm vein. |
|
| Mirikizumab - Subcutaneous (SC) | Experimental | Participants received a single dose of 200 mg, 400 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
|
| Placebo - SC | Placebo Comparator | Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
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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 Drug-Related Treatment-Emergent Adverse Events (TEAEs) | Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of serious adverse events (SAEs) and other non-serious adverse events (NSAEs), regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section. | Baseline through Day 85 |
| Visual Analog Scale (VAS) Pain Score for Subcutaneous Injection Site | The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (>30 and ≤70), and severe pain (>70). Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain). | 0 min, 0.25 hours (h), 0.5 h, 1 h, 2 h and 4 h post first injection |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab | PK: Cmax of Mirikizumab was evaluated. | Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), 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 |
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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 |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Xuhui District | Shanghai Municipality | 20031 | China | ||
| Peking University First Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Intravenous (IV) | Participants received a single dose of placebo administered IV using a forearm vein. |
| FG001 | 300 Milligram (mg) Mirikizumab IV | Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes. |
| FG002 | 600 mg Mirikizumab IV | Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes. |
| FG003 | 1200 mg Mirikizumab IV | Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours. |
| FG004 | Placebo Subcutaneous (SC) | Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
| FG005 | 200 mg Mirikizumab SC | Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
| FG006 | 400 mg Mirikizumab SC | Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo IV | Participants received a single dose of placebo administered IV using a forearm vein. |
| BG001 | 300 mg Mirikizumab IV | Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes. |
| 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 Drug-Related Treatment-Emergent Adverse Events (TEAEs) | Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of serious adverse events (SAEs) and other non-serious adverse events (NSAEs), regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section. | All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment. | Posted | Number | participants | Baseline through Day 85 |
|
Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
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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 IV | Participants received a single dose of placebo administered IV using a forearm vein. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | 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 28, 2020 | Nov 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2018 | Nov 10, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Mirikizumab - SC | Drug | Administered SC |
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| Placebo - IV | Drug | Administered IV |
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| Placebo - SC | Drug | Administered SC |
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PK: AUC(0-∞) of Mirikizumab was evaluated. |
| Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose |
| PK: AUC From Time Zero to Time T, Where T is the Last Sample With a Measurable Concentration (AUC[0-tlast]) of Mirikizumab | PK: AUC(0-tlast) of Mirikizumab was evaluated. | Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose |
| Beijing |
| 100034 |
| China |
| BG002 | 600 mg Mirikizumab IV | Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes. |
| BG003 | 1200 mg Mirikizumab IV | Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours. |
| BG004 | Placebo SC | Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
| BG005 | 200 mg Mirikizumab SC | Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
| BG006 | 400 mg Mirikizumab SC | Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
| BG007 | 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 |
| 300 mg Mirikizumab IV |
Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes. |
| OG002 | 600 mg Mirikizumab IV | Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes. |
| OG003 | 1200 mg Mirikizumab IV | Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours. |
| OG004 | Placebo SC | Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
| OG005 | 200 mg Mirikizumab SC | Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
| OG006 | 400 mg Mirikizumab SC | Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). |
|
|
| Primary | Visual Analog Scale (VAS) Pain Score for Subcutaneous Injection Site | The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (>30 and ≤70), and severe pain (>70). Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain). | All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment. As per statistical analysis plan, VAS pain score was analyzed only for SC dose. | Posted | Mean | Standard Deviation | millimeter (mm) | 0 min, 0.25 hours (h), 0.5 h, 1 h, 2 h and 4 h post first injection |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab | PK: Cmax of Mirikizumab was evaluated. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (μg/mL) | Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose |
|
|
|
| Secondary | 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 randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day per milliliter (μg*day/mL) | Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose |
|
|
|
| Secondary | PK: AUC From Time Zero to Time T, Where T is the Last Sample With a Measurable Concentration (AUC[0-tlast]) of Mirikizumab | PK: AUC(0-tlast) of Mirikizumab was evaluated. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*day/mL | Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | 300 mg Mirikizumab IV | Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes. | 0 | 10 | 0 | 10 | 7 | 10 |
| EG002 | 600 mg Mirikizumab IV | Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes. | 0 | 10 | 0 | 10 | 9 | 10 |
| EG003 | 1200 mg Mirikizumab IV | Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours. | 0 | 10 | 0 | 10 | 3 | 10 |
| EG004 | Placebo SC | Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). | 0 | 4 | 0 | 4 | 3 | 4 |
| EG005 | 200 mg Mirikizumab SC | Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). | 0 | 10 | 0 | 10 | 4 | 10 |
| EG006 | 400 mg Mirikizumab SC | Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). | 0 | 10 | 0 | 10 | 5 | 10 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Animal scratch | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| White blood cell count abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Menstruation delayed | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Rhinitis hypertrophic | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
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