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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMAA | 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 and how the drug affects the body. The study will last about 3 months for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo IV | Placebo Comparator | Participants with psoriasis will receive a single dose of placebo matching mirikizumab intravenously (IV) |
|
| Mirikizumab IV | Experimental | Participants with psoriasis will receive a single escalating dose of 5 milligram (mg), 20 mg, 60 mg, 120 mg, 200 mg, 350 mg, or 600 mg mirikizumab, IV |
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| Mirikizumab SC | Experimental | Healthy participants will receive a single dose of 120 mg mirikizumab subcutaneously (SC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab- IV | Biological | Administered IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration | This outcome has the list of adverse events which are related to the study drug. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module. | Baseline through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828 | IV Arms: Day 1 Predose, Postdose (End of Infusion, 2, 6 and 24h), Days 4, 8, 15, 22, 29, 43, 57, 71, and 85. SC Arm: Day 1 Predose, Postdose (6 and 24h), Days 4, 8, 11, 15, 22, 29, 43, 57, 71, and 85 | |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 |
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Inclusion Criteria (Psoriasis participants):
Inclusion Criteria (Healthy participants):
Exclusion Criteria (Psoriasis and healthy participants):
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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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Waterloo | Ontario | N2J 1C4 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo, single dose, administered intravenously (IV) |
| FG001 | 5 mg LY3074828 | 5 milligram (mg) LY3074828, single dose, administered IV |
| FG002 | 20 mg LY3074828 | 20 mg LY3074828, single dose, administered IV |
| FG003 | 60 mg LY3074828 | 60 mg LY3074828, single dose, administered IV |
| FG004 | 120 mg LY3074828 | 120 mg LY3074828, single dose, administered IV |
| FG005 | 120 mg LY3074828 SC | 120 mg LY3074828, single dose, administered subcutaneously (SC) |
| FG006 | 200 mg LY3074828 | 200 mg LY3074828, single dose, administered IV |
| FG007 | 350 mg LY3074828 | 350 mg LY3074828, single dose, administered IV |
| FG008 | 600 mg LY3074828 | 600 mg LY3074828, single dose, administered IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Safety Population: all randomized participants who received any amount of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered intravenously (IV) |
| BG001 | 5 mg LY3074828 | 5 mg LY3074828 administered IV |
| Units | Counts |
|---|---|
| Participants |
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| 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 Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration | This outcome has the list of adverse events which are related to the study drug. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module. | Safety Population: all randomized participants who received any amount of study drug. | Posted | Number | Participants | Baseline through Week 12 |
|
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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 | Placebo, single dose, administered intravenously (IV) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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| Mirikizumab - SC | Biological | Administered SC |
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| Placebo - IV | Biological | Administered IV |
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| IV Arms: Day 1 Predose, Postdose (End of Infusion, 2, 6 and 24h), Days 4, 8, 15, 22, 29, 43, 57, 71, and 85. SC Arm: Day 1 Predose, Postdose (6 and 24h), Days 4, 8, 11, 15, 22, 29, 43, 57, 71, and 85 |
| Canada |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Montreal | Quebec | H2K4L5 | Canada |
| Lost to Follow-up |
|
| BG002 |
| 20 mg LY3074828 |
20 mg LY3074828 administered IV |
| BG003 | 60 mg LY3074828 | 60 mg LY3074828 administered IV |
| BG004 | 120 mg LY3074828 | 120 mg LY3074828 administered IV |
| BG005 | 120 mg LY3074828 SC | 120 mg LY3074828 administered subcutaneously (SC) |
| BG006 | 200 mg LY3074828 | 200 mg LY3074828 administered IV |
| BG007 | 350 mg LY3074828 | 350 mg LY3074828 administered IV |
| BG008 | 600 mg LY3074828 | 600 mg LY3074828 administered IV |
| BG009 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
|
| OG002 | 20 mg LY3074828 | 20 mg LY3074828, single dose, administered IV |
| OG003 | 60 mg LY3074828 | 60 mg LY3074828, single dose, administered IV |
| OG004 | 120 mg LY3074828 | 120 mg LY3074828, single dose, administered IV |
| OG005 | 120 mg LY3074828 SC | 120 mg LY3074828, single dose, administered subcutaneously (SC) |
| OG006 | 200 mg LY3074828 | 200 mg LY3074828, single dose, administered IV |
| OG007 | 350 mg LY3074828 | 350 mg LY3074828, single dose, administered IV |
| OG008 | 600 mg LY3074828 | 600 mg LY3074828, single dose, administered IV |
|
|
| Secondary | Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828 | All randomized participants who received any amount of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg•day/mL (microgram•day/milliliters) | IV Arms: Day 1 Predose, Postdose (End of Infusion, 2, 6 and 24h), Days 4, 8, 15, 22, 29, 43, 57, 71, and 85. SC Arm: Day 1 Predose, Postdose (6 and 24h), Days 4, 8, 11, 15, 22, 29, 43, 57, 71, and 85 |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | All randomized participants who received any amount of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL (microgram/milliliter) | IV Arms: Day 1 Predose, Postdose (End of Infusion, 2, 6 and 24h), Days 4, 8, 15, 22, 29, 43, 57, 71, and 85. SC Arm: Day 1 Predose, Postdose (6 and 24h), Days 4, 8, 11, 15, 22, 29, 43, 57, 71, and 85 |
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|
|
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | 5 mg LY3074828 | 5 mg LY3074828, single dose, administered IV | 0 | 3 | 3 | 3 |
| EG002 | 20 mg LY3074828 | 20 mg LY3074828, single dose, administered IV | 0 | 5 | 5 | 5 |
| EG003 | 60 mg LY3074828 | 60 mg LY3074828, single dose, administered IV | 0 | 5 | 5 | 5 |
| EG004 | 120 mg LY3074828 | 120 mg LY3074828, single dose, administered IV | 0 | 5 | 2 | 5 |
| EG005 | 120 mg LY3074828 SC | 120 mg LY3074828, single dose, administered subcutaneously (SC) | 0 | 5 | 4 | 5 |
| EG006 | 200 mg LY3074828 | 200 mg LY3074828, single dose, administered IV | 0 | 5 | 4 | 5 |
| EG007 | 350 mg LY3074828 | 350 mg LY3074828, single dose, administered IV | 0 | 5 | 4 | 5 |
| EG008 | 600 mg LY3074828 | 600 mg LY3074828, single dose, administered IV | 0 | 5 | 4 | 5 |
| Conjunctival haemorrhage | Eye disorders | MedDRA 17 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 17 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 17 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 17 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 17 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 17 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 17 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 17 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 17 | Systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA 17 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 17 | Systematic Assessment |
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| Tinea pedis | Infections and infestations | MedDRA 17 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 17 | Systematic Assessment |
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| Electric shock | Injury, poisoning and procedural complications | MedDRA 17 | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA 17 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 17 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 17 | Systematic Assessment |
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| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 17 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17 | Systematic Assessment |
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| Dizziness exertional | Nervous system disorders | MedDRA 17 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 17 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 17 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17 | Systematic Assessment |
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| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 17 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 17 | Systematic Assessment |
|
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