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| ID | Type | Description | Link |
|---|---|---|---|
| J2T-MC-KGBG | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to look at the amount of the study drug, lebrikizumab, that gets into the blood stream and how long it takes the body to get rid of lebrikizumab (LY3650150) when given using either a pre-filled autoinjector (AI) or a pre-filled syringe with needle safety device (PFS-NSD). The safety and tolerability of lebrikizumab will also be evaluated. The study will last up to 102 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lebrikizumab (Reference) - Pre-Filled Syringe with Needle Safety Device | Experimental | 2-milliliter (mL) (125 milligrams per milliliter [mg/mL]) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD). |
|
| Lebrikizumab (Test) - Autoinjector | Experimental | 2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab | PK: Cmax of Lebrikizumab | Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99 |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab | PK: AUC[0-∞] of Lebrikizumab | Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99 |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab | PK: AUC[0-tlast] of Lebrikizumab | Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99 |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) | 2-milliliters (mL) (125 milligrams per milliliter [mg/mL]) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD). |
| FG001 | Lebrikizumab (Test) - Autoinjector (AI) | 2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) | 2-mL (125 mg/mL) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD). |
| BG001 | Lebrikizumab (Test) - Autoinjector (AI) |
| 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 Lebrikizumab | PK: Cmax of Lebrikizumab | All participants who received a full dose of Lebrikizumab and had evaluable PK sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99 |
|
Up to 99 days
All randomized participants who received at least one dose of study drug. 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 | Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) | 2-mL (125 mg/mL) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-595-5979 | 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 17, 2021 | May 9, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2022 | May 16, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
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| Springfield |
| Missouri |
| 65802 |
| United States |
| Covance Dallas | Dallas | Texas | 75247 | United States |
| LabCorp CRU, Inc. | Madison | Wisconsin | 53704 | United States |
| Unable to comply with study schedule |
|
| Screen Failure - Randomized but Did Not Receive Study Drug |
|
2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI). |
| BG002 | 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 |
|
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab | PK: AUC[0-∞] of Lebrikizumab | All participants who received a full dose of Lebrikizumab and had evaluable PK sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*day per milliliter (µg*d/mL) | Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99 |
|
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab | PK: AUC[0-tlast] of Lebrikizumab | All participants who received a full dose of Lebrikizumab and had evaluable PK sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg*d/mL | Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99 |
|
|
|
|
| 0 |
| 122 |
| 0 |
| 122 |
| 39 |
| 122 |
| EG001 | Lebrikizumab (Test) - Autoinjector (AI) | 2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI). | 0 | 119 | 0 | 119 | 26 | 119 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Change of bowel habit | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Faeces discoloured | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Oral disorder | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Retching | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site pruritus | 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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| Injection site warmth | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Oedema peripheral | 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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| Ulcer | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Vessel puncture site reaction | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Allergy to arthropod sting | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Tinea versicolour | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Vulvovaginitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Sars-cov-2 test positive | Investigations | MedDRA 24.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | 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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| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Menstruation irregular | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Hiccups | 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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| Rhinitis allergic | 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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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Ingrown hair | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
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