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| ID | Type | Description | Link |
|---|---|---|---|
| I1F-MC-RHCT | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to compare three different formulations of ixekizumab. One formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two formulations (Test 1 and Test 2) have not been approved. This study will compare how much of each of the three formulations get into the blood stream. Information about any side effects that may occur will also be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixekizumab (Reference) | Experimental | Reference formulation ixekizumab 80 milligram (mg) administered as a subcutaneous (SC) injection in a prefilled syringe. |
|
| Ixekizumab (Test 1) | Experimental | Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe. |
|
| Ixekizumab (Test 2) | Experimental | Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixekizumab | Biological | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab | Pharmacokinetics (PK): Maximum Concentration (Cmax) of a single dose of Ixekizumab | Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose |
| PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab | Area under the plasma concentration versus time curve from time zero to the last measured concentration value (AUC[0-tlast]). AUC 0-tlast is equal to AUC (0-85) days where the last time point was 85 Days ± 3 Days. | Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab. | Area under the plasma concentration versus time curve from zero to infinity (AUC[0-∞]) of a single dose of Ixekizumab. | Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post 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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States |
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Participants were randomized to 1 of 3 treatments, Reference, Test Formulation 1 or Test Formulation 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixekizumab (Reference) | Reference formulation ixekizumab 80 milligram (mg) administered as a subcutaneous (SC) injection in a prefilled syringe. |
| FG001 | Ixekizumab (Test 1) | Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe. |
| FG002 | Ixekizumab (Test 2) | Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe. |
| 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 | Ixekizumab (Reference) | Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe. |
| BG001 | Ixekizumab (Test 1) | Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe. |
| 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 Ixekizumab | Pharmacokinetics (PK): Maximum Concentration (Cmax) of a single dose of Ixekizumab | 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/milliliter (ug/mL) | Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose |
|
Up to 12 Weeks
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 | Ixekizumab (Reference) | Reference formulation ixekizumab 80 mg administered as a subcutaneous (SC) injection in a prefilled syringe. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Periorbital abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 21.1 | 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 | May 9, 2019 | Mar 12, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2018 | Mar 12, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C549079 | ixekizumab |
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| BG002 | Ixekizumab (Test 2) | Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe. |
| BG003 | 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 |
|
| OG002 | Ixekizumab (Test 2) | Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe. |
|
|
| Primary | PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Ixekizumab | Area under the plasma concentration versus time curve from time zero to the last measured concentration value (AUC[0-tlast]). AUC 0-tlast is equal to AUC (0-85) days where the last time point was 85 Days ± 3 Days. | 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/milliliter (ug*day/mL) | Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose |
|
|
|
| Primary | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Ixekizumab. | Area under the plasma concentration versus time curve from zero to infinity (AUC[0-∞]) of a single dose of Ixekizumab. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*day/mL | Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 4 |
| 33 |
| EG001 | Ixekizumab (Test 1) | Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe. | 0 | 33 | 0 | 33 | 2 | 33 |
| EG002 | Ixekizumab (Test 2) | Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe. | 1 | 33 | 1 | 33 | 5 | 33 |
| Phaeohyphomycotic brain abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Cerebral venous thrombosis | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
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