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| ID | Type | Description | Link |
|---|---|---|---|
| I1F-MC-RHCS | Other Identifier | Eli Lilly and Company |
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At the protocol-specified interim analysis, the sponsor decided to stop the trial.
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The purpose of this study is to compare the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. Information about any side effects (including injection site reactions [ISRs]) will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixekizumab (Reference) | Experimental | Reference formulation 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods. |
|
| Ixekizumab (Test 1) | Experimental | Test 1 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods. |
|
| Ixekizumab (Test 2) | Experimental | Test 2 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixekizumab | Biological | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Injection Pain Visual Analog Scale (VAS) Score | 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). | Day 1, 8, and 15: Immediately (within 1 minute) after injection |
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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 | Dallas | Texas | 75247-4989 | United States | ||
| Covance Clinical Research Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35449322 | Derived | Chabra S, Gill BJ, Gallo G, Zhu D, Pitou C, Payne CD, Accioly A, Puig L. Ixekizumab Citrate-Free Formulation: Results from Two Clinical Trials. Adv Ther. 2022 Jun;39(6):2862-2872. doi: 10.1007/s12325-022-02126-0. Epub 2022 Apr 21. |
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Participants were randomized to a treatment sequence in one of three periods. The study was stopped for some participants per sponsor decision and these participants did not move on to subsequent periods in the study at the protocol interim analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: ABC | A: Reference formulation 80 milligram (mg) of Ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in Period 1. B: Test 1 formulation 80 mg of Ixekizumab administered as an subcutaneous SC injection in a prefilled syringe in Period 2. C: Test 2 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 3. Sequence 1: ABC (Reference, Test 1, then Test 2) |
| FG001 | Sequence 2: BCA | B: Test 1 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 1. C: Test 2 formulation 80 mg of Ixekizumab administered as a SC injection in a prefilled syringe in Period 2. A: Reference formulation 80 mg of Ixekizumab administered as a SC injection in a prefilled syringe in Period 3. Sequence 2: BCA (Test 1, Test 2, Then Reference) |
| FG002 | Sequence 3: CAB | C: Test 2 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 1. A: Reference: formulation 80 mg of Ixekizumab administered as a SC injection in a prefilled syringe in Period 2. B: Test 1 formulation 80 mg of Ixekizumab administered as an SC injection in a prefilled syringe in Period 3. Sequence 3: CAB (Test 2, Reference, Then Test 1) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Day 1) |
| ||||||||||||||||
| Period 2 (Day 8) |
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| Period 3 (Day 15) |
|
All randomized participants who received at least one dose of intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All randomized participants who received at least one 80 milligram (mg) dose of ixekizumab administered as an SC injection in a prefilled syringe in one of three periods. |
| 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 | Injection Pain Visual Analog Scale (VAS) Score | 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 in a treatment sequence. | Posted | Mean | Standard Deviation | millimeter (mm) | Day 1, 8, and 15: Immediately (within 1 minute) after injection |
|
Up to 85 Days
All randomized participants who received at least one dose of intervention.
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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 80 mg ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 21.1 | Systematic Assessment |
At protocol-specified interim analysis, the sponsor decided to stop trial.
| 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 30, 2019 | Mar 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 8, 2019 | Mar 4, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C549079 | ixekizumab |
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| Madison |
| Wisconsin |
| 53704 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
| 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 | Ixekizumab (Test 1) | Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe in one of three study periods. |
| OG002 | Ixekizumab (Test 2) | Test 2 formulation ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods. |
|
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| 3 |
| 61 |
| EG001 | Ixekizumab (Test 1) | Test 1 formulation ixekizumab 80mg administered as an SC injection in a prefilled syringe in one of three study periods. | 0 | 63 | 0 | 63 | 5 | 63 |
| EG002 | Ixekizumab (Test 2) | Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe in one of three study periods. | 0 | 61 | 0 | 61 | 6 | 61 |
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