A Phase 1 interventional study of Ixekizumab in Healthy, sponsored by Eli Lilly and Company. Terminated at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-30.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
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.
Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
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Exclusion Criteria:
Reference formulation 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection in a prefilled syringe in one of three study periods.
Biological: Ixekizumab
Test 1 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.
Biological: Ixekizumab
Test 2 formulation 80 mg ixekizumab administered as an SC injection in a prefilled syringe in one of three study periods.
Biological: Ixekizumab
Administered SC
Also known as: LY2439821
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).
Time frame: Day 1, 8, and 15: Immediately (within 1 minute) after injection
| Milestone | Sequence 1: ABC | Sequence 2: BCA | Sequence 3: CAB |
|---|---|---|---|
| Started | 24 | 24 | 22 |
| Received intervention | 24 | 24 | 22 |
| Completed | 24 | 24 | 22 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence 1: ABC | Sequence 2: BCA | Sequence 3: CAB |
|---|---|---|---|
| Started | 24 | 24 | 22 |
| Received at least one dose of study drug | 24 | 24 | 22 |
| Completed | 15 | 15 | 15 |
| Not completed | 9 | 9 | 7 |
| Withdrew: Adverse event | 1 | 2 | 2 |
| Withdrew: Physician decision | 0 | 1 | 0 |
| Withdrew: Sponsor decision | 8 | 6 | 5 |
| Milestone | Sequence 1: ABC | Sequence 2: BCA | Sequence 3: CAB |
|---|---|---|---|
| Started | 15 | 15 | 15 |
| Completed | 15 | 15 | 15 |
| Not completed | 0 | 0 | 0 |
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).
| millimeter (mm) | Ixekizumab (Reference) | Ixekizumab (Test 1) | Ixekizumab (Test 2) |
|---|---|---|---|
| Injection Pain Visual Analog Scale (VAS) Score | 25.3 ± 24.7 | 3.3 ± 7.0 | 4.1 ± 8.2 |
Collected over Up to 85 Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ixekizumab (Reference) | 0/61 (0%) | 0/61 (0%) | 3/61 (4.9%) |
| Ixekizumab (Test 1) | 0/63 (0%) | 0/63 (0%) | 5/63 (7.9%) |
| Ixekizumab (Test 2) | 0/61 (0%) | 0/61 (0%) | 6/61 (9.8%) |
| Event | Ixekizumab (Reference) | Ixekizumab (Test 1) | Ixekizumab (Test 2) |
|---|---|---|---|
| Injection site reactionGeneral disorders | 3/61 | 5/63 | 6/61 |
All randomized participants who received at least one dose of intervention.
| Age, Continuous(Years) | All Study Participants |
|---|---|
| Mean | 44.5 ± 13.5 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 37 |
| Male | 33 |
| Ethnicity (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| Hispanic or Latino | 11 |
| Not Hispanic or Latino | 59 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 6 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 20 |
| White | 41 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Study Participants |
|---|---|
| United States | 70 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jan 2019 to primary completion in Jul 2019, 5 months.
Results were first posted in Jul 2020, 1 year after primary completion.
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This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ixekizumab