A Phase 1 interventional study of Mirikizumab- IV and Mirikizumab - SC in Psoriasis, sponsored by Eli Lilly and Company. Completed at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
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.
1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.
This study's enrollment of 45 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →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.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Psoriasis participants):
Inclusion Criteria (Healthy participants):
Exclusion Criteria (Psoriasis and healthy participants):
Participants with psoriasis will receive a single dose of placebo matching mirikizumab intravenously (IV)
Biological: Placebo - IV
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
Biological: Mirikizumab- IV
Healthy participants will receive a single dose of 120 mg mirikizumab subcutaneously (SC).
Biological: Mirikizumab - SC
Administered IV
Also known as: LY3074828
Administered SC
Also known as: LY3074828
Administered IV
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.
Time frame: Baseline through Week 12
Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828
Time frame: 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
Time frame: 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
| Milestone | Placebo | 5 mg LY3074828 | 20 mg LY3074828 | 60 mg LY3074828 | 120 mg LY3074828 | 120 mg LY3074828 SC | 200 mg LY3074828 | 350 mg LY3074828 | 600 mg LY3074828 |
|---|---|---|---|---|---|---|---|---|---|
| Started | 7 | 3 | 5 | 5 | 5 | 5 | 5 | 5 | 5 |
| Completed | 7 | 3 | 4 | 5 | 5 | 5 | 5 | 5 | 4 |
| Not completed | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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.
| Participants | Placebo | 5 mg LY3074828 | 20 mg LY3074828 | 60 mg LY3074828 | 120 mg LY3074828 | 120 mg LY3074828 SC | 200 mg LY3074828 | 350 mg LY3074828 | 600 mg LY3074828 |
|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration | 1 | 1 | 2 | 0 | 0 | 3 | 1 | 0 | 0 |
| μg•day/mL (microgram•day/milliliters) | 5 mg LY3074828 | 20 mg LY3074828 | 60 mg LY3074828 | 120 mg LY3074828 | 120 mg LY3074828 SC | 200 mg LY3074828 | 350 mg LY3074828 | 600 mg LY3074828 |
|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828 | NA ± NA | 33.6 ± 17 | 117 ± 15 | 287 ± 29 | 114 ± 49 | 366 ± 12 | 556 ± 25 | 1360 ± 23 |
| μg/mL (microgram/milliliter) | 5 mg LY3074828 | 20 mg LY3074828 | 60 mg LY3074828 | 120 mg LY3074828 | 120 mg LY3074828 SC | 200 mg LY3074828 | 350 mg LY3074828 | 600 mg LY3074828 |
|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | 1.60 ± 22 | 5.34 ± 6 | 20.6 ± 29 | 41.1 ± 15 | 7.28 ± 23 | 68.8 ± 19 | 91.8 ± 6 | 220 ± 24 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/7 (0%) | 6/7 (85.7%) |
| 5 mg LY3074828 | — | 0/3 (0%) | 3/3 (100%) |
| 20 mg LY3074828 | — | 0/5 (0%) | 5/5 (100%) |
| 60 mg LY3074828 | — | 0/5 (0%) | 5/5 (100%) |
| 120 mg LY3074828 | — | 0/5 (0%) | 2/5 (40%) |
| 120 mg LY3074828 SC | — | 0/5 (0%) | 4/5 (80%) |
| 200 mg LY3074828 | — | 0/5 (0%) | 4/5 (80%) |
| 350 mg LY3074828 | — | 0/5 (0%) | 4/5 (80%) |
| 600 mg LY3074828 | — | 0/5 (0%) | 4/5 (80%) |
| Event | Placebo | 5 mg LY3074828 | 20 mg LY3074828 | 60 mg LY3074828 | 120 mg LY3074828 | 120 mg LY3074828 SC | 200 mg LY3074828 | 350 mg LY3074828 | 600 mg LY3074828 |
|---|---|---|---|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 3/7 | 0/3 | 4/5 | 4/5 | 0/5 | 1/5 | 1/5 | 1/5 | 1/5 |
| DiarrhoeaGastrointestinal disorders | 0/7 | 2/3 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
| Injection site painGeneral disorders | 0/7 | 0/3 | 0/5 | 0/5 | 0/5 | 3/5 | 0/5 | 0/5 | 0/5 |
| HeadacheNervous system disorders | 2/7 | 0/3 | 1/5 | 0/5 | 1/5 | 1/5 | 3/5 | 0/5 | 3/5 |
| DysmenorrhoeaReproductive system and breast disorders | 0/7 | 0/3 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 1/2 |
| Abdominal painGastrointestinal disorders | 0/7 | 0/3 | 0/5 | 0/5 | 0/5 | 2/5 | 0/5 | 0/5 | 0/5 |
| NauseaGastrointestinal disorders | 0/7 | 0/3 | 2/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
| LacerationInjury, poisoning and procedural complications | 0/7 | 0/3 | 0/5 | 0/5 | 0/5 | 0/5 | 1/5 | 0/5 | 2/5 |
| Muscle strainInjury, poisoning and procedural complications | 0/7 | 0/3 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 2/5 | 0/5 |
| Conjunctival haemorrhageEye disorders | 0/7 | 1/3 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
Safety Population: all randomized participants who received any amount of study drug.
| Age, Continuous(Years) | Placebo | 5 mg LY3074828 | 20 mg LY3074828 | 60 mg LY3074828 | 120 mg LY3074828 | 120 mg LY3074828 SC | 200 mg LY3074828 | 350 mg LY3074828 | 600 mg LY3074828 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 44.7 ± 13.39 | 51.0 ± 13.08 | 43.4 ± 13.32 | 44.0 ± 9.14 | 43.8 ± 13.33 | 37.2 ± 13.33 | 53.2 ± 14.55 | 37.4 ± 11.37 | 42.2 ± 10.57 | 43.8 ± 12.37 |
| Sex: Female, Male(Participants) | Placebo | 5 mg LY3074828 | 20 mg LY3074828 | 60 mg LY3074828 | 120 mg LY3074828 | 120 mg LY3074828 SC | 200 mg LY3074828 | 350 mg LY3074828 | 600 mg LY3074828 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 2 | 4 | 0 | 2 | 5 | 2 | 1 | 2 | 18 |
| Male | 7 | 1 | 1 | 5 | 3 | 0 | 3 | 4 | 3 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | 5 mg LY3074828 | 20 mg LY3074828 | 60 mg LY3074828 | 120 mg LY3074828 | 120 mg LY3074828 SC | 200 mg LY3074828 | 350 mg LY3074828 | 600 mg LY3074828 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Not Hispanic or Latino | 7 | 3 | 5 | 5 | 5 | 4 | 5 | 5 | 5 | 44 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | 5 mg LY3074828 | 20 mg LY3074828 | 60 mg LY3074828 | 120 mg LY3074828 | 120 mg LY3074828 SC | 200 mg LY3074828 | 350 mg LY3074828 | 600 mg LY3074828 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 7 | 3 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 45 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo | 5 mg LY3074828 | 20 mg LY3074828 | 60 mg LY3074828 | 120 mg LY3074828 | 120 mg LY3074828 SC | 200 mg LY3074828 | 350 mg LY3074828 | 600 mg LY3074828 | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 7 | 3 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 45 |
The record gives a start of Oct 2013, a primary completion of Feb 2015 and a completion of Feb 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2024, 9 years 5 months after primary completion.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mirikizumab