Psoriasis
Conditions
Brief summary
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.
Interventions
BIOLOGICALMirikizumab- IV
Administered IV
BIOLOGICALMirikizumab - SC
Administered SC
BIOLOGICALPlacebo - IV
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(Psoriasis participants): * Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline * Plaque psoriasis involving \>2% body surface area (BSA) in affected skin other than the face and scalp at screening and baseline * Are willing and able to washout topicals for at least 14 days before baseline on the 2 target lesions Inclusion Criteria (Healthy participants): * Are overtly healthy males or females, as determined by medical history and physical examination * Are women not of childbearing potential * Are between the ages of 18 and 65 years, inclusive, at the time of screening * Have a body mass index between 18.5 and 32.0 kilogram per square meter (kg/m2), inclusive, and a minimum body weight of 55 kg * Have clinical laboratory test results within normal reference range for the central laboratory, or results with acceptable deviations that are judged to be not clinically significant by the investigator * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures * Have given written informed consent approved by Lilly and the ERB governing the site
Exclusion criteria
(Psoriasis and healthy participants): * Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy). Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval * Within 28 days prior to baseline: have received systemic nonbiologic psoriasis therapy * Within 14 days prior to baseline: have received topical psoriasis treatment * Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of data * Have had clinically significant symptomatic herpes zoster within 3 months of screening * Show evidence of active or latent tuberculosis (TB) * Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study * Have significant allergies to humanized monoclonal antibodies or any components of the mirikizumab product formulation or have a history of significant atopy * Have had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years and cervical carcinoma in situ, with no evidence of recurrence within 5 years prior to baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration | Baseline through Week 12 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828 | 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 | 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 |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo administered intravenously (IV) | 7 |
| 5 mg LY3074828 5 mg LY3074828 administered IV | 3 |
| 20 mg LY3074828 20 mg LY3074828 administered IV | 5 |
| 60 mg LY3074828 60 mg LY3074828 administered IV | 5 |
| 120 mg LY3074828 120 mg LY3074828 administered IV | 5 |
| 120 mg LY3074828 SC 120 mg LY3074828 administered subcutaneously (SC) | 5 |
| 200 mg LY3074828 200 mg LY3074828 administered IV | 5 |
| 350 mg LY3074828 350 mg LY3074828 administered IV | 5 |
| 600 mg LY3074828 600 mg LY3074828 administered IV | 5 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | 600 mg LY3074828 | 350 mg LY3074828 | 200 mg LY3074828 | 120 mg LY3074828 SC | 120 mg LY3074828 | 60 mg LY3074828 | 20 mg LY3074828 | 5 mg LY3074828 |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 44.7 Years STANDARD_DEVIATION 13.39 | 43.8 Years STANDARD_DEVIATION 12.37 | 42.2 Years STANDARD_DEVIATION 10.57 | 37.4 Years STANDARD_DEVIATION 11.37 | 53.2 Years STANDARD_DEVIATION 14.55 | 37.2 Years STANDARD_DEVIATION 13.33 | 43.8 Years STANDARD_DEVIATION 13.33 | 44.0 Years STANDARD_DEVIATION 9.14 | 43.4 Years STANDARD_DEVIATION 13.32 | 51.0 Years STANDARD_DEVIATION 13.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 44 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 5 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 45 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 3 Participants |
| Region of Enrollment Canada | 7 Participants | 45 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Female | 0 Participants | 18 Participants | 2 Participants | 1 Participants | 2 Participants | 5 Participants | 2 Participants | 0 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 27 Participants | 3 Participants | 4 Participants | 3 Participants | 0 Participants | 3 Participants | 5 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 7 | 3 / 3 | 5 / 5 | 5 / 5 | 2 / 5 | 4 / 5 | 4 / 5 | 4 / 5 | 4 / 5 |
| serious Total, serious adverse events | 0 / 7 | 0 / 3 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
Primary
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
Population: Safety Population: all randomized participants who received any amount of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration | 1 Participants |
| 5 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 Participants |
| 20 mg LY3074828 | Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration | 2 Participants |
| 60 mg LY3074828 | Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration | 0 Participants |
| 120 mg LY3074828 | Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration | 0 Participants |
| 120 mg LY3074828 SC | Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration | 3 Participants |
| 200 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 Participants |
| 350 mg LY3074828 | Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration | 0 Participants |
| 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 | 0 Participants |
Secondary
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
Population: All randomized participants who received any amount of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828 | NA μg•day/mL (microgram•day/milliliters) | — |
| 5 mg LY3074828 | Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828 | 33.6 μg•day/mL (microgram•day/milliliters) | Geometric Coefficient of Variation 17 |
| 20 mg LY3074828 | Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828 | 117 μg•day/mL (microgram•day/milliliters) | Geometric Coefficient of Variation 15 |
| 60 mg LY3074828 | Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828 | 287 μg•day/mL (microgram•day/milliliters) | Geometric Coefficient of Variation 29 |
| 120 mg LY3074828 | Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828 | 114 μg•day/mL (microgram•day/milliliters) | Geometric Coefficient of Variation 49 |
| 120 mg LY3074828 SC | Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828 | 366 μg•day/mL (microgram•day/milliliters) | Geometric Coefficient of Variation 12 |
| 200 mg LY3074828 | Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828 | 556 μg•day/mL (microgram•day/milliliters) | Geometric Coefficient of Variation 25 |
| 350 mg LY3074828 | Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828 | 1360 μg•day/mL (microgram•day/milliliters) | Geometric Coefficient of Variation 23 |
Secondary
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
Population: All randomized participants who received any amount of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | 1.60 μg/mL (microgram/milliliter) | Geometric Coefficient of Variation 22 |
| 5 mg LY3074828 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | 5.34 μg/mL (microgram/milliliter) | Geometric Coefficient of Variation 6 |
| 20 mg LY3074828 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | 20.6 μg/mL (microgram/milliliter) | Geometric Coefficient of Variation 29 |
| 60 mg LY3074828 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | 41.1 μg/mL (microgram/milliliter) | Geometric Coefficient of Variation 15 |
| 120 mg LY3074828 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | 7.28 μg/mL (microgram/milliliter) | Geometric Coefficient of Variation 23 |
| 120 mg LY3074828 SC | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | 68.8 μg/mL (microgram/milliliter) | Geometric Coefficient of Variation 19 |
| 200 mg LY3074828 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | 91.8 μg/mL (microgram/milliliter) | Geometric Coefficient of Variation 6 |
| 350 mg LY3074828 | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 | 220 μg/mL (microgram/milliliter) | Geometric Coefficient of Variation 24 |