ClinicalTrials.gg
CompletedNCT01947933Updated Jul 25, 2024Results posted

A Safety Study of Mirikizumab (LY3074828)

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

Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
45 participants (actual)

Study arms

  • Placebo comparator
    Placebo IV

    Participants with psoriasis will receive a single dose of placebo matching mirikizumab intravenously (IV)

    Biological: Placebo - IV

  • Experimental
    Mirikizumab 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

  • Experimental
    Mirikizumab SC

    Healthy participants will receive a single dose of 120 mg mirikizumab subcutaneously (SC).

    Biological: Mirikizumab - SC

Interventions

  • BiologicalMirikizumab- IV

    Administered IV

    Also known as: LY3074828

  • Administered SC

    Also known as: LY3074828

  • BiologicalPlacebo - IV

    Administered IV

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

07

Results

Posted Jul 25, 2024

Participant flow

Participant flow — Overall Study
MilestonePlacebo5 mg LY307482820 mg LY307482860 mg LY3074828120 mg LY3074828120 mg LY3074828 SC200 mg LY3074828350 mg LY3074828600 mg LY3074828
Started735555555
Completed734555554
Not completed001000001
Withdrew: Withdrawal by subject001000000
Withdrew: Lost to follow-up000000001

Outcome measures

PrimaryNumber 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
Reported as:
Number · Participants
Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration
ParticipantsPlacebo5 mg LY307482820 mg LY307482860 mg LY3074828120 mg LY3074828120 mg LY3074828 SC200 mg LY3074828350 mg LY3074828600 mg LY3074828
Number of Participants With One or More Adverse Event(s) (AEs) Considered by the Investigator to Be Related to Study Drug Administration112003100
SecondaryPharmacokinetics (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
Reported as:
Geometric mean · μg•day/mL (microgram•day/milliliters)
Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828
μg•day/mL (microgram•day/milliliters)5 mg LY307482820 mg LY307482860 mg LY3074828120 mg LY3074828120 mg LY3074828 SC200 mg LY3074828350 mg LY3074828600 mg LY3074828
Pharmacokinetics (PK): Area Under Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3074828NA ± NA33.6 ± 17117 ± 15287 ± 29114 ± 49366 ± 12556 ± 251360 ± 23
SecondaryPharmacokinetics (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
Reported as:
Geometric mean · μg/mL (microgram/milliliter)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828
μg/mL (microgram/milliliter)5 mg LY307482820 mg LY307482860 mg LY3074828120 mg LY3074828120 mg LY3074828 SC200 mg LY3074828350 mg LY3074828600 mg LY3074828
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY30748281.60 ± 225.34 ± 620.6 ± 2941.1 ± 157.28 ± 2368.8 ± 1991.8 ± 6220 ± 24

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
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%)
Most frequent other events
Showing 10 of 39
Most frequent other events
EventPlacebo5 mg LY307482820 mg LY307482860 mg LY3074828120 mg LY3074828120 mg LY3074828 SC200 mg LY3074828350 mg LY3074828600 mg LY3074828
NasopharyngitisInfections and infestations3/70/34/54/50/51/51/51/51/5
DiarrhoeaGastrointestinal disorders0/72/30/50/50/50/50/50/50/5
Injection site painGeneral disorders0/70/30/50/50/53/50/50/50/5
HeadacheNervous system disorders2/70/31/50/51/51/53/50/53/5
DysmenorrhoeaReproductive system and breast disorders0/70/30/50/50/50/50/50/51/2
Abdominal painGastrointestinal disorders0/70/30/50/50/52/50/50/50/5
NauseaGastrointestinal disorders0/70/32/50/50/50/50/50/50/5
LacerationInjury, poisoning and procedural complications0/70/30/50/50/50/51/50/52/5
Muscle strainInjury, poisoning and procedural complications0/70/30/50/50/50/50/52/50/5
Conjunctival haemorrhageEye disorders0/71/30/50/50/50/50/50/50/5

Baseline characteristics

Safety Population: all randomized participants who received any amount of study drug.

Age, Continuous
Age, Continuous(Years)Placebo5 mg LY307482820 mg LY307482860 mg LY3074828120 mg LY3074828120 mg LY3074828 SC200 mg LY3074828350 mg LY3074828600 mg LY3074828Total
Mean44.7 ± 13.3951.0 ± 13.0843.4 ± 13.3244.0 ± 9.1443.8 ± 13.3337.2 ± 13.3353.2 ± 14.5537.4 ± 11.3742.2 ± 10.5743.8 ± 12.37
Sex: Female, Male
Sex: Female, Male(Participants)Placebo5 mg LY307482820 mg LY307482860 mg LY3074828120 mg LY3074828120 mg LY3074828 SC200 mg LY3074828350 mg LY3074828600 mg LY3074828Total
Female02402521218
Male71153034327
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo5 mg LY307482820 mg LY307482860 mg LY3074828120 mg LY3074828120 mg LY3074828 SC200 mg LY3074828350 mg LY3074828600 mg LY3074828Total
Hispanic or Latino0000010001
Not Hispanic or Latino73555455544
Unknown or Not Reported0000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo5 mg LY307482820 mg LY307482860 mg LY3074828120 mg LY3074828120 mg LY3074828 SC200 mg LY3074828350 mg LY3074828600 mg LY3074828Total
American Indian or Alaska Native0000000000
Asian0000000000
Native Hawaiian or Other Pacific Islander0000000000
Black or African American0000000000
White73555555545
More than one race0000000000
Unknown or Not Reported0000000000
Region of Enrollment
Region of Enrollment(Participants)Placebo5 mg LY307482820 mg LY307482860 mg LY3074828120 mg LY3074828120 mg LY3074828 SC200 mg LY3074828350 mg LY3074828600 mg LY3074828Total
Canada73555555545
08

Study locations

2 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Waterloo, Ontario N2J 1C4, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Montreal, Quebec H2K4L5, Canada
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

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.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2013
First posted
Sep 23, 2013
Start
Oct 2013
Primary completionActual
Feb 2015
CompletionActual
Feb 2015
Results first posted
Jul 25, 2024
Last update
Jul 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01947933
Responsible party
Sponsor
First posted
Sep 23, 2013
Start date
Oct 2013
Primary completion
Feb 2015
Completion
Feb 2015
Results posted
Jul 25, 2024
Last update
Jul 25, 2024

Study contacts

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
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Mirikizumab

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