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A Safety Study of Mirikizumab (LY3074828)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01947933
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 18, 2013
First Posted Date  ICMJE September 23, 2013
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2013)
Number of Participants with One or More Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through 12 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01947933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2017)
  • Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Mirikizumab [ Time Frame: Baseline through 12 Weeks ]
  • Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Mirikizumab [ Time Frame: Baseline through 12 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2013)
  • Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3074828 [ Time Frame: Baseline through 12 Weeks ]
  • Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3074828 [ Time Frame: Baseline through 12 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of Mirikizumab (LY3074828)
Official Title  ICMJE A Phase I, Randomized, Placebo-Controlled Study of LY3074828, an Anti-IL-23 Humanized Antibody
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Biological: Mirikizumab- IV
    Administered IV
    Other Name: LY3074828
  • Biological: Mirikizumab - SC
    Administered SC
    Other Name: LY3074828
  • Biological: Placebo - IV
    Administered IV
Study Arms  ICMJE
  • Placebo Comparator: Placebo IV
    Participants with psoriasis will receive a single dose of placebo matching mirikizumab intravenously (IV)
    Intervention: 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
    Intervention: Biological: Mirikizumab- IV
  • Experimental: Mirikizumab SC
    Healthy participants will receive a single dose of 120 mg mirikizumab subcutaneously (SC).
    Intervention: Biological: Mirikizumab - SC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2015)
45
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2013)
40
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01947933
Other Study ID Numbers  ICMJE 15039
I6T-MC-AMAA ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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
PRS Account Eli Lilly and Company
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP