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A Safety Study of LY3074828

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01947933
First received: September 18, 2013
Last updated: March 19, 2015
Last verified: March 2015
  Purpose
The main purpose of this study is to evaluate the safety of the study drug known as LY3074828. 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.

Condition Intervention Phase
Psoriasis
Biological: LY3074828 - IV
Biological: LY3074828 - SQ
Biological: Placebo - IV
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Randomized, Placebo-Controlled Study of LY3074828, an Anti-IL-23 Humanized Antibody

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 45
Study Start Date: October 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo IV
Participants with psoriasis will receive a single dose of placebo matching LY3074828 intravenously (IV)
Biological: Placebo - IV
Administered IV
Experimental: LY3074828 IV
Participants with psoriasis will receive a single escalating dose of LY3074828 starting at 5 mg, IV
Biological: LY3074828 - IV
Administered IV
Experimental: LY3074828 SQ
Healthy participants will receive a single dose of LY3074828 subcutaneously (SQ). .
Biological: LY3074828 - SQ
Administered SQ

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 LY3074828 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947933

Locations
Canada, Ontario
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, Canada, N2J 1C4
Canada, Quebec
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, Canada, H2K4L5
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01947933     History of Changes
Other Study ID Numbers: 15039
I6T-MC-AMAA ( Other Identifier: Eli Lilly and Company )
Study First Received: September 18, 2013
Last Updated: March 19, 2015

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 24, 2017