Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY3041658 in Participants With Skin Diseases

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: NCT02896868
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 7, 2016
First Posted Date  ICMJE September 12, 2016
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE November 8, 2016
Actual Primary Completion Date March 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Dosing Day 1 through Day 127 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
  • Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658 [ Time Frame: Dosing Day 1 through Day 127 ]
  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) During Dosing Interval at Steady State (AUCss) of LY3041658 [ Time Frame: Dosing Day 1 through Day 127 ]
  • Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3041658 [ Time Frame: Dosing Day 1 through Day 127 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3041658 in Participants With Skin Diseases
Official Title  ICMJE A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3041658 in Patients With Skin Diseases
Brief Summary The main purpose of this study is to investigate the safety and tolerability of the study drug known as LY3041658 in participants with certain types of skin diseases. The study will measure how the body absorbs, breaks down and gets rid of LY3041658. It will last about 127 days for each participant, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Skin Diseases
  • Psoriasis
Intervention  ICMJE
  • Drug: LY3041658
    Administered IV.
  • Drug: Placebo
    Administered IV.
Study Arms  ICMJE
  • Experimental: LY3041658
    LY3041658 administered intravenously (IV) once every two weeks over 6 weeks (four doses).
    Intervention: Drug: LY3041658
  • Placebo Comparator: Placebo
    Placebo administered IV once every two weeks over 6 weeks (four doses).
    Intervention: Drug: Placebo
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
Estimated Enrollment  ICMJE
 (submitted: September 7, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 19, 2019
Actual Primary Completion Date March 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Investigator confirmed diagnosis of certain skin diseases for at least 6 months.
  • Active skin lesions that are not responding to standard therapies.
  • Willing to undergo pre- and post-treatment skin biopsies of lesions.

Exclusion Criteria:

- Have other skin diseases that may interfere with evaluation of the specified skin disease being studied.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02896868
Other Study ID Numbers  ICMJE 15165
I7P-MC-DSAB ( 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 1, 2019

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