Back to resultsA Study of LY3361237 in Participants With Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3361237
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Have chronic plaque psoriasis for at least 6 months
- Be willing and able to undergo skin biopsies
- Body mass index (BMI) within the range of 18 to 40 kilograms per meter squared (kg/m²)
- Female participants must agree to use birth control during the study
Exclusion Criteria:
- Have had certain types of infection within the last six months
- Have a clinically significant active infection, or recent acute active infection within the last 30 days
- Have other serious or unstable illnesses
- Have a history of organ or bone marrow transplant
- Have received any live vaccine within the last 4 weeks prior to screening
- Have received systemic nonbiologic psoriasis therapy within 4 weeks prior to study day 1
- Have received topical psoriasis treatment within 14 days prior to study day 1
- Have excessive skin exposure or use tanning booths for at least 4 weeks prior to study day 1
Sites / Locations
- MC Comac Medical
- Budai Irgalmasrendi Korhaz
- All Med - Lodz
- Ai Centrum Medyczne Sp. Z O.O. Sp.K.
- WIP Warsaw IBD Point Profesor Kierkus
- Pratia - Warsaw
- Summit Clinical Research, s.r.o. - Bratislava
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LY3361237
Placebo
Arm Description
LY3361237 administered subcutaneously (SC).
Placebo administered SC.
Outcomes
Primary Outcome Measures
Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of LY3361237 During the Dosing Interval
PK: Cmin of LY3361237 During the Dosing Interval
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04975295
Brief Title
A Study of LY3361237 in Participants With Psoriasis
Official Title
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Participants With Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
November 29, 2022 (Actual)
Study Completion Date
November 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to learn more about the safety and tolerability of LY3361237 and any side effects that might be associated with it when given to participants with psoriasis. LY3361237 will be administered by injections just under the skin. The study will last up to 41 weeks and may include up to 15 visits to the study center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3361237
Arm Type
Experimental
Arm Description
LY3361237 administered subcutaneously (SC).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC.
Intervention Type
Drug
Intervention Name(s)
LY3361237
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Baseline through Day 253
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of LY3361237 During the Dosing Interval
Description
PK: Cmin of LY3361237 During the Dosing Interval
Time Frame
Day 1 predose through Day 253
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have chronic plaque psoriasis for at least 6 months
Be willing and able to undergo skin biopsies
Body mass index (BMI) within the range of 18 to 40 kilograms per meter squared (kg/m²)
Female participants must agree to use birth control during the study
Exclusion Criteria:
Have had certain types of infection within the last six months
Have a clinically significant active infection, or recent acute active infection within the last 30 days
Have other serious or unstable illnesses
Have a history of organ or bone marrow transplant
Have received any live vaccine within the last 4 weeks prior to screening
Have received systemic nonbiologic psoriasis therapy within 4 weeks prior to study day 1
Have received topical psoriasis treatment within 14 days prior to study day 1
Have excessive skin exposure or use tanning booths for at least 4 weeks prior to study day 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
MC Comac Medical
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
All Med - Lodz
City
Lodz
ZIP/Postal Code
94048
Country
Poland
Facility Name
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Pratia - Warsaw
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Summit Clinical Research, s.r.o. - Bratislava
City
Bratislava
ZIP/Postal Code
831
Country
Slovakia
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/5M4E6fdkjelSDEBizWd8Bg
Description
A Study of LY3361237 in Participants With Psoriasis
Learn more about this trial
A Study of LY3361237 in Participants With Psoriasis
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