A Study of LY3361237 in Participants With Psoriasis

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: LY3361237

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1606
    • MC Comac Medical
• Hungary
  • Budapest, Hungary, 1027
    • Budai Irgalmasrendi Kórház
• Poland
  • Lodz, Poland, 94048
    • All Med - Lodz
  • Poznan, Poland, 61-113
    • Ai Centrum Medyczne Sp. Z O.O. Sp.K.
  • Warszawa, Poland, 00-728
    • WIP Warsaw IBD Point Profesor Kierkus
  • Warszawa, Poland, 01-868
    • Pratia - Warsaw
• Slovakia
  • Bratislava, Slovakia, 831
    • Summit Clinical Research, s.r.o. - Bratislava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered SC.	Drug: Placebo; Administered SC
Experimental: LY3361237; LY3361237 administered subcutaneously (SC).	Drug: LY3361237; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline through Day 253

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of LY3361237 During the Dosing Interval	PK: Cmin of LY3361237 During the Dosing Interval	Day 1 predose through Day 253

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Study of LY3361237 in Participants With Psoriasis

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 17291; I9S-MC-BTAC (Other Identifier: Eli Lilly and Company); 2019-003187-40 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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