A Study of LY3361237 in Participants With Psoriasis

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: LY3361237; Drug: Placebo

• Registration Number: NCT04975295
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-23
• Study Start: 2021-07-27
• Primary Completion: 2022-11-29
• Study Completion: 2022-11-29
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3361237	LY3361237	LY3361237 administered subcutaneously (SC).
Placebo	Placebo	Placebo administered SC.

Primary Outcome Measures

Name	Time	Method
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	Baseline through Day 253	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

Name	Time	Method
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of LY3361237 During the Dosing Interval	Day 1 predose through Day 253	PK: Cmin of LY3361237 During the Dosing Interval

Trial Locations

Locations (7)

MC Comac Medical; 🇧🇬 Sofia, Bulgaria

All Med - Lodz; 🇵🇱 Lodz, Poland

Pratia - Warsaw; 🇵🇱 Warszawa, Poland

Budai Irgalmasrendi Korhaz; 🇭🇺 Budapest, Hungary

WIP Warsaw IBD Point Profesor Kierkus; 🇵🇱 Warszawa, Poland

Summit Clinical Research, s.r.o. - Bratislava; 🇸🇰 Bratislava, Slovakia

Ai Centrum Medyczne Sp. Z O.O. Sp.K.; 🇵🇱 Poznan, Poland