A Study of LY3361237 in Participants With Psoriasis

NCT ID: NCT04975295

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2022-11-29

Brief Summary

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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

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3361237

LY3361237 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3361237

Intervention Type DRUG

Administered SC

Placebo

Placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3361237

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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MC Comac Medical

Sofia, , Bulgaria

Site Status

Budai Irgalmasrendi Korhaz

Budapest, , Hungary

Site Status

All Med - Lodz

Lodz, , Poland

Site Status

Ai Centrum Medyczne Sp. Z O.O. Sp.K.

Poznan, , Poland

Site Status

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Site Status

Pratia - Warsaw

Warsaw, , Poland

Site Status

Summit Clinical Research, s.r.o. - Bratislava

Bratislava, , Slovakia

Site Status

Countries

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Bulgaria Hungary Poland Slovakia

Related Links

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https://trials.lillytrialguide.com/en-US/trial/5M4E6fdkjelSDEBizWd8Bg

A Study of LY3361237 in Participants With Psoriasis

Other Identifiers

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I9S-MC-BTAC

Identifier Type: OTHER

Identifier Source: secondary_id

2019-003187-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17291

Identifier Type: -

Identifier Source: org_study_id

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