A Study of LY3041658 in Adults With Hidradenitis Suppurativa

NCT ID: NCT04493502

Last Updated: 2023-04-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2022-10-13

Brief Summary

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The reason for this study is to see if the study drug LY3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (HS).

Detailed Description

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Conditions

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Hidradenitis Suppurativa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3041658

Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).

Group Type EXPERIMENTAL

LY3041658

Intervention Type DRUG

Administered IV

Placebo

Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV

LY3041658

Intervention Type DRUG

Administered IV

Interventions

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Placebo

Administered IV

Intervention Type DRUG

LY3041658

Administered IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis of HS for at least 6 months
* Have HS lesions in at least 2 different anatomic areas
* Have inadequate response or intolerance to a 28 day course of oral antibiotics
* Have a total count of abscesses and inflammatory nodules greater than or equal to 4
* Agree to use a topical antiseptic daily
* Agree to stop using topical antibiotics during the study. In certain cases, oral antibiotics will be allowed

Exclusion Criteria

* Have more than 20 draining fistulae
* Have received any biologic medication (adalimumab, etc.) for the treatment of HS
* Plan to use oral opioids for HS-related pain during the study
* Uncontrolled depression or suicidal thoughts
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Northwest Arkansas Clinical Trials Center

Rogers, Arkansas, United States

Site Status

First OC Dermatology

Fountain Valley, California, United States

Site Status

Dermatology Research Associates

Los Angeles, California, United States

Site Status

Skin Care Research, Inc

Hollywood, Florida, United States

Site Status

Nova Clinical Research, LLC

Miami, Florida, United States

Site Status

ForCare Clinical Research

Tampa, Florida, United States

Site Status

Marietta Dermatology Clinical Research

Marietta, Georgia, United States

Site Status

Advanced Medical Research

Sandy Springs, Georgia, United States

Site Status

Allcutis Research, Inc.

Beverly, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

ALLCUTIS Research

Portsmouth, New Hampshire, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

UC Physicians Office Dermatology

Cincinnati, Ohio, United States

Site Status

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Westmead Hospital

Northmead, New South Wales, Australia

Site Status

Sunshine Coast University Hospital

Birtinya, QID, Australia

Site Status

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Fremantle Dermatology

Fremantle, Western Australia, Australia

Site Status

Holdsworth House Medical Practice

Sydney, , Australia

Site Status

Countries

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United States Australia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://trials.lillytrialguide.com/en-US/trial/1U6Tipcu8f5y3goGhoMTA1

A Study of LY3041658 in Adults With Hidradenitis Suppurativa

Other Identifiers

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I7P-MC-DSAD

Identifier Type: OTHER

Identifier Source: secondary_id

17497

Identifier Type: -

Identifier Source: org_study_id

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