A Study of LY3041658 in Adults With Hidradenitis Suppurativa
NCT ID: NCT04493502
Last Updated: 2023-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2020-08-26
2022-10-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY3041658
Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).
LY3041658
Administered IV
Placebo
Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.
Placebo
Administered IV
LY3041658
Administered IV
Interventions
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Placebo
Administered IV
LY3041658
Administered IV
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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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
First OC Dermatology
Fountain Valley, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Skin Care Research, Inc
Hollywood, Florida, United States
Nova Clinical Research, LLC
Miami, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Marietta Dermatology Clinical Research
Marietta, Georgia, United States
Advanced Medical Research
Sandy Springs, Georgia, United States
Allcutis Research, Inc.
Beverly, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
ALLCUTIS Research
Portsmouth, New Hampshire, United States
Duke University Medical Center
Durham, North Carolina, United States
UC Physicians Office Dermatology
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Westmead Hospital
Northmead, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, QID, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
Holdsworth House Medical Practice
Sydney, , Australia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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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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