- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04493502
A Study of LY3041658 in Adults With Hidradenitis Suppurativa
April 26, 2023 updated by: Eli Lilly and Company
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3041658 in Adults With Moderate-to-Severe Hidradenitis Suppurativa
The reason for this study is to see if the study drug LY3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (HS).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Sydney, Australia, 2010
- Holdsworth House Medical Practice
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New South Wales
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Northmead, New South Wales, Australia, 2152
- Westmead Hospital
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QID
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Birtinya, QID, Australia, 4575
- Sunshine Coast University Hospital
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Victoria
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Parkville, Victoria, Australia, 03050
- The Royal Melbourne Hospital
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Western Australia
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Fremantle, Western Australia, Australia, 6160
- Fremantle Dermatology
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Arkansas
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Rogers, Arkansas, United States, 72758
- Northwest Arkansas Clinical Trials Center
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California
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Fountain Valley, California, United States, 92708
- First OC Dermatology
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Los Angeles, California, United States, 90045
- Dermatology Research Associates
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Florida
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Hollywood, Florida, United States, 33021
- Skin Care Research, Inc
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Miami, Florida, United States, 33125
- Nova Clinical Research, LLC
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Tampa, Florida, United States, 33613-1244
- Forcare Clinical Research
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Georgia
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Marietta, Georgia, United States, 30060
- Marietta Dermatology Clinical Research
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Sandy Springs, Georgia, United States, 30328
- Advanced Medical Research
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Massachusetts
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Beverly, Massachusetts, United States, 01915
- Allcutis Research, Inc.
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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New Hampshire
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Portsmouth, New Hampshire, United States, 03801
- ALLCUTIS Research
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45267
- UC Physicians Office Dermatology
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Cleveland, Ohio, United States, 44106
- University Hospitals Case Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LY3041658
Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).
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Administered IV
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Placebo Comparator: Placebo
Placebo administered IV.
Participants will switch to 600 mg LY3041658 administered IV after week 16.
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Administered IV
Administered IV
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
Time Frame: Week 16
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The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (sum of abscesses and inflammatory nodules [AN count]) with no increase in abscess count (A count) and no increase in draining fistulae count (DF count) relative to baseline.
Non-responder imputation (NRI): Participants with missing data were considered non-responders.
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Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count
Time Frame: Baseline, Week 16
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Mean Change from baseline in total AN count at Week 16 was reported.
Abscess and inflammatory nodule were counted for the Hidradenitis Suppurativa (HS) affected anatomical regions.
The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.
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Baseline, Week 16
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Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)
Time Frame: Baseline, Week 16
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The Skin Pain - HS Numeric Rating Scale (NRS) is a patient-administered, single-question, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no skin pain" and 10 representing "skin pain as bad as you can imagine."
The recall period is 7 days.
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Baseline, Week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 26, 2020
Primary Completion (Actual)
March 15, 2022
Study Completion (Actual)
October 13, 2022
Study Registration Dates
First Submitted
July 29, 2020
First Submitted That Met QC Criteria
July 29, 2020
First Posted (Actual)
July 30, 2020
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 26, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17497
- I7P-MC-DSAD (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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