A Study of LY3041658 in Adults With Hidradenitis Suppurativa
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
2 other identifiers
interventional
72
2 countries
20
Brief Summary
The reason for this study is to see if the study drug LY3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (HS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2020
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedStudy Start
First participant enrolled
August 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2022
CompletedResults Posted
Study results publicly available
April 28, 2023
CompletedApril 28, 2023
April 1, 2023
1.6 years
July 29, 2020
March 14, 2023
April 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
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.
Week 16
Secondary Outcomes (2)
Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count
Baseline, Week 16
Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)
Baseline, Week 16
Study Arms (2)
LY3041658
EXPERIMENTALParticipants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).
Placebo
PLACEBO COMPARATORPlacebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758, United States
First OC Dermatology
Fountain Valley, California, 92708, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Skin Care Research, Inc
Hollywood, Florida, 33021, United States
Nova Clinical Research, LLC
Miami, Florida, 33125, United States
ForCare Clinical Research
Tampa, Florida, 33613-1244, United States
Marietta Dermatology Clinical Research
Marietta, Georgia, 30060, United States
Advanced Medical Research
Sandy Springs, Georgia, 30328, United States
Allcutis Research, Inc.
Beverly, Massachusetts, 01915, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
ALLCUTIS Research
Portsmouth, New Hampshire, 03801, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
UC Physicians Office Dermatology
Cincinnati, Ohio, 45267, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Westmead Hospital
Northmead, New South Wales, 2152, Australia
Sunshine Coast University Hospital
Birtinya, QID, 4575, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 03050, Australia
Fremantle Dermatology
Fremantle, Western Australia, 6160, Australia
Holdsworth House Medical Practice
Sydney, 2010, Australia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2020
First Posted
July 30, 2020
Study Start
August 26, 2020
Primary Completion
March 15, 2022
Study Completion
October 13, 2022
Last Updated
April 28, 2023
Results First Posted
April 28, 2023
Record last verified: 2023-04-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.