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A Study of LY3041658 in Adults With Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
LY3041658
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwest Arkansas Clinical Trials Center
  • First OC Dermatology
  • Dermatology Research Associates
  • Skin Care Research, Inc
  • Nova Clinical Research, LLC
  • ForCare Clinical Research
  • Marietta Dermatology Clinical Research
  • Advanced Medical Research
  • Allcutis Research, Inc.
  • Beth Israel Deaconess Medical Center
  • Washington University School of Medicine
  • ALLCUTIS Research
  • Duke University Medical Center
  • UC Physicians Office Dermatology
  • University Hospitals Case Medical Center
  • Westmead Hospital
  • Sunshine Coast University Hospital
  • The Royal Melbourne Hospital
  • Fremantle Dermatology
  • Holdsworth House Medical Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3041658

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count
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.
Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)
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.

Full Information

First Posted
July 29, 2020
Last Updated
April 26, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04493502
Brief Title
A Study of LY3041658 in Adults With Hidradenitis Suppurativa
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 1, 2023
Overall Recruitment Status
Completed
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
October 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3041658
Arm Type
Experimental
Arm Description
Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
LY3041658
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count
Description
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.
Time Frame
Baseline, Week 16
Title
Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)
Description
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.
Time Frame
Baseline, Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Arkansas Clinical Trials Center
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Skin Care Research, Inc
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Nova Clinical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Marietta Dermatology Clinical Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Advanced Medical Research
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Allcutis Research, Inc.
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
ALLCUTIS Research
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
UC Physicians Office Dermatology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Westmead Hospital
City
Northmead
State/Province
New South Wales
ZIP/Postal Code
2152
Country
Australia
Facility Name
Sunshine Coast University Hospital
City
Birtinya
State/Province
QID
ZIP/Postal Code
4575
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
03050
Country
Australia
Facility Name
Fremantle Dermatology
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Holdsworth House Medical Practice
City
Sydney
ZIP/Postal Code
2010
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/1U6Tipcu8f5y3goGhoMTA1
Description
A Study of LY3041658 in Adults With Hidradenitis Suppurativa

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A Study of LY3041658 in Adults With Hidradenitis Suppurativa

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