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A Study of LY3041658 in Adults With Hidradenitis Suppurativa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04493502
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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).

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Placebo Drug: LY3041658 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 26, 2020
Estimated Primary Completion Date : December 6, 2021
Estimated Study Completion Date : July 4, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3041658
LY3041658 given intravenously (IV).
 Drug: LY3041658
Given IV
Placebo Comparator: Placebo
Placebo given IV. Participants will switch to LY3041658 given IV after week 16.
 Drug: Placebo
Given IV

Drug: LY3041658
Given IV


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: Week 16 ]
    Percentage of Participants Achieving HiSCR


Secondary Outcome Measures :
  1. Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules [ Time Frame: Baseline, Week 16 ]
    Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules

  2. Mean Change from Baseline in Skin Pain on the HS Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 16 ]
    Mean Change from Baseline in Skin Pain on the HS NRS


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493502


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04493502    
Other Study ID Numbers: 17497
I7P-MC-DSAD ( Other Identifier: Eli Lilly and Company )
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration