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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04493502
Recruitment Status : Completed
First Posted : July 30, 2020
Results First Posted : April 28, 2023
Last Update Posted : April 28, 2023
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)
Actual Enrollment : 72 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
Actual Primary Completion Date : March 15, 2022
Actual Study Completion Date : October 13, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3041658
Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).
 Drug: LY3041658
Administered IV
Placebo Comparator: Placebo
Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.
 Drug: Placebo
Administered IV

Drug: LY3041658
Administered IV


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 [ Time Frame: 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 :
  1. Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count [ Time Frame: Baseline, Week 16 ]
    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.

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


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


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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] August 13, 2021
Statistical Analysis Plan  [PDF] June 1, 2021

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
Results First Posted: April 28, 2023
Last Update Posted: April 28, 2023
Last Verified: April 1, 2023
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
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration