Back to resultsA Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Primary Purpose
Hidradenitis Suppurativa
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Eltrekibart
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of HS for at least 12 months. Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III. Have an (abscess plus inflammatory nodule) count of at least 5. Agree to use topical antiseptics daily. Had an inadequate response or intolerance to a 28-day course of oral antibiotics. Exclusion Criteria: Have more than 20 draining fistulae. Have had surgical treatment for HS in the last 4 weeks before randomization. Have an active skin disease or condition, that could interfere with the assessment of HS. Have a current or recent acute, active infection. Are immunocompromised. Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening.
Sites / Locations
- Revival Research Institute - TroyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Eltrekibart Dose 1
Eltrekibart Dose 2
Eltrekibart Dose 3
Placebo
Arm Description
Eltrekibart will be given subcutaneously (SC).
Eltrekibart will be given SC.
Eltrekibart will be given SC.
Placebo will be given.
Outcomes
Primary Outcome Measures
Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Secondary Outcome Measures
Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules
Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)
Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart
Full Information
NCT ID
NCT06046729
First Posted
September 14, 2023
Last Updated
October 23, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT06046729
Brief Title
A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Official Title
A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2023 (Actual)
Primary Completion Date
July 20, 2025 (Anticipated)
Study Completion Date
July 8, 2026 (Anticipated)
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
This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits.
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
Model Description
Phase 2b
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eltrekibart Dose 1
Arm Type
Experimental
Arm Description
Eltrekibart will be given subcutaneously (SC).
Arm Title
Eltrekibart Dose 2
Arm Type
Experimental
Arm Description
Eltrekibart will be given SC.
Arm Title
Eltrekibart Dose 3
Arm Type
Experimental
Arm Description
Eltrekibart will be given SC.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be given.
Intervention Type
Drug
Intervention Name(s)
Eltrekibart
Other Intervention Name(s)
LY3041658
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules
Time Frame
Baseline, Week 16
Title
Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)
Time Frame
Baseline, Week 16
Title
Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart
Time Frame
Baseline through Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of HS for at least 12 months.
Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III.
Have an (abscess plus inflammatory nodule) count of at least 5.
Agree to use topical antiseptics daily.
Had an inadequate response or intolerance to a 28-day course of oral antibiotics.
Exclusion Criteria:
Have more than 20 draining fistulae.
Have had surgical treatment for HS in the last 4 weeks before randomization.
Have an active skin disease or condition, that could interfere with the assessment of HS.
Have a current or recent acute, active infection.
Are immunocompromised.
Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
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
Revival Research Institute - Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Moiin
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 European Union (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
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/424355
Description
A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Learn more about this trial
A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
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