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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06046729




Registration number
NCT06046729
Ethics application status
Date submitted
14/09/2023
Date registered
21/09/2023

Titles & IDs
Public title
A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Scientific title
A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Secondary ID [1] 0 0
I7P-MC-DSAF
Secondary ID [2] 0 0
18518
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eltrekibart
Treatment: Drugs - Placebo

Experimental: Eltrekibart Dose 1 - Eltrekibart will be given subcutaneously (SC).

Experimental: Eltrekibart Dose 2 - Eltrekibart will be given SC.

Experimental: Eltrekibart Dose 3 - Eltrekibart will be given SC.

Placebo comparator: Placebo - Placebo will be given.


Treatment: Drugs: Eltrekibart
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [2] 0 0
Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)
Timepoint [2] 0 0
Baseline, Week 16
Secondary outcome [3] 0 0
Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart
Timepoint [3] 0 0
Baseline through Week 16

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 0 0
Sinclair Dermatology - East Melbourne - East Melbourne
Recruitment hospital [5] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Fremantle Dermatology - Fremantle
Recruitment hospital [7] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment postcode(s) [7] 0 0
2010 - Sydney
Recruitment outside Australia
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Arizona
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California
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Illinois
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Indiana
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Michigan
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Nebraska
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Wisconsin
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Canada
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Alberta
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Canada
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Manitoba
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New Brunswick
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Canada
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Ontario
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Canada
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Quebec
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Hessen
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Germany
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Nordrhein-Westfalen
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Germany
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Westfalen
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Germany
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Berlin
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Germany
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Hamburg
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Greece
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Attiki
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Greece
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Thessaloníki
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Greece
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Heraklion
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Poland
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Dolnoslaskie
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Mazowieckie
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Pomorskie
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Slaskie

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06046729