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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
Country [1] 0 0
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Arizona
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Arkansas
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New Hampshire
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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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Utah
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Washington
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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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Canada
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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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Irakleío
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Greece
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Thessaloníki
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Poland
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Dolnoslaskie
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Lodzkie
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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


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