Clinical trial NCT06046729: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 2b
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
timeFrame: Week 16
Secondary outcomes:
measure: Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules
timeFrame: Baseline, Week 16
measure: Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)
timeFrame: Baseline, Week 16
measure: Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart
timeFrame: Baseline through Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Phoenix
country: United States
facility: Saguaro Dermatology Associates, LLC - Probity - PPDS
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Research Trials, LLC
state: Arkansas
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology Research Inc
state: California
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Santa Monica
country: United States
facility: Dermatology Institute and Skin Care Center
state: California
city: Farmington
country: United States
facility: University of Connecticut
state: Connecticut
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Skin Research of South Florida
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Tampa
country: United States
facility: Alliance Clinical Research of Tampa
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research, PC
state: Georgia
city: Skokie
country: United States
facility: NorthShore Medical Group Dermatology - Skokie
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Bowling Green
country: United States
facility: Equity Medical - Bowling Green
state: Kentucky
city: Louisville
country: United States
facility: Derm Research LLC
state: Kentucky
city: Marriottsville
country: United States
facility: Care Access-Marriottsville
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Troy
country: United States
facility: Revival Research Institute - Troy
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, P.C
state: Nebraska
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, Inc.
state: New Hampshire
city: Charlotte
country: United States
facility: Darst Dermatology
state: North Carolina
city: Charlotte
country: United States
facility: Dermatology Specialists of Charlotte
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Camp Hill
country: United States
facility: DermDox Centers for Dermatology
state: Pennsylvania
city: Sugarloaf
country: United States
facility: DermDox Dermatology Centers
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Columbia Dermatology & Aesthetics
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee (IC Research)
state: Tennessee
city: Nashville
country: United States
facility: Advanced Research Experts
state: Tennessee
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Frisco
country: United States
facility: North Texas Clinical Research
state: Texas
city: South Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Darlinghurst
country: Australia
facility: East Sydney Doctors
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: East Melbourne
country: Australia
facility: Sinclair Dermatology - East Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
city: Calgary
country: Canada
facility: Beacon Dermatology
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Dermasurgery Centre
state: Alberta
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Fredericton
country: Canada
facility: Brunswick Dermatology Center
state: New Brunswick
city: Barrie
country: Canada
facility: Simcoderm Medical & Surgical Dermatology Centre
state: Ontario
city: London
country: Canada
facility: DermEffects - Probity - PPDS
state: Ontario
city: Quebec City
country: Canada
facility: Center de Recherche St Louis
state: Quebec
city: Erlangen
country: Germany
facility: Hautklinik Erlangen
state: Bayern
city: Blankenfelde-Mahlow
country: Germany
facility: Hautarztpraxis Mahlow
state: Brandenburg
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Bochum
country: Germany
facility: Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: Universitätsklinikum Münster - Albert Schweitzer Campus
state: Westfalen
city: Berlin
country: Germany
facility: Hautzentrum Friedrichshain - Dermatologie
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Athens
country: Greece
facility: Hospital of Venereal and Skin Diseases A.Syggros
state: Attiki
city: Athens
country: Greece
facility: Hospital of Venereal and Skin Diseases A.Syggros
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion Loc. 1
state: Irakleío
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki
state: Thessaloníki
city: Wroclaw
country: Poland
facility: Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Wro Medica
state: Dolnoslaskie
city: Lodz
country: Poland
facility: Dermoklinika-Centrum Medyczne s.c
state: Lodzkie
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
state: Mazowieckie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
state: Pomorskie
city: Malbork
country: Poland
facility: Klinika Badawcza Centrum Badan Klinicznych Wojciech Brzezicki
state: Pomorskie
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
state: Śląskie
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: