Clinical trial • Phase II • Immunology|Dermatology

HUMANISED IGG4 KAPPA MONOCLONAL ANTIBODY AGAINST CXCL1, CXCL2, CXCL3, CXCL5, CXCL6, CXCL7 AND CXCL8 for Hidradenitis suppurativa (moderate to severe)

Phase II trial of HUMANISED IGG4 KAPPA MONOCLONAL ANTIBODY AGAINST CXCL1, CXCL2, CXCL3, CXCL5, CXCL6, CXCL7 AND CXCL8 for Hidradenitis suppurativa (modera…

Overview

Trial Therapeutic Area
Immunology|Dermatology
Trial Disease
Hidradenitis suppurativa (moderate to severe)
Trial Stage
Phase II
Drug Modality
Monoclonal antibody|Other

Key dates

Initial CTIS Submission Date
28-02-2024
First CTIS Authorization Date
17-06-2024

Trial design

Randomised, 0.9% sodium chloride (placebo), dose/schedule not specified-controlled Phase II trial in Germany, Greece, Poland.

Randomised
Yes
Comparator
0.9% sodium chloride (placebo), dose/schedule not specified
Target Sample Size
227

Eligibility

Recruits 227 Vulnerable population flag selected. Subject information and informed consent forms provided (Main ICF and Pregnant Participant ICF and Pregnant Partner Consent). ICFs and recruitment materials are available in multiple languages (Polish, Greek, German, English, Ukrainian) according to uploaded documents..

Vulnerable Population
Vulnerable population flag selected. Subject information and informed consent forms provided (Main ICF and Pregnant Participant ICF and Pregnant Partner Consent). ICFs and recruitment materials are available in multiple languages (Polish, Greek, German, English, Ukrainian) according to uploaded documents.

Inclusion criteria

  • {"criterion_text":"- 1. Have a diagnosis of HS for at least 12 months.\n- 2. Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be Hurley Stage II or III.\n- 3. Have an (abscess plus inflammatory nodule) count of at least 5.\n- 4. Agree to use topical antiseptics daily.\n- 5. Had an inadequate response or intolerance to a 28-day course of oral antibiotics."}

Exclusion criteria

  • {"criterion_text":"- 1. Have more than 20 draining fistulae.\n- 2. Have had surgical treatment for HS in the last 4 weeks before randomization.\n- 3. Have an active skin disease or condition, that could interfere with the assessment of HS.\n- 4. Have a current or recent acute, active infection.\n- 5. Are immunocompromised.\n- 6. Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) [Time Frame: Week 16]","definition_or_measurement_approach":"Time Frame: Week 16"}

Recruitment

Planned Sample Size
227
Recruitment Window Months
23
Consent Approach
Informed consent obtained using Main ICFs (subject information and informed consent form). Specific forms for pregnant participants and pregnant partner consent are available. Documents uploaded in multiple languages (Polish, Greek, German, English, Ukrainian). Trial population is adults; consent provided by participants (no assent forms for minors indicated).

Methods

  • Use of recruitment materials and local site channels: posters, flipcharts, trifolds, ring cards, study appointment cards, discussion guides, study-recruitment posters, GP / HCP referral letters, thank-you cards (country-specific materials available for Poland, Greece, Germany).
  • Development and printing of recruitment material by third party (Jumo Health USA Inc.)

Geography

Total Number Of Sites
20
Total Number Of Participants
90

Germany

Earliest CTIS Part Ii Submission Date
07-06-2024
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
663
Number Of Sites
8
Number Of Participants
37

Sites

Site Name
Universitaet Muenster
Department Name
Klinik für Hautkrankheiten, Universitätsklinikum Münster (UKM)
Contact Person Name
Nina Magnolo
Contact Person Email
nina.magnolo@ukmuenster.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Hautklinik
Contact Person Name
Michael Sticherling
Site Name
Goethe University Frankfurt
Department Name
Klinische Forschung
Contact Person Name
Andreas Pinter
Contact Person Email
pinter-klifo-ffm@gmx.de
Site Name
Hautzentrum Friedrichshein
Contact Person Name
Jens Rossbacher
Contact Person Email
rossbacher@hzfh.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
Contact Person Name
Matthias Augustin
Contact Person Email
m.augustin@uke.de
Site Name
St. Josef-Hospital
Department Name
Dermatologische Studienambulanz
Contact Person Name
Falk Bechara
Site Name
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
Department Name
Dermatologische Gemeinschaftspraxis Mahlow
Contact Person Name
Michael Sebastian
Contact Person Email
m.sebastian@derma-mahlow.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik für Dermatologie und Allergologie, Zentrum für Hauterkrankungen,Klinisches Studienzentrum
Contact Person Name
Jörg Wenzel
Contact Person Email
joerg.wenzel@ukb.uni-bonn.de

Greece

Earliest CTIS Part Ii Submission Date
14-06-2024
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
656
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Department Name
General Department of Dermatology and Venereology
Contact Person Name
Vasiliki Chasapi
Contact Person Email
chasapiresearch@gmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Dermatology Department
Contact Person Name
Konstantinos Krasagakis
Contact Person Email
krasagak@med.uoc.gr
Site Name
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Department Name
1st Department of Dermatology and Venereology
Contact Person Name
Alexandros Stratigos
Contact Person Email
alstrat2@gmail.com
Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
B’ clinic of skin and venereal diseases
Contact Person Name
Elisabeth Lazaridou
Contact Person Email
bethlaz@auth.gr

Poland

Earliest CTIS Part Ii Submission Date
11-06-2024
Latest Decision Or Authorization Date
01-04-2026
Processing Time Days
659
Number Of Sites
8
Number Of Participants
33

Sites

Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Contact Person Name
Irena Walecka-Herniczek
Contact Person Email
irena.walecka@cskmswia.gov.pl
Site Name
Pratia S.A.
Contact Person Name
Kamila Płaczek
Contact Person Email
kplaczek@pratia.pl
Site Name
Dermoklinika-Medyczne Centrum s.c.
Contact Person Name
Joanna Narbutt
Contact Person Email
joanna.narbutt@onet.pl
Site Name
Wromedica I Bielicka A Strzalkowska s.c.
Contact Person Name
Wojciech Baran
Contact Person Email
wojciech.baran@umw.edu.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Contact Person Name
Roman Nowicki
Contact Person Email
rnowicki@gumed.edu.pl
Site Name
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
Contact Person Name
Jacek Szepietowski
Contact Person Email
jacek.szepietowski@umw.edu.pl
Site Name
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
Contact Person Name
Anna Sobieszek-Kundro
Site Name
NZOZ Labderm s.c.
Contact Person Name
Beata Bergler-Czop
Contact Person Email
bettina2@tlen.pl

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Charles River Laboratories Montreal ULC
Responsibilities
PK analysis testing, reporting, and sample management (i.e., receipt, storage, and shipment)
Name
WCG Clinical Inc.
Responsibilities
site training portal
Name
PPD Development LP
Responsibilities
multiple trial support roles (codes: 1,11,12,13,2,4,5,6,7,8)
Name
Pra International
Responsibilities
biomarkers - testing, reporting, and sample management (i.e., receipt, storage, and shipment)
Name
Pharmaceutical Product Development LLC
Responsibilities
testing and reporting
Name
PPD Global Central Labs
Responsibilities
testing, reporting, and sample management (i.e., receipt, storage, and shipment)
Name
Eurofins Viracor Biopharma Services LLC
Responsibilities
testing, reporting, and sample management (i.e., receipt, storage, and shipment)

Third parties

  • {"country":"Canada","full_name":"Charles River Laboratories Montreal ULC","duties_or_roles":"PK analysis testing, reporting, and sample management (i.e., receipt, storage, and shipment); code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eurofins Viracor Biopharma Services LLC","duties_or_roles":"testing, reporting, and sample management (i.e., receipt, storage, and shipment); code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"site training portal","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"testing, reporting, and sample management (i.e., receipt, storage, and shipment); code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"eCOA licensing and translation","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Global Central Labs LLC","duties_or_roles":"sample management (i.e., receipt, storage, and shipment)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"development and printing of recruitment material","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes: 1,11,12,13,2,4,5,6,7,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pra International","duties_or_roles":"biomarkers - testing, reporting, and sample management (i.e., receipt, storage, and shipment); code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"testing and reporting","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Empatica Inc.","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Eltrekibart
Active Substance
HUMANISED IGG4 KAPPA MONOCLONAL ANTIBODY AGAINST CXCL1, CXCL2, CXCL3, CXCL5, CXCL6, CXCL7 AND CXCL8
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous injection
Route
Subcutaneous injection
Investigational Product Name
0.9% sodium chloride
Modality
Other

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