Clinical trial • Phase II • Immunology|Dermatology

brivekimig for Hidradenitis suppurativa

Phase II trial of brivekimig for Hidradenitis suppurativa. Randomised, placebo; dose and schedule not specified-controlled. 119 participants.

Overview

Trial Therapeutic Area
Immunology|Dermatology
Trial Disease
Hidradenitis suppurativa
Trial Stage
Phase II
Drug Modality
Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
28-08-2025
First CTIS Authorization Date
22-12-2025

Trial design

Randomised, placebo; dose and schedule not specified-controlled Phase II trial in Hungary, Italy, Spain and others.

Randomised
Yes
Comparator
Placebo; dose and schedule not specified
Target Sample Size
119

Eligibility

Recruits 119 paediatric patients.

Vulnerable Population
Vulnerable population selected. Subject information and informed consent documents include child-specific informed consent (L1-sis-icf-child-fr) and partner-pregnancy ICF documents (L1-sis-icf-partner-pregnancy-*) indicating specific consent materials for pregnancy/partners and children; consent handled via the provided L1 subject information and informed consent form documents in multiple languages.

Inclusion criteria

  • {"criterion_text":"- Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline."}
  • {"criterion_text":"- Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III."}
  • {"criterion_text":"- Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history"}
  • {"criterion_text":"- Participants must be either biologic-naive or biologic-experienced"}
  • {"criterion_text":"- Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline visit"}
  • {"criterion_text":"- Participant must have a draining tunnel count of ≤20 at the Baseline visit."}

Exclusion criteria

  • {"criterion_text":"- Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS."}
  • {"criterion_text":"- Active suicidality and therefore significant suicide risk, as judged by the Investigator"}
  • {"criterion_text":"- A history of an Adverse Event (AE) attributed to or related to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate re-administration of an anti-TNF class therapy."}
  • {"criterion_text":"- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study."}
  • {"criterion_text":"- History (within last 2 years prior to Baseline visit) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator."}
  • {"criterion_text":"- History of recurrent or recent serious infection"}
  • {"criterion_text":"- Known history of significant immunosuppression"}
  • {"criterion_text":"- History of solid organ transplant or stem cell transplant."}
  • {"criterion_text":"- History of splenectomy."}
  • {"criterion_text":"- History of moderate to severe congestive heart failure."}
  • {"criterion_text":"- History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease."}
  • {"criterion_text":"- Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured."}
  • {"criterion_text":"- History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)","definition_or_measurement_approach":"Proportion of participants achieving HiSCR50"}
  • {"endpoint_text":"- Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)","definition_or_measurement_approach":"Proportion of participants achieving HiSCR90"}
  • {"endpoint_text":"- Change from Baseline in draining tunnel count at Week 16.","definition_or_measurement_approach":"Change from baseline measured at Week 16"}
  • {"endpoint_text":"- Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16","definition_or_measurement_approach":"Change from baseline in IHS4 absolute score at Week 16"}
  • {"endpoint_text":"- Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8","definition_or_measurement_approach":"Proportion of participants achieving response on HS-SAQ skin pain NRS at Week 8"}
  • {"endpoint_text":"- Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16.","definition_or_measurement_approach":"Change from baseline in HiSQOL total score at Week 16"}
  • {"endpoint_text":"- Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16.","definition_or_measurement_approach":"Change from baseline in DLQI total score at Week 16"}
  • {"endpoint_text":"- Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies.","definition_or_measurement_approach":"Count of participants experiencing TEAEs, SAEs and laboratory anomalies"}
  • {"endpoint_text":"- Serum brivekimig concentration throughout the study","definition_or_measurement_approach":"Serum concentration measurements of brivekimig collected throughout the study"}
  • {"endpoint_text":"- Incidence of treatment-emergent (TE) anti-drug antibody responses.","definition_or_measurement_approach":"Incidence of treatment-emergent anti-drug antibody responses"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
119
Recruitment Window Months
29
Consent Approach
Informed consent is obtained using Subject Information and Informed Consent Form (L1 SIS ICF) documents; multiple language versions of the ICFs are available (examples: en, hu, it, es, nl, fr, de, cs, pl, el). Child-specific ICF (L1-sis-icf-child-fr and others) and partner-pregnancy ICF documents are present, indicating age-specific consent materials and partner/pregnancy information. Consent and subject information are handled via the provided L1 and L2 documents as listed in the CTIS documents.

Methods

  • Posters — site-level posters for patients (country-specific versions present: HU, IT, ES, NL, PL, CS, FR, DE, EL, etc.)
  • Flyers — printed flyers for public/patients (country-specific versions present)
  • Social media adverts — digital recruitment via social media channels (country-specific versions present)
  • HCP referral letters — letters to healthcare professionals to refer eligible patients
  • Employer letters — letters to employers to help reach potential participants
  • Study brochure / trifold brochure — informational printed brochures for patients
  • Participant invitation/participant letter — direct mailed or handed letters to potential participants
  • Videos / videoscript — video materials for recruitment (placebo videoscript referenced)
  • Patient reminder cards and visit preparation materials

Geography

Total Number Of Sites
43
Total Number Of Participants
132

Hungary

Earliest CTIS Part Ii Submission Date
27-11-2025
Latest Decision Or Authorization Date
07-01-2026
Processing Time Days
41
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
University Of Debrecen
Department Name
Debreceni Egyetem Borgyogyaszati Klinika
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.unideb.hu
Site Name
University Of Pecs
Department Name
Pecsi Tudományegyetem Bor, Nemikortani es Onkodermatológiai Klinika
Contact Person Name
Zsuzsanna Lengyel
Contact Person Email
lengyel.zsuzsanna@pte.hu
Site Name
Vita Verum Medical Bt.
Department Name
Vitaverum Medical Bt
Contact Person Name
Viktor Gerzanics
Contact Person Email
gerzanicsviktor75@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
28-11-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
25
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Azienda USL Toscana Centro
Department Name
Azienda USL Toscana Centro - Presidio Ospedaliero Piero Palagi
Contact Person Name
Francesca Prignano
Contact Person Email
francesca.prignano@unifi.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Presidio Ospedaliero Gaspare Rodolico
Contact Person Name
Giuseppe Micali
Contact Person Email
gmicalitrial@gmail.com
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
IRCCS Regina Elena - IFO Respiratorio
Contact Person Name
Maria concetta Fargnoli

Spain

Earliest CTIS Part Ii Submission Date
05-12-2025
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
35
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Hospital De Manises
Department Name
Hospital de Manises
Contact Person Name
Antonio Martorell
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Hospital Universitario de Gran Canaria Doctor Negrín
Contact Person Name
Elena Castro-Gonzalez
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Complejo Hospitalario Universitario de Santiago (CHUS)
Contact Person Name
Maria Isabel Rodriguez Blanco
Site Name
Hospital Universitario Puerta Del Mar
Department Name
Hospital Universitario Puerta del Mar
Contact Person Name
David Jimenez Gallo
Contact Person Email
davidjimenezgallo@gmail.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Hospital Virgen de las Nieves
Contact Person Name
Alejandro Molina-Leyva
Contact Person Email
alejandromolinaleyva@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Hospital Universitario La Paz Dermatology
Contact Person Name
Pedro Herranz Pinto
Contact Person Email
pherranzp@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hospital General Universitario Gregorio Marañón Hospital Gregorio Marañon
Contact Person Name
Cristina Ciudad Blanco
Contact Person Email
cristinaciudadblanco@gmail.com
Site Name
Hospital Universitario Puerta Del Mar (additional site listing)
Department Name
Hospital Universitario Puerta del Mar

Netherlands

Earliest CTIS Part Ii Submission Date
09-12-2025
Latest Decision Or Authorization Date
31-12-2025
Processing Time Days
22
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Universitair Medisch Centrum Groningen
Contact Person Name
Barbara Horvath
Contact Person Email
b.horvath@umcg.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Erasmus Medisch Centrum
Contact Person Name
Hessel Van Der Zee
Contact Person Email
h.vanderzee@erasmusmc.nl

Poland

Earliest CTIS Part Ii Submission Date
04-12-2025
Latest Decision Or Authorization Date
04-01-2026
Processing Time Days
31
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Dermed Centrum Medyczne Sp. z o.o.
Department Name
DERMED Centrum Medyczne Sp. z o.o.
Contact Person Name
Aleksandra Kaszuba
Contact Person Email
akaszuba@op.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Klinika Dermatologii
Contact Person Name
Irena Walecka Herniczek
Contact Person Email
dermatologia@pimmswia.gov.pl
Site Name
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
Department Name
Cityclinic Przychodnia Lekarsko- Psychologiczna Matusiak Spółka Partnerska
Contact Person Name
Jacek Szepietowski
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Uniwersyteckie Centrum Dermatologii Ogolnej i Onkologicznej
Contact Person Name
Alina Jankowska-Konsur
Contact Person Email
alina.konsur@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
27-11-2025
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
42
Number Of Sites
4
Number Of Participants
21

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Fakultní nemocnice Ostrava Kozni oddeleni
Contact Person Name
Yvetta Vantuchova
Contact Person Email
yvetta.vantuchova@fno.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Fakultní nemocnice v Motole Dermatovenerologicke oddeleni
Contact Person Name
Alena Machovcova
Contact Person Email
alena.machovcova@fnmotol.cz
Site Name
CCR Ostrava s.r.o.
Department Name
CCR Ostrava
Contact Person Name
SYLVA ZAJICOVA
Contact Person Email
sylva.zajicova@ccrostrava.com
Site Name
Sanatorium Profesora Arenbergera
Department Name
Sanatorium Profesora Arenbergera
Contact Person Name
Monika Arenbergerova
Contact Person Email
arenbergerova@email.cz

France

Earliest CTIS Part Ii Submission Date
12-12-2025
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
10
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Courlancy Sante
Department Name
Polyclinique Courlancy-Bezannes
Contact Person Name
Ziad REGUIAI
Contact Person Email
dr-reguiai@orange.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service Dermatologie
Contact Person Name
Marion Marcaillou
Contact Person Email
marcaillou.m@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
CHU Saint-Etienne – Hopital Nord
Contact Person Name
Jean-Luc Perrot
Contact Person Email
j.luc.perrot@chu-st-etienne.fr
Site Name
Hospices Civils De Lyon
Department Name
HCL Lyon - Hopital Edouard Herriot Service de Dermatologie
Contact Person Name
Axel.P Villani
Contact Person Email
axel.villani@chu-lyon.fr
Site Name
Hopital Prive D Antony
Department Name
Hôpital Privé d'Antony Service de Dermatologie
Contact Person Name
Becherel Pierre-Andre
Contact Person Email
p.becherel@ramsaygds.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
General Hospital of Athens Alexandra
Contact Person Name
Olivier COGREL
Contact Person Email
olivier.cogrel@chu-bordeaux.fr

Germany

Earliest CTIS Part Ii Submission Date
28-11-2025
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
25
Number Of Sites
9
Number Of Participants
25

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Sascha Gerdes
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Andreas Pinter
Contact Person Email
pinter-klifo-ffm@gmx.de
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Klinik für Dermatologie und Allergologie
Contact Person Name
Falk Bechara
Contact Person Email
falk.bechara@kklbo.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik und Poliklinik II
Contact Person Name
Dagmar Presser
Contact Person Email
Presser_D1@ukw.de
Site Name
Dermatologische Praxis an der Hase
Department Name
Dermatologisches Studienzentrum an der Hase
Contact Person Name
Ansgar Weyergraf
Contact Person Email
aweyergraf_dzosn@web.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Hautklinik und Poliklinik Abteilung für Dermatologie und Allergologie
Contact Person Name
Caroline Mann
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Hautklinik Allgemeine Dermatologie und Venerologie
Contact Person Name
Nina Magnolo
Contact Person Email
nina.magnolo@ukmuenster.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (additional listing)
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Site Name
Additional German site listing

Greece

Earliest CTIS Part Ii Submission Date
04-11-2025
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
114
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
B Dermatology Clinic
Contact Person Name
Elisavet Lazaridou
Contact Person Email
bethlaz@auth.gr
Site Name
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Department Name
1st Department of Dermatology
Contact Person Name
Alexander Stratigos
Contact Person Email
alstrat2@gmail.com
Site Name
Andreas Syngros Hospital Of Venereal And Dermatological Diseases (additional listing)
Department Name
Dermatology and Neurology Department
Contact Person Name
Vasiliki Chasapi
Contact Person Email
chasapiresearch@gmail.com
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
4th Department Internal Medicine
Contact Person Name
Evangelos Giamarellos-Bourboulis
Contact Person Email
egiamarel@med.uoa.gr

Sponsor

Primary sponsor

Full Name
Sanofi-Aventis Recherche & Developpement
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Eresearchtechnology Inc.
Responsibilities
e-COA
Name
Labcorp Central Laboratory Services LP
Name
Suvoda LLC
Name
Accellacare Limited
Responsibilities
Home nursing
Name
Medidata Solutions Inc.
Name
ESMS Global Limited
Responsibilities
Centralized 24-hour Emergency System: eSMS
Name
Marken

Third parties

  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"e-COA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Accellacare Limited","duties_or_roles":"Home nursing","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Marken","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
brivekimig
Modality
Monoclonal antibody
Investigational Product Name
Placebo
Modality
Other

Related trials

Other published trials that may interest you.