Clinical trial • Phase III • Dermatology
SONELOKIMAB for Hidradenitis suppurativa
Phase III trial of SONELOKIMAB for Hidradenitis suppurativa. open-label. 317 participants.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Hidradenitis suppurativa
- Trial Stage
- Phase III
- Drug Modality
- Other antibody
Key dates
- Initial CTIS Submission Date
- 09-05-2025
- First CTIS Authorization Date
- 29-08-2025
Trial design
open-label Phase III trial in Bulgaria, Czechia, France and others.
- Open Label
- Yes
- Target Sample Size
- 317
Eligibility
Recruits 317 Participants must be able to understand and provide signed informed consent, or assent with parental/legal guardian consent, as applicable, per local regulations and guidelines..
- Pregnancy Exclusion
- 3. Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or (if women of childbearing potential [WOCBP]) must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. WOCBP must have a negative urine pregnancy test in the week prior to the first administration of study treatment in this study (Week 0). Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment (See Protocol Appendix 1 for the definitions of nonchildbearing potential, childbearing potential, and highly effective methods of contraception).
- Vulnerable Population
- Participants must be able to understand and provide signed informed consent, or assent with parental/legal guardian consent, as applicable, per local regulations and guidelines.
Inclusion criteria
- {"criterion_text":"- 1. Participants who have received the second to last and/or last dose, as planned in the parental study, and have completed the EOT visit (Week 52 [M1095-HS-301/302] or Week 24 [M1095-HS-304])."}
- {"criterion_text":"- 2. Participants must have received their last dose of study treatment in the parental study no more than 8 weeks before the first dose in this OLE study."}
- {"criterion_text":"- 3. Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or (if women of childbearing potential [WOCBP]) must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. WOCBP must have a negative urine pregnancy test in the week prior to the first administration of study treatment in this study (Week 0). Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment (See Protocol Appendix 1 for the definitions of nonchildbearing potential, childbearing potential, and highly effective methods of contraception)."}
- {"criterion_text":"- 4. Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment."}
- {"criterion_text":"- 5. Participants are considered reliable and capable of adhering to the protocol, visit schedule, and medication intake, according to the judgment of the investigator."}
- {"criterion_text":"- 6. Participants are able to understand and provide signed informed consent, or assent with parental/legal guardian consent, as applicable, per local regulations and guidelines."}
Exclusion criteria
- {"criterion_text":"- 1.\tParticipants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study, as below:"}
- {"criterion_text":"- 2. Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in this protocol (Section 6.9.2)."}
- {"criterion_text":"- 3. Participants who plan to participate in another interventional study for a drug or device during this study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Treatment-emergent adverse event (TEAEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- 2. Serious adverse event (SAEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- 3. TEAEs leading to study withdrawal","definition_or_measurement_approach":""}
- {"endpoint_text":"- 4. Adverse event of special interest (AESIs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- 5. Vital signs, and ECG results","definition_or_measurement_approach":""}
- {"endpoint_text":"- 6. Abnormal laboratory parameters (hematology, clinical chemistry)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 317
- Recruitment Window Months
- 32
- Consent Approach
- Signed informed consent to be provided by participants; assent with parental/legal guardian consent where applicable (per local regulations). Subject information and ICF documents available in multiple languages (examples present in the submission: English, Bulgarian, French, Hungarian, Spanish, Portuguese, Dutch, Italian, Czech, German, Polish, Slovak, Norwegian).
Geography
- Total Number Of Participants
- 317
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 12-08-2025
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 20
- Number Of Participants
- 48
Sites
- Site Name
- Umbal - Prof. D-R Stoyan Kirkovich AD
- Department Name
- Clinic of skin and venereal diseases
- Principal Investigator Name
- Evgeniya Hristakieva
- Principal Investigator Email
- ehristakieva@gmail.com
- Contact Person Name
- Evgeniya Hristakieva
- Contact Person Email
- ehristakieva@gmail.com
- Site Name
- Diagnostic-Consultative Center Alexandrovska EOOD
- Principal Investigator Name
- Snejina Vassileva
- Principal Investigator Email
- snejina.vassileva@gmail.com
- Contact Person Name
- Snejina Vassileva
- Contact Person Email
- snejina.vassileva@gmail.com
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- Clinic of Skin and Venereal Diseases
- Principal Investigator Name
- Dimitar Gospodinov
- Principal Investigator Email
- dkg@abv.bg
- Contact Person Name
- Dimitar Gospodinov
- Contact Person Email
- dkg@abv.bg
- Site Name
- Medical Center Hera EOOD
- Principal Investigator Name
- Maria Ratkova
- Principal Investigator Email
- maria.ratkova@heraclinics.com
- Contact Person Name
- Maria Ratkova
- Contact Person Email
- maria.ratkova@heraclinics.com
- Site Name
- Military Medical Academy
- Department Name
- Clinic of skin and venereal diseases
- Principal Investigator Name
- Vessel Kantardjiev
- Principal Investigator Email
- v.kantarjiev@vma.bg
- Contact Person Name
- Vessel Kantardjiev
- Contact Person Email
- v.kantarjiev@vma.bg
- Site Name
- ASMC IPSMC Skin And Venereal Diseases
- Principal Investigator Name
- Ivan Botev
- Principal Investigator Email
- botev2@yahoo.com
- Contact Person Name
- Ivan Botev
- Contact Person Email
- botev2@yahoo.com
- Site Name
- Dkc Fokus-5 Lzip OOD
- Principal Investigator Name
- Grisha Mateev
- Principal Investigator Email
- grisha_mateev@yahoo.com
- Contact Person Name
- Grisha Mateev
- Contact Person Email
- grisha_mateev@yahoo.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 05-08-2025
- Latest Decision Or Authorization Date
- 03-09-2025
- Processing Time Days
- 29
- Number Of Participants
- 18
Sites
- Site Name
- Kožní ordinace
- Principal Investigator Name
- Petr Arenberger
- Principal Investigator Email
- avemedica@email.cz
- Contact Person Name
- Petr Arenberger
- Contact Person Email
- avemedica@email.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Kožní oddělení
- Principal Investigator Name
- Yvetta Vantuchová
- Principal Investigator Email
- yvetta.vantuchova@fno.cz
- Contact Person Name
- Yvetta Vantuchová
- Contact Person Email
- yvetta.vantuchova@fno.cz
France
- Earliest CTIS Part Ii Submission Date
- 03-07-2025
- Latest Decision Or Authorization Date
- 03-09-2025
- Processing Time Days
- 62
- Number Of Participants
- 25
Sites
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Dermatology department
- Principal Investigator Name
- Laurent Misery
- Principal Investigator Email
- laurent.misery@chu-brest.fr
- Contact Person Name
- Laurent Misery
- Contact Person Email
- laurent.misery@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Dermatology department
- Principal Investigator Name
- Serge Boulinguez
- Principal Investigator Email
- boulinguez.s@chu-toulouse.fr
- Contact Person Name
- Serge Boulinguez
- Contact Person Email
- boulinguez.s@chu-toulouse.fr
- Site Name
- Direction Centrale Du Service De Sante Des Armees
- Department Name
- Dermatology Department
- Principal Investigator Name
- Aude Roussel
- Principal Investigator Email
- aude.roussel@intradef.gouv.fr
- Contact Person Name
- Aude Roussel
- Contact Person Email
- aude.roussel@intradef.gouv.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Dermatology department
- Principal Investigator Name
- Axel Villani
- Principal Investigator Email
- axel.villani@chu-lyon.fr
- Contact Person Name
- Axel Villani
- Contact Person Email
- axel.villani@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Dermatology department
- Principal Investigator Name
- Jean-Luc Perrot
- Principal Investigator Email
- j.luc.perrot@chu-st-etienne.fr
- Contact Person Name
- Jean-Luc Perrot
- Contact Person Email
- j.luc.perrot@chu-st-etienne.fr
- Site Name
- Hopital Prive D Antony
- Department Name
- Department of Dermatology
- Principal Investigator Name
- Pierre-Andre Becherel
- Principal Investigator Email
- p.becherel@ramsaygds.fr
- Contact Person Name
- Pierre-Andre Becherel
- Contact Person Email
- p.becherel@ramsaygds.fr
Hungary
- Earliest CTIS Part Ii Submission Date
- 04-06-2025
- Latest Decision Or Authorization Date
- 02-09-2025
- Processing Time Days
- 90
- Number Of Participants
- 12
Sites
- Site Name
- Obudai Egeszseguegyi Centrum Kft.
- Principal Investigator Name
- Beáta Bakos
- Principal Investigator Email
- beata.bakos@oec.hu
- Contact Person Name
- Beáta Bakos
- Contact Person Email
- beata.bakos@oec.hu
- Site Name
- University Of Pecs
- Department Name
- Bőr-, Nemikórtani és Onkodermatológiai Klinika
- Principal Investigator Name
- Zsuzsanna Lengyel
- Principal Investigator Email
- lengyel.zsuzsanna@pte.hu
- Contact Person Name
- Zsuzsanna Lengyel
- Contact Person Email
- lengyel.zsuzsanna@pte.hu
- Site Name
- Derma-B Kft.
- Principal Investigator Name
- Emese Herédi
- Principal Investigator Email
- emeseheredi@gmail.com
- Contact Person Name
- Emese Herédi
- Contact Person Email
- emeseheredi@gmail.com
- Site Name
- University Of Debrecen
- Department Name
- Bőrgyógyászati Klinika
- Principal Investigator Name
- Andrea Szegedi
- Principal Investigator Email
- aszegedi@med.unideb.hu
- Contact Person Name
- Andrea Szegedi
- Contact Person Email
- aszegedi@med.unideb.hu
Netherlands
- Earliest CTIS Part Ii Submission Date
- 27-08-2025
- Latest Decision Or Authorization Date
- 02-09-2025
- Processing Time Days
- 6
- Number Of Participants
- 5
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Dermatology
- Principal Investigator Name
- Hessel Van der Zee
- Principal Investigator Email
- dermaresearch@erasmusmc.nl
- Contact Person Name
- Hessel Van der Zee
- Contact Person Email
- dermaresearch@erasmusmc.nl
Norway
- Earliest CTIS Part Ii Submission Date
- 08-08-2025
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 24
- Number Of Participants
- 2
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Dermatology
- Principal Investigator Name
- Olav Sundnes
- Principal Investigator Email
- olasun@ous-hf.no
- Contact Person Name
- Olav Sundnes
- Contact Person Email
- olasun@ous-hf.no
Poland
- Earliest CTIS Part Ii Submission Date
- 01-08-2025
- Latest Decision Or Authorization Date
- 08-09-2025
- Processing Time Days
- 38
- Number Of Participants
- 144
Sites
- Site Name
- Clinical Research Center Sp. z o.o. Medic-R sp.k.
- Department Name
- -
- Principal Investigator Name
- Magdalena Czarnecka-Operacz
- Principal Investigator Email
- kontakt@cr-center.pl
- Contact Person Name
- Magdalena Czarnecka-Operacz
- Contact Person Email
- kontakt@cr-center.pl
- Site Name
- Pratia S.A.
- Department Name
- PRATIA MCM KRAKÓW
- Principal Investigator Name
- Dorota Kołodziejczyk
- Principal Investigator Email
- biuro.mcm@pratia.com
- Contact Person Name
- Dorota Kołodziejczyk
- Contact Person Email
- biuro.mcm@pratia.com
- Site Name
- Clinical Best Solutions Sp. z o.o. S.K.
- Department Name
- -
- Principal Investigator Name
- Mariusz Sikora
- Principal Investigator Email
- g.fiutkowski@clinicalCbs.com
- Contact Person Name
- Mariusz Sikora
- Contact Person Email
- g.fiutkowski@clinicalCbs.com
Slovakia
- Earliest CTIS Part Ii Submission Date
- 02-07-2025
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 61
- Number Of Participants
- 3
Sites
- Site Name
- Fakultna Nemocnica Trnava
- Department Name
- Dermatovenerologická klinika
- Principal Investigator Name
- Peter Kozub
- Principal Investigator Email
- peter.kozub.derm@gmail.com
- Contact Person Name
- Peter Kozub
- Contact Person Email
- peter.kozub.derm@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 27-06-2025
- Latest Decision Or Authorization Date
- 03-09-2025
- Processing Time Days
- 68
- Number Of Participants
- 56
Sites
- Site Name
- Hospital Universitario Puerta Del Mar
- Department Name
- Dermatology
- Principal Investigator Name
- David Jimenez Gallo
- Principal Investigator Email
- david.jimenez.gallo.sspa@juntadeandalucia.es
- Contact Person Name
- David Jimenez Gallo
- Contact Person Email
- david.jimenez.gallo.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Dermatology
- Principal Investigator Name
- Juan Alberto Ruano Ruiz
- Principal Investigator Email
- juan.ruano@imibic.org
- Contact Person Name
- Juan Alberto Ruano Ruiz
- Contact Person Email
- juan.ruano@imibic.org
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Dermatology
- Principal Investigator Name
- Maria Ángeles Florez Menendez
- Principal Investigator Email
- angeles.florez.menendez@sergas.es
- Contact Person Name
- Maria Ángeles Florez Menendez
- Contact Person Email
- angeles.florez.menendez@sergas.es
Belgium
- Earliest CTIS Part Ii Submission Date
- 05-08-2025
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 111
- Number Of Participants
- 5
Sites
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Dermatology
- Principal Investigator Name
- Arjen Nikkels
- Principal Investigator Email
- Af.nikkels@chuliege.be
- Contact Person Name
- Arjen Nikkels
- Contact Person Email
- Af.nikkels@chuliege.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Dermatology
- Principal Investigator Name
- Jo Lambert
- Principal Investigator Email
- Jo.lambert@uzgent.be
- Contact Person Name
- Jo Lambert
- Contact Person Email
- Jo.lambert@uzgent.be
- Site Name
- UZ Leuven
- Department Name
- Dermatology
- Principal Investigator Name
- An Van Laethem
- Principal Investigator Email
- An.vanlaethem@uzleuven.be
- Contact Person Name
- An Van Laethem
- Contact Person Email
- An.vanlaethem@uzleuven.be
Portugal
- Earliest CTIS Part Ii Submission Date
- 14-07-2025
- Latest Decision Or Authorization Date
- 29-10-2025
- Processing Time Days
- 107
- Number Of Participants
- 9
Sites
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Dermatology
- Principal Investigator Name
- Joana Antunes
- Principal Investigator Email
- joana.antunes@ulssm.min-saude.pt
- Contact Person Name
- Joana Antunes
- Contact Person Email
- joana.antunes@ulssm.min-saude.pt
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Dermatology
- Principal Investigator Name
- Ines Lobo
- Principal Investigator Email
- u08253@chporto.min-saude.pt
- Contact Person Name
- Ines Lobo
- Contact Person Email
- u08253@chporto.min-saude.pt
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Department Name
- Dermatology
- Principal Investigator Name
- Joana Cabete
- Principal Investigator Email
- joana.cabete@ulssjose.min-saude.pt
- Contact Person Name
- Joana Cabete
- Contact Person Email
- joana.cabete@ulssjose.min-saude.pt
Italy
- Earliest CTIS Part Ii Submission Date
- 21-07-2025
- Latest Decision Or Authorization Date
- 02-09-2025
- Processing Time Days
- 43
- Number Of Participants
- 36
Sites
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Dermatology Unit Operational address: Via Pace,9,Milano 20122 - Italy
- Principal Investigator Name
- Angelo Valerio Marzano
- Principal Investigator Email
- angelo.marzano@unimi.it
- Contact Person Name
- Angelo Valerio Marzano
- Contact Person Email
- angelo.marzano@unimi.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- Dipartimento Di Medicina E Chirurgia
- Principal Investigator Name
- Luca Stingeni
- Principal Investigator Email
- luca.stingeni@unipg.it
- Contact Person Name
- Luca Stingeni
- Contact Person Email
- luca.stingeni@unipg.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Medical Science-Section of Dermatology U
- Principal Investigator Name
- Simone Ribero
- Principal Investigator Email
- simone.ribero@unito.it
- Contact Person Name
- Simone Ribero
- Contact Person Email
- simone.ribero@unito.it
Germany
- Earliest CTIS Part Ii Submission Date
- 07-08-2025
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 25
- Number Of Participants
- 129
Sites
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Institute for Health Services Research
- Principal Investigator Name
- Matthias Augustin
- Principal Investigator Email
- m.augustin@uke.de
- Contact Person Name
- Matthias Augustin
- Contact Person Email
- m.augustin@uke.de
- Site Name
- Universitaet Muenster
- Department Name
- Clinic for Skin Disease
- Principal Investigator Name
- Nina Magnolo
- Principal Investigator Email
- Nina.magnolo@ukmuenster.de
- Contact Person Name
- Nina Magnolo
- Contact Person Email
- Nina.magnolo@ukmuenster.de
- Site Name
- St. Josef-Hospital
- Department Name
- Clinic for Dermatology, Venerology and Allergology
- Principal Investigator Name
- Falk Bechara
- Principal Investigator Email
- Falk.bechara@klinikum-bochum.de
- Contact Person Name
- Falk Bechara
- Contact Person Email
- Falk.bechara@klinikum-bochum.de
Sponsor
Primary sponsor
- Full Name
- MoonLake Immunotherapeutics AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Eresearchtechnology Inc.
- Responsibilities
- eCOA and ECG services
- Name
- Olink Proteomics AB
- Responsibilities
- Serum biomarkers
- Name
- Icon Clinical Research Limited
- Responsibilities
- codes: 1,12,2,5,6
- Name
- Medidata Solutions Inc.
- Responsibilities
- code: 7
Third parties
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA and ECG services","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"Olink Proteomics AB","duties_or_roles":"Serum biomarkers","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes: 1,12,2,5,6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code: 7","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Sonelokimab
- Active Substance
- SONELOKIMAB
- Modality
- Other antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Maximum Dose
- 120 mg/ml
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