Clinical trial • Phase II • Dermatology
TULISOKIBART for Hidradenitis suppurativa
Phase II trial of TULISOKIBART for Hidradenitis suppurativa.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Hidradenitis suppurativa
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 08-04-2025
- First CTIS Authorization Date
- 04-08-2025
Trial design
Randomised, tulisokibart (mk-7240) administered via subcutaneous solution for injection in pre-filled injector; placebo for mk-7240 (placebo comparator). dose and schedule not specified in ctis record.-controlled Phase II trial across 13 sites in Italy, France, Germany and others.
- Randomised
- Yes
- Comparator
- tulisokibart (MK-7240) administered via subcutaneous solution for injection in pre-filled injector; Placebo for MK-7240 (placebo comparator). Dose and schedule not specified in CTIS record.
- Target Sample Size
- 162
Eligibility
Recruits 162 isVulnerablePopulationSelected: false. Informed consent will be obtained using the provided L1_ICF Main consent documents (country-specific versions listed in the dossier). No vulnerable population (e.g., children) is indicated in the CTIS record..
- Vulnerable Population
- isVulnerablePopulationSelected: false. Informed consent will be obtained using the provided L1_ICF Main consent documents (country-specific versions listed in the dossier). No vulnerable population (e.g., children) is indicated in the CTIS record.
Inclusion criteria
- {"criterion_text":"- Has signs and symptoms of hidradenitis suppurativa (HS) for ≥ 6 months prior to Screening and a clinical diagnosis of HS at Screening"}
- {"criterion_text":"- Has moderate or severe HS defined as a total combined number of ≥ 5 abscesses and/or inflammatory nodules, with HS lesions present in ≥ 2 distinct anatomical areas and ≥ 1 anatomic area of HS involvement characterized as Hurley Stage II or III"}
- {"criterion_text":"- Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to systemic antibiotics for treatment of HS"}
- {"criterion_text":"- Has ≤20 draining tunnel count at Screening and Randomization"}
Exclusion criteria
- {"criterion_text":"- Has other active skin conditions that may, in the judgment of the investigator, interfere with the assessment of HS"}
- {"criterion_text":"- Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy"}
- {"criterion_text":"- Has a transplanted organ and requires continued systemic immunosuppression"}
- {"criterion_text":"- Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years"}
- {"criterion_text":"- Has had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments"}
- {"criterion_text":"- Has a known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)"}
- {"criterion_text":"- Has any active infection"}
- {"criterion_text":"- Has active tuberculosis"}
- {"criterion_text":"- Has had major surgery within the past 3 months or has a major surgery planned during the study"}
- {"criterion_text":"- Has a history of clinically significant drug or alcohol abuse within the past 6 months"}
- {"criterion_text":"- Has prior exposure to tulisokibart"}
- {"criterion_text":"- Has undergone laser therapy or surgical procedures for their lesions within the past 6 weeks or is planning to have laser therapy or surgical procedures for lesions during participation in the study"}
- {"criterion_text":"- Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR)50 at Week 16","definition_or_measurement_approach":"Assessed as the proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR)50 at Week 16"}
Secondary endpoints
- {"endpoint_text":"- Percentage of Participants Achieving HiSCR75 at Week 16","definition_or_measurement_approach":"Assessed as the proportion of participants achieving HiSCR75 at Week 16"}
- {"endpoint_text":"- Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16","definition_or_measurement_approach":"Mean change from baseline in DLQI score at Week 16"}
- {"endpoint_text":"- Percentage of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":"Proportion of participants reporting one or more adverse events during the study"}
- {"endpoint_text":"- Percentage of Participants Who Discontinue Study Intervention Due to an AE","definition_or_measurement_approach":"Proportion of participants who discontinue study intervention because of an adverse event"}
Recruitment
- Planned Sample Size
- 162
- Recruitment Window Months
- 31
- Consent Approach
- Informed consent obtained using country-specific L1_ICF Main consent documents (multiple country versions listed: Italy, France, Germany, Spain, Netherlands). No assent or minor-consent documents are indicated in the CTIS record.
Methods
- Country-specific recruitment arrangements documents (K1) are provided (Italy, France, Germany, Spain, Netherlands)
- Patient-facing materials provided per country: posters, patient flyers, brochures (K2 documents listed for each country)
- Local site recruitment via listed hospital/clinic sites (site contact details present in the record)
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 46
Italy
- Earliest CTIS Part Ii Submission Date
- 30-06-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 232
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- SOD CLINICA DERMATOLOGICA
- Principal Investigator Name
- Elisa Molinelli
- Principal Investigator Email
- elisa.molinelli@ospedaliriuniti.marche.it
- Contact Person Name
- Elisa Molinelli
- Contact Person Email
- elisa.molinelli@ospedaliriuniti.marche.it
France
- Earliest CTIS Part Ii Submission Date
- 12-06-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 249
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Direction Centrale Du Service De Sante Des Armees
- Department Name
- Dermatology
- Principal Investigator Name
- Thierry Boye
- Principal Investigator Email
- thierry.boye@yahoo.fr
- Contact Person Name
- Thierry Boye
- Contact Person Email
- thierry.boye@yahoo.fr
- Site Name
- Hospital Edouard Herriot
- Department Name
- Dermatology
- 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 Bordeaux
- Department Name
- Dermatology
- Principal Investigator Name
- Olivier Cogrel
- Principal Investigator Email
- olivier.cogrel@chu-bordeaux.fr
- Contact Person Name
- Olivier Cogrel
- Contact Person Email
- olivier.cogrel@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Dermatology
- Principal Investigator Name
- Bénédicte Oulès
- Principal Investigator Email
- benedicte.oules@aphp.fr
- Contact Person Name
- Bénédicte Oulès
- Contact Person Email
- benedicte.oules@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 03-07-2025
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 232
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Dermatologie, Venerologie und Allergologie
- Principal Investigator Name
- Sonja Molin
- Principal Investigator Email
- georgios.kokolakis@charite.de
- Contact Person Name
- Sonja Molin
- Contact Person Email
- georgios.kokolakis@charite.de
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Klinik für Dermatologie, Venerologie und Allergologie
- Principal Investigator Name
- Andreas Pinter
- Principal Investigator Email
- andreas.pinter@unimedizin-ffm.de
- Contact Person Name
- Andreas Pinter
- Contact Person Email
- andreas.pinter@unimedizin-ffm.de
Spain
- Earliest CTIS Part Ii Submission Date
- 04-07-2025
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 234
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Dermatologia
- Principal Investigator Name
- Alejandro Molina Leyva
- Principal Investigator Email
- alejandro.molina.sspa@juntadeandalucia.es
- Contact Person Name
- Alejandro Molina Leyva
- Contact Person Email
- alejandro.molina.sspa@juntadeandalucia.es
- Site Name
- Hospital De Manises
- Department Name
- Dermatologia
- Principal Investigator Name
- Antonio Jaime Martorell Calatayud
- Principal Investigator Email
- martorell_antcal@gva.es
- Contact Person Name
- Antonio Jaime Martorell Calatayud
- Contact Person Email
- martorell_antcal@gva.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Dermatologia
- Principal Investigator Name
- Jordi Mollet Sánchez
- Principal Investigator Email
- jordi.mollet@vallhebron.cat
- Contact Person Name
- Jordi Mollet Sánchez
- Contact Person Email
- jordi.mollet@vallhebron.cat
- Site Name
- Bellvitge University Hospital
- Department Name
- Dermatologia
- Principal Investigator Name
- Montserrat Bonfill Ortí
- Principal Investigator Email
- bonfill@bellvitgehospital.cat
- Contact Person Name
- Montserrat Bonfill Ortí
- Contact Person Email
- bonfill@bellvitgehospital.cat
Netherlands
- Earliest CTIS Part Ii Submission Date
- 25-07-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 206
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Dermatology
- Principal Investigator Name
- Hessel Van der Zee
- Principal Investigator Email
- startup.dermaresearch@erasmusmc.nl
- Contact Person Name
- Hessel Van der Zee
- Contact Person Email
- startup.dermaresearch@erasmusmc.nl
- Site Name
- Amphia Hospital
- Department Name
- Dermatology
- Principal Investigator Name
- Bas Prens
- Principal Investigator Email
- researchdermatologie@amphia.nl
- Contact Person Name
- Bas Prens
- Contact Person Email
- researchdermatologie@amphia.nl
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International Corp.
- Responsibilities
- EUB services (call center and medical services) (sponsorDuties code: 15)
- Name
- Syneos Health Clinique Inc.
- Responsibilities
- sponsorDuties code: 4
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties code: 4
- Name
- QPS LLC
- Responsibilities
- sponsorDuties code: 4
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties code: 7
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sponsorDuties codes: 15; value: EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Diagnostic Services Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- tulisokibart
- Active Substance
- TULISOKIBART
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- prodAuthStatus: 1
- Investigational Product Name
- Placebo for MK-7240
- Modality
- Other
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