Clinical trial • Phase II • Dermatology
RITLECITINIB TOSILATE for Hidradenitis suppurativa
Phase II trial of RITLECITINIB TOSILATE for Hidradenitis suppurativa.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Hidradenitis suppurativa
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 20-11-2025
- First CTIS Authorization Date
- 11-03-2026
Trial design
Randomised, placebo for pf-06651600-15 (placebo arm). dose and schedule not specified in provided data.-controlled Phase II trial in Greece, Poland, Spain and others.
- Randomised
- Yes
- Comparator
- Placebo for pf-06651600-15 (placebo arm). Dose and schedule not specified in provided data.
- Target Sample Size
- 49
- Trial Duration For Participant
- 112
Eligibility
Recruits 49 No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are adults (aged ≥18). Subject information and informed consent forms are provided (documents list includes informed consent forms for multiple countries/languages)..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are adults (aged ≥18). Subject information and informed consent forms are provided (documents list includes informed consent forms for multiple countries/languages).
Inclusion criteria
- {"criterion_text":"- Eligible participants must be aged ≥18 years old to ≤75 years of age with a documented clinical diagnosis of HS for at least 6 months."}
- {"criterion_text":"- Participants must have moderate to severe disease at baseline, defined as Hurley Stage II or III with ≥5 inflammatory lesions (abscesses and/or nodules not including draining fistulas) across at least 2 distinct anatomical areas."}
- {"criterion_text":"- Participants must have had an inadequate response to at least a 4-week course of systemic therapy for HS, or a documented medical reason as to why systemic treatment is not appropriate."}
Exclusion criteria
- {"criterion_text":"- ≥20 draining fistula count"}
- {"criterion_text":"- confounding dermatologic conditions"}
- {"criterion_text":"- prior use of a JAK inhibitor or BTK inhibitor"}
- {"criterion_text":"- any significant medical or psychiatric illness"}
- {"criterion_text":"- a maximum of approximately 40% of enrolled participants may have received prior anti-TNF-α treatment, IL-17 inhibitor, or IL-23 inhibitor"}
Endpoints
Primary endpoints
- {"endpoint_text":"- HiSCR50 response at Week 16","definition_or_measurement_approach":"Assessed by Hidradenitis Suppurativa Clinical Response (HiSCR)50."}
Secondary endpoints
- {"endpoint_text":"- HiSCR50 response at Weeks 1, 2, 4, 6, 8, and Week 12.","definition_or_measurement_approach":"HiSCR50 response measured at specified weeks."}
- {"endpoint_text":"- HiSCR75 response at Weeks 1, 2, 4, 6, 8, 12 and Week 16.","definition_or_measurement_approach":"HiSCR75 response measured at specified weeks."}
- {"endpoint_text":"- HiSCR90 response at Weeks 1, 2, 4, 6, 8, 12 and Week 16.","definition_or_measurement_approach":"HiSCR90 response measured at specified weeks."}
- {"endpoint_text":"- Response based on a total abscess and nodule (AN) count of 0 or 1 at Week 16.","definition_or_measurement_approach":"Total AN count assessed at Week 16; responder defined as AN count of 0 or 1."}
- {"endpoint_text":"- Response based on a total AN count of 0, 1, or 2 at Week 16.","definition_or_measurement_approach":"Total AN count assessed at Week 16; responder defined as AN count of 0, 1, or 2."}
- {"endpoint_text":"- Percent (%) change from baseline (CFB) in total AN count at Weeks 1, 2, 4, 6, 8, 12 and 16.","definition_or_measurement_approach":"Percent change from baseline in total AN count measured at specified weeks."}
- {"endpoint_text":"- Absolute score and CFB in HS-IGA at Weeks 1, 2, 4, 6, 8, 12 and 16.","definition_or_measurement_approach":"Absolute HS-IGA score and change from baseline measured at specified weeks."}
- {"endpoint_text":"- Response based on achieving a HS-IGA=0 or 1 at Weeks 1, 2, 4, 6, 8, 12 and 16.","definition_or_measurement_approach":"HS-IGA responder defined as HS-IGA = 0 or 1 measured at specified weeks."}
- {"endpoint_text":"- Participants who experience an HS flare, defined as at least a 25% increase in total AN count with a minimum increase of 2 relative to Baseline, at Weeks 4, 8, 12 and 16.","definition_or_measurement_approach":"HS flare defined as ≥25% increase in total AN count with minimum absolute increase of 2 vs baseline; assessed at Weeks 4, 8, 12, 16."}
- {"endpoint_text":"- CFB in Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) at Weeks 1, 2, 4, 6, 8, 12 and 16.","definition_or_measurement_approach":"Change from baseline in HSSDD scores measured at specified weeks."}
- {"endpoint_text":"- Skin pain NRS30 response, at worst and on average, respectively, at Weeks 1, 2, 4, 6, 8, 12, and 16, among participants with baseline skin pain numeric rating scale (NRS) ≥3.","definition_or_measurement_approach":"NRS30 skin pain response (worst and average) among participants with baseline NRS ≥3, measured at specified weeks."}
- {"endpoint_text":"- %CFB in skin pain NRS, at worst and on average, respectively, in participants with baseline skin pain NRS ≥3, at Weeks 1, 2, 4, 6, 8, 12, and 16.","definition_or_measurement_approach":"Percent change from baseline in skin pain NRS (worst and average) among participants with baseline NRS ≥3, measured at specified weeks."}
- {"endpoint_text":"- CFB in skin pain NRS, at worst and on average, respectively, at Weeks 1, 2, 4, 6, 8, 12, and 16.","definition_or_measurement_approach":"Change from baseline in skin pain NRS (worst and average) measured at specified weeks."}
- {"endpoint_text":"- Skin pain NRS50 response, at worst and on average, respectively, at Weeks 1, 2, 4, 6, 8, 12, and 16, among participants with baseline skin pain NRS ≥3.","definition_or_measurement_approach":"NRS50 skin pain response (worst and average) among participants with baseline NRS ≥3, measured at specified weeks."}
- {"endpoint_text":"- Skin pain NRS70 response, at worst and on average, respectively, at Weeks 1, 2, 4, 6, 8, 12, and 16, among participants with baseline skin pain NRS ≥3.","definition_or_measurement_approach":"NRS70 skin pain response (worst and average) among participants with baseline NRS ≥3, measured at specified weeks."}
- {"endpoint_text":"- Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation","definition_or_measurement_approach":"Incidence of TEAEs, SAEs and AEs leading to discontinuation monitored/recorded over study period."}
- {"endpoint_text":"- Incidence of clinically significant laboratory abnormalities over time","definition_or_measurement_approach":"Clinically significant laboratory abnormalities tracked over time."}
- {"endpoint_text":"- Absolute score and CFB in Hidradenitis Suppurativa Quality of Life (HiSQOL) at Weeks 1, 2, 4, 6, 8, 12 and 16.","definition_or_measurement_approach":"Absolute HiSQOL score and change from baseline measured at specified weeks."}
- {"endpoint_text":"- Absolute score and % CFB in IHS4 at Weeks 1, 2, 4, 6, 8, 12 and 16.","definition_or_measurement_approach":"Absolute IHS4 score and percent change from baseline measured at specified weeks."}
Recruitment
- Planned Sample Size
- 49
- Recruitment Window Months
- 11
- Consent Approach
- Informed consent is obtained from each participant (adults ≥18). Subject information and informed consent form documents are provided for participating countries; available document entries include English, Greek, Polish, Spanish and German versions.
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 71
Greece
- Earliest CTIS Part Ii Submission Date
- 29-12-2025
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 73
- Number Of Sites
- 7
- Number Of Participants
- 12
Sites
- Site Name
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
- Department Name
- 1st Department of Dermatology and Venerology
- Principal Investigator Name
- Alexandros Stratigos
- Principal Investigator Email
- alstrat2@gmail.com
- Contact Person Name
- Alexandros Stratigos
- Contact Person Email
- alstrat2@gmail.com
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 4th Department of Internal Medicine
- Principal Investigator Name
- Evangelos Giamarellos-Bourboulis
- Principal Investigator Email
- egiamarel@med.uoa.gr
- Contact Person Name
- Evangelos Giamarellos-Bourboulis
- Contact Person Email
- egiamarel@med.uoa.gr
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- 2nd Department of Dermatology and Venereolgy
- Principal Investigator Name
- Elisavet Lazaridou
- Principal Investigator Email
- bethlaz@auth.gr
- Contact Person Name
- Elisavet Lazaridou
- Contact Person Email
- bethlaz@auth.gr
- Site Name
- General University Hospital Of Larissa
- Department Name
- Dermatology Department
- Principal Investigator Name
- Efterpi Zafeiriou
- Principal Investigator Email
- zafevi@o365.uth.gr
- Contact Person Name
- Efterpi Zafeiriou
- Contact Person Email
- zafevi@o365.uth.gr
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Dermatology Department
- Principal Investigator Name
- Konstantinos Krasagakis
- Principal Investigator Email
- krasagak@med.uoc.gr
- Contact Person Name
- Konstantinos Krasagakis
- Contact Person Email
- krasagak@med.uoc.gr
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 2nd Department of Dermatology and Venereology
- Principal Investigator Name
- Alexandros Katoulis
- Principal Investigator Email
- alexanderkatoulis@yahoo.co.uk
- Contact Person Name
- Alexandros Katoulis
- Contact Person Email
- alexanderkatoulis@yahoo.co.uk
- Site Name
- Athens Medical Center S.A.
- Department Name
- Dermatology Department
- Principal Investigator Name
- Markos Papakonstantis
- Principal Investigator Email
- markospapakonstantis@gmail.com
- Contact Person Name
- Markos Papakonstantis
- Contact Person Email
- markospapakonstantis@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 20-02-2026
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 35
- Number Of Sites
- 11
- Number Of Participants
- 39
Sites
- Site Name
- Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
- Principal Investigator Name
- Jacek Szepietowski
- Principal Investigator Email
- jacek.szepietowski.work@gmail.com
- Contact Person Name
- Jacek Szepietowski
- Contact Person Email
- jacek.szepietowski.work@gmail.com
- Site Name
- Klinika Ambroziak Sp. z o.o.
- Principal Investigator Name
- Justyna Skibinska
- Principal Investigator Email
- principalskibinska@klinikaambroziak.pl
- Contact Person Name
- Justyna Skibinska
- Contact Person Email
- principalskibinska@klinikaambroziak.pl
- Site Name
- Soft Skin Medical Center Dr Elzbieta Wojtowicz-Prus
- Principal Investigator Name
- Elzbieta Wojtowicz-Prus
- Principal Investigator Email
- wojtowiczprus.ela@gmail.com
- Contact Person Name
- Elzbieta Wojtowicz-Prus
- Contact Person Email
- wojtowiczprus.ela@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
- Department Name
- Klinika Dermatologii i Dermatologii Onkologicznej
- Principal Investigator Name
- Adam Reich
- Principal Investigator Email
- adamandrzejreich@gmail.com
- Contact Person Name
- Adam Reich
- Contact Person Email
- adamandrzejreich@gmail.com
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Principal Investigator Name
- Irena Walecka-Herniczek
- Principal Investigator Email
- irena.walecka@pimmswia.gov.pl
- Contact Person Name
- Irena Walecka-Herniczek
- Contact Person Email
- irena.walecka@pimmswia.gov.pl
- Site Name
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Department Name
- Twoja Przychodnia SCM
- Principal Investigator Name
- Tadeusz Debniak
- Principal Investigator Email
- debniak@twojaprzychodnia.com
- Contact Person Name
- Tadeusz Debniak
- Contact Person Email
- debniak@twojaprzychodnia.com
- Site Name
- Royalderm Sp. z o.o.
- Principal Investigator Name
- Witold Owczarek
- Principal Investigator Email
- witold.owczarek@dermedicus.pl
- Contact Person Name
- Witold Owczarek
- Contact Person Email
- witold.owczarek@dermedicus.pl
- Site Name
- Centrum Badan Klinicznych Pi-House Sp. z o.o.
- Principal Investigator Name
- Damian Kadylak
- Principal Investigator Email
- d.kadylak@pihouse.pl
- Contact Person Name
- Damian Kadylak
- Contact Person Email
- d.kadylak@pihouse.pl
- Site Name
- Trialmed Sp. z o.o.
- Principal Investigator Name
- Ewa Ring
- Principal Investigator Email
- dermasters@wp.pl
- Contact Person Name
- Ewa Ring
- Contact Person Email
- dermasters@wp.pl
- Site Name
- Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
- Principal Investigator Name
- Hubert Arasiewicz
- Principal Investigator Email
- hubert.arasiewicz@gmail.com
- Contact Person Name
- Hubert Arasiewicz
- Contact Person Email
- hubert.arasiewicz@gmail.com
- Site Name
- Dermedic Jacek Zdybski
- Principal Investigator Name
- Piotr Parcheta
- Principal Investigator Email
- piotr.parcheta@zdybski.pl
- Contact Person Name
- Piotr Parcheta
- Contact Person Email
- piotr.parcheta@zdybski.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 15-01-2026
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 77
- Number Of Sites
- 5
- Number Of Participants
- 8
Sites
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Dermatología
- Principal Investigator Name
- Cristina Ciudad Blanco
- Principal Investigator Email
- cristinaciudadblanco@gmail.com
- Contact Person Name
- Cristina Ciudad Blanco
- Contact Person Email
- cristinaciudadblanco@gmail.com
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Dermatology
- Principal Investigator Name
- Alejandro Molina Leyva
- Principal Investigator Email
- alejandromolinaleyva@gmail.com
- Contact Person Name
- Alejandro Molina Leyva
- Contact Person Email
- alejandromolinaleyva@gmail.com
- Site Name
- Hospital De Manises
- Department Name
- Dermatology
- Principal Investigator Name
- Antonio Martorell Calatayud
- Principal Investigator Email
- antmarto@Hotmail.com
- Contact Person Name
- Antonio Martorell Calatayud
- Contact Person Email
- antmarto@Hotmail.com
- Site Name
- Complexo Hospitalario Universitario De Pontevedra
- Department Name
- Dermatology department
- Principal Investigator Name
- Teresa Abalde Pintos
- Principal Investigator Email
- Teresa.abalde.pintos@sergas.es
- Contact Person Name
- Teresa Abalde Pintos
- Contact Person Email
- Teresa.abalde.pintos@sergas.es
- Site Name
- Hospital Universitario Puerta Del Mar
- Department Name
- Dermatology Medical- Surgical and Venerology
- Principal Investigator Name
- David Jimenez Gallo
- Principal Investigator Email
- Davidjimenezgallo@gmail.com
- Contact Person Name
- David Jimenez Gallo
- Contact Person Email
- Davidjimenezgallo@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 19-02-2026
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 20
- Number Of Sites
- 6
- Number Of Participants
- 12
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Principal Investigator Name
- Caroline Mann
- Principal Investigator Email
- caroline.mann@unimedizin-mainz.de
- Contact Person Name
- Caroline Mann
- Contact Person Email
- caroline.mann@unimedizin-mainz.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Principal Investigator Name
- Matthias Augustin
- Principal Investigator Email
- augustin@cedef.de
- Contact Person Name
- Matthias Augustin
- Contact Person Email
- augustin@cedef.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Principal Investigator Name
- Diamant Thaci
- Principal Investigator Email
- diamant.thaci@uksh.de
- Contact Person Name
- Diamant Thaci
- Contact Person Email
- diamant.thaci@uksh.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Principal Investigator Name
- Dagmar Presser
- Principal Investigator Email
- presser_d1@ukw.de
- Contact Person Name
- Dagmar Presser
- Contact Person Email
- presser_d1@ukw.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Principal Investigator Name
- Roland Aschoff
- Principal Investigator Email
- roland.aschoff@uniklinikum-dresden.de
- Contact Person Name
- Roland Aschoff
- Contact Person Email
- roland.aschoff@uniklinikum-dresden.de
- Site Name
- Goethe University Frankfurt
- Principal Investigator Name
- Andreas Pinter
- Principal Investigator Email
- pinter-klifo-ffm@gmx.de
- Contact Person Name
- Andreas Pinter
- Contact Person Email
- pinter-klifo-ffm@gmx.de
Sponsor
Primary sponsor
- Full Name
- Pfizer Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Meeting Protocol Worldwide LP
- Responsibilities
- patient reimboursement
- Name
- Continuum Clinical LLC
- Name
- Iqvia Biotech LLC
- Name
- Pharmaceutical Product Development LLC
- Name
- Icon Clinical Research Limited
- Responsibilities
- clinician support
Third parties
- {"country":"United States","full_name":"Meeting Protocol Worldwide LP","duties_or_roles":"patient reimboursement","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Continuum Clinical LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"clinician support","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ritlecitinib Tosilate
- Active Substance
- RITLECITINIB TOSILATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 1
- Investigational Product Name
- Placebo for pf-06651600-15
- Modality
- Other
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