Clinical trial • Phase II • Immunology|Dermatology
RITLECITINIB TOSILATE for Chronic spontaneous urticaria
Phase II trial of RITLECITINIB TOSILATE for Chronic spontaneous urticaria.
Overview
- Trial Therapeutic Area
- Immunology|Dermatology
- Trial Disease
- Chronic spontaneous urticaria
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 30-10-2025
- First CTIS Authorization Date
- 25-02-2026
Trial design
Randomised, placebo for pf-06651600-15, 100 mg; placebo for pf-06651600-15, 50 mg (placebo-controlled arms). Phase II trial across 29 sites in Bulgaria, Germany, Spain and others.
- Randomised
- Yes
- Comparator
- Placebo for pf-06651600-15, 100 mg; Placebo for pf-06651600-15, 50 mg (placebo-controlled arms).
- Target Sample Size
- 104
- Trial Duration For Participant
- 168
Eligibility
Recruits 104 No vulnerable populations selected (isVulnerablePopulationSelected = false). Study enrols adults (≥18 years). Consent obtained from participants; no assent/parental consent processes for minors are described..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected = false). Study enrols adults (≥18 years). Consent obtained from participants; no assent/parental consent processes for minors are described.
Inclusion criteria
- {"criterion_text":"- adults (aged ≥18 years old or minimum legal adult age as defined per local regulation, whichever is greater)\n- clinical diagnosis of CSU for ≥3 months at the time of screening who remain symptomatic despite treatment with second generation H1-antihistamines (sgAH) (at locally approved dose or higher) and are anti-IgEnaïve or anti-IgE-experienced (who stopped, could not tolerate, or did not adequately respond)"}
Exclusion criteria
- {"criterion_text":"- Participants will not be eligible if their urticaria is solely due to inducible urticaria, have active dermatological diseases other than CSU with urticaria wheels or angioedema or other skin diseases associated with chronic itching."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in UAS7 at Week 12","definition_or_measurement_approach":"Change from baseline in UAS7 score at Week 12 (comparison of UAS7 at Week 12 versus baseline)."}
- {"endpoint_text":"- Incidence of TEAEs, SAEs, and AEs leading to discontinuation","definition_or_measurement_approach":"Incidence (frequency) of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) resulting in discontinuation, as recorded during the study period."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in UAS7 at all timepoints except Week 12","definition_or_measurement_approach":"Change from baseline in UAS7 score at scheduled timepoints other than Week 12."}
- {"endpoint_text":"- Change from baseline in ISS7 at Week 12","definition_or_measurement_approach":"Change from baseline in ISS7 score at Week 12."}
- {"endpoint_text":"- Change from baseline in HSS7 at Week 12","definition_or_measurement_approach":"Change from baseline in HSS7 score at Week 12."}
- {"endpoint_text":"- Achieving complete response defined as UAS7=0 at Week 12","definition_or_measurement_approach":"Proportion of participants with UAS7 equal to 0 at Week 12 (complete response)."}
- {"endpoint_text":"- Achieving UAS7 ≤6 at Week 12","definition_or_measurement_approach":"Proportion of participants with UAS7 ≤ 6 at Week 12."}
- {"endpoint_text":"- Achieving complete response defined as ISS7=0 at Week 12","definition_or_measurement_approach":"Proportion of participants with ISS7 equal to 0 at Week 12."}
- {"endpoint_text":"- Achieving complete response defined as HSS7=0 at Week 12","definition_or_measurement_approach":"Proportion of participants with HSS7 equal to 0 at Week 12."}
- {"endpoint_text":"- Time to achieving UAS7 ≤6","definition_or_measurement_approach":"Time-to-event (time in days/weeks) from baseline to first occurrence of UAS7 ≤ 6."}
- {"endpoint_text":"- Time to achieving improvement from baseline ≥10 in UAS7","definition_or_measurement_approach":"Time-to-event from baseline to first occurrence of an improvement of ≥10 points in UAS7 compared to baseline."}
- {"endpoint_text":"- Incidence of TEAEs, SAEs, and AEs leading to discontinuation","definition_or_measurement_approach":"Incidence (frequency) of TEAEs, SAEs and AEs leading to discontinuation assessed across study visits."}
Recruitment
- Digital Remote Recruitment
- True, includes planned social media posts and digital recruitment mockup text (documents referencing 'post on socialmedia' and 'mockuptext' for Poland).
- Planned Sample Size
- 104
- Recruitment Window Months
- 12
- Consent Approach
- Informed consent obtained from adult participants (study enrols adults ≥18). Subject information and informed consent form documents available in multiple languages (documents present for BG, EN, DE, ES, PL). No assent or parental consent processes for minors are described.
Methods
- Country/site-specific recruitment arrangements documented (recruitment arrangements documents present for BG, DE, ES, PL).
- Printed recruitment materials: posters and leaflets (documents titled 'Recruiment Material', 'poster', 'leaflet' for Poland sites).
- Social media posts for site recruitment (documents titled 'site1095_post on socialmedia' and related mockup text for Poland).
- Site-level recruitment (clinic/ hospital sites listed with local contacts).
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 104
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 30-01-2026
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 31
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Medical Center Pulmo-2018 EOOD
- Principal Investigator Name
- Daniel Yankov
- Principal Investigator Email
- dr.d.yankov@abv.bg
- Contact Person Name
- Daniel Yankov
- Contact Person Email
- dr.d.yankov@abv.bg
- Site Name
- Diagnostic And Consulting Center 1 Pernik EOOD
- Principal Investigator Name
- Violina Filipova
- Principal Investigator Email
- dr_vfilipova@abv.bg
- Contact Person Name
- Violina Filipova
- Contact Person Email
- dr_vfilipova@abv.bg
- Site Name
- Asclepius Medical Center OOD
- Principal Investigator Name
- Boyka Stoyanova
- Principal Investigator Email
- dr.boyka.stoyanova@gmail.com
- Contact Person Name
- Boyka Stoyanova
- Contact Person Email
- dr.boyka.stoyanova@gmail.com
- Site Name
- Diagnostic-consultative center “Aleksandrovska” EOOD
- Principal Investigator Name
- Borislava Krusheva
- Principal Investigator Email
- b_krusheva_md@yahoo.com
- Contact Person Name
- Borislava Krusheva
- Contact Person Email
- b_krusheva_md@yahoo.com
- Site Name
- Diagnostic Consultative Centre Ascendent EOOD
- Principal Investigator Name
- Nadya Tosheva
- Principal Investigator Email
- nadya.derm@abv.bg
- Contact Person Name
- Nadya Tosheva
- Contact Person Email
- nadya.derm@abv.bg
- Site Name
- Medical Center Pulmovision Ltd.
- Principal Investigator Name
- Shasine Veli
- Principal Investigator Email
- dr_veli@abv.bg
- Contact Person Name
- Shasine Veli
- Contact Person Email
- dr_veli@abv.bg
- Site Name
- Medical Center Hera EOOD
- Principal Investigator Name
- Denislava Nedeva
- Principal Investigator Email
- denislava.nedeva@gmail.com
- Contact Person Name
- Denislava Nedeva
- Contact Person Email
- denislava.nedeva@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 05-02-2026
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 20
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Hautarztpraxis Dr. Leitz Und Kollegen
- Principal Investigator Name
- Nicolas Leitz
- Principal Investigator Email
- nicolas.leitz@tri-derm.de
- Contact Person Name
- Nicolas Leitz
- Contact Person Email
- nicolas.leitz@tri-derm.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Campus Benjamin Franklin
- Principal Investigator Name
- Martin Metz
- Principal Investigator Email
- Martin.Metz@charite.de
- Contact Person Name
- Martin Metz
- Contact Person Email
- Martin.Metz@charite.de
- Site Name
- Universitaetsklinikum Giessen und Marburg GmbH
- Principal Investigator Name
- Wolfgang Pfützner
- Principal Investigator Email
- wolfgang.pfuetzner@med.uni-marburg.de
- Contact Person Name
- Wolfgang Pfützner
- Contact Person Email
- wolfgang.pfuetzner@med.uni-marburg.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Klinik und Poliklinik für Dermatologie
- Principal Investigator Name
- Andrea Bauer
- Principal Investigator Email
- andrea.bauer@uniklinikum-dresden.de
- Contact Person Name
- Andrea Bauer
- Contact Person Email
- andrea.bauer@uniklinikum-dresden.de
- Site Name
- Universitaet Leipzig
- Department Name
- Department of Dermatology
- Principal Investigator Name
- Jan Simon
- Principal Investigator Email
- jan.simon@medizin.uni-leipzig.de
- Contact Person Name
- Jan Simon
- Contact Person Email
- jan.simon@medizin.uni-leipzig.de
- Site Name
- Helios Universitaetsklinikum Wuppertal
- Department Name
- Campus Barmen
- Principal Investigator Name
- Galina Balakirski
- Principal Investigator Email
- galina.balakirski@helios-gesundheit.de
- Contact Person Name
- Galina Balakirski
- Contact Person Email
- galina.balakirski@helios-gesundheit.de
- Site Name
- Universitätsklinikum Münster
- Principal Investigator Name
- Mathias Sulk
- Principal Investigator Email
- mathias.sulk@ukmuenster.de
- Contact Person Name
- Mathias Sulk
- Contact Person Email
- mathias.sulk@ukmuenster.de
Spain
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 30
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Universitario Fundacion Alcorcon
- Department Name
- Dermatology
- Principal Investigator Name
- José Luis López Estebaranz
- Principal Investigator Email
- jllopez@fhalcorcon.es
- Contact Person Name
- José Luis López Estebaranz
- Contact Person Email
- jllopez@fhalcorcon.es
- Site Name
- Hospital Arnau De Vilanova De Valencia
- Department Name
- Dermatology
- Principal Investigator Name
- Francisco Javier Miquel Miquel
- Principal Investigator Email
- miquel_framiq@gva.es
- Contact Person Name
- Francisco Javier Miquel Miquel
- Contact Person Email
- miquel_framiq@gva.es
- Site Name
- Hospital Del Mar
- Department Name
- Dermatology
- Principal Investigator Name
- Ana María Giménez Arnau
- Principal Investigator Email
- anamariagimenezarnau@gmail.com
- Contact Person Name
- Ana María Giménez Arnau
- Contact Person Email
- anamariagimenezarnau@gmail.com
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Dermatology
- Principal Investigator Name
- Juan Alberto Ruano Ruiz
- Principal Investigator Email
- juanruanoruiz@mac.com
- Contact Person Name
- Juan Alberto Ruano Ruiz
- Contact Person Email
- juanruanoruiz@mac.com
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Dermatology
- Principal Investigator Name
- Laura Bernal Masferrer
- Principal Investigator Email
- informacion.sector2@salud.aragon.es
- Contact Person Name
- Laura Bernal Masferrer
- Contact Person Email
- informacion.sector2@salud.aragon.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Dermatology
- Principal Investigator Name
- Mercedes Rodríguez Serna
- Principal Investigator Email
- merroser@gmail.com
- Contact Person Name
- Mercedes Rodríguez Serna
- Contact Person Email
- merroser@gmail.com
- Site Name
- Clinica Gaias Santiago
- Department Name
- Dermatology
- Principal Investigator Name
- Hae Jin Suh Oh
- Principal Investigator Email
- haejinensayos@hotmail.com
- Contact Person Name
- Hae Jin Suh Oh
- Contact Person Email
- haejinensayos@hotmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 07-03-2026
- Processing Time Days
- 33
- Number Of Sites
- 8
- Number Of Participants
- 25
Sites
- Site Name
- Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
- Department Name
- ALERGO-MED Ośrodek Badań Klinicznych Sp. z o.o.
- Principal Investigator Name
- Bernadetta Majorek-Olechowska
- Principal Investigator Email
- bernadettaolechowska@gmail.com
- Contact Person Name
- Bernadetta Majorek-Olechowska
- Contact Person Email
- bernadettaolechowska@gmail.com
- Site Name
- Etg Warszawa Sp. z o.o.
- Principal Investigator Name
- Maria Zegadło-Mylik
- Principal Investigator Email
- m.zegadlomylik@etg-network.com
- Contact Person Name
- Maria Zegadło-Mylik
- Contact Person Email
- m.zegadlomylik@etg-network.com
- Site Name
- Melita Medical Sp. z o.o.
- Principal Investigator Name
- Marita Nittner-Marszalska
- Principal Investigator Email
- marmarsz@gmail.com
- Contact Person Name
- Marita Nittner-Marszalska
- Contact Person Email
- marmarsz@gmail.com
- Site Name
- LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
- Principal Investigator Name
- Dorota Krasowska
- Principal Investigator Email
- dor.krasowska@gmail.com
- Contact Person Name
- Dorota Krasowska
- Contact Person Email
- dor.krasowska@gmail.com
- Site Name
- Trialmed Sp. z o.o.
- Department Name
- Trialmed CRS Warszawa
- 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 Badan Klinicznych Pi-House Sp. z o.o.
- Principal Investigator Name
- Beata Imko-Walczuk
- Principal Investigator Email
- b.walczuk@pihouse.pl
- Contact Person Name
- Beata Imko-Walczuk
- Contact Person Email
- b.walczuk@pihouse.pl
- Site Name
- M2M Med. Sp. z o.o. Sp. j.
- Principal Investigator Name
- Magdalena Kolanko
- Principal Investigator Email
- kolankomagdalena@gmail.com
- Contact Person Name
- Magdalena Kolanko
- Contact Person Email
- kolankomagdalena@gmail.com
- Site Name
- Klinika Osipowicz & Turkowski Sp. z o.o.
- Principal Investigator Name
- Katarzyna Osipowicz
- Principal Investigator Email
- osipowicz.kasia@gmail.com
- Contact Person Name
- Katarzyna Osipowicz
- Contact Person Email
- osipowicz.kasia@gmail.com
Sponsor
Primary sponsor
- Full Name
- Pfizer Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Ppd Inc.
- Responsibilities
- code 4
- Name
- Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.
- Responsibilities
- code 4
- Name
- Iqvia Inc.
- Responsibilities
- Electronic COA (eCOA) Support Services
- Name
- Premier Research International LLC
- Responsibilities
- Dictionary Coding
Third parties
- {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"York Bioanalytical Solutions Limited","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Electronic COA (eCOA) Support Services\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Premier Research International LLC","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Dictionary Coding\"}]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ritlecitinib tosilate
- Active Substance
- RITLECITINIB TOSILATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 50
- Investigational Product Name
- Ritlecitinib Tosilate
- Active Substance
- RITLECITINIB TOSILATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 100
- Investigational Product Name
- Placebo for pf-06651600-15, 100 mg
- Modality
- Other
- Investigational Product Name
- Placebo for pf-06651600-15, 50 mg
- Modality
- Other
- Investigational Product Name
- LORATADINE
- Active Substance
- LORATADINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 10
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