Clinical trial • Phase III • Dermatology
RITLECITINIB TOSILATE for Non-segmental vitiligo
Phase III trial of RITLECITINIB TOSILATE for Non-segmental vitiligo.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Non-segmental vitiligo
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 08-01-2024
- First CTIS Authorization Date
- 29-04-2024
Trial design
Randomised, placebo arms using matching placebo capsules (placebo 50 mg capsule qd and placebo 100 mg capsule qd orally) are used as comparators in randomized withdrawal and other cohorts; there is no active comparator arm besides ritlecitinib doses.-controlled Phase III trial in Italy, Spain, Poland and others.
- Randomised
- Yes
- Comparator
- Placebo arms using matching placebo capsules (placebo 50 mg capsule QD and placebo 100 mg capsule QD orally) are used as comparators in randomized withdrawal and other cohorts; there is no active comparator arm besides ritlecitinib doses.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 331
- Trial Duration For Participant
- 364
Eligibility
Recruits 331 paediatric patients.
- Pregnancy Exclusion
- Experienced an event requiring discontinuation from Study B7981040 as outlined in the protocol (lab abnormalities, ECG changes, pregnancy, etc)
- Vulnerable Population
- Adolescents (12 to <18 years) are treated as a vulnerable population: adolescents are eligible only if approved by the local IRB/EC and regulatory authority. Pediatric-specific informed consent/assent materials are provided (Pediatric ICD, Assent factcard, Assent for older children). Parent/legal guardian informed consent (ICD for parents/legal guardians) and age-appropriate assent procedures are included in study documentation in multiple languages; assent factcards and pediatric information sheets are referenced for handling assent/consent.
Inclusion criteria
- {"criterion_text":"- Participants ≥18 years of age at Screening in Study B7981040. Adolescents (12 to <18 years of age at Screening in the parent study) are also eligible for this study if approved by the local IRB/EC and regulatory health authority. Where these approvals have not been granted, only participants ≥18 years of age will be enrolled.\n- Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040 can be enrolled (refer to Appendix 15 for definitions of stable and active nonsegmental vitiligo in Study B7981040).\n- Must agree to not use any other treatments for vitiligo from Screening through the final follow-up visit. See Section 6.9 for information regarding rescue treatment.\n- The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040."}
Exclusion criteria
- {"criterion_text":"- Participant met the parent study (Study B7981040) discontinuation criteria or discontinued the parent study for any safety-related event: Experienced an event requiring discontinuation from Study B7981040 as outlined in the protocol (lab abnormalities, ECG changes, pregnancy, etc) or; Experienced any AEs that in the judgement of the investigator or the sponsor would deem the participant not appropriate for enrollment in the LTE study (any participant with an SAE considered potential event of interest by the adjudication committee should be discussed with the sponsor) or; Experienced any SAEs that are confirmed events of interest by the adjudication/review committee or; Experienced any clinically meaningful decline in hearing from BL in the parent study.\n- Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.\n- TB Infection History:Countries in which TB incidence has been reported at a rate of >10 cases per 100,000 persons per WHO or local country epidemiology data only.\n- Other Medical Conditions: Other medical conditions which in the opinion of the investigator or Pfizer make the participant inappropriate for entry into this study or unwilling/unable to comply with study procedures and lifestyle requirements; History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention; Considered in imminent need for surgery or with elective surgery scheduled to occur during the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of TEAEs, SAEs, and AEs leading to discontinuation","definition_or_measurement_approach":"Incidence counted as treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) that lead to discontinuation as reported during study treatment and follow-up."}
- {"endpoint_text":"- Incidence of clinically significant laboratory abnormalities.","definition_or_measurement_approach":"Incidence based on laboratory test results judged to be clinically significant (per protocol-defined thresholds) reported during study visits."}
Secondary endpoints
- {"endpoint_text":"- Response based on T-VASI75 (defined as at least 75% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA","definition_or_measurement_approach":"T-VASI75 = at least 75% improvement in total VASI from the Study B7981040 baseline, assessed at all scheduled time points per Schedule of Activities (SoA)."}
- {"endpoint_text":"- Response based on F-VASI75 (defined as at least 75% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA","definition_or_measurement_approach":"F-VASI75 = at least 75% improvement in facial VASI from Study B7981040 baseline, assessed at scheduled time points."}
- {"endpoint_text":"- Response based on T-VASI50 (defined as at least 50% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA","definition_or_measurement_approach":"T-VASI50 = at least 50% improvement in total VASI from Study B7981040 baseline, assessed at scheduled time points."}
- {"endpoint_text":"- Percent Change from Study B7981040 BL in F-VASI at all time points in the SoA","definition_or_measurement_approach":"Percent change in facial VASI compared with Study B7981040 baseline at each scheduled time point."}
- {"endpoint_text":"- Percent Change from Study B7981040 BL in T-VASI at all time points in the SoA","definition_or_measurement_approach":"Percent change in total VASI compared with Study B7981040 baseline at each scheduled time point."}
- {"endpoint_text":"- Response based on stabilization of disease at all time points after Week 8, defined as: <15-point increase in T-VASI from Study B7981040 Baseline (based on twice the magnitude of the smallest detectable change of 7.1 points in T-VASI) [38]; AND meeting all other criteria for stability","definition_or_measurement_approach":"Stabilization defined as <15-point increase in T-VASI from Study B7981040 baseline and meeting additional protocol-specified stability criteria, assessed after Week 8 at scheduled visits."}
- {"endpoint_text":"- Response based on F-VASI50 (defined as at least 50% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA","definition_or_measurement_approach":"F-VASI50 = at least 50% improvement in facial VASI from Study B7981040 baseline, assessed at scheduled time points."}
- {"endpoint_text":"- Response based on F-VASI90 (defined as at least 90% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA","definition_or_measurement_approach":"F-VASI90 = at least 90% improvement in facial VASI from Study B7981040 baseline, assessed at scheduled time points."}
- {"endpoint_text":"- Response based on F-VASI100 (defined as 100% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA","definition_or_measurement_approach":"F-VASI100 = 100% improvement in facial VASI from Study B7981040 baseline, assessed at scheduled time points."}
- {"endpoint_text":"- Response based on T-VASI90 (defined as at least 90% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA","definition_or_measurement_approach":"T-VASI90 = at least 90% improvement in total VASI from Study B7981040 baseline, assessed at scheduled time points."}
- {"endpoint_text":"- Response based on T-VASI100 (defined as 100% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA","definition_or_measurement_approach":"T-VASI100 = 100% improvement in total VASI from Study B7981040 baseline, assessed at scheduled time points."}
- {"endpoint_text":"- Response based on improvement in Patient Global Impression of Severity – Face (PGIS-F) at all time points in SoA","definition_or_measurement_approach":"Improvement in PGIS-F as reported by participants at scheduled time points per SoA."}
- {"endpoint_text":"- Response based on improvement in PGIS-V at all time points in the SoA","definition_or_measurement_approach":"Improvement in PGIS-V (patient global impression of vitiligo severity) at scheduled time points."}
- {"endpoint_text":"- Response based on scoring at least “moderately better” on PGIC-F at all time points in the SoA","definition_or_measurement_approach":"Participant-reported Global Impression of Change for face (PGIC-F) of at least 'moderately better' at scheduled assessments."}
- {"endpoint_text":"- Response based on scoring at least “moderately better” on PGIC-V at all time points in the SoA","definition_or_measurement_approach":"Participant-reported Global Impression of Change for overall vitiligo (PGIC-V) of at least 'moderately better' at scheduled assessments."}
Recruitment
- Planned Sample Size
- 331
- Recruitment Window Months
- 30
- Consent Approach
- Adults provide written informed consent using the Adult ICD. For adolescents/pediatric participants age-appropriate Pediatric ICD and assent materials are provided (Assent factcard, Assent for older children). Parent/legal guardian informed consent is required for minors (documents: 'ICD_Main_Parents_Legal Guardians' present). Informed consent/assent materials and recruitment documents are available in multiple languages (English, Italian, Spanish, Polish, German, Bulgarian as shown by available ICD and recruitment documents). Adolescents (12 to <18) are eligible only where local IRB/EC and regulatory authority approval for pediatric participation has been granted.
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 137
Italy
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 17-12-2024
- Processing Time Days
- 263
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- U.O. C. Dermatologia Clinica
- Principal Investigator Name
- Alessia Pacifico
- Principal Investigator Email
- alessia.pacifico@ifo.it
- Contact Person Name
- Alessia Pacifico
- Contact Person Email
- alessia.pacifico@ifo.it
- Number Of Participants
- 1
Spain
- Earliest CTIS Part Ii Submission Date
- 18-03-2024
- Latest Decision Or Authorization Date
- 08-08-2025
- Processing Time Days
- 508
- Number Of Sites
- 5
- Number Of Participants
- 24
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Dermatology
- Principal Investigator Name
- Pedro Herranz Pinto
- Principal Investigator Email
- pedro.herranz@salud.madrid.org
- Contact Person Name
- Pedro Herranz Pinto
- Contact Person Email
- pedro.herranz@salud.madrid.org
- Number Of Participants
- 24
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Dermatology
- Principal Investigator Name
- Diana Alejandra Sandoval Clavijo
- Principal Investigator Email
- alesancla@hotmail.com
- Contact Person Name
- Diana Alejandra Sandoval Clavijo
- Contact Person Email
- alesancla@hotmail.com
- Site Name
- Hospital General 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
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- Dermatology
- Principal Investigator Name
- Alicia Lourdes Gonzalez Quesada
- Principal Investigator Email
- ali_gq@hotmail.com
- Contact Person Name
- Alicia Lourdes Gonzalez Quesada
- Contact Person Email
- ali_gq@hotmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Dermatology
- Principal Investigator Name
- Gonzalo Segurado Miravalles
- Principal Investigator Email
- gonzalo.segurado@salud.madrid.org
- Contact Person Name
- Gonzalo Segurado Miravalles
- Contact Person Email
- gonzalo.segurado@salud.madrid.org
Poland
- Earliest CTIS Part Ii Submission Date
- 25-03-2024
- Latest Decision Or Authorization Date
- 11-08-2025
- Processing Time Days
- 504
- Number Of Sites
- 5
- Number Of Participants
- 79
Sites
- Site Name
- Dermoklinika-Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
- Department Name
- Dermatology
- Principal Investigator Name
- Aleksandra Lesiak
- Principal Investigator Email
- lesiak_ola@interia.pl
- Contact Person Name
- Aleksandra Lesiak
- Contact Person Email
- lesiak_ola@interia.pl
- Site Name
- Royalderm Agnieszka Nawrocka
- Department Name
- Dermatology
- 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
- Dermedic Jacek Zdybski
- Department Name
- Dermatology
- Principal Investigator Name
- Jacek Zdybski
- Principal Investigator Email
- jacek_z@icloud.com
- Contact Person Name
- Jacek Zdybski
- Contact Person Email
- jacek_z@icloud.com
- Site Name
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Department Name
- Dermatology
- Principal Investigator Name
- Tadeusz Dębniak
- Principal Investigator Email
- debniak@twojaprzychodnia.com
- Contact Person Name
- Tadeusz Dębniak
- Contact Person Email
- debniak@twojaprzychodnia.com
- Site Name
- DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c.
- Department Name
- Dermatology
- Principal Investigator Name
- Rafał Czajkowski
- Principal Investigator Email
- r.czajkowski@dermodent.pl
- Contact Person Name
- Rafał Czajkowski
- Contact Person Email
- r.czajkowski@dermodent.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 08-04-2024
- Latest Decision Or Authorization Date
- 06-08-2025
- Processing Time Days
- 485
- Number Of Sites
- 4
- Number Of Participants
- 23
Sites
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Dermatology
- 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
- Hautarztpraxis Dr. Leitz Und Kollegen
- Department Name
- Dermatology
- 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
- Thermalsole und Schwefelbad Bentheim GmbH
- Department Name
- Fachklinik Bad Bentheim
- Principal Investigator Name
- Athanasios Tsianakas
- Principal Investigator Email
- a.tsianakas@fk-bentheim.de
- Contact Person Name
- Athanasios Tsianakas
- Contact Person Email
- a.tsianakas@fk-bentheim.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Dermatology
- Principal Investigator Name
- Michael Sticherling
- Principal Investigator Email
- michael.sticherling@uk-erlangen.de
- Contact Person Name
- Michael Sticherling
- Contact Person Email
- michael.sticherling@uk-erlangen.de
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 22-04-2024
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 609
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Umbal - Prof. D-R Stoyan Kirkovich AD
- Department Name
- Dermatology and Venerology
- Principal Investigator Name
- Evgeniya Hristakieva
- Principal Investigator Email
- ehristakieva@gmail.com
- Contact Person Name
- Evgeniya Hristakieva
- Contact Person Email
- ehristakieva@gmail.com
- Site Name
- Asclepius Medical Center OOD
- Department Name
- Dermatology
- 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 Alexandrovska EOOD (Sofiya)
- Department Name
- Dermatology
- Principal Investigator Name
- Petyo Brezoev
- Principal Investigator Email
- drbrezoev@abv.bg
- Contact Person Name
- Petyo Brezoev
- Contact Person Email
- drbrezoev@abv.bg
- Site Name
- Diagnostic-Consultative Center Alexandrovska EOOD (Sofiya, second site)
- Department Name
- Dermatology
- Principal Investigator Name
- Snejina Vassileva
- Principal Investigator Email
- snejina.vassileva@gmail.com
- Contact Person Name
- Snejina Vassileva
- Contact Person Email
- snejina.vassileva@gmail.com
Sponsor
Primary sponsor
- Full Name
- Pfizer Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties codes: 1, 5; contact Clinicaltrial.Enquiries@parexel.com
Third parties
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1, 5","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ritlecitinib Tosilate (50 mg capsule)
- Active Substance
- RITLECITINIB TOSILATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 50 mg QD
- Dose Levels
- 50 mg
- Frequency
- QD
- Maximum Dose
- 50 mg
- Investigational Product Name
- Ritlecitinib Tosilate (100 mg capsule)
- Active Substance
- RITLECITINIB TOSILATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 100 mg QD
- Dose Levels
- 100 mg
- Frequency
- QD
- Maximum Dose
- 100 mg
- Investigational Product Name
- Capsule to match PF-06651600 (Ritlecitinib) 50 mg (placebo)
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- ORAL
- Starting Dose
- 50 mg capsule QD (placebo)
- Dose Levels
- 50 mg (placebo)
- Frequency
- QD
- Maximum Dose
- 50 mg (placebo)
- Investigational Product Name
- Capsule to match pf-06651600 (ritlecitinib) 100 mg (placebo)
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- ORAL
- Starting Dose
- 100 mg capsule QD (placebo)
- Dose Levels
- 100 mg (placebo)
- Frequency
- QD
- Maximum Dose
- 100 mg (placebo)
- Investigational Product Name
- DEXAMETHASONE
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Not authorised (product role auxiliary)
- Maximum Dose
- 4 mg
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