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A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Vitiligo (Active and Stable) (Tranquillo)

Primary Purpose

Non-segmental Vitiligo (Both Active and Stable Vitiligo)

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ritlecitinib
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-segmental Vitiligo (Both Active and Stable Vitiligo) focused on measuring Non-segmental vitiligo (both active and stable vitiligo)

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants ≥18 years of age, inclusive. Adolescents (12 to <18 years of age) are also eligible for this study, but only 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. Adolescent participants will not be enrolled in the United States.

    Disease Characteristics:

  2. Eligible participants must have at both Screening and Baseline:

    • A clinical diagnosis of non segmental vitiligo for at least 3 months; and
    • BSA involvement 4%-60% inclusive, excluding involvements at palms of the hands, dorsal aspect of fingers and thumbs including metacarpophalangeal joints, soles of the feet, or dorsal aspect of the feet; and
    • BSA ≥0.5% involvement on the face (face is defined as including the area on the forehead to the original hairline, on the check to the jawline vertically to the jawline, and laterally from the corner of the mouth to the tragus. The face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids; and
    • F-VASI ≥0.5 & T-VASI ≥3; and
    • Either active or stable disease non segmental vitiligo at both Screening and Baseline visits. All participants who do not have the features of active vitiligo (defined below) are required to have stable disease.

    Active vitiligo is defined as:

    • Participants will be classified as having active vitiligo based on the presence of at least one active lesion at baseline defined as one of the following:
    • New/extending lesion(s) in the 3 months prior to Screening visit (confirmed by photographs or medical record):
    • Confetti-like lesion(s);
    • Trichrome lesion(s);
    • Koebner phenomenon/phenomena (excluding Type 1 [history based on isomorphic reaction]). The Koebner phenomenon manifests as depigmentation at sites of trauma, usually in a linear arrangement.

    Stable vitiligo is defined as an absence of signs of active disease. All participants who do not have the features of active vitiligo (defined above) are required to have stable disease.

    Eligibility is determined at Screening based on the resulting scores from the local in-person reads of F-VASI, T-VASI, and BSA.

    Other Inclusion Criteria:

  3. If receiving concomitant medications for any reason other than vitiligo, participant must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant must be willing to stay on a stable regimen during the duration of the study.
  4. Must agree to stop all other treatments for vitiligo from Screening through the final follow-up visit.

Exclusion Criteria:

  1. Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria:

    • Suicidal ideation associated with actual intent and a method or plan in the past year: "Yes" answers on items 4 or 5 of the C-SSRS administered at the screening visit.
    • Previous history of suicidal behaviors in the past 5 years: "Yes" answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS.
    • For adults, any lifetime history of serious suicidal behavior or recurrent suicidal behavior. For adolescents, any previous lifetime history of suicidal behavior.
  2. Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin:

    • Participants that have other types of vitiligo that do not meet criteria for active or stable vitiligo as noted in inclusion criterion #2 (including, but not limited to, segmental vitiligo and mixed vitiligo).
    • Currently have active forms of other hypopigmentation (including but not limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation [melanoma and mycosis fungoides], post-inflammatory hypopigmentation, pityriasis alba [minor manifestation of atopic dermatitis], senile leukoderma [age-related depigmentation], chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, melasma, and congenital hypopigmentation disorder including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetrica hereditarian, xeroderma pigmentosum, and nevus depigmentosus). NOTE: Coexistence of halo nevus/nevi (also known as Sutton nevus/nevi) is permitted.
    • Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (for example, morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or Baseline Visit that in the opinion of the investigator would interfere with evaluation of vitiligo or response to treatment.
    • Leukotrichia in more than 33% of the face surface area affected with vitiligo lesions OR leukotrichia in more than 33% of the total body surface area affected with vitiligo lesions.
    • Have active acute or chronic skin infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to first dose on Day 1, or superficial skin infections within 2 weeks prior to first dose on Day 1. NOTE: participants may be rescreened after the infection resolves.
  3. General Infection History:

    • Having a history of systemic infection requiring hospitalization, parenteral antimicrobial, antiviral (including biologic treatment), antiparasitic, antiprotozoal, or antifungal therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 1.
    • Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1 or superficial skin infections within 2 weeks prior to first dose on Day 1. NOTE: participants may be rescreened after the infection resolves.
    • Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium TB
  4. Specific Viral Infection History:

    • History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
    • Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility.
    • Participants who are positive for HCVAb and HCV RNA will not be eligible for this study.
    • Have a known immunodeficiency disorder (including positive serology for HIV at screening) or a first-degree relative with a hereditary immunodeficiency.
  5. Medical Conditions, Other:

    • Other medical or psychiatric condition including recent (within the past year) or 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.
    • Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (eg, untreated hypovitaminosis D or hypothyroidism), pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator or Pfizer (or designee), the participant is inappropriate for entry into this study, or unwilling/unable to comply with study procedures and lifestyle requirements.
    • Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered current, fluctuating or progressive.
    • Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
    • Abnormal findings on the Screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB, general infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to screening. Documentation of the official reading must be located and available in the source documentation.
    • Long QT Syndrome, a family history of Long QT Syndrome, or a history of TdP.
    • Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.

    Prior/Concomitant Therapy:

  6. Have received any of the prohibited treatment regimens specified.

    Prior/Concurrent Clinical Study Experience:

  7. Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).

    Diagnostic Assessments:

  8. Any of the following abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:

    • Renal impairment
    • Hepatic dysfunction
  9. Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities

    Other Exclusion Criteria:

  10. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • University of Alabama at Birmingham Faculty Office Towers (RegulatoryRecruiting
  • California Dermatology & Clinical Research InstituteRecruiting
  • Center For Dermatology Clinical Research, Inc.
  • Marvel Clinical ResearchRecruiting
  • Wallace Medical Group, IncRecruiting
  • AudiologyRecruiting
  • MedStar Washington Hospital CenterRecruiting
  • Center for Dermatology and Dermatologic SurgeryRecruiting
  • Encore Medical Research of Boynton BeachRecruiting
  • Skin Care ResearchRecruiting
  • JC AudiologyRecruiting
  • Millennium Clinical Research
  • Tory Sullivan, MD PA
  • Ziaderm Research, LLCRecruiting
  • Olympian Clinical ResearchRecruiting
  • ForCare Clinical ResearchRecruiting
  • Tower Imaging, LLC dba TGH Imaging powered by TowerRecruiting
  • Marietta Dermatology Clinical Research, IncRecruiting
  • Advanced Medical Research, PC.Recruiting
  • Dawes Fretzin Clinical Research Group, LLCRecruiting
  • DelRicht ResearchRecruiting
  • The NeuroMedical Center (XRay)Recruiting
  • DelRicht ResearchRecruiting
  • Prairieville Family Hospital (XRay)Recruiting
  • Callender Center for Clinical Research
  • Visage Dermatology and Aesthetic CenterRecruiting
  • Lawrence J Green, MD LLCRecruiting
  • Massachusetts General HospitalRecruiting
  • MetroBoston Clinical Partners, LLCRecruiting
  • University of Massachusetts Chan Medical SchoolRecruiting
  • University of MichiganRecruiting
  • Hamzavi Dermatology - CantonRecruiting
  • Skin Specialists, PCRecruiting
  • University of New Mexico Health Sciences CenterRecruiting
  • SUNY Downstate Health Sciences University
  • Icahn School of Medicine at Mount SinaiRecruiting
  • University of North Carolina Medical CenterRecruiting
  • Clinical & Translational Research Center (CTRC)Recruiting
  • Accellacare - WilmingtonRecruiting
  • AccellacareRecruiting
  • PMG Research of Wilmington, LLCRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Remington Davis Clinical ResearchRecruiting
  • Medical University of South CarolinaRecruiting
  • Bellaire Dermatology AssociatesRecruiting
  • Modern Research Associates, PLLCRecruiting
  • Alpesh D. Desai, DO PLLC - ResearchRecruiting
  • Alpesh D. Desai, DO PLLC
  • Austin Institute for Clinical ResearchRecruiting
  • Progressive Clinical ResearchRecruiting
  • Texas Dermatology and Laser SpecialistsRecruiting
  • Dermatology Clinical Research Center of San AntonioRecruiting
  • The Skin HospitalRecruiting
  • North Eastern Health SpecialistsRecruiting
  • Skin Health Institute Inc.Recruiting
  • Sinclair DermatologyRecruiting
  • The Alfred HospitalRecruiting
  • MC "Asklepiy" OODRecruiting
  • DCC Aleksandrovska EOODRecruiting
  • UMHAT "Prof. dr. Stoyan Kirkovich" ADRecruiting
  • Dermatology Research InstituteRecruiting
  • CARe ClinicRecruiting
  • SKiN HealthRecruiting
  • Lynderm Research Inc.Recruiting
  • DermEdge ResearchRecruiting
  • Oshawa Clinic Dermatology TrialsRecruiting
  • North York Research IncRecruiting
  • Centre de Recherche Dermatologique du Quebec metropolitainRecruiting
  • Centre de Recherche Saint-LouisRecruiting
  • Fujian Medical University Affiliated First HospitalRecruiting
  • Dermatology Hospital of Southern Medical UniversityRecruiting
  • Guangzhou First People's HospitalRecruiting
  • The First Hospital of WuhanRecruiting
  • The First Hospital of China Medical University/Dermatology and STD Department
  • Huashan Hospital Fudan UniversityRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • First Affiliated Hospital of Kunming Medical UniversityRecruiting
  • Zhejiang Provincial People's Hospital/Dermatology DepartmentRecruiting
  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang UniversityRecruiting
  • The first Affiliated hospital of Wenzhou medical University
  • The first Affiliated hospital of Wenzhou medical UniversityRecruiting
  • Praxis Leitz und KollegenRecruiting
  • Universitaetsklinikum ErlangenRecruiting
  • Fachklinik Bad BentheimRecruiting
  • Universitätsklinikum MünsterRecruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuor
  • Istituti Fisioterapici Ospitalieri (IFO) - Roma
  • Istituti Fisioterapici Ospitalieri (IFO)
  • Policlinico S. Orsola- Malpighi
  • Azienda Ospedaliera Spedali Civili di BresciaRecruiting
  • Nagoya City University HospitalRecruiting
  • Tohoku University HospitalRecruiting
  • Dermatology and Ophthalmology Kume ClinicRecruiting
  • Tokyo Medical University HospitalRecruiting
  • Sugamo Kobayashi Derma ClinicRecruiting
  • Yamanashi Prefectural Central HospitalRecruiting
  • Nippon Medical School Hospital
  • Nippon Medical School HospitalRecruiting
  • Dongguk University Ilsan HospitalRecruiting
  • The Catholic University Of Korea St. Vincent's HospitalRecruiting
  • Ajou University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Centro de Dermatologia de Monterrey
  • Sociedad de Metabolismo y Corazon S.C.
  • Sociedad de Metabolismo Y Corazon Sc
  • Arké SMO S.A de C.V
  • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.Recruiting
  • Royalderm Agnieszka NawrockaRecruiting
  • Twoja Przychodnia SCM
  • Twoja Przychodnia SCMRecruiting
  • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. LesiakRecruiting
  • Dermedic Jacek ZdybskiRecruiting
  • Clinresco Centres
  • Task Central
  • Hospital Universitario Reina SofiaRecruiting
  • Hospital Universitario de Gran Canaria Doctor Negrín
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Universitario La Paz
  • Istanbul Universitesi- Cerrahpasa, Cerrahpasa Tip Fakultesi
  • Erciyes Universitesi Tıp Fakultesi HastaneleriRecruiting
  • Celal Bayar Universitesi Hafta Sultan HastanesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ritlecitinib 50 mg

Placebo

Arm Description

Ritlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)

Placebo (placebo arm; approximately 200 participants)

Outcomes

Primary Outcome Measures

F-VASI75 and T-VASI50 comprise the primary endpoint family at 52 weeks
To evaluate the efficacy of ritlecitinib 50 mg QD compared to placebo in adult and adolescent participants with non segmental vitiligo. Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline) and proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline).
For the EU: Proportion of participants achieving F-VASI75 at Week 52.
To assess the comparative efficacy of ritlecitinib 50 mg QD compared to placebo over a 52 week period in facial vitiligo. Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).

Secondary Outcome Measures

For the EU: Proportion of participants achieving T-VASI50 at Week 52
To evaluate the efficacy of ritlecitinib 50 mg QD compared to placebo in adult and adolescent participants with non segmental vitiligo. Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline).
Proportion of participants achieving F-VASI75 at Week 36.
To assess the comparative efficacy of ritlecitinib 50 mg QD compared to placebo over a 36 week period in facial vitiligo. Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).
Proportion of participants achieving F-VASI75 at Week 24.
To assess the comparative efficacy of ritlecitinib 50 mg QD compared to placebo over a 24 week period in facial vitiligo. Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).
Patient Global Impression of Severity-Face
To assess the effect of ritlecitinib 50 mg QD compared to placebo on the PGIS-F at Week 52
Patient Global Impression of Severity-Overall Vitiligo
To assess the effect of ritlecitinib 50 mg QD compared to placebo on the PGIS-V at Week 52
Patient Global Impression of Change-Overall Vitiligo
To assess the effect of ritlecitinib 50 mg QD compared to placebo on the PGIC-V at Weeks 36 and 52. For EU only
Patient Global Impression of Severity-Overall Vitiligo
To assess the effect of ritlecitinib 50 mg QD compared to placebo on the PGIS-V at Weeks 36 and 52. For EU only
Stabilization of disease
The difference in the proportion of participants with stable disease at all timepoints in participants with non segmental vitiligo treated with ritlecitinib 50 mg QD compared to placebo.
CDLQI/DLQI
To evaluate the change from baseline in DLQI or CDLQI at weeks 36 and 52 in participants with non segmental vitiligo treated with ritlecitinib 50 mg QD compared to placebo
Patient Global Impression of Change-Face
To evaluate the proportion of responders based on achieving at least "moderately better" on PGIC-F at weeks 36 and 52 in participants with non segmental vitiligo treated with ritlecitinib 50 mg QD compared to placebo
Patient Global Impression of Severity-Face
To evaluate the proportion of responders based on achieving improvment in PGIS-F at weeks 36 and 52 in participants with non segmental vitiligo treated with ritlecitinib 50 mg QD compared to placebo
Hospital Anxiety and Depression Scale
To assess the effect of ritlecitinib 50 mg QD compared to placebo on depression and anxiety subscales of the HADS at weeks 36 and 52
Incidence of TEAEs, SAEs, and AEs leading to discontinuation. Incidence of clinically significant laboratory abnormalities
To evaluate the safety and tolerability of ritlecitinib in adult and adolescent participants with non segmental vitiligo

Full Information

First Posted
October 6, 2022
Last Updated
October 5, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05583526
Brief Title
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Vitiligo (Active and Stable)
Acronym
Tranquillo
Official Title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NON SEGMENTAL VITILIGO
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 27, 2025 (Anticipated)
Study Completion Date
June 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Vitiligo (Active and Stable)
Detailed Description
Study B7981040 is a Phase 3 randomized, double-blind, 52-week placebo-controlled, multi center study investigating the efficacy, safety, and tolerability of ritlecitinib in adult and adolescent participants with non segmental vitiligo (both active and stable vitiligo).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-segmental Vitiligo (Both Active and Stable Vitiligo)
Keywords
Non-segmental vitiligo (both active and stable vitiligo)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, parallel-group, vehicle controlled.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ritlecitinib 50 mg
Arm Type
Experimental
Arm Description
Ritlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (placebo arm; approximately 200 participants)
Intervention Type
Drug
Intervention Name(s)
Ritlecitinib
Intervention Description
50 mg capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching capsule
Primary Outcome Measure Information:
Title
F-VASI75 and T-VASI50 comprise the primary endpoint family at 52 weeks
Description
To evaluate the efficacy of ritlecitinib 50 mg QD compared to placebo in adult and adolescent participants with non segmental vitiligo. Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline) and proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline).
Time Frame
52 weeks
Title
For the EU: Proportion of participants achieving F-VASI75 at Week 52.
Description
To assess the comparative efficacy of ritlecitinib 50 mg QD compared to placebo over a 52 week period in facial vitiligo. Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
For the EU: Proportion of participants achieving T-VASI50 at Week 52
Description
To evaluate the efficacy of ritlecitinib 50 mg QD compared to placebo in adult and adolescent participants with non segmental vitiligo. Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline).
Time Frame
52 weeks
Title
Proportion of participants achieving F-VASI75 at Week 36.
Description
To assess the comparative efficacy of ritlecitinib 50 mg QD compared to placebo over a 36 week period in facial vitiligo. Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).
Time Frame
36 weeks
Title
Proportion of participants achieving F-VASI75 at Week 24.
Description
To assess the comparative efficacy of ritlecitinib 50 mg QD compared to placebo over a 24 week period in facial vitiligo. Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).
Time Frame
24 weeks
Title
Patient Global Impression of Severity-Face
Description
To assess the effect of ritlecitinib 50 mg QD compared to placebo on the PGIS-F at Week 52
Time Frame
52 weeks
Title
Patient Global Impression of Severity-Overall Vitiligo
Description
To assess the effect of ritlecitinib 50 mg QD compared to placebo on the PGIS-V at Week 52
Time Frame
52 weeks
Title
Patient Global Impression of Change-Overall Vitiligo
Description
To assess the effect of ritlecitinib 50 mg QD compared to placebo on the PGIC-V at Weeks 36 and 52. For EU only
Time Frame
36 and 52 weeks
Title
Patient Global Impression of Severity-Overall Vitiligo
Description
To assess the effect of ritlecitinib 50 mg QD compared to placebo on the PGIS-V at Weeks 36 and 52. For EU only
Time Frame
36 and 52 weeks
Title
Stabilization of disease
Description
The difference in the proportion of participants with stable disease at all timepoints in participants with non segmental vitiligo treated with ritlecitinib 50 mg QD compared to placebo.
Time Frame
52 Weeks
Title
CDLQI/DLQI
Description
To evaluate the change from baseline in DLQI or CDLQI at weeks 36 and 52 in participants with non segmental vitiligo treated with ritlecitinib 50 mg QD compared to placebo
Time Frame
36 and 52 weeks
Title
Patient Global Impression of Change-Face
Description
To evaluate the proportion of responders based on achieving at least "moderately better" on PGIC-F at weeks 36 and 52 in participants with non segmental vitiligo treated with ritlecitinib 50 mg QD compared to placebo
Time Frame
36 and 52 weeks
Title
Patient Global Impression of Severity-Face
Description
To evaluate the proportion of responders based on achieving improvment in PGIS-F at weeks 36 and 52 in participants with non segmental vitiligo treated with ritlecitinib 50 mg QD compared to placebo
Time Frame
36 and 52 weeks
Title
Hospital Anxiety and Depression Scale
Description
To assess the effect of ritlecitinib 50 mg QD compared to placebo on depression and anxiety subscales of the HADS at weeks 36 and 52
Time Frame
36 and 52 weeks
Title
Incidence of TEAEs, SAEs, and AEs leading to discontinuation. Incidence of clinically significant laboratory abnormalities
Description
To evaluate the safety and tolerability of ritlecitinib in adult and adolescent participants with non segmental vitiligo
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants ≥18 years of age, inclusive. Adolescents (12 to <18 years of age) are also eligible for this study, but only 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. Adolescent participants will not be enrolled in the United States. Disease Characteristics: Eligible participants must have at both Screening and Baseline: A clinical diagnosis of non segmental vitiligo for at least 3 months; and BSA involvement 4%-60% inclusive, excluding involvements at palms of the hands, dorsal aspect of fingers and thumbs including metacarpophalangeal joints, soles of the feet, or dorsal aspect of the feet; and BSA ≥0.5% involvement on the face (face is defined as including the area on the forehead to the original hairline, on the check to the jawline vertically to the jawline, and laterally from the corner of the mouth to the tragus. The face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids; and F-VASI ≥0.5 & T-VASI ≥3; and Either active or stable disease non segmental vitiligo at both Screening and Baseline visits. All participants who do not have the features of active vitiligo (defined below) are required to have stable disease. Active vitiligo is defined as: Participants will be classified as having active vitiligo based on the presence of at least one active lesion at baseline defined as one of the following: New/extending lesion(s) in the 3 months prior to Screening visit (confirmed by photographs or medical record): Confetti-like lesion(s); Trichrome lesion(s); Koebner phenomenon/phenomena (excluding Type 1 [history based on isomorphic reaction]). The Koebner phenomenon manifests as depigmentation at sites of trauma, usually in a linear arrangement. Stable vitiligo is defined as an absence of signs of active disease. All participants who do not have the features of active vitiligo (defined above) are required to have stable disease. Eligibility is determined at Screening based on the resulting scores from the local in-person reads of F-VASI, T-VASI, and BSA. Other Inclusion Criteria: If receiving concomitant medications for any reason other than vitiligo, participant must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant must be willing to stay on a stable regimen during the duration of the study. Must agree to stop all other treatments for vitiligo from Screening through the final follow-up visit. Exclusion Criteria: Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria: Suicidal ideation associated with actual intent and a method or plan in the past year: "Yes" answers on items 4 or 5 of the C-SSRS administered at the screening visit. Previous history of suicidal behaviors in the past 5 years: "Yes" answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS. For adults, any lifetime history of serious suicidal behavior or recurrent suicidal behavior. For adolescents, any previous lifetime history of suicidal behavior. Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin: Participants that have other types of vitiligo that do not meet criteria for active or stable vitiligo as noted in inclusion criterion #2 (including, but not limited to, segmental vitiligo and mixed vitiligo). Currently have active forms of other hypopigmentation (including but not limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation [melanoma and mycosis fungoides], post-inflammatory hypopigmentation, pityriasis alba [minor manifestation of atopic dermatitis], senile leukoderma [age-related depigmentation], chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, melasma, and congenital hypopigmentation disorder including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetrica hereditarian, xeroderma pigmentosum, and nevus depigmentosus). NOTE: Coexistence of halo nevus/nevi (also known as Sutton nevus/nevi) is permitted. Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (for example, morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or Baseline Visit that in the opinion of the investigator would interfere with evaluation of vitiligo or response to treatment. Leukotrichia in more than 33% of the face surface area affected with vitiligo lesions OR leukotrichia in more than 33% of the total body surface area affected with vitiligo lesions. Have active acute or chronic skin infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to first dose on Day 1, or superficial skin infections within 2 weeks prior to first dose on Day 1. NOTE: participants may be rescreened after the infection resolves. General Infection History: Having a history of systemic infection requiring hospitalization, parenteral antimicrobial, antiviral (including biologic treatment), antiparasitic, antiprotozoal, or antifungal therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 1. Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1 or superficial skin infections within 2 weeks prior to first dose on Day 1. NOTE: participants may be rescreened after the infection resolves. Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium TB Specific Viral Infection History: History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster. Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility. Participants who are positive for HCVAb and HCV RNA will not be eligible for this study. Have a known immunodeficiency disorder (including positive serology for HIV at screening) or a first-degree relative with a hereditary immunodeficiency. Medical Conditions, Other: Other medical or psychiatric condition including recent (within the past year) or 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. Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (eg, untreated hypovitaminosis D or hypothyroidism), pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator or Pfizer (or designee), the participant is inappropriate for entry into this study, or unwilling/unable to comply with study procedures and lifestyle requirements. Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered current, fluctuating or progressive. Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease. Abnormal findings on the Screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB, general infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to screening. Documentation of the official reading must be located and available in the source documentation. Long QT Syndrome, a family history of Long QT Syndrome, or a history of TdP. Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. Prior/Concomitant Therapy: Have received any of the prohibited treatment regimens specified. Prior/Concurrent Clinical Study Experience: Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Diagnostic Assessments: Any of the following abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat: Renal impairment Hepatic dysfunction Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities Other Exclusion Criteria: Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Alabama at Birmingham Faculty Office Towers (Regulatory
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Individual Site Status
Recruiting
Facility Name
Center For Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Marvel Clinical Research
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Name
Wallace Medical Group, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90056
Country
United States
Individual Site Status
Recruiting
Facility Name
Audiology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Dermatology and Dermatologic Surgery
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Name
Encore Medical Research of Boynton Beach
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33436
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Care Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
JC Audiology
City
Lutz
State/Province
Florida
ZIP/Postal Code
33548
Country
United States
Individual Site Status
Recruiting
Facility Name
Millennium Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Tory Sullivan, MD PA
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ziaderm Research, LLC
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Recruiting
Facility Name
Olympian Clinical Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Recruiting
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Tower Imaging, LLC dba TGH Imaging powered by Tower
City
Tampa
State/Province
Florida
ZIP/Postal Code
33618
Country
United States
Individual Site Status
Recruiting
Facility Name
Marietta Dermatology Clinical Research, Inc
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Medical Research, PC.
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Name
DelRicht Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Name
The NeuroMedical Center (XRay)
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States
Individual Site Status
Recruiting
Facility Name
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Name
Prairieville Family Hospital (XRay)
City
Prairieville
State/Province
Louisiana
ZIP/Postal Code
70769
Country
United States
Individual Site Status
Recruiting
Facility Name
Callender Center for Clinical Research
City
Glenn Dale
State/Province
Maryland
ZIP/Postal Code
20769
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Visage Dermatology and Aesthetic Center
City
Largo
State/Province
Maryland
ZIP/Postal Code
20774
Country
United States
Individual Site Status
Recruiting
Facility Name
Lawrence J Green, MD LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
MetroBoston Clinical Partners, LLC
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Massachusetts Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Hamzavi Dermatology - Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States
Individual Site Status
Recruiting
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Individual Site Status
Recruiting
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Name
SUNY Downstate Health Sciences University
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
University of North Carolina Medical Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical & Translational Research Center (CTRC)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare - Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28411
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28411
Country
United States
Individual Site Status
Recruiting
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28411
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Remington Davis Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Bellaire Dermatology Associates
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
Modern Research Associates, PLLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Alpesh D. Desai, DO PLLC - Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Individual Site Status
Recruiting
Facility Name
Alpesh D. Desai, DO PLLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Austin Institute for Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Individual Site Status
Recruiting
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
The Skin Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Name
North Eastern Health Specialists
City
Campbelltown
State/Province
South Australia
ZIP/Postal Code
5074
Country
Australia
Individual Site Status
Recruiting
Facility Name
Skin Health Institute Inc.
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sinclair Dermatology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
MC "Asklepiy" OOD
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
DCC Aleksandrovska EOOD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT "Prof. dr. Stoyan Kirkovich" AD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Dermatology Research Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Recruiting
Facility Name
CARe Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4P 1K4
Country
Canada
Individual Site Status
Recruiting
Facility Name
SKiN Health
City
Cobourg
State/Province
Ontario
ZIP/Postal Code
K9A 0Z4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Individual Site Status
Recruiting
Facility Name
DermEdge Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Oshawa Clinic Dermatology Trials
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1B9
Country
Canada
Individual Site Status
Recruiting
Facility Name
North York Research Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2N3A6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre de Recherche Dermatologique du Quebec metropolitain
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre de Recherche Saint-Louis
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fujian Medical University Affiliated First Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
Dermatology Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510091
Country
China
Individual Site Status
Recruiting
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of China Medical University/Dermatology and STD Department
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan Sheng
ZIP/Postal Code
650032
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Provincial People's Hospital/Dermatology Department
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
The first Affiliated hospital of Wenzhou medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The first Affiliated hospital of Wenzhou medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Praxis Leitz und Kollegen
City
Stuttgart
State/Province
Baden-württemberg
ZIP/Postal Code
70178
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
State/Province
Niedersachsen
ZIP/Postal Code
48455
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster
City
Münster
State/Province
Nordrhein-westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuor
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Istituti Fisioterapici Ospitalieri (IFO) - Roma
City
Roma
State/Province
RM
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Istituti Fisioterapici Ospitalieri (IFO)
City
Roma
State/Province
RM
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Policlinico S. Orsola- Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dermatology and Ophthalmology Kume Clinic
City
Sakai City
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sugamo Kobayashi Derma Clinic
City
Toshima-Ku
State/Province
Tokyo
ZIP/Postal Code
170-0002
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nippon Medical School Hospital
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Nippon Medical School Hospital
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dongguk University Ilsan Hospital
City
Goyang-si
State/Province
Kyǒnggi-do
ZIP/Postal Code
10326
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University Of Korea St. Vincent's Hospital
City
Suwon-si
State/Province
Kyǒnggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Kyǒnggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Centro de Dermatologia de Monterrey
City
Monterrey
State/Province
Nuevo LEÓN
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Sociedad de Metabolismo y Corazon S.C.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Sociedad de Metabolismo Y Corazon Sc
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Arké SMO S.A de C.V
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
City
Osielsko
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
86-031
Country
Poland
Individual Site Status
Recruiting
Facility Name
Royalderm Agnieszka Nawrocka
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-962
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia SCM
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-500
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Twoja Przychodnia SCM
City
Szczecin
State/Province
Zachodniopomorskie
ZIP/Postal Code
71-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Recruiting
Facility Name
Dermedic Jacek Zdybski
City
Ostrowiec Witokrzyski
State/Province
Świętokrzyskie
ZIP/Postal Code
27-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinresco Centres
City
Kempton Park
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Task Central
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7530
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
State/Province
Andalucía
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Gran Canaria Doctor Negrín
City
Las Palmas de Gran Canaria
State/Province
Canarias
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Istanbul Universitesi- Cerrahpasa, Cerrahpasa Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Erciyes Universitesi Tıp Fakultesi Hastaneleri
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Celal Bayar Universitesi Hafta Sultan Hastanesi
City
Manisa
ZIP/Postal Code
45030
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7981040
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Vitiligo (Active and Stable)

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