Clinical trial NCT05583526: A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Stable Nonsegmental Vitiligo
Active Nonsegmental Vitiligo
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-10-17
Enrollment: 581
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, parallel-group, vehicle controlled.
Primary purpose: TREATMENT

Brief summary: A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental Vitiligo (Active and Stable) Tranquillo

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 nonsegmental vitiligo (both active and stable vitiligo).

Eligibility criteria: Inclusion Criteria:

1. Participants ≥18 years of age at Screening. 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.

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

   * A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and
   * BSA involvement 4%-60% inclusive, excluding involvements at palms of the hands, 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 cheek 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 nonsegmental 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); Confetti-like depigmentation is characterized by the presence of numerous 1-mm to 5-mm depigmented macules in clusters;
   * Trichrome lesion(s);Trichrome lesions have a hypopigmented zone of varying width between normal and completely depigmented skin, resulting in 3 different hues of skin;
   * 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 and Baseline 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 disorders of pigmentation (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 (all types, including mixed), 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 a 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. 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:

   * 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.
   * 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.
   * 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 acute, 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) that may increase the risk associated with study participation 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.
   * Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery or with elective surgery scheduled to occur during the study.

   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 that do not affect vitiligo within 4 weeks of Day 1 \[Baseline\] or within 5 half-lives, 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.
11. Adolescent participants 12 to \<18 years of age without one of the following:

    * Documented evidence from a health professional of having received varicella vaccination (2 doses); or
    * Evidence of prior exposure to VZV based on serological testing (ie, a positive VZV IgG Ab result) at Screening.

Primary outcomes:
measure: US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and T-VASI50 at Week 52
timeFrame: Week 52
measure: Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52
timeFrame: Week 52
measure: Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs), leading to discontinuation, and clinically significant laboratory abnormalities
timeFrame: Baseline through Week 52
Secondary outcomes:
measure: US-Only: Response based on F-VASI75 at 24 and 36 weeks
timeFrame: Weeks 24 and 36
measure: US-Only: Response based on T-VASI50 at 24 and 36 weeks
timeFrame: Weeks 24 and 36
measure: US-Only: Response based on T-VASI75 at 52 weeks
timeFrame: Week 52
measure: US-Only: Percentage change from baseline (% CFB) in F-VASI at 24, 36, and 52 weeks
timeFrame: Weeks 24, 36, and 52
measure: US-Only: Percentage change from baseline (% CFB) in T-VASI at 24, 36, and 52 weeks
timeFrame: Weeks 24, 36, and 52
measure: US-Only: Patient Global Impression of Severity-Face (PGIS-F)
timeFrame: Week 52
measure: US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
timeFrame: Week 52
measure: Global (Other than US): Response based on F-VASI75 at 24 and 36 weeks
timeFrame: Weeks 24 and 36
measure: Global (Other Than US): Response based on T-VASI50 at 24, 36, and 52 weeks
timeFrame: Weeks 24, 36, and 52
measure: Global (Other than US): Percentage change from baseline (% CFB) in F-VASI at 24, 36, and 52 weeks
timeFrame: Weeks 24, 36, and 52
measure: Global (Other than US): Percentage change from baseline (% CFB) in T-VASI at 24, 36, and 52 weeks
timeFrame: Weeks 24, 36, and 52
measure: Global (Other than US): Patient Global Impression of Severity-Face (PGIS-F)
timeFrame: Weeks 24, 36, and 52
measure: Global (Other than US): Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
timeFrame: Weeks 24, 36, and 52
measure: All Countries: Proportion of participants achieving disease stabilization
timeFrame: Baseline through week 52
measure: Response based on T-VASI50
timeFrame: Baseline through week 4, week 8, week 12, week 48
measure: Response based on F-VASI75
timeFrame: Baseline through week 4, week 8, week 12, week 48
measure: Response based on T-VASI75
timeFrame: Baseline through week 4, week 8, week 12, week 24, week 36, week 48
measure: Proportion of participants with sustained improvement in T-VASI
timeFrame: Week 36 through week 52
measure: Proportion of participants with sustained improvement in F-VASI
timeFrame: Week 36 through week 52
measure: All Countries: Time to rescue medication
timeFrame: Baseline through week 52
measure: Percentage change from baseline in F-VASI
timeFrame: Baseline through week 52
measure: Percentage change from baseline in T-VASI
timeFrame: Baseline through week 52
measure: Response based on T-VASI90
timeFrame: Baseline through week 52
measure: Response based on T-VASI100
timeFrame: Baseline through week 52
measure: Response based on F-VASI50
timeFrame: Baseline through week 52
measure: Response based on F-VASI90
timeFrame: Baseline through week 52
measure: Response based on F-VASI100
timeFrame: Baseline through week 52
measure: Patient Global Impression of Severity-Face (PGIS-F)
timeFrame: Weeks 24 and 36
measure: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
timeFrame: Weeks 24 and 36
measure: Patient Global Impression of Change-Face (PGIC-F)
timeFrame: Weeks 24, 36, and 52
measure: Patient Global Impression of Change- Overall Vitiligo (PGIC-V)
timeFrame: Weeks 24, 36, and 52
measure: Change from baseline in Dermatology Life Quality Index (DLQI) or Children Dermatology Life Quality Index (CDLQI)
timeFrame: Week 52
measure: Change from baseline in the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Week 52
measure: The proportion of patients achieving absence of depression on HADS depression subscale
timeFrame: Week 52
measure: The proportion of patients achieving absence of anxiety on HADS anxiety subscale
timeFrame: Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Faculty Office Towers (Regulatory
state: Alabama
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group, Inc
state: California
city: Washington
country: United States
facility: Audiology
state: District of Columbia
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Center for Dermatology and Dermatologic Surgery
state: District of Columbia
city: Boynton Beach
country: United States
facility: Encore Medical Research of Boynton Beach
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research
state: Florida
city: Miami
country: United States
facility: Clever Medical Research
state: Florida
city: North Miami Beach
country: United States
facility: Ziaderm Research LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Olympian Clinical Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research, PC.
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Baton Rouge
country: United States
facility: Velocity Clinical Research at The Dermatology Clinic, Baton Rouge
state: Louisiana
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: Baton Rouge
country: United States
facility: The NeuroMedical Center (XRay)
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Prairieville
country: United States
facility: Prairieville Family Hospital (XRay)
state: Louisiana
city: Bowie
country: United States
facility: Visage Dermatology and Aesthetic Center
state: Maryland
city: Rockville
country: United States
facility: Lawrence J Green, MD LLC
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Canton
country: United States
facility: Hamzavi Dermatology - Canton
state: Michigan
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Brooklyn
country: United States
facility: SUNY Downstate Health Sciences University
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Chapel Hill
country: United States
facility: Clinical & Translational Research Center (CTRC)
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare - Wilmington
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Remington Davis Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis, Inc
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PLLC
state: Texas
city: Houston
country: United States
facility: Alpesh D. Desai, DO PLLC - Research
state: Texas
city: Houston
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Darlinghurst
country: Australia
facility: The Skin Hospital
state: New South Wales
city: Campbelltown
country: Australia
facility: North Eastern Health Specialists
state: South Australia
city: Carlton
country: Australia
facility: Skin Health Institute Inc.
state: Victoria
city: East Melbourne
country: Australia
facility: Dr Rodney Sinclair Pty Ltd
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Dupnitsa
country: Bulgaria
facility: MC "Asklepiy" OOD
city: Sofia
country: Bulgaria
facility: DCC Aleksandrovska EOOD
city: Stara Zagora
country: Bulgaria
facility: UMHAT "Prof. dr. Stoyan Kirkovich" AD
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Red Deer
country: Canada
facility: CaRe Clinic
state: Alberta
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Toronto
country: Canada
facility: North York Research Inc
state: Ontario
city: Whitby
country: Canada
facility: Whitby Health Centre Dermatology trials
state: Ontario
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Fuzhou
country: China
facility: Fujian Medical University Affiliated First Hospital
state: Fujian
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Wuhan
country: China
facility: The First Hospital of Wuhan
state: Hubei
city: Shenyang
country: China
facility: The First Hospital of China Medical University/Dermatology and STD Department
state: Liaoning
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan Sheng
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital/Dermatology Department
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Wenzhou
country: China
facility: The first Affiliated hospital of Wenzhou medical University
state: Zhejiang
city: Stuttgart
country: Germany
facility: Praxis Leitz und Kollegen
state: Baden-württemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
state: Bayern
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
state: Niedersachsen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-westfalen
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas, IRCCS
state: Milano
city: Roma
country: Italy
facility: Istituti Fisioterapici Ospitalieri (IFO)
state: RM
city: Bologna
country: Italy
facility: Policlinico S. Orsola- Malpighi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Sakai City
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Osaka
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Toshima-Ku
country: Japan
facility: Sugamo Kobayashi Derma Clinic
state: Tokyo
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Kyǒnggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital
state: Kyǒnggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [seoul]
city: Mexico City
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Centro de Dermatologia de Monterrey
state: Nuevo LEÓN
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon S.C.
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo Y Corazon Sc
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Osielsko
country: Poland
facility: DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
state: Mazowieckie
city: Szczecin
country: Poland
facility: Twoja Przychodnia SCM
state: Zachodniopomorskie
city: Lodz
country: Poland
facility: Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
state: Łódzkie
city: Ostrowiec Witokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
state: Świętokrzyskie
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
state: Canarias
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Córdoba
country: Spain
facility: AUDIKA
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Istanbul
country: Turkey
facility: Istanbul Universitesi- Cerrahpasa, Cerrahpasa Tip Fakultesi
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri
city: Manisa
country: Turkey
facility: Celal Bayar Universitesi Hafta Sultan Hastanesi
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: