A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
Tranquillo 2
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBO-CONTROLLED MULTI-CENTER STUDY WITH A DOUBLE-BLIND 52-WEEK EXTENSION PERIOD WITH RANDOMIZED DOSE UP/DOSE DOWN TITRATION INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT PARTICIPANTS WITH NONSEGMENTAL VITILIGO
2 other identifiers
interventional
1,571
18 countries
228
Brief Summary
The purpose of this study is to learn about the safety and effects of the study medicine ritlecitinib for the possible treatment of nonsegmental vitiligo. Vitiligo causes white patches on your skin when the cells that give your skin color are destroyed. Nonsegmental means that it can affect both sides of the body such as both knees and both hands. Ritlecitinib has been tested in earlier clinical studies and has a favorable safety profile. At present there are no approved medications taken by mouth to treat nonsegmental vitiligo. This study is seeking participants who:
- Are 18 years of age or older.
- are confirmed to have nonsegmental vitiligo for at least 3 months.
- Are willing to stop all other treatments that they may be taking for vitiligo. In this study participants will be chosen by chance, like drawing names out of a hat to receive 1 of 3 treatments:
- Part I where two different amounts of ritlecitinib (50 mg and 100 mg) are taken once daily. It will be compared to placebo. Placebo is a dummy capsule. It doesn't have any medicine used in the study. Participants receiving placebo who have not responded to treatment after 52 weeks will be given 100 milligrams or 50 milligrams of ritlecitinib for the remaining 52 weeks of the study.
- In Part II, participants will only receive 100 milligrams of ritlecitinib. About 1000 participants will take part in Part I and around 450 in Part II globally. The study will compare the experiences of people receiving ritlecitinib to those of the people who do not. This will help see if ritlecitinib is safe and effective. People in Part I will be in this study for about 26 months and people in Part II will be in this study for about 14 months. During the study, participants in part I will need to visit the study site at least 17 times. In part II, participants will visit at least 11 times. Participants will undergo various tests and procedures such as:
- vitiligo rating,
- physical examinations,
- hearing tests,
- blood tests,
- x-ray,
- ECG,
- photographs of areas with vitiligo. Participants will be asked to complete questionnaires about their vitiligo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
Typical duration for phase_3
228 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedStudy Start
First participant enrolled
November 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2027
March 27, 2026
March 1, 2026
3.7 years
October 2, 2023
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and Total body Vitiligo Area Scoring Index 50 (T-VASI50) at Week 52
Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline) and T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)
52 Weeks
Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52
Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).
52 Weeks
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to discontinuation.
To evaluate the safety and tolerability of ritlecitinib in adult participants with non segmental vitiligo
Baseline through 108 weeks
Incidence of Clinically significant laboratory abnormalities.
Baseline through 108 weeks
Secondary Outcomes (28)
Response based on F-VASI75 at 24 and 36 weeks
24 and 36 Weeks
US-Only: Response based on T-VASI50 at 24 and 36 weeks
24 and 36 weeks
Global (Other than US):Patient Global Impression of Severity-Face (PGIS-F)
Week 24, 36 and week 52
Global (Other than US): Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
Week 24, 36 and week 52
Global (Other Than US): Response based on T-VASI50 at Week 24, 36 and 52
Week 24, 36 and 52
- +23 more secondary outcomes
Study Arms (4)
Arm 1- Ritlecitinib 100 milligrams (mg)
EXPERIMENTALRandomized to Ritlecitinib 100 mg QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status.
Arm 2- Ritlecitinib 50mg
EXPERIMENTALRandomized to Ritlecitinib 50 mg QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status.
Arm 3- Placebo
PLACEBO COMPARATORRandomized to Placebo QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status.
Arm 4- Ritlecitinib 100mg
EXPERIMENTALNon-randomized open-label Ritlecitinib 100mg QD for 52 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Participants aged 18 years (or the minimum age of consent in accordance with local regulations) or older (no upper age limit) at Screening.
- Meeting reproductive criteria for female participants.
- Disease Characteristics:
- Eligible participants must have at both Screening and BL:
- A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and
- BSA involvement 4% to 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 to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. 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 and T-VASI ≥3; and
- Either active or stable nonsegmental vitiligo at Screening and BL visits. All participants who do not have the features of active vitiligo (defined below) will be classified as having 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 BL defined as one of the following:
- New/extending lesions(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.
- +5 more criteria
You may not qualify if:
- Medical Conditions:
- Any 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.
- Any psychiatric condition including recent or active suicidal ideation or behavior that meets defined criteria.
- Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin:
- 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, but not limited to morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or BL 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 infection within 2 weeks prior to first dose on Day 1. NOTE: participants may be rescreened after the infection resolves.
- General Infection History:
- Have 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 tuberculosis.
- Specific Viral Infection History:
- History (single episode) of disseminated HZ or disseminated herpes simplex or recurrent (more than one episode of) localized, dermatomal HZ.
- Infected with HBV or HCV: all participants will undergo screening for HBV and HBC for eligibility.
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (228)
Center for Dermatology and Plastic Surgery/CCT Research
Scottsdale, Arizona, 85260, United States
Dermatology Trial Associates
Bryant, Arkansas, 72022, United States
First OC Dermatology Research Inc
Fountain Valley, California, 92708, United States
Seaside Audiology Vertigo & Ear Specialists
Huntington Beach, California, 92648, United States
Wallace Medical Group, Inc
Los Angeles, California, 90056, United States
Kaiser Permanente
Oakland, California, 94611, United States
Cura Clinical Research - Oxnard
Oxnard, California, 93030, United States
Mission Dermatology Center
Rancho Santa Margarita, California, 92688, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Integrative Skin Science and Research
Sacramento, California, 95815, United States
University of California San Diego - La Jolla
San Diego, California, 92122, United States
Wolverine Clinical Trials
Santa Ana, California, 92706, United States
Encore Medical Research of Boynton Beach
Boynton Beach, Florida, 33436, United States
FXM Clinical Research - Fort Lauderdale
Fort Lauderdale, Florida, 33308, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
Clever Medical Research
Miami, Florida, 33126, United States
Miami Dermatology and Laser Research
Miami, Florida, 33133, United States
SouthCoast Research Center
Miami, Florida, 33136, United States
University of Miami
Miami, Florida, 33136, United States
Bio-Medical Research LLC
Miami, Florida, 33144, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Skin Research of South Florida
Miami, Florida, 33173, United States
Well Pharma Medical Research, Corp.
Miami, Florida, 33173, United States
FXM Clinical Research - Miami
Miami, Florida, 33175, United States
Health and Life Research Institute
Miami, Florida, 33176, United States
University of Miami, Kendall Office
Miami, Florida, 33176, United States
Floridian Research Institute Llc
Miami, Florida, 33179, United States
Sanitas Research
Miami, Florida, 33186, United States
Wellness Clinical Research
Miami Lakes, Florida, 33016, United States
FXM Clinical Research - Miramar
Miramar, Florida, 33027, United States
GCP Research, Global Clinical professionals
St. Petersburg, Florida, 33705, United States
Advanced Clinical Research Institute
Tampa, Florida, 33607, United States
USF Health
Tampa, Florida, 33612, United States
Sidney P. Smith, MD, PC dba Georgia Skin & Cancer Clinic
Savannah, Georgia, 31419, United States
Endeavor Health Audiology -CHICAGO
Chicago, Illinois, 60625, United States
Endeavor Health Audiology -LAKE BLUFF
Lake Bluff, Illinois, 60044, United States
Endeavor Health Audiology-NORTHBROOK
Northbrook, Illinois, 60062, United States
Endeavor Health Audiology-SKOKIE
Skokie, Illinois, 60076, United States
Endeavor Health-Dermatology Clinical Trials Unit
Skokie, Illinois, 60077, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
The South Bend Clinic, LLC
South Bend, Indiana, 46617, United States
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, 20850, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326, United States
CS Mott Center
Detroit, Michigan, 48201, United States
Wayne Health
Detroit, Michigan, 48201, United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87102, United States
OptiSkin Medical
New York, New York, 10128, United States
DermResearchCenter of New York, Inc.
Stony Brook, New York, 11790, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28211, United States
Darst Dermatology
Charlotte, North Carolina, 28277, United States
Bexley Dermatology Research
Bexley, Ohio, 43209, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, 43213, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Columbia Dermatology & Aesthetics
Columbia, South Carolina, 29212, United States
Palmetto Clinical Trial Services - Greenville
Greenville, South Carolina, 29615, United States
Center for Clinical Studies
Houston, Texas, 77004, United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78660, United States
Complete Dermatology
Sugar Land, Texas, 77479, United States
The Woodlands Dermatology Associates, PA
The Woodlands, Texas, 77380, United States
University of Utah
Murray, Utah, 84107, United States
Springville Dermatology - Springville/CCT Research
Springville, Utah, 84663, United States
Eurofins CRL
Forest, Virginia, 24551, United States
Paratus Clinical Research Woden
Phillip, Australian Capital Territory, 2606, Australia
St George Dermatology & Skin Cancer Centre
Kogarah, New South Wales, 2217, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Veracity Clinical Research
Woolloongabba, Queensland, 4102, Australia
North Eastern Health Specialists
Campbelltown, South Australia, 5074, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Dr Rodney Sinclair Pty Ltd
East Melbourne, Victoria, 3002, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Institute for Skin, Health and Immunity
Mitcham, Victoria, 3132, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Fremantle Dermatology
Fremantle, Western Australia, 6160, Australia
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-capitale, Région de, 1070, Belgium
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-capitale, Région de, 1200, Belgium
UZ Gent
Ghent, Oost-vlaanderen, 9000, Belgium
UZ Leuven
Leuven, Vlaams-brabant, 3000, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
ASMC - IPSMC - skin and venereal diseases
Sofia, Sofia (stolitsa), 1407, Bulgaria
Diagnostic Consultative Center Aleksandrovska
Sofia, Sofia (stolitsa), 1431, Bulgaria
Diagnostic Consultative Centre (DCC) - Foкus 5
Sofia, Sofia (stolitsa), 1463, Bulgaria
Clinic EvroDerma
Sofia, Sofia (stolitsa), 1606, Bulgaria
MHAT Pazardzhik
Pazardzhik, 4400, Bulgaria
Diagnostic Consultative Center 1 - Pernik
Pernik, 2300, Bulgaria
Medical Center Exacta Medica
Pleven, 5800, Bulgaria
Medical Center Prolet EOOD
Rousse, 7000, Bulgaria
Diagnostic Consultative Center "Ascendent"
Sofia, 1202, Bulgaria
Diagnostic - Consultative Center XXVIII - Sofia
Sofia, 1528, Bulgaria
"Diagnostic - Consultative Center XX - Sofia" EOOD
Sofia, 1618, Bulgaria
UMHAT "Prof. Dr. Stoyan Kirkovich"AD
Stara Zagora, 6003, Bulgaria
Center for Skin and Venereal Diseases - Veliko Tarnovo
Veliko Tarnovo, 5000, Bulgaria
Multiprofile Hospital for Active Treatment Sv. Panteleymon - Yambol AD
Yambol, 8600, Bulgaria
Dermatology Research Institute
Calgary, Alberta, T2J 7E1, Canada
Alberta Dermasurgery Centre
Edmonton, Alberta, T6G 1C3, Canada
The Skin Care Centre
Vancouver, British Columbia, V5Z 4E8, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1, Canada
Medicor Research Inc
Greater Sudbury, Ontario, P3C 1X3, Canada
Sudbury Skin Clinique
Greater Sudbury, Ontario, P3C 1X8, Canada
DermEffects
London, Ontario, N6H 5L5, Canada
DermEdge Research
Mississauga, Ontario, L4Y 4C5, Canada
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5, Canada
JRB Research Inc.
Ottawa, Ontario, K1K 4L2, Canada
York Dermatology Clinic & Research Centre
Richmond Hill, Ontario, L4B 1L1, Canada
North York Research Inc
Toronto, Ontario, M2N 3A6, Canada
Dermatology on Bloor - Research Toronto
Toronto, Ontario, M4W 2N4, Canada
Centre de Recherche Saint-Louis
Montreal, Quebec, H1Y 3L1, Canada
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1, Canada
Centre de Recherche Saint-Louis
Sherbrooke, Quebec, J1G 1X9, Canada
Diex Recherche Sherbrooke
Sherbrooke, Quebec, J1L 0H8, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 2C1, Canada
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, S7T 0G3, Canada
Diex Recherche Quebec
Québec, G1V 4T3, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, G1V 4X7, Canada
Alpha Recherche Clinique
Québec, G2J 0C4, Canada
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, 100050, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, 350005, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050030, China
NanYang First people's hospital
Nanyang, Henan, 473000, China
The First Hospital of Wuhan
Wuhan, Hubei, 430022, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014010, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Chengdu second people's hospital
Chengdu, Sichuan, 610017, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Hangzhou Third Hospital
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Shanghai General Hospital
Shanghai, 200080, China
Rosenpark Research GmbH
Darmstadt, Hesse, 64283, Germany
Klinikum Bielefeld gem. GmbH
Bielefeld, North Rhine-Westphalia, 33647, Germany
Klinikum Bielefeld Rosenhöhe
Bielefeld, North Rhine-Westphalia, 33647, Germany
Hautzentrum im Jahrhunderthaus
Bochum, North Rhine-Westphalia, 44793, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
BAG Drs. Med. Quist PartG
Mainz, Rhineland-Palatinate, 55128, Germany
Hautarztpraxis Dr. Beatrice Gerlach
Dresden, Saxony, 01097, Germany
Hautarztpraxis Dr. Neubauer
Leipzig, Saxony, 04207, Germany
HNO-Praxis Dr. Kugler in Magdeburg
Magdeburg, Saxony-Anhalt, 39104, Germany
Magdeburger Company for Medical Studies and Services
Magdeburg, Saxony-Anhalt, 39104, Germany
Radiologie Ulrichshaus
Magdeburg, Saxony-Anhalt, 39104, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, 7632, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, 6720, Hungary
Trial Pharma - Semper Medical Center
Békéscsaba, 5600, Hungary
Óbudai Egészségügyi Centrum
Budapest, 1036, Hungary
Orvostudomanyi Kutato es Fejleszto Kft
Debrecen, 4027, Hungary
DERMA-B Egészségügyi és Szolgáltató
Debrecen, 4031, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Derm-Surg Egészségügyi Szolgáltató és Tanácsadó Kft.
Kaposvár, 7400, Hungary
ASL1 Avezzano-Sulmona-L'Aquila
L’Aquila, Abruzzo, 67100, Italy
Presidio Ospedaliero Firenze Centro Piero Palagi
Florence, Firenze, 50125, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
IRCCS Istituti Fisioterapici Ospitalieri
Roma, RM, 00144, Italy
Ospedale Israelitico
Rome, ROMA, 00148, Italy
Istituto Dermopatico Immacolata
Rome, ROMA, 00167, Italy
Ospedale Civile - Azienda Ospedaliera Universitaria di Cagliari
Cagliari, 09124, Italy
Japan Community Health Care Organization Chukyo Hospital
Nagoya, Aichi-ken, 457-8510, Japan
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741, Japan
Juntendo University Urayasu Hospital
Urayasu, Chiba, 279-0021, Japan
Takarazuka City Hospital
Takarazuka, Hyōgo, 665-0827, Japan
Tokyo Medical University Ibaraki Medical Center
Inashiki-gun, Ibaraki, 300-0395, Japan
Kindai University Nara Hospital
Ikoma, Nara, 630-0293, Japan
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8519, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505, Japan
Trials in Medicine
Mexico City, Mexico City, 06700, Mexico
Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC
Morelia, Michoacán, 58249, Mexico
Cri Centro Regiomontano de Investigacion
Monterrey, Nuevo León, 64060, Mexico
Servicios Hospitalarios de Mexico S.A. DE C.V.
Chihuahua City, 31238, Mexico
Arké SMO S.A de C.V
Veracruz, 91900, Mexico
Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny I Alergologiczny Prof.Dr Hab.Med. Barbara Z
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-650, Poland
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka
Krakow, Lesser Poland Voivodeship, 30-002, Poland
Krakowskie Centrum Medyczne
Krakow, Lesser Poland Voivodeship, 31-501, Poland
ETG Warszawa
Warsaw, Masovian Voivodeship, 02-677, Poland
Klinika Ambroziak Dermatologia
Warsaw, Masovian Voivodeship, 02-953, Poland
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, 02-962, Poland
Specderm Poznanska sp.j.
Bialystok, Podlaskie Voivodeship, 15-375, Poland
ClinicMed Daniluk, Nowak Spółka komandytowa
Bialystok, Podlaskie Voivodeship, 15-879, Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611, Poland
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, 71-500, Poland
"DERMED" Centrum Medyczne Sp. z o.o.
Lodz, Łódź Voivodeship, 90-265, Poland
Cardiovascular Radiology Institute
San Juan, 00909, Puerto Rico
Clinical Research Puerto Rico
San Juan, 00909, Puerto Rico
Centro de Audiología y Balance
San Juan, 00927, Puerto Rico
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, Banská Bystrica Region, 97517, Slovakia
SANARE, s.r.o
Svidník, Presov, 089 01, Slovakia
Fakultna nemocnica Trnava
Trnava, Trnava Region, 917 02, Slovakia
CLINIQ s.r.o.
Bratislava, 811 09, Slovakia
BeneDerma
Bratislava, 841 02, Slovakia
Derma therapy spol. s.r.o.
Bratislava, 851 01, Slovakia
Poliklinika ProCare Kosice s.r.o.
Košice, 040 23, Slovakia
Topskin pro s.r.o.
Košice, 04001, Slovakia
AUDIKA
Córdoba, Andalusia, 14001, Spain
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [barcelona], 08916, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona [barcelona], 08907, Spain
Clínica Gaias - Santiago
Santiago de Compostela, Galicia [galicia], 15702, Spain
Hospital Universitario Infanta Leonor
Madrid, Madrid, Comunidad de, 28031, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Clinica Universidad de Navarra
Madrid, 28027, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Clínica Gaias - Santiago
Santiago de Compostela, 15702, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833401, Taiwan
National Taiwan University Hospital
Taipei, 100225, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, 333, Taiwan
Gazi University Health Research and Application Center Gazi Hospital
Ankara, 06560, Turkey (Türkiye)
Bezmialem Vakf Üniversitesi
Istanbul, 34093, Turkey (Türkiye)
West Middlesex University Hospital
Isleworth, England, TW7 6AF, United Kingdom
Southampton General Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Guy's & St Thomas' NHS Foundation Trust
London, London, CITY of, SE1 9RT, United Kingdom
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2023
First Posted
October 10, 2023
Study Start
November 8, 2023
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
July 30, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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.