Stable Nonsegmental VitiligoPhase 3Tranquillo 2NCT06072183
A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
A Phase 3 study testing Ritlecitinib in people with Stable Nonsegmental Vitiligo and Active Nonsegmental Vitiligo, run by Pfizer at 229 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Nonsegmental Vitiligo, Active Nonsegmental Vitiligo
- What is being tested?
- Ritlecitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,571 participants
- Where
- 229 sitesin 18 countries
- Study dates
- 8 Nov 2023to 30 Jul 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Stable vitiligo is defined as:
- Participants will be classified as having stable vitiligo based on an absence of signs of active disease. All participants who do not have the features of active vitiligo (defined above) will be classified as having 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.
- Additional inclusion criteria are:
- 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.
Who cannot join
- 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:
- Participants that have other types of vitiligo that do not meet criteria for active or stable vitiligo as noted in inclusion criteria (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.
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- 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.
- 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.
- Other Medical Conditions:
- 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 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). 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:
- Have received any of the prohibited treatment regimens specified.
- Prior/Concurrent Clinical Study Experience:
- 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:
- Any of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:
- Renal impairment
- Hepatic dysfunction
- Other laboratory abnormalities
- 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.
Trial locations and contacts
229 sites in 18 countries.
229 sites in 18 countries
United States68 sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87102
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
Bexley Dermatology Research
Bexley, Ohio, 43209
Encore Medical Research of Boynton Beach
Boynton Beach, Florida, 33436
Dermatology Trial Associates
Bryant, Arkansas, 72022
Medical University of South Carolina
Charleston, South Carolina, 29425
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28211
Darst Dermatology
Charlotte, North Carolina, 28277
Endeavor Health Audiology -CHICAGO
Chicago, Illinois, 60625
Columbia Dermatology & Aesthetics
Columbia, South Carolina, 29212
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, 43213
CS Mott Center
Detroit, Michigan, 48201
Wayne Health
Detroit, Michigan, 48201
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202
Eurofins Cosmetics CRL LLC
Forest, Virginia, 24551
FXM Clinical Research - Fort Lauderdale
Fort Lauderdale, Florida, 33308
First OC Dermatology Research Inc
Fountain Valley, California, 92708
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29615
Direct Helpers Research Center
Hialeah, Florida, 33012
Wellness Clinical Research, LLC
Hialeah, Florida, 33012
Center for Clinical Studies
Houston, Texas, 77004
Seaside Audiology Vertigo & Ear Specialists
Huntington Beach, California, 92648
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Endeavor Health Audiology -LAKE BLUFF
Lake Bluff, Illinois, 60044
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516
Wallace Medical Group, Inc
Los Angeles, California, 90056
Clever Medical Research
Miami, Florida, 33126
Miami Dermatology and Laser Institute
Miami, Florida, 33133
SouthCoast Research Center
Miami, Florida, 33136
University of Miami Dermatology Clinical Trials Unit
Miami, Florida, 33136
University of Miami
Miami, Florida, 33136
Bio-Medical Research LLC
Miami, Florida, 33144
New Horizon Research Center
Miami, Florida, 33165
Skin Research of South Florida
Miami, Florida, 33173
Well Pharma Medical Research, Corp.
Miami, Florida, 33173
FXM Clinical Research - Miami
Miami, Florida, 33175
Health and Life Research Institute
Miami, Florida, 33176
University of Miami, Kendall Office
Miami, Florida, 33176
Floridian Research Institute Llc
Miami, Florida, 33179
Sanitas Research
Miami, Florida, 33186
FXM Clinical Research Miramar, LLC
Miramar, Florida, 33027
University of Utah
Murray, Utah, 84107
OptiSkin Medical
New York, New York, 10128
Endeavor Health Audiology-NORTHBROOK
Northbrook, Illinois, 60062
Kaiser Permanente
Oakland, California, 94611
Cura Clinical Research - Oxnard
Oxnard, California, 93030
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Mission Dermatology Center
Rancho Santa Margarita, California, 92688
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, 20850
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Integrative Skin Science and Research
Sacramento, California, 95815
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
University of California San Diego - La Jolla
San Diego, California, 92122
Wolverine Clinical Trials
Santa Ana, California, 92706
Sidney P. Smith, MD, PC dba Georgia Skin & Cancer Clinic
Savannah, Georgia, 31419
Center for Dermatology and Plastic Surgery/CCT Research
Scottsdale, Arizona, 85260
Endeavor Health Audiology-SKOKIE
Skokie, Illinois, 60076
Endeavor Health-Dermatology Clinical Trials Unit
Skokie, Illinois, 60077
The South Bend Clinic, LLC
South Bend, Indiana, 46617
Springville Dermatology - Springville/CCT Research
Springville, Utah, 84663
GCP Research, Global Clinical professionals
St. Petersburg, Florida, 33714
DermResearchCenter of New York, Inc.
Stony Brook, New York, 11790
Complete Dermatology
Sugar Land, Texas, 77479
Advanced Clinical Research Institute
Tampa, Florida, 33607
USF Health
Tampa, Florida, 33612
The Woodlands Dermatology Associates, PA
The Woodlands, Texas, 77380
Canada23 sites
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M 7G1
Dermatology Research Institute
Calgary, Alberta, T2J 7E1
Alberta Dermasurgery Centre
Edmonton, Alberta, T6G 1C3
Medicor Research Inc
Greater Sudbury, Ontario, P3C 1X3
Sudbury Skin Clinique
Greater Sudbury, Ontario, P3C 1X8
DermEffects
London, Ontario, N6H 5L5
DermEdge Research
Mississauga, Ontario, L4Y 4C5
Centre de Recherche Saint-Louis (Montréal)
Montreal, Quebec, H1Y 3L1
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1
The Centre for Clinical Trials
Oakville, Ontario, L6J 7W5
JRB Research Inc.
Ottawa, Ontario, K1K 4L2
Diex Recherche Quebec
Québec, Quebec, G1V 4T3
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, Quebec, G1V 4X7
Alpha Recherche Clinique
Québec, Quebec, G2J 0C4
York Dermatology Clinic & Research Centre
Richmond Hill, Ontario, L4B 1L1
Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 2C1
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, S7T 0G3
Centre de Recherche Saint-Louis
Sherbrooke, Quebec, J1G 1X9
Diex Recherche Sherbrooke
Sherbrooke, Quebec, J1L 0H8
North York Research Inc
Toronto, Ontario, M2N 3A6
Dermatology on Bloor - Research Toronto
Toronto, Ontario, M4W 2N4
The Skin Care Centre
Vancouver, British Columbia, V5Z 4E8
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4
China22 sites
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014010
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, 100050
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
The First Hospital of Jilin University
Changchun, Jilin, 130021
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Chengdu second people's hospital
Chengdu, Sichuan, 610017
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, 350005
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Hangzhou Third Hospital
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
NanYang First people's hospital
Nanyang, Henan, 473000
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Shanghai General Hospital
Shanghai, 200080
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050030
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
The First Hospital of Wuhan
Wuhan, Hubei, 430022
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Bulgaria14 sites
MHAT Pazardzhik
Pazardzhik, Pazardzhik, 4400
Diagnostic Consultative Center 1 - Pernik
Pernik, Pernik, 2300
Medical Center Exacta Medica
Pleven, Pleven, 5800
Medical Center Prolet EOOD
Rousse, Ruse, 7000
Diagnostic - Consultative Center XXVIII - Sofia
Sofia, Sofia, 1528
"Diagnostic - Consultative Center XX - Sofia" EOOD
Sofia, Sofia, 1618
ASMC - IPSMC - skin and venereal diseases
Sofia, Sofia (stolitsa), 1407
Diagnostic Consultative Center Aleksandrovska
Sofia, Sofia (stolitsa), 1431
Diagnostic Consultative Centre (DCC) - Foкus 5
Sofia, Sofia (stolitsa), 1463
Clinic EvroDerma
Sofia, Sofia (stolitsa), 1606
Diagnostic Consultative Center "Ascendent"
Sofia, 1202
UMHAT "Prof. Dr. Stoyan Kirkovich"AD
Stara Zagora, Stara Zagora, 6003
Center for Skin and Venereal Diseases - Veliko Tarnovo
Veliko Tarnovo, Veliko Tarnovo, 5000
Multiprofile Hospital for Active Treatment Sv. Panteleymon - Yambol AD
Yambol, Yambol, 8600
Germany12 sites
Klinikum Bielefeld gem. GmbH
Bielefeld, North Rhine-Westphalia, 33647
Klinikum Bielefeld Rosenhöhe
Bielefeld, North Rhine-Westphalia, 33647
Hautzentrum im Jahrhunderthaus
Bochum, North Rhine-Westphalia, 44793
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127
Rosenpark Research GmbH
Darmstadt, Hesse, 64283
Hautarztpraxis Dr. Beatrice Gerlach
Dresden, Saxony, 01097
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Hautarztpraxis Dr. Neubauer
Leipzig, Saxony, 04207
HNO-Praxis Dr. Kugler in Magdeburg
Magdeburg, Saxony-Anhalt, 39104
Magdeburger Company for Medical Studies and Services
Magdeburg, Saxony-Anhalt, 39104
Radiologie Ulrichshaus
Magdeburg, Saxony-Anhalt, 39104
BAG Drs. Med. Quist PartG
Mainz, Rhineland-Palatinate, 55128
Spain12 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona [barcelona], 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, BARCELONA, 08041
AUDIKA
Córdoba, Andalusia, 14001
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona [barcelona], 08907
Clinica Universidad de Navarra
Madrid, Madrid, 28027
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario Infanta Leonor
Madrid, Madrid, Comunidad de, 28031
Clínica Gaias - Santiago
Santiago de Compostela, Galicia [galicia], 15702
Clínica Gaias - Santiago
Santiago de Compostela, 15702
Hospital Universitari i Politecnic La Fe
Valencia, VALÈNCIA, 46026
Hospital Universitario Miguel Servet
Zaragoza, ZARAGOZA, 50009
Australia11 sites
North Eastern Health Specialists
Campbelltown, South Australia, 5074
Dr Rodney Sinclair Pty Ltd
East Melbourne, Victoria, 3002
Fremantle Dermatology
Fremantle, Western Australia, 6160
St George Dermatology & Skin Cancer Centre
Kogarah, New South Wales, 2217
The Alfred Hospital
Melbourne, Victoria, 3004
Institute for Skin, Health and Immunity
Mitcham, Victoria, 3132
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Paratus Clinical Research Woden
Phillip, Australian Capital Territory, 2606
Royal North Shore Hospital
St Leonards, New South Wales, 2065
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Veracity Clinical Research
Woolloongabba, Queensland, 4102
Poland11 sites
Specderm Poznanska sp.j.
Bialystok, Podlaskie Voivodeship, 15-375
ClinicMed Daniluk, Nowak Spółka komandytowa
Bialystok, Podlaskie Voivodeship, 15-879
Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny I Alergologiczny Prof.Dr Hab.Med. Barbara Z
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-650
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, 40-611
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka
Krakow, Lesser Poland Voivodeship, 30-002
Krakowskie Centrum Medyczne
Krakow, Lesser Poland Voivodeship, 31-501
"DERMED" Centrum Medyczne Sp. z o.o.
Lodz, Łódź Voivodeship, 90-265
Twoja Przychodnia SCM
Szczecin, West Pomeranian Voivodeship, 71-500
ETG Warszawa
Warsaw, Masovian Voivodeship, 02-677
Klinika Ambroziak Dermatologia
Warsaw, Masovian Voivodeship, 02-953
Royalderm Agnieszka Nawrocka
Warsaw, Masovian Voivodeship, 02-962
Japan10 sites
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8519
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192
Kindai University Nara Hospital
Ikoma, Nara, 630-0293
Tokyo Medical University Ibaraki Medical Center
Inashiki-gun, Ibaraki, 300-0395
Japan Community Health Care Organization Chukyo Hospital
Nagoya, Aichi-ken, 457-8510
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741
Takarazuka City Hospital
Takarazuka, Hyōgo, 665-0827
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505
Juntendo University Urayasu Hospital
Urayasu, Chiba, 279-0021
Hungary8 sites
Trial Pharma - Semper Medical Center
Békéscsaba, Békéscsaba, 5600
Óbudai Egészségügyi Centrum
Budapest, Budapest, 1036
Orvostudomanyi Kutato es Fejleszto Kft
Debrecen, Debrecen, 4027
Debreceni Egyetem Klinikai Kozpont
Debrecen, Debrecen, 4032
DERMA-B Egészségügyi és Szolgáltató
Debrecen, 4031
Derm-Surg Egészségügyi Szolgáltató és Tanácsadó Kft.
Kaposvár, 7400
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, 7632
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, 6720
Slovakia8 sites
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, Banská Bystrica Region, 97517
CLINIQ s.r.o.
Bratislava, 811 09
BeneDerma
Bratislava, 841 02
Derma therapy spol. s.r.o.
Bratislava, 851 01
Poliklinika ProCare Kosice s.r.o.
Košice, 040 23
Topskin pro s.r.o.
Košice, 04001
SANARE, s.r.o
Svidník, Presov, 089 01
Fakultna nemocnica Trnava
Trnava, Trnava Region, 917 02
Italy7 sites
Ospedale Civile - Azienda Ospedaliera Universitaria di Cagliari
Cagliari, CAGLIARI, 09124
Presidio Ospedaliero Firenze Centro Piero Palagi
Florence, FIRENZE, 50125
ASL1 Avezzano-Sulmona-L'Aquila
L’Aquila, Abruzzo, 67100
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
IRCCS Istituti Fisioterapici Ospitalieri
Roma, RM, 00144
Ospedale Israelitico
Rome, ROMA, 00148
Istituto Dermopatico Immacolata
Rome, ROMA, 00167
Belgium5 sites
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-capitale, Région de, 1070
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-capitale, Région de, 1200
UZ Gent
Ghent, OOST-VLAANDEREN, 9000
UZ Leuven
Leuven, VLAAMS-BRABANT, 3000
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, LIÈGE, 4000
Mexico5 sites
Servicios Hospitalarios de Mexico S.A. DE C.V.
Chihuahua City, Chihuahua, 31238
Trials in Medicine
Mexico City, Mexico City, 06700
Cri Centro Regiomontano de Investigacion
Monterrey, Nuevo León, 64060
Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC
Morelia, Michoacán, 58249
Arké SMO S.A de C.V
Veracruz, Veracruz, 91900
Taiwan5 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833401
Taipei Veterans General Hospital
Taipei, Taipei, 11217
National Taiwan University Hospital
Taipei, 100225
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, TAOYUAN, 333
Puerto Rico3 sites
Cardiovascular Radiology Institute
San Juan, 00909
Clinical Research Puerto Rico
San Juan, 00909
Centro de Audiología y Balance
San Juan, 00927
United Kingdom3 sites
West Middlesex University Hospital
Isleworth, England, TW7 6AF
Guy's & St Thomas' NHS Foundation Trust
London, London, CITY of, SE1 9RT
Southampton General Hospital
Southampton, HAMPSHIRE, SO16 6YD
Turkey (Türkiye)2 sites
Gazi University Health Research and Application Center Gazi Hospital
Ankara, Ankara, 06560
Bezmialem Vakf Üniversitesi
Istanbul, Istanbul, 34093
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Study B7981080 is a Phase 3 randomized, double-blind, multicenter study with a 52-week placebo-controlled period (Part Ia) followed by a double-blind 52-week extension period (Part Ib) that includes randomized dose-up/down titration and a de novo 52-week non-randomized open-label cohort (Part II), investigating the efficacy, safety, and tolerability of ritlecitinib 100 mg QD and 50 mg QD compared with placebo in adult participants with nonsegmental active or stable vitiligo
- Being tested
- Ritlecitinib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitlecitinibDrug
100mg Capsule
RitlecitinibDrug
50mg Capsule
PlaceboDrug
Matching capsule
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- Ritlecitinib 100 milligrams (mg) | Experimental | Randomized to Ritlecitinib 100 mg QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status. Receives: Drug: Ritlecitinib |
| Arm 2- Ritlecitinib 50mg | Experimental | Randomized to Ritlecitinib 50 mg QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status. Receives: Drug: Ritlecitinib |
| Arm 3- Placebo | Placebo comparator | Randomized to Placebo QD for 52 weeks before progressing into the up/down titration extension period, rerandomized according to responder status. Receives: Drug: Placebo |
| Arm 4- Ritlecitinib 100mg | Experimental | Non-randomized open-label Ritlecitinib 100mg QD for 52 weeks. Receives: Drug: Ritlecitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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
Measured: Baseline through 108 weeks
Incidence of Clinically significant laboratory abnormalities.
Measured: Baseline through 108 weeks
Secondary outcomes (28)
Response based on F-VASI75 at 24 and 36 weeks
Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline.
Measured: 24 and 36 Weeks
US-Only: Response based on T-VASI50 at 24 and 36 weeks
Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline).
Measured: 24 and 36 weeks
Global (Other than US):Patient Global Impression of Severity-Face (PGIS-F)
To assess the effect of ritlecitinib compared to placebo on the PGIS-F at Week 24, 36 and 52
Measured: Week 24, 36 and week 52
Global (Other than US): Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
To assess the effect of ritlecitinib compared to placebo on the PGIS-V at Week 24, 36 and 52
Measured: Week 24, 36 and week 52
Global (Other Than US): Response based on T-VASI50 at Week 24, 36 and 52
Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline).
Measured: Week 24, 36 and 52
Patient Global Impression of Change-Face (PGIC-F)
To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Weeks 36 and 52.
Measured: Week 36 and week 52
Patient Global Impression of Change- Overall vitiligo(PGIC-V)
To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Weeks 36 and 52.
Measured: Week 36 and week 52
Change from baseline in Dermatology Life Quality Index (DLQI)
To evaluate the change from baseline in DLQI at week 52
Measured: Week 52
Proportion of participants achieving disease stabilization
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 and 100mg compared to placebo
Measured: Baseline through week 104
Response based on T-VASI50
Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)
Measured: Baseline through week 4, week 8, week 12, week 48, week 56, week 60, week 64, week 76, week 88 and week 104.
Response based on F-VASI75
Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)
Measured: Baseline through week 4, week 8, week 12, week 48, week 56, week 60, week 64, week 76, week 88 and week 104.
Response based on T-VASI75
Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)
Measured: Baseline through week 4, week 8, week 12, week 24, week 36, week 48, week 56, week 60, week 64, week 76, week 88 and week 104.
Global (Other than US): Response based on T-VASI75
Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)
Measured: Baseline through week 52
Proportion of participants with sustained improvement in T-VASI
Defined as maintenance of ≥T-VASI50 from Week 36 to Week 52
Measured: Week 36 through week 52
Proportion of participants with sustained improvement in F-VASI
Defined as maintenance of ≥F-VASI75 from Week 36 to 52
Measured: Week 36 through week 52
Time to rescue medication use
Measured: Baseline through week 104
US-Only: Percentage change from baseline (% CFB) in F-VASI at Weeks 24, 36 and 52
To compare the efficacy of ritlecitinib 100 mg QD versus placebo on % CFB in F-VASI at Weeks 24, 36 and 52
Measured: Weeks 24, 36 and 52
US-Only: % CFB in T-VASI at weeks 24, 36 and 52
To compare the efficacy of ritlecitinib 100 mg QD versus placebo on % CFB in T-VASI at Weeks 24,36 and 52
Measured: Weeks 24, 36 and 52
Response based on T-VASI90
Proportion of participants achieving T-VASI90 (defined as at least 90% improvement in T-VASI from Baseline)
Measured: Baseline through week 52
Response based on T-VASI100
Proportion of participants achieving T-VASI90 (defined as at least 100% improvement in T-VASI from Baseline)
Measured: Baseline through week 52
Response based on F-VASI50
Proportion of participants achieving F-VASI50 (defined as at least 50% improvement in F-VASI from Baseline).
Measured: Baseline through week 104
Change from baseline in the Hospital Anxiety and Depression Scale (HADS)
To assess the effect of ritlecitinib compared to placebo on depression and anxiety subscales of the HADS at week 52
Measured: Week 52
The proportion of patients achieving absence of depression on HADS depression subscale
Response based on a 'normal' subscale score indicative of an absence of depression (in participants with baseline HADS subscale scores indicative of depression)
Measured: Week 52
The proportion of patients achieving absence of anxiety on HADS anxiety subscale
Response based on a 'normal' subscale score indicative of an absence of anxiety (in participants with baseline HADS subscale scores indicative of anxiety)
Measured: Week 52
US-Only: Patient Global Impression of Severity-Face (PGIS-F)
To assess the effect of ritlecitinib compared to placebo on the PGIS-F at 52
Measured: Week 52
US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
To assess the effect of ritlecitinib compared to placebo on the PGIS-V at 52
Measured: Week 52
% CFB in F-VASI at Week 4, 8, 12, 48, 56, 60, 64, 76, 88 and 104.
To compare the efficacy of ritlecitinib 100 mg QD versus placebo on % CFB in F-VASI at all time points
Measured: Baseline through week 104
% CFB in T-VASI at Week 4, 8, 12, 48, 56, 60, 64, 76, 88 and 104.
To compare the efficacy of ritlecitinib 100 mg QD versus placebo on % CFB in T-VASI at all time points
Measured: Baseline through week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start8 Nov 2023
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable Nonsegmental VitiligoStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,571 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072183
- Sponsor's protocol ID
- B7981080
- Other IDs
- 2022-502518-98-00
- Acronym
- Tranquillo 2
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Lukic T, Ghosh P, Napatalung L, Wang C, Kurosky SK, Hamzavi I, Sinclair R, Xiang L, Steil K, Rosmarin D, Parsad D, Ezzedine K, Adiri R. Description of the Tranquillo Phase 3 Clinical Trial Designs/Study Protocols to Assess Ritlecitinib in Adults and Adolescents with Nonsegmental Vitiligo. Dermatol Ther (Heidelb). 2026 Jul;16(7):3709-3727. doi: 10.1007/s13555-026-01724-y. Epub 2026 May 22.
PubMed 42171987