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VitiligoPhase 3Tranquillo LTENCT06163326

A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo

A Phase 3 study testing Ritlecitinib and Ritlecitinib 100 mg in people with Vitiligo, run by Pfizer at 73 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV). Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Vitiligo
What is being tested?
Ritlecitinib and Ritlecitinib 100 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
394 participants
Where
73 sitesin 13 countries
Study dates
19 Jan 2024to 31 Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants ≥18 years of age at Screening in Study B7981040. Adolescents (12 to <18 years of age at Screening in the parent study) are also eligible for this study if approved by the local IRB/EC and regulatory health authority.
  • Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040
  • The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040

Who cannot join

  • Participant met the parent study (Study 7981040) discontinuation criteria or discontinued the parent study for any safety-related event
  • Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation

Trial locations and contacts

73 sites in 13 countries.

73 sites in 13 countries

United States22 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87102

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • DelRicht Research

    Baton Rouge, Louisiana, 70809

  • Encore Medical Research of Boynton Beach

    Boynton Beach, Florida, 33436

  • SUNY Downstate Health Sciences University

    Brooklyn, New York, 11203

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27516

  • Clinical & Translational Research Center (CTRC)

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Remington-Davis, Inc

    Columbus, Ohio, 43215

  • Modern Research Associates, PLLC

    Dallas, Texas, 75231

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024

  • Skin Care Research

    Hollywood, Florida, 33021

  • Alpesh D. Desai, DO PLLC

    Houston, Texas, 77008

  • Austin Institute for Clinical Research

    Houston, Texas, 77056

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Wallace Medical Group, Inc

    Los Angeles, California, 90056

  • Lawrence J. Green, MD LLC

    Rockville, Maryland, 20850

  • ForCare Clinical Research

    Tampa, Florida, 33613

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28411

  • Wilmington Health, PLLC

    Wilmington, North Carolina, 28411

Other trials in United States

Canada7 sites

  • Dermatology Research Institute

    Calgary, Alberta, T2J 7E1

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X3

  • DermEdge Research

    Mississauga, Ontario, L4Y 4C5

  • Centre de Recherche Dermatologique du Quebec metropolitain

    Québec, G1V 4X7

  • Centre de Recherche Saint-Louis inc.

    Québec, G1W 4R4

  • CaRe Clinic

    Red Deer, Alberta, T4P 1K4

  • North York Research Inc

    Toronto, Ontario, M2N3A6

Other trials in Canada

Japan6 sites

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi, 400-8506

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, Osaka, 593-8324

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

Other trials in Japan

Australia5 sites

  • North Eastern Health Specialists

    Campbelltown, South Australia, 5074

  • Skin Health Institute Inc.

    Carlton, Victoria, 3053

  • The Skin Hospital

    Darlinghurst, New South Wales, 2010

  • Dr Rodney Sinclair Pty Ltd

    East Melbourne, Victoria, 3002

  • The Alfred Hospital

    Melbourne, Victoria, 3004

Other trials in Australia

China5 sites

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, 510091

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

  • The First Hospital of China Medical University/Dermatology and STD Department

    Shenyang, Liaoning, 110001

  • The First Hospital of Wuhan

    Wuhan, Hubei, 430022

Other trials in China

Poland5 sites

  • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, Łódź Voivodeship, 90-436

  • DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

    Osielsko, Kuyavian-Pomeranian Voivodeship, 86-031

  • Dermedic Jacek Zdybski

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

  • Twoja Przychodnia SCM

    Szczecin, West Pomeranian Voivodeship, 71-500

  • Royalderm Agnieszka Nawrocka

    Warsaw, Masovian Voivodeship, 02-962

Other trials in Poland

Spain5 sites

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña], 08036

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

  • AUDIKA

    Córdoba, 14001

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, LAS Palmas, 35010

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

Other trials in Spain

Mexico4 sites

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, Mexico City, 06720

  • Centro de Dermatologia de Monterrey

    Monterrey, Nuevo León, 64460

  • Arké SMO S.A de C.V

    Veracruz, 91900

  • Sociedad de Metabolismo y Corazon S.C.

    Veracruz, 91900

Other trials in Mexico

Turkey (Türkiye)4 sites

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi

    Istanbul, İ̇stanbul, 34899

  • Istanbul Universitesi Cerrahpasa

    Istanbul, 34098

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri

    Kayseri

  • Celal Bayar University Hafsa Sultan Hospital

    Manisa, 45030

Other trials in Turkey (Türkiye)

Bulgaria3 sites

  • Medical Centre "Asklepiy"

    Dupnitsa, Kyustendil, 2600

  • Diagnostic Consultative Center Aleksandrovska

    Sofia, Sofia (stolitsa), 1431

  • UMHAT "Prof. Dr. Stoyan Kirkovich"AD

    Stara Zagora, 6003

Other trials in Bulgaria

Germany3 sites

  • Fachklinik Bad Bentheim

    Bad Bentheim, Lower Saxony, 48455

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

  • Praxis Leitz und Kollegen

    Stuttgart, Baden-Wurttemberg, 70178

Other trials in Germany

South Korea3 sites

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 03722

  • The Catholic University Of Korea St. Vincent's Hospital

    Suwon, Kyǒnggi-do, 16247

  • Ajou University Hospital

    Suwon, Kyǒnggi-do, 16499

Other trials in South Korea

United Kingdom1 site

  • Guy's & St Thomas' NHS Foundation Trust

    London, SE1 9RT

Other trials in United Kingdom

About this study

Official title: A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTICENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV).

Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin.

Read more

Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show:

  • if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo)
  • Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study
  • Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study.

This study is seeking for participants who:

  • have non-segmental vitiligo (either active or stable) and
  • received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it.

All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. On study visit days, you must take the medication at the study site, and not at home.

Participants may receive the study medicine or placebo for up to 52 weeks.

The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo.

Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study.

Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.

Conditions
Vitiligo
Being tested
Ritlecitinib, Ritlecitinib 100 mg, Placebo
Keywords
Stable vitiligo, Active vitiligo, Adults, Adolescents
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RitlecitinibDrug

    Ritlecitinib 50 mg capsule once daily

  • Ritlecitinib 100 mgDrug

    Ritlecitinib 100 mg capsule once daily

  • PlaceboDrug

    Matching capsule once daily

Study groups in NCT06163326
Study groupRoleWhat they receive
Arm 1ExperimentalParticipants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040. Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned.
Receives: Drug: Ritlecitinib; Drug: Ritlecitinib 100 mg; Drug: Placebo
Arm 2ExperimentalParticipants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned
Receives: Drug: Ritlecitinib; Drug: Ritlecitinib 100 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation

    To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo

    Measured: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)

  2. Incidence of clinically significant laboratory abnormalities

    To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo

    Measured: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)

Secondary outcomes (16)

  1. Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52

    Proportion of participants achieving at least a 75% improvement in T-VASI from Baseline

    Measured: Baseline to week 52

  2. Response based on F-VASI75 at weeks 4, 8, 12, 24, 36 and 52

    Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline

    Measured: Baseline to week 52

  3. Response based on T-VASI50 at weeks 4, 8, 12, 24, 36 and 52

    Proportion of participants achieving at least a 50% improvement in T-VASI from Baseline

    Measured: Baseline to Week 52

  4. Response based on F-VASI50 at weeks 4, 8, 12, 24, 36 and 52

    Proportion of participants achieving at least a 50% improvement in F-VASI from Baseline

    Measured: Baseline to week 52

  5. Response based on T-VASI90 at weeks 4, 8, 12, 24, 36 and 52

    Proportion of participants achieving at least a 90% improvement in T-VASI from Baseline

    Measured: Baseline to week 52

  6. Response based on F-VASI90 at weeks 4, 8, 12, 24, 36 and 52

    Proportion of participants achieving at least a 90% improvement in F-VASI from Baseline

    Measured: Baseline to week 52

  7. Response based on T-VASI100 at weeks 4, 8, 12, 24, 36 and 52

    Proportion of participants achieving at least a 100% improvement in T-VASI from Baseline

    Measured: Baseline to week 52

  8. Response based on F-VASI100 at weeks 4, 8, 12, 24, 36 and 52

    Proportion of participants achieving at least a 100% improvement in F-VASI from Baseline

    Measured: Baseline to week 52

  9. Patient Global Impression of Severity-Face (PGIS-F) at weeks 24, 36, and 52

    To assess the effect of ritlecitinib compared to placebo on the PGIC-F at weeks 24, 36, and 52

    Measured: Baseline to week 52

  10. Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at weeks 24, 36, and 52

    To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Week 24, 36, and 52

    Measured: Baseline to week 52

  11. Patient Global Impression of Change-Face (PGIC-F) at week 24, 36, and 52

    To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Week 24, 36, and 52

    Measured: Baseline to week 52

  12. Patient Global Impression of Change- Overall vitiligo (PGIC-V) at weeks 24, 36, and 52

    To assess the effect of ritlecitinib compared to placebo on the PGIC-V at weeks 24, 36, and 52

    Measured: Baseline to week 52

  13. Proportion of participants achieving disease stabilization

    The difference in the proportion of participants with stable disease at all scheduled timepoints

    Measured: Baseline to week 52

  14. Percentage change from baseline (%CFB) in F-VASI at weeks 4, 8, 12, 24, 36, and 52

    To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo

    Measured: Baseline to week 52

  15. Percentage change from baseline (%CFB) in T-VASI at weeks 4, 8, 12, 24, 36, and 52

    To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo

    Measured: Baseline to week 52

  16. Time to loss of response (<F-VASI75 and <T-VASI50 at the same visit).

    To compare the efficacy of ritlecitinib 100 mg QD, 50 mg QD, and placebo

    Measured: Baseline to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start19 Jan 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

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
394 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06163326
Sponsor's protocol ID
B7981041
Other IDs
2023-505804-42-00, 2023
Acronym
Tranquillo LTE
Status last verified
Sep 2026
First submitted
30 Nov 2023
Last updated
28 Sep 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ritlecitinib and Ritlecitinib 100 mg in people with Vitiligo, run by Pfizer at 73 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Canada, Japan, Australia, China and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation (time frame: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06163326, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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