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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06163326




Registration number
NCT06163326
Ethics application status
Date submitted
30/11/2023
Date registered
8/12/2023

Titles & IDs
Public title
A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo
Scientific title
A PHASE 3 OPEN-LABEL, MULTI-CENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO
Secondary ID [1] 0 0
2023-505804-42-00
Secondary ID [2] 0 0
B7981041
Universal Trial Number (UTN)
Trial acronym
Tranquillo LTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitiligo 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ritlecitinib
Treatment: Drugs - Ritlecitinib 100 mg
Treatment: Drugs - Placebo

Experimental: Arm 1 - Participants 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.

Experimental: Arm 2 - Participants 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


Treatment: Drugs: Ritlecitinib
Ritlecitinib 50 mg capsule once daily

Treatment: Drugs: Ritlecitinib 100 mg
Ritlecitinib 100 mg capsule once daily

Treatment: Drugs: Placebo
Matching capsule once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
Timepoint [1] 0 0
Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
Primary outcome [2] 0 0
Incidence of clinically significant laboratory abnormalities
Timepoint [2] 0 0
Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
Secondary outcome [1] 0 0
Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52
Timepoint [1] 0 0
Baseline to week 52
Secondary outcome [2] 0 0
Response based on F-VASI75 at weeks 4, 8, 12, 24, 36 and 52
Timepoint [2] 0 0
Baseline to week 52
Secondary outcome [3] 0 0
Response based on T-VASI50 at weeks 4, 8, 12, 24, 36 and 52
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
Response based on F-VASI50 at weeks 4, 8, 12, 24, 36 and 52
Timepoint [4] 0 0
Baseline to week 52
Secondary outcome [5] 0 0
Response based on T-VASI90 at weeks 4, 8, 12, 24, 36 and 52
Timepoint [5] 0 0
Baseline to week 52
Secondary outcome [6] 0 0
Response based on F-VASI90 at weeks 4, 8, 12, 24, 36 and 52
Timepoint [6] 0 0
Baseline to week 52
Secondary outcome [7] 0 0
Response based on T-VASI100 at weeks 4, 8, 12, 24, 36 and 52
Timepoint [7] 0 0
Baseline to week 52
Secondary outcome [8] 0 0
Response based on F-VASI100 at weeks 4, 8, 12, 24, 36 and 52
Timepoint [8] 0 0
Baseline to week 52
Secondary outcome [9] 0 0
Patient Global Impression of Severity-Face (PGIS-F) at weeks 24, 36, and 52
Timepoint [9] 0 0
Baseline to week 52
Secondary outcome [10] 0 0
Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at weeks 24, 36, and 52
Timepoint [10] 0 0
Baseline to week 52
Secondary outcome [11] 0 0
Patient Global Impression of Change-Face (PGIC-F) at week 24, 36, and 52
Timepoint [11] 0 0
Baseline to week 52
Secondary outcome [12] 0 0
Patient Global Impression of Change- Overall vitiligo (PGIC-V) at weeks 24, 36, and 52
Timepoint [12] 0 0
Baseline to week 52
Secondary outcome [13] 0 0
Proportion of participants achieving disease stabilization
Timepoint [13] 0 0
Baseline to week 52
Secondary outcome [14] 0 0
Percentage change from baseline (%CFB) in F-VASI at weeks 4, 8, 12, 24, 36, and 52
Timepoint [14] 0 0
Baseline to week 52
Secondary outcome [15] 0 0
Percentage change from baseline (%CFB) in T-VASI at weeks 4, 8, 12, 24, 36, and 52
Timepoint [15] 0 0
Baseline to week 52

Eligibility
Key inclusion criteria
* 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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2027
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
North Eastern Health Specialists - Campbelltown
Recruitment hospital [2] 0 0
Skin Health Institute Inc. - Carlton
Recruitment hospital [3] 0 0
Dr Rodney Sinclair Pty Ltd - East Melbourne
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
5074 - Campbelltown
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Kyustendil
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Sofia (stolitsa)
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Stara Zagora
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
China
State/province [19] 0 0
Fujian
Country [20] 0 0
China
State/province [20] 0 0
Guangdong
Country [21] 0 0
China
State/province [21] 0 0
Hubei
Country [22] 0 0
China
State/province [22] 0 0
Liaoning
Country [23] 0 0
China
State/province [23] 0 0
Shanghai
Country [24] 0 0
China
State/province [24] 0 0
Yunnan
Country [25] 0 0
Germany
State/province [25] 0 0
Baden-württemberg
Country [26] 0 0
Germany
State/province [26] 0 0
Niedersachsen
Country [27] 0 0
Germany
State/province [27] 0 0
Nordrhein-westfalen
Country [28] 0 0
Japan
State/province [28] 0 0
Aichi
Country [29] 0 0
Japan
State/province [29] 0 0
Miyagi
Country [30] 0 0
Japan
State/province [30] 0 0
Osaka
Country [31] 0 0
Japan
State/province [31] 0 0
Tokyo
Country [32] 0 0
Japan
State/province [32] 0 0
Yamanashi
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Kyonggi-do
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul-teukbyeolsi [seoul]
Country [35] 0 0
Mexico
State/province [35] 0 0
Nuevo LEÓN
Country [36] 0 0
Mexico
State/province [36] 0 0
Veracruz
Country [37] 0 0
Poland
State/province [37] 0 0
Kujawsko-pomorskie
Country [38] 0 0
Poland
State/province [38] 0 0
Mazowieckie
Country [39] 0 0
Poland
State/province [39] 0 0
Zachodniopomorskie
Country [40] 0 0
Poland
State/province [40] 0 0
Lódzkie
Country [41] 0 0
Poland
State/province [41] 0 0
Swietokrzyskie
Country [42] 0 0
Spain
State/province [42] 0 0
Andalucía
Country [43] 0 0
Spain
State/province [43] 0 0
Catalunya [cataluña]
Country [44] 0 0
Spain
State/province [44] 0 0
LAS Palmas
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid, Comunidad DE
Country [46] 0 0
Spain
State/province [46] 0 0
Córdoba
Country [47] 0 0
Turkey
State/province [47] 0 0
Istanbul
Country [48] 0 0
Turkey
State/province [48] 0 0
Kayseri
Country [49] 0 0
Turkey
State/province [49] 0 0
Manisa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06163326