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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05583526




Registration number
NCT05583526
Ethics application status
Date submitted
6/10/2022
Date registered
17/10/2022
Date last updated
15/10/2024

Titles & IDs
Public title
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) Tranquillo
Scientific title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NON SEGMENTAL VITILIGO
Secondary ID [1] 0 0
Tranquillo
Secondary ID [2] 0 0
B7981040
Universal Trial Number (UTN)
Trial acronym
Tranquillo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stable Nonsegmental Vitiligo 0 0
Active Nonsegmental 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 - Placebo

Experimental: Ritlecitinib 50 mg - Ritlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)

Placebo comparator: Placebo - Placebo (placebo arm; approximately 200 participants)


Treatment: Drugs: Ritlecitinib
50 mg capsule

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

Outcomes
Primary outcome [1] 0 0
US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and T-VASI50 at Week 52
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52
Timepoint [2] 0 0
Week 52
Primary outcome [3] 0 0
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs), leading to discontinuation, and clinically significant laboratory abnormalities
Timepoint [3] 0 0
Baseline through Week 52
Secondary outcome [1] 0 0
US-Only: Response based on F-VASI75 at 24 and 36 weeks
Timepoint [1] 0 0
Weeks 24 and 36
Secondary outcome [2] 0 0
US-Only: Response based on T-VASI50 at 24 and 36 weeks
Timepoint [2] 0 0
Weeks 24 and 36
Secondary outcome [3] 0 0
US-Only: Response based on T-VASI75 at 52 weeks
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
US-Only: Percentage change from baseline (% CFB) in F-VASI at 24, 36, and 52 weeks
Timepoint [4] 0 0
Weeks 24, 36, and 52
Secondary outcome [5] 0 0
US-Only: Percentage change from baseline (% CFB) in T-VASI at 24, 36, and 52 weeks
Timepoint [5] 0 0
Weeks 24, 36, and 52
Secondary outcome [6] 0 0
US-Only: Patient Global Impression of Severity-Face (PGIS-F)
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Global (Other than US): Response based on F-VASI75 at 24 and 36 weeks
Timepoint [8] 0 0
Weeks 24 and 36
Secondary outcome [9] 0 0
Global (Other Than US): Response based on T-VASI50 at 24, 36, and 52 weeks
Timepoint [9] 0 0
Weeks 24, 36, and 52
Secondary outcome [10] 0 0
Global (Other than US): Percentage change from baseline (% CFB) in F-VASI at 24, 36, and 52 weeks
Timepoint [10] 0 0
Weeks 24, 36, and 52
Secondary outcome [11] 0 0
Global (Other than US): Percentage change from baseline (% CFB) in T-VASI at 24, 36, and 52 weeks
Timepoint [11] 0 0
Weeks 24, 36, and 52
Secondary outcome [12] 0 0
Global (Other than US): Patient Global Impression of Severity-Face (PGIS-F)
Timepoint [12] 0 0
Weeks 24, 36, and 52
Secondary outcome [13] 0 0
Global (Other than US): Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
Timepoint [13] 0 0
Weeks 24, 36, and 52
Secondary outcome [14] 0 0
All Countries: Proportion of participants achieving disease stabilization
Timepoint [14] 0 0
Baseline through week 52
Secondary outcome [15] 0 0
Response based on T-VASI50
Timepoint [15] 0 0
Baseline through week 4, week 8, week 12, week 48
Secondary outcome [16] 0 0
Response based on F-VASI75
Timepoint [16] 0 0
Baseline through week 4, week 8, week 12, week 48
Secondary outcome [17] 0 0
Response based on T-VASI75
Timepoint [17] 0 0
Baseline through week 4, week 8, week 12, week 24, week 36, week 48
Secondary outcome [18] 0 0
Proportion of participants with sustained improvement in T-VASI
Timepoint [18] 0 0
Week 36 through week 52
Secondary outcome [19] 0 0
Proportion of participants with sustained improvement in F-VASI
Timepoint [19] 0 0
Week 36 through week 52
Secondary outcome [20] 0 0
All Countries: Time to rescue medication
Timepoint [20] 0 0
Baseline through week 52
Secondary outcome [21] 0 0
Percentage change from baseline in F-VASI
Timepoint [21] 0 0
Baseline through week 52
Secondary outcome [22] 0 0
Percentage change from baseline in T-VASI
Timepoint [22] 0 0
Baseline through week 52
Secondary outcome [23] 0 0
Response based on T-VASI90
Timepoint [23] 0 0
Baseline through week 52
Secondary outcome [24] 0 0
Response based on T-VASI100
Timepoint [24] 0 0
Baseline through week 52
Secondary outcome [25] 0 0
Response based on F-VASI50
Timepoint [25] 0 0
Baseline through week 52
Secondary outcome [26] 0 0
Response based on F-VASI90
Timepoint [26] 0 0
Baseline through week 52
Secondary outcome [27] 0 0
Response based on F-VASI100
Timepoint [27] 0 0
Baseline through week 52
Secondary outcome [28] 0 0
Patient Global Impression of Severity-Face (PGIS-F)
Timepoint [28] 0 0
Weeks 24 and 36
Secondary outcome [29] 0 0
Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
Timepoint [29] 0 0
Weeks 24 and 36
Secondary outcome [30] 0 0
Patient Global Impression of Change-Face (PGIC-F)
Timepoint [30] 0 0
Weeks 24, 36, and 52
Secondary outcome [31] 0 0
Patient Global Impression of Change- Overall Vitiligo (PGIC-V)
Timepoint [31] 0 0
Weeks 24, 36, and 52
Secondary outcome [32] 0 0
Change from baseline in Dermatology Life Quality Index (DLQI) or Children Dermatology Life Quality Index (CDLQI)
Timepoint [32] 0 0
Week 52
Secondary outcome [33] 0 0
Change from baseline in the Hospital Anxiety and Depression Scale (HADS)
Timepoint [33] 0 0
Week 52
Secondary outcome [34] 0 0
The proportion of patients achieving absence of depression on HADS depression subscale
Timepoint [34] 0 0
Week 52
Secondary outcome [35] 0 0
The proportion of patients achieving absence of anxiety on HADS anxiety subscale
Timepoint [35] 0 0
Week 52

Eligibility
Key inclusion criteria
1. Participants =18 years of age at Screening. Adolescents (12 to <18 years of age) are also eligible for this study, but only if approved by the local IRB/EC and regulatory health authority. Where these approvals have not been granted, only participants =18 years of age will be enrolled.

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

* A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and
* BSA involvement 4%-60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet; and
* BSA =0.5% involvement on the face (face is defined as including the area on the forehead to the original hairline, on the cheek vertically to the jawline, and laterally from the corner of the mouth to the tragus. The face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids; and
* F-VASI =0.5 & T-VASI =3; and
* Either active or stable disease nonsegmental vitiligo at both Screening and Baseline visits. All participants who do not have the features of active vitiligo (defined below) are required to have stable disease.

Active vitiligo is defined as:
* Participants will be classified as having active vitiligo based on the presence of at least one active lesion at baseline defined as one of the following:
* New/extending lesion(s) in the 3 months prior to Screening visit (confirmed by photographs or medical record):
* Confetti-like lesion(s); Confetti-like depigmentation is characterized by the presence of numerous 1-mm to 5-mm depigmented macules in clusters;
* Trichrome lesion(s);Trichrome lesions have a hypopigmented zone of varying width between normal and completely depigmented skin, resulting in 3 different hues of skin;
* Koebner phenomenon/phenomena (excluding Type 1 [history based on isomorphic reaction]). The Koebner phenomenon manifests as depigmentation at sites of trauma, usually in a linear arrangement.

Stable vitiligo is defined as an absence of signs of active disease. All participants who do not have the features of active vitiligo (defined above) are required to have stable disease.

Eligibility is determined at Screening and Baseline based on the resulting scores from the local in-person reads of F-VASI, T-VASI, and BSA.

Other
3. If receiving concomitant medications for any reason other than vitiligo, participant must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant must be willing to stay on a stable regimen during the duration of the study.
4. Must agree to stop all other treatments for vitiligo from Screening through the final follow-up visit.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria:

* Suicidal ideation associated with actual intent and a method or plan in the past year: "Yes" answers on items 4 or 5 of the C-SSRS administered at the screening visit.
* Previous history of suicidal behaviors in the past 5 years: "Yes" answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS.
* For adults, any lifetime history of serious suicidal behavior or recurrent suicidal behavior. For adolescents, any previous lifetime history of suicidal behavior.
2. Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin:

* Participants that have other types of vitiligo that do not meet criteria for active or stable vitiligo as noted in inclusion criterion #2 (including, but not limited to, segmental vitiligo and mixed vitiligo).
* Currently have active forms of other disorders of pigmentation (including but not limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation [melanoma and mycosis fungoides], post-inflammatory hypopigmentation, pityriasis alba [minor manifestation of atopic dermatitis], senile leukoderma [age-related depigmentation], chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, melasma (all types, including mixed), and congenital hypopigmentation disorder including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetrica hereditarian, xeroderma pigmentosum, and nevus depigmentosus). NOTE: Coexistence of halo nevus/nevi (also known as Sutton nevus/nevi) is permitted.
* Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (for example, morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or Baseline Visit that in the opinion of the investigator would interfere with evaluation of vitiligo or response to treatment.
* Leukotrichia in more than 33% of the face surface area affected with vitiligo lesions OR leukotrichia in more than 33% of the total body surface area affected with vitiligo lesions.
* Have a superficial skin infections within 2 weeks prior to first dose on Day 1. NOTE: participants may be rescreened after the infection resolves.
3. General Infection History:

* Having a history of systemic infection requiring hospitalization, parenteral antimicrobial, antiviral (including biologic treatment), antiparasitic, antiprotozoal, or antifungal therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 1.
* Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1. NOTE: participants may be rescreened after the infection resolves.
* Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium TB
4. Specific Viral Infection History:

* History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
* Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility.
* Participants who are positive for HCVAb and HCV RNA will not be eligible for this study.
* Have a known immunodeficiency disorder (including positive serology for HIV at screening) or a first-degree relative with a hereditary immunodeficiency.
5. Medical Conditions, Other:

* Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (eg, untreated hypovitaminosis D or hypothyroidism), pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator or Pfizer (or designee), the participant is inappropriate for entry into this study, or unwilling/unable to comply with study procedures and lifestyle requirements.
* History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.
* Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating or progressive.
* Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
* Abnormal findings on the Screening chest imaging (eg, chest x-ray) that may increase the risk associated with study participation including, but not limited to, presence of active TB, general infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to screening. Documentation of the official reading must be located and available in the source documentation.
* Long QT Syndrome, a family history of Long QT Syndrome, or a history of TdP.
* Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
* Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery or with elective surgery scheduled to occur during the study.

Prior/Concomitant Therapy:
6. Have received any of the prohibited treatment regimens specified.

Prior/Concurrent Clinical Study Experience:
7. Previous administration with an investigational drug or vaccine that do not affect vitiligo within 4 weeks of Day 1 [Baseline] or within 5 half-lives, whichever is longer.

Diagnostic Assessments:
8. Any of the following abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:

* Renal impairment
* Hepatic dysfunction
9. Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities

Other
10. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
11. Adolescent participants 12 to <18 years of age without one of the following:

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

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
1/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/12/2025
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
The Skin Hospital - Darlinghurst
Recruitment hospital [2] 0 0
North Eastern Health Specialists - Campbelltown
Recruitment hospital [3] 0 0
Skin Health Institute Inc. - Carlton
Recruitment hospital [4] 0 0
Dr Rodney Sinclair Pty Ltd - East Melbourne
Recruitment hospital [5] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
5074 - Campbelltown
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
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New Mexico
Country [13] 0 0
United States of America
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New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
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Ohio
Country [16] 0 0
United States of America
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South Carolina
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United States of America
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Texas
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Bulgaria
State/province [18] 0 0
Dupnitsa
Country [19] 0 0
Bulgaria
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Sofia
Country [20] 0 0
Bulgaria
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Stara Zagora
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
China
State/province [24] 0 0
Fujian
Country [25] 0 0
China
State/province [25] 0 0
Guangdong
Country [26] 0 0
China
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Hubei
Country [27] 0 0
China
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Liaoning
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Tianjin
Country [30] 0 0
China
State/province [30] 0 0
Yunnan Sheng
Country [31] 0 0
China
State/province [31] 0 0
Zhejiang
Country [32] 0 0
Germany
State/province [32] 0 0
Baden-württemberg
Country [33] 0 0
Germany
State/province [33] 0 0
Bayern
Country [34] 0 0
Germany
State/province [34] 0 0
Niedersachsen
Country [35] 0 0
Germany
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Nordrhein-westfalen
Country [36] 0 0
Italy
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Lazio
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Italy
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Lombardia
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Italy
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Milano
Country [39] 0 0
Italy
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RM
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Italy
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Bologna
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Italy
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Brescia
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Japan
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Aichi
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Yamanashi
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Korea, Republic of
State/province [47] 0 0
Kyonggi-do
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Seoul-teukbyeolsi [seoul]
Country [49] 0 0
Mexico
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Distrito Federal
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Mexico
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Nuevo LEÓN
Country [51] 0 0
Mexico
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Veracruz
Country [52] 0 0
Poland
State/province [52] 0 0
Kujawsko-pomorskie
Country [53] 0 0
Poland
State/province [53] 0 0
Mazowieckie
Country [54] 0 0
Poland
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Zachodniopomorskie
Country [55] 0 0
Poland
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Lódzkie
Country [56] 0 0
Poland
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Swietokrzyskie
Country [57] 0 0
South Africa
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Eastern CAPE
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South Africa
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Gauteng
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South Africa
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Western CAPE
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Spain
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Andalucía
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Spain
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Canarias
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Madrid
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Turkey
State/province [65] 0 0
Istanbul
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Turkey
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Kayseri
Country [67] 0 0
Turkey
State/province [67] 0 0
Manisa
Country [68] 0 0
United Kingdom
State/province [68] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental Vitiligo (Active and Stable) Tranquillo
Trial website
https://clinicaltrials.gov/study/NCT05583526
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05583526