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A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) Tranquillo

PHASE3RECRUITING

A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental Vitiligo (Active and Stable) Tranquillo.

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Study details:

Study B7981040 is 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 nonsegmental vitiligo (both active and stable vitiligo).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

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.

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.

Exclusion criteria

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.

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.

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

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.

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:

* 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 laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:

* Renal impairment

* Hepatic dysfunction

* Screening 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.

* 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.

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Eligibility

Age eligible for study : 12 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-12-01

Primary completion: 2025-12-20

Study completion finish: 2025-12-20

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05583526

Intervention or treatment

DRUG: Ritlecitinib

DRUG: Placebo

Conditions

• Stable Nonsegmental Vitiligo
• Active Nonsegmental Vitiligo

Image related to Stable Nonsegmental Vitiligo

Condition: Stable Nonsegmental Vitiligo, Active Nonsegmental Vitiligo
DRUG: Ritlecitinib and other drugs
Melbourne, Victoria, Australia and more
Sponsor: Pfizer

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

The Alfred Hospital

Research sites nearby

Select from list below to view details:

The Alfred Hospital
Melbourne, Victoria, Australia
The Skin Hospital
Darlinghurst, New South Wales, Australia
North Eastern Health Specialists
Campbelltown, South Australia, Australia
Skin Health Institute Inc.
Carlton, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Ritlecitinib 50 mg Ritlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)	DRUG: Ritlecitinib 50 mg capsule
PLACEBO_COMPARATOR: Placebo Placebo (placebo arm; approximately 200 participants)	DRUG: Placebo Matching capsule

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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	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)	Week 52
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)	Week 52
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs), leading to discontinuation, and clinically significant laboratory abnormalities	Safety and tolerability of ritlecitinib in participants with nonsegmental vitiligo	Baseline through Week 52

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
US-Only: Response based on F-VASI75 at 24 and 36 weeks	Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline	Weeks 24 and 36
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)	Weeks 24 and 36
US-Only: Response based on T-VASI75 at 52 weeks	Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)	Week 52
US-Only: Percentage change from baseline (% CFB) in F-VASI at 24, 36, and 52 weeks	Median % CFB in F-VASI in participants treated with ritlecitinib 50 mg QD versus placebo	Weeks 24, 36, and 52
US-Only: Percentage change from baseline (% CFB) in T-VASI at 24, 36, and 52 weeks	Median % CFB in T-VASI in participants treated with ritlecitinib 50 mg QD versus placebo	Weeks 24, 36, and 52
US-Only: Patient Global Impression of Severity-Face (PGIS-F)	Proportion of responders based on PGIS-F at 52 weeks	Week 52
US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)	Proportion of responders based on PGIS-V at 52 weeks	Week 52
Global (Other than US): Response based on F-VASI75 at 24 and 36 weeks	Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)	Weeks 24 and 36
Global (Other Than US): Response based on T-VASI50 at 24, 36, and 52 weeks	Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)	Weeks 24, 36, and 52
Global (Other than US): Percentage change from baseline (% CFB) in F-VASI at 24, 36, and 52 weeks	Median % CFB in F-VASI in participants treated with ritlecitinib 50 mg QD versus placebo	Weeks 24, 36, and 52
Global (Other than US): Percentage change from baseline (% CFB) in T-VASI at 24, 36, and 52 weeks	Median % CFB in T-VASI in participants treated with ritlecitinib 50 mg QD versus placebo	Weeks 24, 36, and 52
Global (Other than US): Patient Global Impression of Severity-Face (PGIS-F)	Proportion of responders based on PGIS-F at 24, 36, and 52 weeks	Weeks 24, 36, and 52
Global (Other than US): Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)	Proportion of responders based on PGIS-V at 24, 36, and 52 weeks	Weeks 24, 36, and 52
All Countries: 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 compared to placebo	Baseline through week 52
Response based on T-VASI50	Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)	Baseline through week 4, week 8, week 12, week 48
Response based on F-VASI75	Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)	Baseline through week 4, week 8, week 12, week 48
Response based on T-VASI75	Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)	Baseline through week 4, week 8, week 12, week 24, week 36, week 48
Proportion of participants with sustained improvement in T-VASI	Defined as maintenance of ≥T-VASI50 from Week 36 to Week 52	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	Week 36 through week 52
All Countries: Time to rescue medication	Comparing time to rescue medication curves and difference in probabilities of using rescue medication	Baseline through week 52
Percentage change from baseline in F-VASI	Median % CFB in F-VASI at appropriate timepoints in participants treated with ritlecitinib 50 mg QD versus placebo	Baseline through week 52
Percentage change from baseline in T-VASI	Median % CFB in T-VASI at appropriate timepoints in participants treated with ritlecitinib 50 mg QD versus placebo	Baseline through week 52
Response based on T-VASI90	Proportion of participants achieving T-VASI90 (defined as at least 90% improvement in T-VASI from Baseline)	Baseline through week 52
Response based on T-VASI100	Proportion of participants achieving T-VASI100 (defined as at least 100% improvement in T-VASI from Baseline)	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).	Baseline through week 52
Response based on F-VASI90	Proportion of participants achieving F-VASI90 (defined as at least 50% improvement in F-VASI from Baseline).	Baseline through week 52
Response based on F-VASI100	Proportion of participants achieving F-VASI100 (defined as at least 100% improvement in F-VASI from Baseline).	Baseline through week 52
Patient Global Impression of Severity-Face (PGIS-F)	Proportion of responders based on PGIS-F at 24 and 26 weeks	Weeks 24 and 36
Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)	Proportion of responders based on PGIS-V at 24 and 36 weeks	Weeks 24 and 36
Patient Global Impression of Change-Face (PGIC-F)	To assess the effect of ritlecitinib compared to placebo on the PGIC-F at 24, 36, and 52 weeks	Weeks 24, 36, and 52
Patient Global Impression of Change- Overall Vitiligo (PGIC-V)	To assess the effect of ritlecitinib compared to placebo on the PGIC-V at 24, 36, and 52 weeks	Weeks 24, 36, and 52
Change from baseline in Dermatology Life Quality Index (DLQI) or Children Dermatology Life Quality Index (CDLQI)	To evaluate the change from baseline in DLQI or CDLQI at week 52	Week 52
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	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)	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)	Week 52

Frequently Asked Questions

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References

Clinical Trials Gov: A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) Tranquillo