Nonsegmental Vitiligo
Conditions
Interventions
Ritlecitinib 100 mg Capsule
Ritlecitinib 50 mg Capsule
Placebo Matching capsule
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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.
Exclusion criteria
Exclusion criteria: 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. 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 kid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| US only Co-Primary Endpoints: Response based on 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)] Global (Other than US): Response based on F-VASI75 at Week 52 [Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)] Incidence of Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events leading to discontinuation (To evaluate the safety and tolerability of ritlecitinib in adult participants with non segmental vitiligo) Incidence of Clinically significant laboratory abnormalities | — |
Secondary
| Measure | Time frame |
|---|---|
| Response based on F-VASI75 at Weeks 24 and 36 [Proportion of participants achieving F-VASI75] US-Only: Response based on T-VASI50 at Weeks 24 and 36 [Proportion of participants achieving T-VASI50] Global (Other Than US): Response based on T-VASI50 at Weeks 24, 36 and 52 [Proportion of participants achieving T-VASI50] US-Only: Response based on T-VASI75 at Week 52 [Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)] Percentage change from baseline (% CFB) in F-VASI at Weeks 24, 36 and 52 (To compare the efficacy of ritlecitinib versus placebo on % CFB in F-VASI) % CFB in T-VASI at Weeks 24, 36 and 52 (To compare the efficacy of ritlecitinib versus placebo on % CFB in T-VASI) US-Only: Patient Global Impression of Severity-Face (PGIS-F) at Week 52 (To assess the effect of ritlecitinib compared to placebo on the PGIS-F) Global (Other than US): PGIS-F at Weeks 24, 36 and 52 (To assess the effect of ritlecitinib compared to placebo on the PGIS-F) US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at Week 52 (To assess the effect of ritlecitinib compared to placebo on the PGIS-V at 52)" Global (Other than US): PGIS-V at Weeks 24, 36 and 52 (To assess the effect of ritlecitinib compared to placebo on the PGIS-V) Proportion of participants achieving disease stabilization (The difference in the proportion of participants with stable disease at all timepoints through Week 104 in participants with non segmental vitiligo treated with ritlecitinib compared to placebo) Response based on T-VASI50 at Weeks 4, 8, 12, 48, 56, 60, 64, 76, 88 and 104 (Proportion of participants achieving T-VASI50) Response based on F-VASI75 at Weeks 4, 8, 12, 48, 56, 60, 64, 76, 88 and 104 (Proportion of participants achieving F-VASI75) Response based on T-VASI75 at Weeks 4, 8, 12, 24, 36, 48, 56, 60, 64, 76, 88 and 104 (Proportion of participants achieving T-VASI75) Global (Other than US): Response based on T-V | — |
Countries
Australia, Belgium, Bulgaria, Canada, China, Germany, Hungary, Italy, Japan, Mexico, Poland, Puerto Rico, Slovakia, Spain, Taiwan, Turkey (Turkiye), United Kingdom, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed