A Phase 3 Randomized, Double-blind, 52-week Placebo-controlled Multi-center Study With a Double-blind 52-week Extension Period With Randomized Dose up/Dose Down Titration Investigating the Efficacy, Safety, and Tolerability of Ritlecitinib in Adult Participants With Nonsegmental Vitiligo (Protocol No: B7981080) (Tranquillo 2)

Pfizer Japan Inc.0 个研究点目标入组 1,450 人开始时间: 2023年12月21日最近更新: 2024年11月14日

试验速览

阶段: 不适用
状态: 招募中
发起方: Pfizer Japan Inc.
入组人数: 1,450
主要终点: Response based on F-VASI75 at Week 52 and T-VASI50 at Week 52

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Treatment Purpose
盲法: Double Blind

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•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
•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.

排除标准

•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
•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
•Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day
•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 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 current, 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). 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 clinical laboratory tests at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:
•Renal impairment
•Hepatic dysfunction
•Other laboratory abnormalities
•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.
•In South Africa only participants are excluded without one of the following:
•Document evidence form a health professional of having received varicella vaccination (two doses); or
•Evidence of prior exposure to VZV based on serological testing (ie a positive VZV IgG Ab result) at Screening.

结局指标

主要结局

Response based on F-VASI75 at Week 52 and T-VASI50 at Week 52

时间窗: 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)

Response based on F-VASI75 at Week 52

时间窗: 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

次要结局

未报告次要终点

研究者

发起方

Pfizer Japan Inc.

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