A Phase II, multicenter, randomized study to evaluate safety and efficacy of topical AB1001 in adult patients with non-segmental vitiligo.

Ahammune Biosciences Pvt. Ltd.4 个研究点分布在 1 个国家目标入组 130 人开始时间: 2026年9月10日最近更新: 2026年2月19日

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 130
试验地点: 4
主要终点: Part 1:

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will be conducted in two parts, Part 1 and Part 2

Part 1: will be an open label study with the objective of establishing safety, tolerability and finding the efficacious dose of AB1001 topical gel. 42 adult participants with nonsegmental vitiligo will be enrolled and randomized in 1:1 ratio to receive either 1% or 3%AB1001 topical gel. Safety, tolerability, indicative efficacy, pharmacokinetic, blood marker and photographic assessment will be conducted as per the Schedule of Assessments (SoA).

Part 2: will be conducted after completion of Part 1 study. This will be a double blind, placebo-controlled study. The safe and efficacious dose strength from Part 1 study will be selected for the Part 2 study. 88 adult participants with non-segmental vitiligo will be enrolled and randomized in 1:1 ratio to receive either the selected strength of AB1001 topical gel or placebo. Efficacy, safety, pharmacokinetic, blood marker and photographic assessment will be conducted as per the SoA.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Male and female participants aged 18 years and 65 years, with clinically confirmed diagnosis of non-segmental vitiligo
•Facial depigmentation involvement of participants with F-VASI ³ 0.25 at screening
•Total body vitiligo area (facial and non-facial) should not exceed 10 percentage BSA at screening.
•Willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator
•Willingness to provide written informed consent prior to any study specific procedure.
•Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at the screening visit and must agree to use an approved method of highly effective birth control for the duration of the study and for at-least 4 weeks following the last dose of IMP
•Male participants sexually active with female partners of childbearing potential must agree to use barrier contraception while enrolled in the study and for at-least 4 weeks following the last dose of IMP.

排除标准

•Participants with only segmental vitiligo at screening
•Participants with only acral, oral and,or genital vitiligo at screening
•Participants with Vitiligo Disease Activity (VIDA) score 3 at screening
•Participants with dermatologic disease confounding evaluation of vitiligo (e.g. pityriasis alba, piebaldism, idiopathic guttate hypomelanosis, leprosy, tinea versicolor, etc.)
•Participants with significant leukotrichia in vitiligo lesions
•Participants receiving medications or investigational drugs within the following period from Randomization: Corticosteroids.
•Intralesional, Intraarticular, Or Oral 15 days -30 days Minocycline 30 days Herbal preparations for the treatment of vitiligo [e.g. Rubia cordifolia (manjistha or majith) and Psoralea coryfolia (bakuchi or bavanchi)] 30 days Any form of phototherapy, including PUVA, NB-UVB, excimer or laser 30 days Any approved or experimental biologic 90 days or 5 half-lives Oral or topical immunomodulators like JAK inhibitors, calcineurin inhibitors, methotrexate, cyclosporin, or other medications like retinoid 90 days
•Participants with history of allergic and-or photosensitivity disorders, including photosensitive lupus at screening
•Any active and-or unstable autoimmune disease judged to be clinically significant by the Investigator
•Any skin disease (e.g. malignant skin lesions, psoriasis, seborrheic dermatitis, etc.) that, in the opinion of the Investigator, would interfere with the IMP application or study assessment
•Participants with previous or current diagnosis of cancer or lymphoproliferative diseases
•Participants with history of melanocyte-keratinocyte transplantation procedure (MKTP) or other surgical treatment for vitiligo
•Participants using or with prior history of usage of any depigmentation treatments with drugs such as monobenzyl ether and hydroquinone
•Participant with a history of serious local infection (e.g., cellulitis, abscess) or systemic infection, or history of treated infection (e.g., pneumonia, septicemia) within 3 months prior to the enrollment visit.
•Acute or chronic infection, and use of anti-microbials (including anti-bacterial, antiviral, or anti-fungal agents) within 30 days prior to enrollment
•Participants with a clinically significant abnormal thyroid-stimulating hormone (TSH) or free T4 at screening
•Any evidence of organ dysfunction or deviation from normal in clinical or laboratory determinations judged to be clinically significant by the Investigator
•Participants who have any serious concomitant illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g. unstable chronic asthma)
•Women who are pregnant or lactating at screening
•Clinically significant abnormal ECG findings at screening
•Serology tests are positive for hepatitis B, hepatitis C, or human immunodeficiency virus, unless they are considered patients with resolved Hepatitis B and C infections (i.e. HBc IgG Ab+ HbsAg -HBV DNA-, HepC Ab+ HCV RNA).
•Participants not willing to adhere to the protocol requirements
•For Part 2 study: Participants previously enrolled in Part 1 and received one or more doses of AB1001.