2025-522309-40-00
尚未招募
2 期
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Zasocitinib in Participants with Nonsegmental Vitiligo.
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- Proportion of participants achieving ≥75% improvement from baseline in F-VASI at Week 24.
概览
简要总结
To evaluate the efficacy of zasocitinib compared to placebo at Week 24 in adult participants with nonsegmental vitiligo.
研究设计
- 分配方式
- Randomized
- 主要目的
- A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Dose-ranging Trial To Evaluate
- 盲法
- Double (Investigator, Analyst, Monitor, Subject, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •1.Participants must have a clinical diagnosis of nonsegmental vitiligo: F-VASI ≥0.5 and 5≤ T-VASI ≤50 at screening and Day
- •2.Participant is aged ≥18 years to ≤75 years old at the time of consent.
- •3.Participant meets the following birth control requirement: An individual with potential for pregnancy who is now of nonchildbearing potential with laboratory confirmation of postmenopausal status; or, if sexually active with a nonsterilized individual who produces sperm, an individual with potential for pregnancy who agrees to use a highly effective method of contraception from the signing of informed consent throughout the duration of the trial. The use of effective contraception will be required for assigned male sex at birth participants. In the EU/EEA and the UK, for participants who elect to use hormonal contraception as a form of highly effective contraception, the investigator must document a favorable benefit-risk assessment to justify the participant’s inclusion in the trial at screening and every 3 months during the trial.
- •4.For participants in the EU/EEA or UK, the investigator must have no reason to believe that the participant would be placed at risk by participating in the trial with regard to the European Commission decision as of 10 March 2023 on measures to minimize risk of serious side effects with JAKi (EMA/142279/2023) and the UK MHRA guideline on JAKi: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality as of 26 April 2023 (Drug Safety Update volume 16, issue 9).
- •5.Participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.
- •6.Participant has provided written informed consent and any required privacy authorization before the initiation of any trial procedures.
排除标准
- •1.Participant has segmental vitiligo
- •10.Non-herpetic viral diseases: a) Participant has presence of HCV antibody and a positive confirmatory test result for HCV RNA (nucleic acid test or polymerase chain reaction). In the EU/EEA and the UK, if the participant has total anti-HCV antibody positivity at screening but is confirmed to have no detectable HCV RNA by PCR testing, HCV RNA PCR testing will be assessed at additional visits per SoA. b) Participant has presence of positive HBsAg, or indeterminate HBsAg, presence of HBV DNA (regardless of serology), or positive anti-HBcAb without concurrent positive HBsAb. In the EU/EEA and the UK, if the participant has total anti-HBc antibody positivity at screening but is confirmed to have no detectable HBV DNA by PCR testing, the participant will repeat HBV DNA PCR testing at additional visits per SoA; if a participant has anti-HBsAb positivity at screening but is confirmed to have no detectable HBV DNA by PCR testing, unless the participant has documented completion of the HBV vaccination series by medical records, the participant will repeat HBV DNA PCR testing at additional visits per SoA. Note: For other countries in which there are hepatitis B screening guidelines, these can be done per local regulations or site’s standard of care. c) Participant has positive results for HIV by serology, regardless of viral load.
- •11.Other infectious diseases: a) Participant has a history of active infection or febrile illness within 7 days prior to Day 1, as assessed by the investigator. b) Participant has a history of symptoms suggestive of systemic or invasive infection within 30 days prior to Day
- •c) Participant has a history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous antimicrobial therapy within 8 weeks prior to Day 1, or oral antimicrobial therapy within 30 days prior to Day
- •d) Participant has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial onychomycosis). e) Participant has a history of an infected joint prosthesis unless that prosthesis has been removed or replaced at least 60 days prior to Day
- •f) Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis). g) Participant had a bacterial infection within 60 days prior to Day 1 for which he or she did not receive treatment.
- •12.Exclusion Criteria 12 excludes participants with recent or chronic infection history that may present a safety risk. This includes acute or recent infections (e.g., any infection or febrile illness within 7 days, systemic illness within 30 days, or serious infections within 8 weeks of Day 1), as well as any history of chronic or opportunistic infections. See protocol for the full list and detailed definitions of infection-related exclusions.
- •13.Participant has any of the following laboratory values at the screening visit, in addition to others listed in the protocol: a) AST or ALT values ≥3 times the ULN. b) Total bilirubin (unconjugated and/or conjugated) ˃1.5 times the ULN. c) Hgb <9.0 g/dL (<90.0 g/L). d) Absolute white blood cell count <3.0 × 109/L (<3000/mm3). e) Absolute neutrophil count of <1.0 × 109/L (<1000/mm3). f) Absolute lymphocyte count of <0.5 × 109/L (<500/mm3). g) Platelet count <100 × 109/L (<100,000/mm3). h) TSH outside the normal reference range AND free T4 or T3 outside the normal reference range. i) Estimated creatinine clearance <30 mL/min based on the Cockcroft-Gault calculation. j) CPK > ULN. CPK may be repeated once; if repeat value is CTCAE Grade 1 or lower (or ≤2.5 × ULN) and no higher than the initial value, participant remains eligible. Investigators should assess the participant for modulating factors including concomitant medications or vigorous exercise that may affect CPK levels.
- •14.Participant has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this trial.
- •15.Participant does not tolerate venipuncture or inability to be venipunctured.
结局指标
主要结局
Proportion of participants achieving ≥75% improvement from baseline in F-VASI at Week 24.
Proportion of participants achieving ≥75% improvement from baseline in F-VASI at Week 24.
次要结局
- Percent change from baseline in the F-VASI at Week 24
- Percent change from baseline in the T-VASI at Week 24
- Proportion of participants achieving ≥50% improvement from baseline in F-VASI at Week 24
- Proportion of participants achieving ≥50% improvement from baseline in T-VASI at Week 24
研究者
Takeda
Scientific
Takeda Development Center Americas Inc.
研究点 (6)
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