jRCT2071250114招募中不适用
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Zasocitinib in Pediatric Participants Aged 4 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
未提供0 个研究点目标入组 110 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
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
入排标准
- 年龄范围
- 4age old over 至 17age old under（—）
- 性别
- All
入选标准
- •Participant has a diagnosis of chronic plaque psoriasis for greater than or equal to (>=) 6 months prior to the screening visit.
- •Participant has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for >=6 months before screening.
- •Participant has moderate-to-severe plaque psoriasis as defined by a Psoriasis Area and Severity Index (PASI) score >=12 and a Static Physician's Global Assessment (sPGA) score >=3 at screening and Day
- •Participant has plaque psoriasis covering >=10 percent (%) of total body surface area (BSA) at screening and Day
- •Participant must be a candidate for phototherapy or systemic therapy.
- •Inclusion Criteria for Part A Cohort 1: The participant is male or female and aged 12 to less than (<) 18 years, inclusive.
- •Inclusion Criteria for Part A Cohort 2 and for Part B: The participant is male or female and aged 4 to <12 years, inclusive.
- •Inclusion Criteria for Part A Cohort 1: The participant must weigh >=40 kilograms (kg) at the time of screening.
排除标准
- •Participant has evidence of nonplaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis). If a participant meets criteria for inclusion based on typical plaque psoriasis presentation, a limited amount of inverse psoriasis is not exclusionary.
- •Participant requires systemic treatment, other than nonsteroidal anti-inflammatory drugs (NSAIDs), during the trial period for an immune-related disease.
- •Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
- •Participant has history of active TB infection, regardless of treatment status and has signs or symptoms of active TB or evidence of latent tuberculosis infection (LTBI).
- •Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 or a history of serious herpetic infection.
- •Participant has a history of chronic or recurrent bacterial disease.
- •Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
- •Participant has any clinically significant medical condition, evidence of an unstable clinical condition or vital signs/physical examination/laboratory/ECG abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of trial results.
- •Participant has any previous exposure to zasocitinib (also known as TAK-279 or NDI-034858) or other TYK2 inhibitors or participated in any trial that included a tyrosine kinase 2 (TYK2) inhibitor, unless participant has documentation of posttrial unblinding that confirms the participant did not receive a TYK2 inhibitor.
- •Participant is not up to date on all required vaccinations according to current immunization guidelines as noted by country-specific pediatric authorities.
研究者
相似试验
尚未招募
不适用
A Study to Find Out How Effective and Safe JNJ-88545223 is for the Treatment of Participants With Active Psoriatic Arthritis (a Long-term Inflammatory Arthritis) (VELOTA)Arthritis, PsoriaticjRCT2031250700240
尚未招募
不适用
A Study of Brenipatide in Adult Participants With Schizophrenia (J2S-MC-GZMK)SchizophreniajRCT2021250053450
尚未招募
3 期
A clinical trial to study the effects of Brexpiprazole in comparison to Aripiprazole in patients suffering from Acute SchizophreniaCTRI/2024/06/069258Torrent Pharmaceuticals Ltd.304
尚未招募
3 期
A Study to assess Change in HbA1C levels and blood glucose levels and safety of Alkems Semaglutide Tablet compared to Rybelsus (Novo-nordisk semaglutide Tablet) in Type 2 Diabetes Mellitus after 24 weeksCTRI/2025/10/096183Alkem Laboratories Limited232
招募中
4 期
A Phase 1, Randomized, Double-Blind, Two-Arm, Two-Way Crossover Study of Pharmacokinetics and Pharmacodynamics of QL09112025-523355-59-00Qilu Pharmaceutical Co. Ltd.76