2024-517262-41-00招募中3 期
A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Children and Adolescents from 5 to less than 18 Years of Age with Active Juvenile Psoriatic Arthritis
Bristol-Myers Squibb Services Unlimited Company13 个研究点 分布在 6 个国家目标入组 29 人开始时间: 2025年2月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 29
- 试验地点
- 13
- 主要终点
- To see how long it takes for the first flare-up of the disease to happen between weeks 16 to 42 in participants who take the medication compared to participants who stopped taking the drug.
研究概览
简要总结
The main goal of this study is to see if deucravacitinib works better than a placebo in kids and teenagers between the ages of 5 and 18 who have Juvenile Psoriatic Arthritis (JPsA).
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants need to have been diagnosed with JPsA. This means a participant has arthritis and skin problems like Psoriasis (PsO), or arthritis with other symptoms like swollen fingers or toes (dactylitis), changes in nails, or a close family member with PsO.
- •Participants need to have at least three joints that are affected by arthritis. This could mean that these joints are swollen, painful, or don't move as well as they should.
- •Participants should have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems
- •Participants need to have been diagnosed with JPsA. This means a participant has arthritis and skin problems like Psoriasis (PsO), or arthritis with other symptoms like swollen fingers or toes (dactylitis), changes in nails, or a close family member with PsO.
- •Participants need to have at least three joints that are affected by arthritis. This could mean that these joints are swollen, painful, or don't move as well as they should.
- •Participants should have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems
排除标准
- •Diagnosis of JPsA before 5 years of age, or certain substances in the blood like Antinuclear Antibodies (ANA) or Rheumatoid Factor (RF) above a certain level.
- •Have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA.
- •Have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months
- •Diagnosis of JPsA before 5 years of age, or certain substances in the blood like Antinuclear Antibodies (ANA) or Rheumatoid Factor (RF) above a certain level.
- •Have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA.
- •Have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months
结局指标
主要结局
To see how long it takes for the first flare-up of the disease to happen between weeks 16 to 42 in participants who take the medication compared to participants who stopped taking the drug.
To see how long it takes for the first flare-up of the disease to happen between weeks 16 to 42 in participants who take the medication compared to participants who stopped taking the drug.
次要结局
- Evaluating amount of deucravacitinib in the body at week 16.
- Assessing how many participants have a flare-up and how many reach different levels of improvement at weeks 16 and 42. Assessing how much the disease has improved from start of the trial and how many have low disease activity or no disease activity at weeks 16 and 42. Assessing how many participants have no disease activity for at least 6 months in a row. Assessing how many have a 75% improvement in their skin symptoms by week 42
- Assessing how many participants find the medicine easy to swallow and taste good at week 16.
- Assessing how the amount of medicine in the body affects the results at week 16.
- Monitoring any side effects, how severe they are, and if they cause anyone to stop the trial. Assessing how many participants develop an eye condition called uveitis.
- Seeing how many people have a flare-up between weeks 16 to 42.
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (13)
Loading locations...
相似试验
招募中
3 期
Efficacy and Safety of Deucravacitinib Compared with Placebo in
Participants with Active Psoriatic Arthritis (PsA) who are Naïve to Biologic
Disease-modifying Anti-rheumatic Drugs2023-506256-25-00Bristol Myers Squibb International Corporation326
招募中
2 期
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety deucravacitinib in patients with chronic hand eczema (investigator-sponsored research)2023-504298-19-00Charite Universitaetsmedizin Berlin KöR57
招募中
3 期
Evaluation of Upadacitinib in Adolescent and Adult Patients with Moderate to Severe Atopic Dermatitis (Eczema)– Measure Up 12022-502938-30-00Abbvie Deutschland GmbH & Co. KG187
招募中
3 期
Evaluation of Upadacitinib in Adolescent and Adult Patients with Moderate to Severe Atopic Dermatitis (Eczema) – Measure Up 22022-502936-38-00Abbvie Deutschland GmbH & Co. KG380
招募中
3 期
A Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of
Deucravacitinib (BMS-986165) in Pediatric Subjects with Moderate to
Severe Plaque Psoriasis2022-502519-13-00Bristol Myers Squibb International Corporation84