JPRN-jRCT2080223630已完成1 期
A Phase 1, open-label, multiple-dose study of KHK4827 in subjects with systemic sclerosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •Subject meets the diagnostic criteria defined in the Guidelines for Systemic Sclerosis (Japanese Dermatological Association 2016) at screening.
- •- Onset of skin phenomenon within 60 months before enrollment
- •- Moderate to severe systemic sclerosis with a modified Rodnan total skin thickness score (mRSS) of 10 to < 30 and progressive skin thickening at screening and at enrollment.
排除标准
- •1) Any of the following significant concomitant diseases:
- •- Type 1 diabetes
- •- Poorly controlled type 2 diabetes (HbA1c > 8.5%)
- •- Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification)
- •- Myocartial infarction, unstable angina, or stroke occurring within 12 months before the first dose of investigational product
- •- Poorly controlled hypertension (systolic pressure > 150 mm Hg or diastolic pressure > 90 mg Hg at screening)
- •- Severe chronic lung disease (%FVC < 60% and %DLco < 40%, calculated according to the Reference Values for Spirometry, Including Viral Capacity, in Japanese Adults Calcluated with the LMS Method and Compared with Previous Values [Japanese Respiratory Society])
- •Major chronic inflammatory diseases or connective tissue diseases other than scleroderma
- •2) Subject has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse, or any other mental health disorder that, in the opinion of the investigators, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- •3) Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment
- •4) Subject has severe depression based on a total score of >= 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment (note: subjects with a total score of 10 to 14 on the PHQ-8 should be referred to a mental health care professional)
研究者
相似试验
未知
1 期
A Phase 1, Open-Label, Multiple-Dose Study of KHK4083 in Subjects with Atopic DermatitisAtopic dermatitisJPRN-jRCT2080223488Kyowa Hakko Kirin Co., Ltd.20
已完成
1 期
A Phase 1 Study of KHK4083 in Subjects With Atopic DermatitisDermatitis, AtopicNCT03096223Kyowa Kirin Co., Ltd.26
未知
1 期
KHK6640 Phase I study (A single dose study in patients with Alzheimer's disease)Alzheimer's diseaseJPRN-jRCT2080222766Kyowa Hakko Kirin Co., Ltd.20
进行中（未招募）
1 期
A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)EUCTR2021-001838-19-ESKeros Therapeutics, Inc.104
进行中（未招募）
1 期
A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)Anemia in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS).MedDRA version: 27.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2021-001838-19-CZKeros Therapeutics, Inc.141