NCT03972280已完成1 期
A Multicenter, Open-label, 2-regimen, Repeat-dose Study to Assess the Safety and Pharmacokinetics of Intravenous CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 39
- 试验地点
- 22
- 主要终点
- AESIs: Grade 3 and 4 infection by causality
研究概览
简要总结
Study CSL324_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis. CSL324 is a novel, recombinant therapy that may treat diseases caused by increased numbers of neutrophils at sites of inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between 18 and 75 years of age, inclusive
- •Confirmed clinical diagnosis of moderate to severe HS as per International Hidradenitis Suppurativa Severity Score System (IHS4) guidelines (ie, IHS4 ≥ 4)
- •PPP differentiated from other forms of pustulosis
- •Psoriasis with a Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) score of ≥
- •Subjects with HS only: inadequate response to at least a 3-month (90 days) trial of oral antibiotics for treatment of HS
- •Subjects with PPP only: confirmed clinical diagnosis of PPP at least 6 months before Screening and inadequate response to topical therapy, phototherapy, and / or previous systemic therapy for the treatment of PPP
排除标准
- •Treatment with any medications and therapies not permitted during the study.
- •History of myeloproliferative disease.
- •Malignancy within 5 years at Screening with the exception of nonmelanoma skin cancer, carcinoma in situ, or prostate cancer not requiring treatment.
- •Current, or a recent clinically significant history of, uncontrolled renal, hepatic(including currently active hepatitis B virus and / or hepatitis C virus), hematologic, endocrine, pulmonary, psychiatric, or cardiac disease, assessed as potentially having an effect on study outcomes as determined by the Investigator and / or Sponsor.
- •Congenital or acquired immunosuppressive condition(s), including human immunodeficiency virus infection.
- •Clinical signs of active infection and / or fever > 38°C during the 7 days before Day
- •Clinically significant abnormalities on physical examination, ECG, or laboratory assessments, or neutropenia (defined as absolute neutrophil count < 2.0 × 109/L) at Screening.
- •Subjects with PPP only: concurrent psoriasis vulgaris (not including scaly scalp and / or ears).
- •Subjects with HS only: > 20 draining fistulas."
结局指标
主要结局
AESIs: Grade 3 and 4 infection by causality
时间窗: Up to 24 weeks
AESIs: Grade 3 and 4 neutropenia by causality
时间窗: Up to 24 weeks
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 24 weeks
TEAEs by casuality
时间窗: Up to 24 weeks
Incidence of adverse events of special interest (AESIs): Grade 3 and 4 neutropenia
时间窗: Up to 24 weeks
TEAEs by severity
时间窗: Up to 24 weeks
Incidence of AESIs: Grade 3 and 4 infection
时间窗: Up to 24 weeks
次要结局
- Cmax of CSL324 in serum for the last dose administered(Up to 22 days after dose)
- Maximum concentration (Cmax) of CSL324 in serum for the first dose administered(Up to 22 days after dose)
- Tmax of CSL324 in serum for the last dose administered(Up to 84 days after dose)
- AUCtau of CSL324 in serum for the last dose administered(Up to 22 days after dose)
- Time to maximum concentration (Tmax) of CSL324 in serum for the first dose administered(Up to 22 days after dose)
- Area under the concentration-time curve during a dosing interval (AUCtau) of CSL324 in serum for the first dose administered(Up to 22 days after dose)
- Total systemic clearance (CLtot) after intravenous dosing of CSL324 in serum for the last dose administered(Up to 22 days after dose)
- Ctrough of CSL324 for each dose of CSL324 administered(Up to 22 days after each dose)
- Half life (t½) of CSL324 in serum for the last dose administered(Up to 84 days after dose)
- Accumulation ratio for AUCtau (ratio between AUCtau of the last dose and of the first dose) and accumulation ratio for Cmax (ratio between Cmax of the last dose and of the first dose)(Up to 22 days after each dose)
- Presence of anti-CSL324 antibodies in serum(Up to 168 days)
- Volume of distribution after intravenous dosing during the terminal elimination phase ( Vz) of CSL324 in serum for the last dose administered(Up to 22 days after dose)
研究者
研究点 (22)
Loading locations...
相似试验
已完成
1 期
A Study in Rheumatoid ArthritisRheumatoid ArthritisNCT01253265Eli Lilly and Company32
已完成
2 期
Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPDPulmonary Disease, Chronic ObstructiveNCT00749411GlaxoSmithKline61
已完成
1 期
Safety and PK of Repeated Doses of IRL201104 in Healthy VolunteersHealthy VolunteerNCT04748536Revolo Biotherapeutics18
已完成
2 期
Trial on Safety and Efficacy of Velmanase Alfa Treatment in Pediatric Patients With Alpha-MannosidosisAlpha-MannosidosisNCT02998879Chiesi Farmaceutici S.p.A.5
已完成
2 期
Study Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)Alzheimer's DiseaseNCT00151333Wyeth is now a wholly owned subsidiary of Pfizer16