EUCTR2018-002299-41-ES进行中（未招募）1 期
A Phase IIa, Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study of an Anti OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 89
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adults (= 18 years but < 75 years of age) with AD for 1 year or longer at Baseline (Day 1; prior to first administration of IMP).
- •- EASI of 12 or higher at the Screening Visit and 16 or higher at Baseline.
- •- vIGA of 3 or 4 at Baseline.
- •- AD involvement of 10% or more of body surface area (BSA) at Baseline.
- •- Documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments.
- •- Must have applied a stable dose of topical bland emollient (simple moisturiser, no additives [e.g., urea]) at least twice daily for at least 7 consecutive days before Baseline.
- •- Able and willing to comply with requested study visits/telephone visits and procedures.
- •- Able and willing to provide punch biopsy of both lesional and non-lesional skin at Baseline.
- •- Able and willing to provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 71
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •- Treatment with any of the following prior to first IMP administration (Baseline):
- •¤ Systemic corticosteroids, and calcineurin inhibitors (tacrolimus and cyclosporin) within 4 weeks;
- •¤ Other systemic immunosuppressive or immunomodulatory drugs (including leukotriene inhibitors) within 3 months;
- •¤ Topical corticosteroids, tacrolimus or pimecrolimus, within 2 weeks;
- •¤ Prescription or non-prescription moisturisers with additives (e.g., urea, filaggrin) within 2 weeks;
- •¤ Phototherapy or allergen immunotherapy within 4 weeks;
- •¤ Regular use (> 2 visits/week) of a tanning booth/parlour within 4 weeks;
- •¤ Dupilumab within 3 months;
- •¤ Investigational therapy for the treatment of other conditions within 5 half-lives or the limit of PD effects or 3 months where the t1/2 is not known.
- •- Known history of or suspected significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- •- Treatment with a live (attenuated) immunisation within 12 weeks prior to Baseline.
- •- Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breast feeding.
- •- Basal and squamous cell skin cancer in the last 3 years prior to Baseline. Any other malignancies in the last 5 years prior to Baseline (excluding in situ cervical carcinoma).
- •- Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody at the Screening Visit.
- •- Severe concomitant illness that would in the Investigator’s opinion inhibit the patient’s participation in the study, including for example, but not limited to, renal disease, neurological conditions, heart failure and pulmonary disease.
- •- Laboratory values at the Screening Visit:
- •¤ Serum creatinine > 1.6 mg/dL (141 µmol/L) in female patients and > 1.9 mg/dL
- •(168 µmol/L) in male patients;
- •¤ Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN);
- •¤ Platelet count < 100 × 109/L;
- •¤ Haemoglobin (Hb): Male < 13.5g/dL and Female <12g/dL;
- •¤ White blood cell count (WBCC) < 3.0 × 109/L;
- •¤ Absolute neutrophil count < 2.0 × 109/L;
- •¤ Absolute lymphocyte count < 0.5 × 109/L;
- •¤ Total bilirubin > ULN.
- •- Participation in any other clinical study, including non-interventional studies.
研究者
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