NL-OMON51103已完成2 期
A phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, of oral FT011 in participants with diffuse systemic sclerosis - CER-FT011-SSc01
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
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
- 18 至 99（—）
入选标准
- •Participants must meet all the following criteria:
- •Provide written informed consent prior to any study procedures and who agree
- •to adhere to all protocol requirements.
- •Aged 18 to 75 years inclusive at the time of consent.
- •Have a classification of systemic sclerosis, as defined by American College
- •of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria
- •with disease duration <=5 years from first non-Raynaud phenomenon manifestation.
- •Have a diagnosis of diffuse cutaneous SSc defined as systemic sclerosis with
- •skin thickening on the upper arms proximal to the elbows, on the upper legs
- •proximal to the knees, or on the trunk.
- •Have skin thickening in a body area suitable for repeat biopsy.
- •Have a mRSS at Screening of >=15 to <=40.
- •FVC >=50% of predicted at Screening.
- •If on azathioprine, mycophenolate mofetil, or hydroxychloroquine, have been
- •on a stable dose for at least 2 months prior to baseline.
- •Participants must agree to use contraception according to protocol section
排除标准
- •Participants must not meet any of the following criteria:
- •Pregnant or breast-feeding, or plan to become pregnant during the study.
- •Have received any IMP within 30 days or 5 half-lives prior to randomisation
- •(4 months if the previous drug was a new chemical entity), whichever is longer.
- •Have known or suspected contraindications to the IMP.
- •Have severe or unstable SSc or end-stage organ involvement as evidenced by:
- •o On an organ transplantation list or has received an organ transplant
- •including autologous stem cell transplant.
- •o Renal crisis within 1 year prior to Baseline.
- •Interstitial lung disease or pulmonary hypertension requiring constant oxygen
- •therapy. This excludes oxygen used to aid sleep or exercise.
- •Gastrointestinal dysmotility requiring total parenteral nutrition or requiring
- •hospitalisation within the 6 months prior to Baseline.
- •Concomitant inflammatory myositis, rheumatoid arthritis, or systemic lupus
- •erythematosus when definite classification criteria for those diseases are met
- •(Bohan and Peter criteria for polymyositis and dermatomyositis)
- •SSc-like illnesses related to exposures or ingestions
- •The use of the following drugs within the specified periods:
- •o Methotrexate in the 2 weeks prior to Day 1
- •o Other anti-fibrotic agents including D-penicillamine or tyrosine
- •kinase inhibitors (nilotinib, imatinib, dasatinib) in the month prior to
- •o Biologic drugs such as tumour necrosing factor (TNF) inhibitors, tocilizumab,
- •or Janus kinase (JAK) inhibitors, in the 3 months prior to Screening.
- •o Rituximab in the 6 months prior to Screening.
- •o Cyclophosphamide oral or intravenous (IV) in the 3 months prior to Screening.
- •o Oral prednisolone >10 mg per day or IV steroids in the month prior to
- •Have any malignancy not considered cured (except basal cell or squamous cell
- •carcinoma of the skin, or carcinoma in situ of the cervix); a subject is
- •considered cured if there has been no evidence of cancer recurrence for the 6
- •years prior to randomisation.
- •Have aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl
- •transferase (GGT), lactate dehydrogenase (LDH), or bilirubin values above the
- •upper limit of normal (ULN) at Screening or Baseline, or evidence of hepatic
- •disease as determined by any one of the following: history of hepatic
- •encephalopathy, history of oesophageal varices, or history of portacaval shunt.
- •Estimated glomerular filtration rate (eGFR) <60mL/min, urinary
- •albumin/creatinine ratio <30mg/g.
- •Haemoglobin < 80 g/L, platelets < 90 x 109/L, or neutrophil count < 1.4 x
- •Other than SSc, have any other medical condition or significant
- •co-morbidities, clinically relevant social or psychiatric conditions, or any
- •finding during Screening, which in the investigator*s opinion may put the
- •subject at risk or interfere with the study objectives.
研究者
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