EUCTR2020-005116-21-ES进行中（未招募）1 期
A phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, oforal FT011 in participants with diffuse systemic sclerosis - FT011 for scleroderma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •1. Provide written informed consent prior to any study procedures and who agree to adhere to all
- •protocol requirements.
- •2. Aged 18 to 75 years inclusive at the time of consent.
- •3. 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.
- •4. 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.
- •5. Have skin thickening in a body area suitable for repeat biopsy.
- •6. Have a mRSS at Screening of =15 to =40.
- •7. FVC =50% of predicted at Screening.
- •8. If on azathioprine, mycophenolate mofetil, or hydroxychloroquine, have been on a stable dose for
- •at least 2 months prior to baseline.
- •9. Participants must agree to use contraception according to protocol section 5.4.4.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Pregnant or breast-feeding, or plan to become pregnant during the study.
- •2. 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.
- •3. Have known or suspected contraindications to the IMP.
- •4. Have severe or unstable SSc or end-stage organ involvement as evidenced by:
- •a. On an organ transplantation list or has received an organ transplant including autologous
- •stem cell transplant.
- •b. Renal crisis within 1 year prior to Baseline.
- •5. Interstitial lung disease or pulmonary hypertension requiring constant oxygen therapy. This
- •excludes oxygen used to aid sleep or exercise.
- •6. Gastrointestinal dysmotility requiring total parenteral nutrition or requiring hospitalisation within
- •the 6 months prior to Baseline.
- •7. 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)
- •8. SSc-like illnesses related to exposures or ingestions
- •9. The use of the following drugs within the specified periods:
- •a. Methotrexate in the 2 weeks prior to Day 1
- •b. Other anti-fibrotic agents including D-penicillamine or tyrosine kinase inhibitors (nilotinib,
- •imatinib, dasatinib) in the month prior to Screening.
- •c. Biologic drugs such as tumour necrosing factor (TNF) inhibitors, tocilizumab, or Janus
- •kinase (JAK) inhibitors, in the 3 months prior to Screening.
- •d. Rituximab in the 6 months prior to Screening.
- •e. Cyclophosphamide oral or IV in the 3 months prior to Screening.
- •f. Oral prednisolone >10 mg per day or IV steroids in the month prior to Screening.
- •10. 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.
- •11. 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.
- •12. Estimated glomerular filtration rate (eGFR) <60mL/min, urinary albumin/creatinine ratio <30mg/g.
- •13. Haemoglobin < 80 g/L, platelets < 90 x 109/L, or neutrophil count < 1.4 x 109/L
- •14. 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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