NCT04647890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
Certa Therapeutics3 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2021年7月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- FT011 Levels in Plasma
研究概览
简要总结
FT011 is an anti-fibrotic drug that is being tested as a treatment for scleroderma. This study is being conducted to see what the body does to the drug (pharmacokinetics), and what the drug does to the body (pharmacodynamics).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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 ≤10 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 ≤
- •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.
- •Women of childbearing potential (WOCPB) and males with partners of child-bearing potential must agree to use highly effective contraception (a failure rate of <1%), for the duration of the study and until three months after their last dose of IMP.
排除标准
- •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:
- •On an organ transplantation list or has received an organ transplant including autologous stem cell transplant.
- •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:
- •Methotrexate in the 2 weeks prior to Day 1
- •Other anti-fibrotic agents including D-penicillamine or tyrosine kinase inhibitors (nilotinib, imatinib, dasatinib) in the month prior to Screening.
- •Biologic drugs such as tumour necrosing factor (TNF) inhibitors, tocilizumab, or Janus kinase (JAK) inhibitors, in the 3 months prior to Screening.
- •Rituximab in the 6 months prior to Screening.
- •Cyclophosphamide oral or IV in the 3 months prior to Screening.
- •Oral prednisolone >10 mg per day or IV steroids in the month prior to Screening.
- •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 109/L
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo once daily for 12 weeks
干预措施: Placebo (Drug)
FT011 200mg
Experimental
200mg once daily for 12 weeks
干预措施: FT011 (Drug)
FT011 400mg
Experimental
400mg once daily for 12 weeks
干预措施: FT011 (Drug)
结局指标
主要结局
FT011 Levels in Plasma
时间窗: Mean of AUC hours post first dose and AUC hours post last dose
Measurement of area under the concentration time curve (AUC). First dose AUC and last dose AUC for each participant were averaged together to calculate a single mean AUC for each active arm
次要结局
- 5-D Itch Scale Change From Baseline(End of treatment (Week 12))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From Baseline to End of Study(Baseline to Week 16)
- Scleroderma Clinical Trial Consortium Damage Index (SCTC-DI) Change From Baseline(End of treatment (Week 12))
- Patient Global Assessment Change From Baseline(End of treatment (Week 12))
- Scleroderma HAQ-DI Change From Baseline(End of treatment (Week 12))
- %FVC Change From Baseline(End of treatment (Week 12))
- mRSS Change From Baseline(End of treatment (week 12))
- Physician Global Assessment Change From Baseline(End of treatment (Week 12))
- Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Week 12(Week 12)
研究者
研究点 (3)
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