EUCTR2020-005764-62-DE进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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.Written informed consent.
- •2.Male or female between the ages of 18 and 75 years, inclusive, at Screening.
- •3.Meets the 2013 American College of Rheumatology/European League
- •Against Rheumatism classification criteria for SSc with a total score of = 9 (Van den Hoogen et al., 2013).
- •4.Classified as having skin involvement proximal to the elbow and/or knee (diffuse cutaneous SSc subset by LeRoy and Medsger, 2001).
- •5.At the time of enrollment, less than or equal to 72 months (6 years) since the onset of the first SSc manifestation, other than Raynaud's phenomenon.
- •6.Skin in the forearm suitable for repeat biopsy (only applicable to the first 110 subjects for whom biopsy will be performed).
- •7.mRSS units =15 at Screening.
- •8.FVC =45% predicted at Screening, as determined by spirometry.
- •9.Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- •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 285
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1.Positive for anti-centromere antibodies with the exception that subjects who are positive for both anti-centromere and anti-topoisomerase 1 antibodies may be enrolled.
- •2.Diagnosed w/sine scleroderma or limited cutaneous SSc.
- •3.Diagnosed w/other autoimmune connective tissue diseases ,except for fibromyalgia, scleroderma-associated myopathy & secondary Sjogren's syndrome.
- •4.Scleroderma renal crisis diagnosed within6months of the Screening Visit.
- •5.Any of the following cardiovascular diseases: a. uncontrolled, severe hypertension(=160/100mmHg)or persistent low blood pressure (systolic blood pressure<90 mmHg)within6months of Screening, b. myocardial infarction within6months of Screening, c. unstable cardiac angina within6months of Screening.
- •6.DLCO<40%predicted(corrected for hemoglobin).If severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) exposure is of clinical concern for any subject, consider using a DLCO up to6months before the Screening Visit.
- •7.Pulmonary arterial hypertension(PAH)by right heart catheterization requiring treatment w/more than1oral PAH-approved therapy or any
- •parenteral therapy. Treatment is allowed for erectile dysfunction and/or Raynaud's phenomenon/digital ulcers.
- •8.Corticosteroid use for conditions other than SSc within4weeks prior to Screening(topical steroids for dermatological conditions& inhaled/intranasal/intra-articular steroids are allowed).
- •9.Use of any other non-steroid immunosuppressive agent, small biologic molecule, cytotoxic or antifibrotic drug within4weeks prior to Screening, including cyclophosphamide, azathioprine(Imuran®)or other immunosuppressive or cytotoxic medication. Exceptions include mycophenolate mofetil (CellCept®),mycophenolic acid(Myfortic®),methotrexate and low-dose prednisone, as follows: use of CellCept =3g/day, Myfortic =2.14g/day, methotrexate =20 mg/week and prednisone =10 mg/day (or equivalent dosing of glucocorticoids) is allowed. See Table 9.1 for full details. Subjects taking CellCept, Myfortic or methotrexate must have been doing so for=6months and the dose must have been stable for =4 weeks prior to the Day 1 Visit. Prednisone must have been at a stable dose for =8 weeks prior to the Day1Visit. It is acceptable to be on background low-dose prednisone &anti-malarial drug along with CellCept, Myfortic or methotrexate. Rituximab must not have been used within 6 months of the Day1Visit.Subjects must not be withdrawn from any standard-of-care treatment that is considered necessary for the clinical management of the subject in order to fulfill the trial eligibility requirements.
- •10.Known active bacterial, viral, fungal, mycobacterial or other infection, including tuberculosis or atypical mycobacterial disease(fungal infections of nail beds are allowed) at the time of randomization.
- •11.Use of a United States Food and Drug Administration-approved agent for SSc or an investigational agent for any condition within 90days or 5half-lives,whichever is longer, prior to Screening or anticipated use during the course of the trial.
- •12.Malignant condition in the past5years(except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
- •13.Women of childbearing potential (WOCBP) or male subjects not agreeing to use highly effective method(s)of birth control throughout
- •the trial and for 4 weeks after last dose of trial drug. Male subjects must refrain from sperm donation and females from egg/ova donation for this same time period. Women are conside
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