EUCTR2020-005764-62-GR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, atScreening.
- •3.Meets the 2013 American College of Rheumatology/European LeagueAgainst 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 thefirst 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 protocoland 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 antitopoisomerase 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 within 6months of the Screening
- •5.Any of the following cardiovascular diseases: a. uncontrolled, severe
- •hypertension(=160/100mmHg) or persistent low blood pressure
- •(systolic blood pressure<90 mmHg) within 6months 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
- 另有 4 项未显示
研究者
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