EUCTR2020-005764-62-NL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
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
- •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 36 months since the onset of the
- •first SSc manifestation, other than Raynaud's phenomenon.
- •6.Skin thickening from SSc in the forearm suitable for repeat biopsy.
- •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.
- •2.Diagnosed with sine scleroderma or limited cutaneous SSc.
- •3.Diagnosed with other autoimmune connective tissue diseases, except
- •for fibromyalgia, scleroderma-associated myopathy and secondary
- •Sjogren's syndrome.
- •4.Scleroderma renal crisis diagnosed within 6 months of the Screening
- •5.Any of the following cardiovascular diseases:
- •a.uncontrolled, severe hypertension (=160/100 mmHg) or persistent
- •low blood pressure (systolic blood pressure <90 mmHg) within 6 months
- •of Screening,
- •b.myocardial infarction within 6 months of Screening,
- •c.unstable cardiac angina within 6 months 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 to 6 months before the
- •Screening Visit.
- •7.Pulmonary arterial hypertension (PAH) by right heart catheterization
- •requiring treatment with more than1 oral 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 within 4 weeks prior
- •to Screening (topical steroids for dermatological conditions and
- •inhaled/intranasal/intra-articular steroids are allowed).
- •9.Use of any other non-steroid immunosuppressive agent, small biologic
- •molecule, cytotoxic or anti-fibrotic drug within 4 weeks of Screening,
- •including cyclophosphamide, azathioprine (Imuran®) or
- •other immunosuppressive or cytotoxic medication.
- •10.Known active bacterial, viral, fungal, mycobacterial or other infection,
- •including tuberculosis or atypical mycobacterial disease (fungal
- •infections of nail beds are allowed).
- •11.Use of a United States Food and Drug Administration-approved agent
- •for SSc or an investigational agent for any condition within 90 days or 5
- •half-lives, whichever is longer, prior to Screening or anticipated
- •use during the course of the trial.
- •12.Malignant condition in the past 5 years (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 1 month 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 considered of childbearing potential if they are not postmenopausal and not surgically sterile (documented bilateral salpingectomy, bilateral oophorectomy, or hysterectomy). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
- •14.Pregnant or lactating women.
- •15.Current drug or alcohol abuse or history of either within the previous
- •2 years, in the opinion of the Investigator or as reported by the subject.
- •16.Previous enrollment in this trial or participation in a prior HZN-825 or
- •SAR100842 clinical trial.
- •17.Known history of positive test for human immunodeficiency virus.
- •18.Active hepatitis (hepatitis B: positive hepatit
研究者
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