NL-OMON49927撤回2 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 - HZNP-HZN-825-301 / Beacon
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 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.
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 Visit.
- •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
- •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 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 t
研究者
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