EUCTR2020-005764-62-ES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 Screening.
- •3. Meets the 2013 American College of Rheumatology/European League Against Rheumatism classificationcriteria 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 knee (diffuse cutaneous SSc subset byLeRoy and Medsger, 2001).
- •5. At the time of enrollment, less than 36 months since the onset of the first SSc manifestation, other thanRaynaud's phenomenon.
- •6. Based on data available through medical history and/or medical records, the subject should have at least 1 ofthe following:
- •a. disease duration =18 months
- •b. increase =3 in mRSS units compared with the last visit within the previous 1 month to 6 months
- •c. involvement of 1 new body area with =2 mRSS units or 2 new body areas with =1 mRSS unit
- •d. documentation of worsening skin thickening for subjects who did not have mRSS performed during theprevious visit
- •e. presence of tendon friction rub at Screening
- •7. Presence of at least 1 of the following features of elevated acute phase reactants at Screening:
- •high-sensitivity C-reactive protein (hsCRP) =0.6 mg/dL (=6 mg/L),
- •erythrocyte sedimentation rate (ESR) =28 mm/hr,
- •platelet count =330 × 109/L (330,000/µL).
- •8. Skin thickening from SSc in the forearm suitable for repeat biopsy.
- •9. mRSS units =15 at Screening.
- •10. FVC =45% predicted at Screening, as determined by spirometry.
- •11. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of thetrial.
- •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 Visit
- •5. Any of the following cardiovascular diseases:
- •a. uncontrolled, severe hypertension (=160/100 mmHg) or persistent low blood pressure (systolic bloodpressure <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 monthsbefore 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 dysfunctionand/or Raynaud's phenomenon/digital ulcers.
- •8. Corticosteroid use for conditions other than SSc within 4 weeks prior to Screening (topical steroids fordermatological conditions and inhaled/ intranasal/intra-articular steroids are allowed).
- •9. Use of any other non-steroid immunosuppressive agent, small biologic molecule, cytotoxic or anti-fibroticdrug within 4 weeks of Screening,
- •including cyclophosphamide, azathioprine (Imuran®) or otherimmunosuppressive or cytotoxic medication.
- •10. Known active bacterial, viral, fungal, mycobacterial or other infection, including tuberculosis or atypicalmycobacterial 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 forany condition within 90 days or 5
- •half-lives, whichever is longer, prior to Screening or anticipated useduring the course of the trial.
- •12. Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of theskin or cervical cancer in situ).
- •13. Women of childbearing potential or male subjects not agreeing to use highly effective method(s) of birthcontrol throughout the trial and for 1
- •month after last dose of trial drug. Male subjects must refrain fromsperm donation and females from egg/ova donation for this same time period.
- •14. Pregnant or lactating women.
- •15. Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of theInvestigator 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 hepatitis B surface antigen and positive anti-hepatitis B core antibody[anti-HBcAb] and negative
- •hepatitis B surface antibody [HBsAb] or positive for HBcAb with a positive testfor HBsAb and with presence of hepatitis B virus DNA at Screening; hepatitis C: positive anti-hepatitis Cvirus [anti-HCV] and positive RNA HCV).
- •19. Current alcoholic liver disease, primary biliary cirrhosis or primary sclerosing cholangitis.
- •20. Previous organ transplant (including allogeneic and autologous marrow transplant).
- •21. International normalized ratio >2, prolonged prothrombin time >1.5 × the upper limit of normal (ULN) orpartial thromboplastin time >1.5 ×ULN at Screening.
- •22. Alanine am
研究者
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