EUCTR2015-005023-11-ES进行中（未招募）1 期
A Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD) - STRATUS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 175
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
- •Subjects are eligible for this trial if they fulfill all of the following inclusion criteria:
- •1. Female or male subjects aged between 18 and 75 years of age who provide informed written consent.
- •2. Subjects fulfilling the 2013 ACR/European League Against Rheumatism criteria for classification of SSc.
- •3. Disease duration of <7 years from first non-Raynaud?s symptom.
- •4. According to central readings: DLCO ?30% predicted, FVC 40% to 85% predicted, and ratio of FVC % predicted to DLCO % predicted <1.8. If these criteria are met, then HRCT of lungs will be performed, and must show at least 5% fibrosis for subjects to be eligible.
- •5. Use of mycophenolate for at least 6 months before the screening visit. The dose must be stable for at least 3 months prior to screening and be in the range as follows: MMF 1.5 to 3 g/day, MPS 1080 to 2160 mg/day.
- •6. For women who are not postmenopausal (= 12 months of non- therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two effective methods of contraception, including at least one highly effective method that can achieve a failure rate of < 1% per year, when used consistently and correctly, and one other reliable method during the treatment period and for at least 90 days after the last dose of study treatment.
- •Examples of contraceptive methods with a failure rate of < 1% per year
- •(highly effective contraceptive methods) include:
- •combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- •progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- •intrauterine device (IUD)
- •intrauterine hormone-releasing system (IUS)
- •bilateral tubal occlusion
- •vasectomized partner
- •sexual abstinence
- •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 149
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1. Any condition that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the trial or that could interfere with the trial objectives, conduct, or evaluation.
- •2. Renal impairment (glomerular filtration rate [GFR] <45 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation) calculated by the central laboratory as follows:
- •GFR (mL/min per 1.73 m^2) = 175 x (standardized serum creatinine)^-
- •1.154 x (age)^-0.203 x 1.212 (if black) x 0.742 (if female)
- •3. Urine dipstick with =3+ protein and urine protein:creatinine ratio >2 mg/mg. Urine protein:creatinine ratio will be determined only if urine dipstick indicates =3+ protein.
- •4. Known diagnosis of obstructive lung disease/emphysema as defined by forced expiratory volume in 1 second (FEV1)/FVC ratio <0.65 and/or significant emphysematous change on screening HRCT according to the central reader.
- •5. Other clinically significant abnormalities on HRCT not attributable to scleroderma or emphysema as defined above, which in the Investigator's opinion make enrollment in the trial inappropriate.
- •6. Known diagnosis of other significant respiratory disorders in the opinion of the Investigator.
- •7. Pulmonary hypertension that fulfills at least one of the following:
- •- Currently being treated with systemic therapy targeted to PAH or pulmonary hypertension;
- •- Considered by the Investigator to require initiation of systemic therapy;
- •- History of transthoracic echocardiography showing at least one of the following (unless right heart catheterization subsequent to these measures did not reveal pulmonary hypertension): tricuspid regurgitation jet >2.8 m/sec, right atrial enlargement (major dimension
- •>53 mm), right ventricular enlargement (mid cavity dimension >35 mm), moderate to severe left ventricular dysfunction;
- •- At screening, N-terminal prohormone brain natriuretic peptide (NT pro- BNP) >3 x the upper limit of normal (ULN), unless, for example, right heart catheterization performed within 2 months did not reveal pulmonary hypertension.
- •8. Current clinical diagnosis of another inflammatory connective tissue disease (eg, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, or dermato/polymyositis); concomitant scleroderma-associated myopathy and fibromyalgia are allowed.
- •9. Clinical suspicion of or recent evidence of significant aspiration within the previous 6 months, such as chemical induced pneumonitis or aspiration pneumonia.
- •10. Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks prior to screening or during the Screening Period, or completion of oral antiinfectives within 2 weeks before screening or use of oral anti-infectives during the Screening Period. Vaginal candidiasis, onychomycosis, and chronically suppressed oral herpes simplex virus would not be exclusionary.
- •11. History of or positive human immunodeficiency virus (HIV), hepatitis C antibody and/or polymerase chain reaction or hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (total and/or immunoglobulin M [IgM]) antibody at screening.
- •12. History of or current diagnosis of active tuberculosis (TB), or untreated latent TB infection (LTBI), determined by a TB skin test with purified protein derivative as evidenced by induration =5 mm or a positive QuantiFERON-TB or positive or borderli
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