EUCTR2015-005023-11-PL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
适应症
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/EULAR 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. A ratio of FVC% predicted to DLCO predicted >1.8% is acceptable if right heart catheterization within 3 months of Screening revealed no pulmonary hypertension. 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 the same mycophenolate regimen (ie, stable dose) in a range of 1.5 to 3 g/day of MMF or 1080 to 2160 mg/day of MPS, for at least 2 months prior to the screening visit daycontinued through Day 1 of the Treatment Period.
- •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 or could interfere with trial objectives, conduct, or evaluation
- •2.Renal impairment (GFR <45 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation) calculated 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 >2mg/mg
- •4.Known diagnosis of obstructive lung disease/emphysema (FEV1/FVC ratio <0.65) and/or significant emphysematous change on screening HRCT
- •5.Other clinically significant abnormalities on HRCT not attributable to scleroderma or emphysema
- •6.Known diagnosis of other significant respiratory disorders
- •7.Pulmonary hypertension that fulfills at least 1 of the following:
- •Current/planned treatment with therapy targeted to PAH or pulmonary hypertension
- •History of transthoracic echocardiography showing at least 1 of the following: 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
- •NT pro-BNP >3xULN
- •8.Current diagnosis of other inflammatory connective tissue disease (eg,systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, or dermato/polymyositis). Concomitant sclerodermaassociated myopathy, fibromyalgia, and secondary Sjögren's are allowed
- •9.Suspected/confirmed significant aspiration within the previous 6 mths
- •10.Active clinically significant viral/bacterial/fungal infection, major episode of infection requiring hospitalization. Treatment with parenteral anti-infectives within 4 wks prior/during Screening Period. Completion of oral anti-infectives within 2 wks of Screening. Use of oral antiinfectives during Screening Period. Vaginal candidiasis, onychomycosis, chronically suppressed oral herpes simplex virus are allowed. Prophylaxis for Pneumocystis jiroveci pneumonia permitted
- •11.History of/positive HIV, HCV antibody and/or PCR or HBsAg and/or HBV core antibody (total and/or IgM) at screening
- •12.History of/current diagnosis of active TB, or untreated latent TB infection (LTBI)
- •13.Presence of uncontrolled or NYHA Class 3 or 4 congestive heart failure
- •14.History of cancer, except adequately treated (ie, no evidence of recurrence within 5 ys prior screening) basal cell/squamous cell carcinomas of the skin (=3 total in lifetime) or carcinoma in situ of the cervix
- •15.Known hypersensitivity to abituzumab DS or DP
- •16.Current smoker (incl. e-cigarettes)/smoking within 4 wks of screening
- •17.Use of agents other than mycophenolate considered by the Inv to have immunomodulating, immunosuppressive, or potential scleroderma disease-modifying properties within 2 mths of screening, e.g. pirfenidone, nintedanib, methotrexate, azathioprine, leflunomide, calcineurin inhibitors, D penicillamine, Potaba, and AIMSPRO. Use of cyclophosphamide within 5 months of screening visit is not permitted. Hydroxychloroquine or chloroquine are permitted if dose stable for at least 4 wks before screening.
- •18.Use of systemic corticosteroids above 10 mg/day prednisone equivalent within 4 wks prior until last dose of study drug. Inhaled and topical corticosteroids are permitted
- •19.Use of any biologic agent within 12 wks or 5 half-lives, whichever is longer, of screening.
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