Abituzumab in SSc-ILD

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 175

Inclusion Criteria

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: 1
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

Exclusion Criteria

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 positi

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials