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/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

Exclusion Criteria

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.
20

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

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