Abituzumab in SSc-ILD

Inclusion Criteria:

- Subjects are eligible for this trial if they fulfill all of the following inclusion
criteria:

- Female or male subjects aged between 18 and 75 years of age who provide informed
written consent.

- Subjects fulfilling the 2013 American College of Rheumatology (ACR) /European League
Against Rheumatism criteria for classification of systemic sclerosis (SSc).

- Disease duration of less than (<) 7 years from first non-Raynaud's symptom.

- Subjects who have been taking the same mycophenolate regimen (stable dose) in a range
of 1.5 to 3 gram (g)/day of Mycophenolate mofetil (MMF) or 1080 to 2160 milligram/day
(mg/day) of MPS for at least 2 months prior to the Screening Visit and continued
through Day 1 of the Treatment Period, of the lung on HRCT according to central
reading.

- According to central readings: Diffusion capacity of the lung for carbon monoxide
(DLCO) greater than or equal to (>=) 30 percent (%) predicted, Forced vital capacity
(FVC) 40% to 85% predicted, and 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 High-resolution computed
tomography (HRCT) of lungs will be performed, and must show at least 5% fibrosis for
subjects to be eligible.

- Female subjects of childbearing potential must use a highly effective method of
contraception to prevent pregnancy for 4 weeks before randomization and must agree to
continue to practice adequate contraception for the duration of their participation in
the trial (up to the last Safety Follow-Up Visit). For the purposes of this trial,
women of childbearing potential are defined as "All female subjects after puberty
unless they are post-menopausal for at least 2 years or are surgically sterile."
Highly effective contraception is defined as 2 barrier methods (eg, female diaphragm
and male condoms); or 1 barrier method with at least one of the following: spermicide,
a hormonal method, or an intrauterine device. Note that because mycophenolate affects
the metabolism of oral contraceptives and may reduce their effectiveness, women
receiving mycophenolate who are using oral contraceptives for birth control should
employ an additional contraceptive method (for example, male or female barrier
method).

Exclusion Criteria:

- 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.

- Renal impairment (glomerular filtration rate [GFR] <45 mL/minute (min)/1.73 square
meter (m^2) as calculated by the Modification of Diet in Renal Disease equation)
calculated as follows: GFR (mL/min per 1.73 m^2) = 175*(standardized serum
creatinine)^-1.154 * (age)^-0.203 * 1.212 (if black) * 0.742 (if female)

- Urine dipstick with >=3 plus protein and urine protein:creatinine ratio more than (>)2
mg/mg.

- Known diagnosis of obstructive lung disease/emphysema (Forced Expiratory Volume
[FEV1]/FVC ratio <0.65) and/or significant emphysematous change on screening HRCT.

- Other clinically significant abnormalities on HRCT not attributable to scleroderma or
emphysema as defined above.

- Known diagnosis of other significant respiratory disorders.

- Pulmonary hypertension that fulfills at least one of the following:

- Current/planned treatment with systemic therapy targeted to Pulmonary arterial
hypertension (PAH) or pulmonary hypertension;

- History of transthoracic echocardiography showing at least one 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;

- N-terminal prohormone brain natriuretic peptide >3*Upper limit of normal (ULN)

- Considered by the investigator to require initiation of systemic targeted PAH
therapy.

- Current clinical diagnosis of another inflammatory connective tissue disease (eg,
systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, or
dermato/polymyositis). Concomitant scleroderma-associated myopathy, fibromyalgia, and
secondary Sjögren's are allowed.

- Suspected/confirmed significant aspiration within the previous 6 months, for example.

- viral/bacterial/fungal infection

- infection requiring hospitalization

- Treatment with parenteral anti-infectives within 4 weeks prior/during Screening
Period

- Completion of oral anti-infectives within 2 weeks of Screening

- Use of oral anti-infectives during Screening Period

- Vaginal candidiasis

- onychomycosis

- chronically suppressed oral herpes simplex virus

- Prophylaxis for Pneumocystis jiroveci pneumonia

- History of/positive Human immunodeficiency virus, hepatitis C antibody and/or
polymerase chain reaction or Hepatitis B surface antigen and/or hepatitis B core
antibody (total and/or Immunoglobulin M) antibody at screening.

- History of/current diagnosis of active tuberculosis (TB), or untreated latent TB
infection (LTBI).

- Presence of uncontrolled or New York Heart Association Class 3 or 4 congestive heart
failure.

- History of cancer, except adequately treated (ie, no evidence of recurrence within 5
years prior screening) basal cell/squamous cell carcinomas of the skin (≤3 total in
lifetime) or carcinoma in situ of the cervix.

- Known hypersensitivity to abituzumab DS or DP.

- Current smoker (incl. e-cigarettes) / smoking within 4 weeks of screening.

- Use of agents other than mycophenolate considered by the Investigator to have
immunomodulating, immunosuppressive, or potential scleroderma disease-modifying
properties within 2 months of screening visit is not allowed (or 5 months prior to the
Screening Visit for cyclophosphamide). Hydroxychloroquine or chloroquine are permitted
if dose has been stable for at least 4 weeks before the screening visit.

- Use of systemic corticosteroids above 10 mg/day prednisone equivalent within 4 weeks
prior until last dose of study drug. Inhaled and topical corticosteroids are
permitted.

- Use of any biologic agent within 12 weeks or 5 half-lives, whichever is longer, of
screening.

- History of anti-CD20 B-cell depleting therapy, eg, rituximab or ocrelizumab within 6
months prior to screening visit.

- Use of anticoagulant or antiplatelet agent (aspirin =<350 mg daily is permitted).

- Clinically significant or predefined abnormalities in lab tests:

- Aspartate aminotransferase, Alanine aminotransferase or alkaline phosphatase
level >2.5*ULN;

- Total bilirubin >1.5*ULN (other than that due to known Gilbert's disease);

- Hemoglobin <5.0 mmol/L (9 g/dL), white blood cell count <2.5*10^9/L, or platelets
<100*10^9/L);

- International normalized ratio or partial thromboplastin time >2.0*ULN;

- Thyroid-stimulating hormone <0.01 or >=7.1 milli international units per litre
(mIU/L).

- Inability to receive IV infusions.

- History of alcohol/drug abuse for 1 year prior screening.

- Pregnancy/breastfeeding/lactation within 3 months prior screening.

- History of thrombotic, thromboembolic, or abnormal bleeding events including
concomitant antiphospholipid antibody syndrome. Subjects with known lupus
anticoagulant and/or anticardiolipin and/or anti-b2 glycoprotein antibodies alone
should not be excluded.

- Legal incapacity/limited legal capacity.

- Receipt/planned live/attenuated vaccination within 12 weeks prior screening until 3
months after last dose of study drug. Seasonal influenza vaccination with inactivated
vaccine formulation is permitted.

- Major surgery requiring hospitalization within 4 weeks prior screening, planned major
surgery for the duration of the trial. Subjects with lung resection.

- History of/planned major organ or hematopoietic stem cell/marrow transplant.

- Severe gastrointestinal disease requiring parenteral nutrition. Other protocol defined
exclusion criteria could apply.