Abituzumab in SSc-ILD

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Systemic Sclerosis-associated Interstitial Lung Disease

In brief

The purpose of this trial was to compare two doses of abituzumab with placebo and determine whether abituzumab was more effective, safer, would be better tolerated and could provoke better immune response than placebo in the treatment of participants with SSc-ILD who already receive constant doses of mycophenolate.

Key facts

Study ID

NCT02745145

Run by

EMD Serono Research & Development Institute, Inc.

People needed

24

Starts

2016-05-31

Expected to finish

2018-05-30

Last updated by the study team

2019-06-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants were eligible for this trial if they fulfill all of the following inclusion criteria:
• Female or male participants aged between 18 and 75 years of age who provide informed written consent.
• Participants 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.
• Participants who had 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 were met, then High-resolution computed tomography (HRCT) of lungs will be performed, and must show at least 5% fibrosis for participants to be eligible.
• Female participants 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 were defined as "All female participants after puberty unless they were post-menopausal for at least 2 years or weresurgically 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 were using oral contraceptives for birth control should employ an additional contraceptive method (for example, male or female barrier method).

You may not qualify if…

• 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 were 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.

Where it is running

• Research site — Los Angeles, California, United States
• Research site — Farmington, Connecticut, United States
• Research site — Washington D.C., District of Columbia, United States
• Research site — Orlando, Florida, United States
• Research site — Weston, Florida, United States
• Research site — Chicago, Illinois, United States
• Research site 1 — Boston, Massachusetts, United States
• Research site 2 — Boston, Massachusetts, United States
• Research site — Ann Arbor, Michigan, United States
• Research site — New Brunswick, New Jersey, United States
• Research site — Great Neck, New York, United States
• Research site 1 — New York, New York, United States
• Research site 2 — New York, New York, United States
• Research site — Portland, Oregon, United States
• Research site — Nashville, Tennessee, United States
• Research site — Dallas, Texas, United States
• Research site — Houston, Texas, United States
• Research site 1 — Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
• Research site 2 — Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
• Research site 3 — Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
• Research site — San Fernando, Buenos Aires, Argentina
• Research site — San Miguel de Tucumán, Tucumán Province, Argentina
• Research site — San Juan, Argentina
• Research site — Camperdown, New South Wales, Australia
• Research site 1 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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