STRATUS ( SysTemic scleRosis AbiTUzumab Study )
Research type
Research Study
Full title
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)
IRAS ID
207606
Contact name
Christopher Denton
Contact email
Sponsor organisation
Merck KGaA
Eudract number
2015-005023-11
Duration of Study in the UK
4 years, 7 months, 30 days
Research summary
This is a phase II clinical research study to find out if the study drug, abituzumab is safe and effective in people who have systemic sclerosis (SSc)-associated interstitial lung disease (SSc-ILD). SSc is an autoimmune disease that can affect many organs, including the stomach, intestines, heart, and lungs. SSc-ILD involves damage to lung tissue and can cause difficulty breathing and worsening lung function.
Abituzumab is a monoclonal antibody. This means that it is an antibody that is active against a specific target in the body. Manufactured antibodies, such as abituzumab are made in a laboratory and used as medications that may help stop the development of fibrosis (progressive scarring) in the lungs of patients with SSc-ILD.
The study drug is given as an infusion (a drip into a vein in the arm) over the course of 1 hour. Patients will be assigned to one of three treatment groups by chance (like flipping a coin). They will receive either 1500 mg of study drug, 500 mg of study drug or placebo. For every five people in the study, two people will receive the 1500 mg dose, one person will receive the 500 mg dose, and two people will receive placebo. Patients will receive study drug or placebo on top of their treatment with mycophenolate. This is a double-blind study which means that neither the patient nor the study team will know whether they are receiving the study drug or placebo.
The maximum length of study per patient is up to 120 weeks which includes up to a 4 week screening period, treatment for 104 weeks and a 12 week follow-up period.
Study assessments include medical history, CT scan, electrocardiogram (ECG), tuberculosis assessment, blood and urine tests, physical examination, measurement of vital signs (including blood pressure, heart rate, body temperature), pulmonary function tests, study questionnaires and examination of skin and fingers.Approximately 175 patients worldwide will be recruited into this study which includes approximately 17 patients from the UK. The study is expected to finish in May 2021.
REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/1138
Date of REC Opinion
8 Jul 2016
REC opinion
Favourable Opinion