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STRATUS, a Phase II Study of Abituzumab in Patients with Systemic Sclerosis-associated Interstitial Lung Disease

Khanna, D; Tashkin, DP; Wells, AU; Seibold, JR; Wax, S; Vazquez-Mateo, C; Fleuranceau-Morel, P; ... Denton, CP; + view all (2021) STRATUS, a Phase II Study of Abituzumab in Patients with Systemic Sclerosis-associated Interstitial Lung Disease. The Journal of Rheumatology , 48 (8) pp. 1295-1298. 10.3899/jrheum.191365. Green open access

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Abstract

OBJECTIVE: To investigate the effects of abituzumab in systemic sclerosis-associated interstitial lung disease (SSc-ILD). METHODS: STRATUS was a Phase II, double-blind, parallel-group, multicenter trial (NCT02745145). Adults (≤75 years) with SSc-ILD on stable mycophenolate were randomized (2:2:1) to receive intravenous abituzumab 1500 mg, placebo, or abituzumab 500 mg every 4 weeks for 104 weeks. Primary endpoint: annual rate of change in absolute FVC. RESULTS: STRATUS was terminated prematurely due to slow enrolment (n=75 screened, n=24 randomized), precluding robust analysis of efficacy. Abituzumab was well-tolerated; no new safety signals were detected. CONCLUSION: Further investigation of abituzumab for treatment of SSc-ILD is required.

Type: Article
Title: STRATUS, a Phase II Study of Abituzumab in Patients with Systemic Sclerosis-associated Interstitial Lung Disease
Location: Canada
Open access status: An open access version is available from UCL Discovery
DOI: 10.3899/jrheum.191365
Publisher version: https://doi.org/10.3899/jrheum.191365
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: clinical trial, integrins, interstitial lung disease, systemic sclerosis
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inflammation
URI: https://discovery.ucl.ac.uk/id/eprint/10111583
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