From: Interstitial lung disease associated with systemic sclerosis (SSc-ILD)
Agent (company) | Type of molecule | Trial name (ClinicalTrial.gov identifier) | Population; sample size | Lung function endpoint/s | Estimated primary completion datea |
---|---|---|---|---|---|
Lanifibranor (Inventiva Pharma) | Peroxisome proliferator-activated receptor agonist | FASST (NCT02503644) | Patients with dcSSc; n = 132 | Changes from baseline in FVC % predicted and DLco % predicted at weeks 24 and 48 (secondary endpoints) | October 2017 |
Anabasum / lenabasum (Corbus Pharmaceuticals) |  | RESOLVE-1 (NCT03398837) | Patients with dcSSc; n = 354 | Change from baseline in FVC at week 53 (secondary endpoint) | March 2020 |
Riociguat (Bayer) | Guanylate cyclase stimulator | RISE-SSc (NCT02283762) | Patients with dcSSc; n = 121 | Change from baseline in FVC % predicted at week 52 (secondary endpoint) | October 2018 (actual) |
Tocilizumab (Hoffmann-La Roche) | Interleukin-6 receptor antagonist | focuSSced (NCT02453256) | Patients with SSc and mRSS of 10–35; n = 212 | Change from baseline in FVC at week 48 (secondary endpoint) | January 2018 (actual) |
Abatacept (Bristol-Myers Squibb) | Elective T-cell costimulation modulator | ASSET (NCT02161406) | Patients with dcSSc; n = 88 | Change from baseline in FVC % predicted at week 52 (secondary endpoint) | September 2018 |
Nintedanib (Boehringer Ingelheim) | Tyrosine kinase inhibitor | SENSCIS (NCT02597933) | Patients with SSc-ILD; n = 580 | Annual rate of decline in FVC (mL/year) over 52 weeks (primary endpoint) | October 2018 |
Ifetroban (Cumberland Pharmaceuticals) | Antagonist of thromboxane A2 / prostaglandin endoperoxide receptor | NCT02682511 | Patients with dcSSc (n = 14) or SSc-PAH (n = 20) | Changes from baseline in FVC and DLco at weeks 12, 26, 52 (secondary endpoints) | December 2019 |
Pirfenidone (Genentech) | Pyridone analogue | NCT03068234 | Patients with SSc; n = 72 | Secondary endpoints: • Changes from baseline in FVC and DLco at weeks 24 and 52 • Assessment of chest CT at weeks 24 and 52 | April 2019 |
Pirfenidone (Genentech) | Pyridone analogue | SLS III (NCT03221257) | Patients with SSc-ILD on background MMF; n = 150 | Changes from baseline at month 18 in: • FVC % predicted (primary endpoint) • DLco % predicted • Mahler Modified Transitional Dyspnoea Index • Total lung capacity (HRCT) • SGRQ total score | April 2021 |
Rituximab (study funded by UK Medical Research Council and National Institute for Health Research) | CD20-directed cytolytic antibody | RECITAL (NCT01862926) | Patients with CTD-ILD; n = 116 | Changes from baseline in FVC at week 24 (primary endpoint) and week 48 (secondary endpoint) | November 2019 |