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Table 1 Ongoing and recently completed Phase II/III randomized controlled trials of potential treatments for SSc-ILD listed on ClinicalTrials.gov

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
  1. aAccording to ClinicalTrials.gov (accessed 12 November 2018)
  2. CRISS Combined Response Index in Diffuse Systemic Sclerosis, CTD-ILD connective tissue disease-associated interstitial lung disease;