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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;