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Table 3 Ongoing randomized controlled trials investigating antifibrotic and immunosuppressive treatments in non-IPF ILD

From: Progression of fibrosing interstitial lung disease

StudyPatient population (sample size)Treatmenta1o endpointSelected 2o endpointsExpected completion date
Antifibrotic medications
 SLS III (Phase 2) NCT03221257SSc-ILD (150)Pirfenidone (added to MMF)Change in FVC over 18 monthsChange in DLCO, mRSS, QOL, DyspneaDecember 2021
 Pirfenidone in SSc-ILD (Phase 3) NCT03856853SSc-ILD (144)PirfenidoneChange in FVC over 52 weeks February 2021
 TRAIL1 (Phase 2) NCT02808871RA-ILD (270)PirfenidoneIncidence of composite endpoint of FVC decline ≥10% or death over 52 weeksFrequency of progressive fibrosis
(FVC decline ≥ 10%, or 5–10% and DLCO decline ≥ 15%)
November 2021
 PirFS NCT03260556PF-sarcoidosis (60)PirfenidoneTime to clinical worsening over 24 monthsChange in FVC and composite physiologic indexDecember 2019
 Pirfenidone Fibrotic HP NCT02958917Fibrotic HP (40)PirfenidoneChange in FVC over 52 weeksProgression-free survivalbDecember 2019
 Pirfenidone in DM-ILD (Phase 3) NCT03857854DM-ILD (152)PirfenidoneChange in FVC over 52 weeks February 2021
Immunosuppressive medications
 RECITAL (Phase 2–3) NCT01862926CTD-ILD (116)Rituximab versus CYCChange in FVC over 48 weeksAdverse events, change in DLCO and QOLNovember 2020
 Bortezomib and MMF in SSc-ILD (Phase 2) NCT02370693SSc-ILD (30)Bortezomib (added to standard of care immunosuppression)Safety over 24 weeksChange in FVC, mRSS, QOLJune 2020
 EvER-ILD (Phase 3) NCT02990286Idiopathic or CTD-associated NSIP (non-responders to first-line immunosuppression) (122)Rituximab (added to standard of care immunosuppression)Change in FVC over 6 monthsChange in 6MWD, DLCO, dyspnea, coughJune 2020
 ATtackMy-ILD (Phase 2) NCT03215927Myositis associated ILD (20)Abatacept (added to standard of care immunosuppression)Change in FVC over 24 weeksProgression-free survivalc and change in dyspneaDecember 2020
  1. Abbreviations: CTD connective tissue disease, CYC cyclophosphamide, DLCO diffusing capacity of the lungs for carbon monoxide, DM dermatomyositis, FVC forced vital capacity, HP hypersensitivity pneumonitis, HRCT high-resolution computed tomography, ILD interstitial lung disease, MMF mycophenolate mofetil, mRSS modified Rodnan skin score, NSIP idiopathic nonspecific interstitial pneumonia, QOL quality of life; SSc, systemic sclerosis, 6MWD 6-min walk distance
  2. acompared to placebo unless otherwise stated
  3. btime to FVC %-predicted decline ≥5%, or 6MWD decline ≥50 m, or progression of fibrosis on HRCT, or acute exacerbation
  4. ctime to FVC%-predicted decline ≥10%, or ≥ 5% and DLCO %-predicted decline ≥15%, or death or lung transplantation