Progression of fibrosing interstitial lung disease

Wong, Alyson W.; Ryerson, Christopher J.; Guler, Sabina A.

doi:10.1186/s12931-020-1296-3

Respiratory Research

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

From: Progression of fibrosing interstitial lung disease

Study	Patient population (sample size)	Treatment^a	1^o endpoint	Selected 2^o endpoints	Expected completion date
Antifibrotic medications
SLS III (Phase 2) NCT03221257	SSc-ILD (150)	Pirfenidone (added to MMF)	Change in FVC over 18 months	Change in DLCO, mRSS, QOL, Dyspnea	December 2021
Pirfenidone in SSc-ILD (Phase 3) NCT03856853	SSc-ILD (144)	Pirfenidone	Change in FVC over 52 weeks		February 2021
TRAIL1 (Phase 2) NCT02808871	RA-ILD (270)	Pirfenidone	Incidence of composite endpoint of FVC decline ≥10% or death over 52 weeks	Frequency of progressive fibrosis (FVC decline ≥ 10%, or 5–10% and DLCO decline ≥ 15%)	November 2021
PirFS NCT03260556	PF-sarcoidosis (60)	Pirfenidone	Time to clinical worsening over 24 months	Change in FVC and composite physiologic index	December 2019
Pirfenidone Fibrotic HP NCT02958917	Fibrotic HP (40)	Pirfenidone	Change in FVC over 52 weeks	Progression-free survival^b	December 2019
Pirfenidone in DM-ILD (Phase 3) NCT03857854	DM-ILD (152)	Pirfenidone	Change in FVC over 52 weeks		February 2021
Immunosuppressive medications
RECITAL (Phase 2–3) NCT01862926	CTD-ILD (116)	Rituximab versus CYC	Change in FVC over 48 weeks	Adverse events, change in DLCO and QOL	November 2020
Bortezomib and MMF in SSc-ILD (Phase 2) NCT02370693	SSc-ILD (30)	Bortezomib (added to standard of care immunosuppression)	Safety over 24 weeks	Change in FVC, mRSS, QOL	June 2020
EvER-ILD (Phase 3) NCT02990286	Idiopathic or CTD-associated NSIP (non-responders to first-line immunosuppression) (122)	Rituximab (added to standard of care immunosuppression)	Change in FVC over 6 months	Change in 6MWD, DLCO, dyspnea, cough	June 2020
ATtackMy-ILD (Phase 2) NCT03215927	Myositis associated ILD (20)	Abatacept (added to standard of care immunosuppression)	Change in FVC over 24 weeks	Progression-free survival^c and change in dyspnea	December 2020

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
^acompared to placebo unless otherwise stated
^btime to FVC %-predicted decline ≥5%, or 6MWD decline ≥50 m, or progression of fibrosis on HRCT, or acute exacerbation
^ctime to FVC%-predicted decline ≥10%, or ≥ 5% and DLCO %-predicted decline ≥15%, or death or lung transplantation

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ISSN: 1465-993X

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