Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)

Summary

To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).

Timeline

Start

2014-06-04

Primary completion

2016-05-05

Completion

2016-09-14

Outcome

Missed primary endpoint

Stopped: “Study terminated per recommendation of iDMC. On iDMC request, protocol amended to include 4-month safety follow-up for patients after withdrawal of riociguat.”

registry p = 0.2074; LS mean difference 21.48 (95% CI -8.75 to 51.71); ANCOVA NCT02138825 ↗

paper Riociguat did not improve 6MWD versus placebo at 26 weeks (least-squares mean difference 21 m; 95% CI -9 to 52). PMID 31416769 ↗

Publications

• Nathan SD, Behr J, Collard HR, Cottin V, Hoeper MM, Martinez FJ, Corte TJ, Keogh AM, Leuchte H, Mogulkoc N, Ulrich S, Wuyts WA, Yao Z, Boateng F, Wells AU. Riociguat for idiopathic interstitial pneumonia-associated pulmonary hypertension (RISE-IIP): a randomised, placebo-controlled phase 2b study. Lancet Respir Med. 2019 Sep;7(9):780-790. doi: 10.1016/S2213-2600(19)30250-4. Epub 2019 Aug 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Riociguat	Other / unclassified	0.5 mg	—
Subject	Riociguat	Other / unclassified	1 mg	—
Subject	Riociguat	Other / unclassified	1.5 mg	—
Subject	Riociguat	Other / unclassified	2 mg	—
Subject	Riociguat	Other / unclassified	2.5 mg	—

Indications