NCT02648048 (ISLAND2) is a Phase 1 clinical trial of Pirfenidone in Idiopathic Pulmonary Fibrosis, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT02648048?

NCT02648048 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT02648048?

Interventions in NCT02648048: Pirfenidone, Vismodegib.

What condition does NCT02648048 study?

NCT02648048 studies Idiopathic Pulmonary Fibrosis.

Is NCT02648048 still recruiting?

NCT02648048 is currently completed. Last updated 30 October 2017.

Last reviewed 2017-10-30 · How we verify

NCT02648048: ISLAND2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis

Completed Phase 1 Last updated 30 October 2017

What this trial tests

Phase 1 trial testing Pirfenidone in Idiopathic Pulmonary Fibrosis in 21 participants. Completed in 30 November 2016.

Timeline

15 January 2016

Primary endpoint
30 November 2016

30 November 2016

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	15 January 2016
Primary completion	30 November 2016
Estimated completion	30 November 2016
Sites	15 locations across United States, Germany

Drugs / interventions tested

Pirfenidone — full drug profile →
Vismodegib (vismodegib) — full drug profile →

Conditions studied

Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 40 to 80, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (IPF) currently being treated with pirfenidone.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Idiopathic Pulmonary Fibrosis and Lung Cancer: Mechanisms and Molecular Targets.
Ballester B, Milara J, Cortijo J. · · 2019 · cited 243× · PMID 30704051 · DOI 10.3390/ijms20030593
Regeneration or Repair? The Role of Alveolar Epithelial Cells in the Pathogenesis of Idiopathic Pulmonary Fibrosis (IPF).
Confalonieri P, Volpe MC, Jacob J, Maiocchi S, et al · · 2022 · cited 106× · PMID 35805179 · DOI 10.3390/cells11132095
Emerging therapies for idiopathic pulmonary fibrosis, a progressive age-related disease.
Mora AL, Rojas M, Pardo A, Selman M. · · 2017 · cited 99× · PMID 29081515 · DOI 10.1038/nrd.2017.225
Sonidegib: mechanism of action, pharmacology, and clinical utility for advanced basal cell carcinomas.
Jain S, Song R, Xie J. · · 2017 · cited 72× · PMID 28352196 · DOI 10.2147/ott.s130910
Targeting GPCR Signaling for Idiopathic Pulmonary Fibrosis Therapies.
Haak AJ, Ducharme MT, Diaz Espinosa AM, Tschumperlin DJ. · · 2020 · cited 56× · PMID 32008852 · DOI 10.1016/j.tips.2019.12.008
Role of pirfenidone in the management of pulmonary fibrosis.
Meyer KC, Decker CA. · · 2017 · cited 46× · PMID 28435277 · DOI 10.2147/tcrm.s81141
Chaotic activation of developmental signalling pathways drives idiopathic pulmonary fibrosis.
Froidure A, Marchal-Duval E, Homps-Legrand M, Ghanem M, et al · · 2020 · cited 40× · PMID 33208483 · DOI 10.1183/16000617.0140-2019
New therapeutics based on emerging concepts in pulmonary fibrosis.
Sontake V, Gajjala PR, Kasam RK, Madala SK. · · 2019 · cited 32× · PMID 30468628 · DOI 10.1080/14728222.2019.1552262

Verify or expand the search:

Other trials of Pirfenidone

Trials testing the same drug.

NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in · Phase 2 · recruiting
NCT07082842 — Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF · Phase 3 · not yet recruiting
NCT07015398 — A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in · Phase 1 · completed
NCT06485635 — Real-life-persistence to Antifibrotic Treatments · completed
NCT06484153 — Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcin · Phase 1, PHASE2 · not yet recruiting

Other recruiting trials for Idiopathic Pulmonary Fibrosis

Currently open trials in the same condition.

NCT05988463 — Dose-Escalation Study of Artesunate Patients With IPF · Phase 1 · recruiting
NCT06241560 — A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in · Phase 2 · recruiting
NCT07407543 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Cauc · Phase 1 · recruiting
NCT07036523 — A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) · Phase 2 · recruiting
NCT07225296 — A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics o · Phase 1 · recruiting

Other Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02648048 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 30 October 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02648048.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing