A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)

Summary

This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter, exploratory Phase 2 study including participants with Idiopathic Pulmonary Fibrosis (IPF), investigating GLPG1205 in addition to the local standard of care (defined as receiving nintedanib, pirfenidone, or neither nintedanib nor pirfenidone).

Timeline

Start

2018-09-27

Primary completion

2020-07-21

Completion

2020-08-14

Outcome

Missed primary endpoint

registry analysis (superiority test); GLPG1205 100 mg vs Placebo; p = 0.495; Least square (LS) mean difference 42.33 (95% CI -81.84 to 166.49); NCT03725852 ↗

paper CONCLUSIONS: Treatment with GLPG1205 did not result in a significant difference in FVC decline versus placebo. PMID 36328358 ↗

Publications

• Background Strambu IR, Fagard L, Ford P, Van Der Aa T, De Haas-Amatsaleh A, Santermans E, Seemayer C. (2020). Idiopathic pulmonary fibrosis (IPF): observations from a Phase 2 trial of GLPG1205 (PINTA). Abstract for European Respiratory Society International Congress 7-9 September 2020.
• Strambu IR, Seemayer CA, Fagard LMA, Ford PA, Van der Aa TAK, de Haas-Amatsaleh AA, Modgill V, Santermans E, Sondag EN, Helmer EG, Maher TM, Costabel U, Cottin V. GLPG1205 for idiopathic pulmonary fibrosis: a phase 2 randomised placebo-controlled trial. Eur Respir J. 2023 Mar 2;61(3):2201794. doi: 10.1183/13993003.01794-2022. Print 2023 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GLPG1205	Small molecule	100 mg	Oral

Indications