Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis
This study will investigate the safety and efficacy of VAY736 administered subcutaneously (s.c.) every 4 weeks for 48 weeks. Approximately, 84 subjects will be randomized in a 1:1 ratio on top of local standard of care (SOC), to receive VAY736 or placebo.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A subject-, investigator-, and sponsor-blinded
Primary Purpose: Treatment
Official Title: A Subject-, Investigator-, and Sponsor-blinded, Randomized, Placebo-controlled, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis
Actual Study Start Date: December 20, 2017
Estimated Primary Completion Date: December 3, 2021
Estimated Study Completion Date: September 8, 2023
Arms:
- Experimental: VAY736
- Placebo Comparator: Placebo
Category | Value |
---|---|
Date last updated at source | 2019-08-26 |
Study type(s) | Interventional |
Expected enrolment | 84 |
Study start date | 2017-12-20 |
Estimated primary completion date | 2021-12-03 |