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Clinical trial

Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis

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Last updated:20th Dec 2017
Identifier: NCT03287414

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

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