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

• Status: Active, not recruiting
• Trial end date: 2022-10-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

1. A diagnosis of definite or probable IPF within 5 years of the screening visit, as defined by Figure 3, Tables 4-6 of the ATS/ERS/JRS/ALAT Diagnostic Guidelines (Raghu et al 2011)

2. FVC 40-90% predicted (inclusive)

3. DLCO, corrected for hemoglobin, 25-79% predicted (inclusive)

4. FEV1/FVC >70%

5. Unlikely to die from cause other than IPF within the next 3 years, in the opinion of the investigator

6. Unlikely to undergo lung transplantation during this trial

Exclusion Criteria:

1. Emphysema > fibrosis on screening HRCT (must be confirmed by central reader)

2. History of major organ, hematopoietic stem cell or bone marrow transplant

3. Clinically diagnosed AE-IPF or other significant clinical worsening within 3 months of randomization

4. New York Heart Association (NYHA) class III/IV Congestive Heart Failure (CHF), Ejection Fraction (EF) <25%

5. Current smoker

6. Prior use of any B-cell depleting therapy (e.g., rituximab, ofatumumab, or other anti-CD20 mAb, anti-CD40, anti-CD19,anti-CD22 mAb, anti-CD52 mAb, or anti-BAFF mAb)

Other protocol-defined inclusion/exclusion criteria may apply.