NCT03287414 is a Phase 2 clinical trial of VAY736 in Idiopathic Pulmonary Fibrosis, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT03287414?

NCT03287414 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT03287414?

Interventions in NCT03287414: VAY736, Placebo, Standard of Care (SoC).

What condition does NCT03287414 study?

NCT03287414 studies Idiopathic Pulmonary Fibrosis.

Is NCT03287414 still recruiting?

NCT03287414 is currently terminated. Last updated 18 June 2024.

Are results published for NCT03287414?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-06-18 · How we verify

NCT03287414

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

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

Terminated Phase 2 Results posted Last updated 18 June 2024

What this trial tests

Phase 2 trial testing VAY736 in Idiopathic Pulmonary Fibrosis in 30 participants. Terminated before completion.

Timeline

20 December 2017

Primary endpoint
25 November 2020

14 February 2022

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	20 December 2017
Primary completion	25 November 2020
Estimated completion	14 February 2022
Sites	16 locations across Italy, Ireland, United Kingdom, Germany, Canada, United States

Drugs / interventions tested

VAY736 — full drug profile →
Placebo
Standard of Care (SoC) — full drug profile →

Conditions studied

Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

Novartis Pharmaceuticals — 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.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline to End of Treatment Epoch (48 Weeks of Treatment) in Forced Vital Capacity (FVC). Primary · From baseline up to 48 weeks post first dose of study treatment

FVC was defined as the maximum amount of air that an individual was able to forcibly exhale from his / her lungs after taking the deepest breath they could. Change from baseline to end of treatment epoch (48 weeks of treatment) in Forced Vital Capacity (FVC) was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseli

Group	Value	95% CI
VAY736	0.039	± 0.1116
Placebo	-0.023	± 0.0773

Percentage of Participants With All-cause Mortality Events Secondary · Up to 48 weeks post first dose of study treatment

All-cause mortality events were defined as deaths due to any cause. Kaplan-Meier estimates of the percentage of participants with the event of interest along with 80% two-sided confidence intervals using Greenwood's formula are provided.

Group	Value	95% CI
VAY736	8.3	2.39 – 26.92
Placebo	0	NA – NA

Percentage of Participants With Survival Idiopathic Pulmonary Fibrosis (IPF) -Related Mortality Events Secondary · Up to 48 weeks post first dose of study treatment

IPF-related mortality events were defined as deaths due to IPF related cause. Kaplan-Meier estimates of the percentage of participants with the event of interest along with 80% two-sided confidence intervals using Greenwood's formula are provided.

Group	Value	95% CI
VAY736	0	NA – NA
Placebo	0	NA – NA

Percentage of Participants With Progression-free Survival (PFS) Events Secondary · Up to 48 weeks post first dose of study treatment

PFS events were divided into: 1) PFS1 events including progression (relative reduction in FVC ≥ 10%) or death due to all causes, and 2) PFS2 events including progression (relative reduction in FVC ≥ 10%) or death due to IPF-related causes. Kaplan-Meier estimates of the percentage of participants with the event of interest (PFS1 events or PFS2 events) along with 80% two-sided confidence intervals using Greenwood's formula are provided.

PFS1

Group	Value	95% CI
VAY736	61.0	38.22 – 84.20
Placebo	31.9	18.04 – 52.51

PFS2

Group	Value	95% CI
VAY736	57.1	33.44 – 82.86
Placebo	31.9	18.04 – 52.51

Percentage of Participants With Disease Progression Events Secondary · Up to 48 weeks post first dose of study treatment

The following disease progression events were considered: a) relative reduction in FVC ≥ 10%; b) relative reduction in Diffusing Capacity of the Lungs (DLCO) ≥ 15%; c) absolute reduction in Six Minute Walk Distance (6MWD) ≥ 50 m. Kaplan-Meier estimates of the percentage of participants with the event of interest along with 80% two-sided confidence intervals using Greenwood's formula are provided.

FVC

Group	Value	95% CI
VAY736	57.1	33.44 – 82.86
Placebo	31.9	18.04 – 52.51

DLCO

Group	Value	95% CI
VAY736	73.8	46.56 – 94.24
Placebo	56.1	38.65 – 75.10

6MWD

Group	Value	95% CI
VAY736	38.3	19.96 – 64.88
Placebo	75.0	58.52 – 88.74

Percentage of Participants With Composite Events Secondary · Up to 48 weeks post first dose of study treatment

Composite events were defined as: 1) death (all-cause mortality), or relative reduction in FVC ≥ 10%, or relative reduction in DLCO ≥ 15%, or relative reduction in 6MWD ≥ 50 m (composite endpoint 1); and 2) Death (IPF-related mortality), or relative reduction in FVC ≥ 10%, or relative reduction in DLCO ≥ 15%, or relative reduction in 6MWD ≥ 50 m (composite endpoint 2). Kaplan-Meier estimates of the percentage of participants with the event of interest along with 80% two-sided confidence intervals using Greenwood's formula are provided.

Composite Endpoint 1

Group	Value	95% CI
VAY736	81.0	63.86 – 93.29
Placebo	66.3	50.84 – 81.18

Composite Endpoint 2

Group	Value	95% CI
VAY736	79.2	61.07 – 92.70
Placebo	66.3	50.84 – 81.18

Change From Baseline to End of Treatment Epoch (48 Weeks of Treatment) in Diffusing Capacity of the Lungs Secondary · From baseline up to 48 weeks post first dose of study treatment

DLCO is a measurement to assess the lungs' ability to transfer gas from inspired air to the bloodstream. DLCO was determined according to ATS guidelines. Change from baseline to end of treatment epoch (48 weeks of treatment) in diffusing capacity of the lung for carbon monoxide (DLCO) was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, tr

Group	Value	95% CI
VAY736	-1.954	± 1.0816
Placebo	-1.033	± 0.7244

Change From Baseline to the End of Treatment Epoch (48 Weeks of Treatment) in 6-minute Walk Distance (6MWD) Secondary · From baseline up to 48 weeks post first dose of study treatment

A standardized 6-minute walk test (6MWT) was performed in accordance with the guidelines of the American Thoracic Society 2002. The distance walked in six minutes (6MWD) was recorded. Change from baseline to end of treatment epoch (48 weeks of treatment) in 6MWD was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and ba

Group	Value	95% CI
VAY736	19.743	± 53.5268
Placebo	-12.479	± 28.9400

Change From Baseline to the End of Treatment Epoch (48 Weeks of Treatment) in Distance Saturation Product Secondary · From baseline up to 48 weeks post first dose of study treatment

Distance saturation product is the product of distance walked and lowest oxygen saturation during the 6-min walk test. Change from baseline to end of treatment epoch (48 weeks of treatment) in distance saturation product was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseline-by-visit as interaction terms. A po

Group	Value	95% CI
VAY736	9.746	± 52.2985
Placebo	-19.420	± 28.3755

Change From Baseline to the End of Treatment Epoch (48 Weeks of Treatment) in Resting Oxygen Saturation Level (on Room Air) Secondary · From baseline up to 48 weeks post first dose of study treatment

Change from baseline to end of treatment epoch (48 weeks of treatment) in resting oxygen saturation (on room air) was analyzed using a Mixed Effects Model for Repeated Measures (MMRM) and considering all assessments collected during the treatment epoch. The model included treatment and visit as fixed effects, standard of care treatment (Nintedanib, Pirfenidone, or no treatment) as factor and baseline value as a covariate, treatment-by-visit and baseline-by-visit as interaction terms. A positive change from baseline indicates improvement. Baseline was defined as the last available assessment pr

Group	Value	95% CI
VAY736	-0.117	± 1.0179
Placebo	-1.887	± 0.9415

Number of Participants With Positive Serum Anti-VAY736 Antibodies Secondary · Day 1, 29, 85, 169, 253 and 337

Number of participants with positive serum anti-VAY736 antibodies. A bridging ELISA method that is designed to detect the presence of anti-VAY736 antibodies in human serum was used.

Day 1

Group	Value	95% CI
VAY736	1
Placebo	3

Day 29

Group	Value	95% CI
VAY736	1
Placebo	2

Day 85

Group	Value	95% CI
VAY736	1
Placebo	1

Day 169

Group	Value	95% CI
VAY736	0
Placebo	2

Day 253

Group	Value	95% CI
VAY736	2
Placebo	1

Day 337

Group	Value	95% CI
VAY736	0
Placebo	0

Ctrough of VAY736 From the Serum Concentration-time Data Secondary · At pre-dose on Day 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309 and 337

The lowest serum concentration of VAY736 observed during a dosing interval at steady state (Ctrough) was determined

Day 1

Group	Value	95% CI
VAY736	0.00	± 0.000

Day 29

Group	Value	95% CI
VAY736	676.79	± 499.931

Day 57

Group	Value	95% CI
VAY736	779.89	± 645.363

Day 85

Group	Value	95% CI
VAY736	786.63	± 501.225

Day 113

Group	Value	95% CI
VAY736	771.88	± 623.268

Day 141

Group	Value	95% CI
VAY736	1316.05	± 877.240

Day 169

Group	Value	95% CI
VAY736	1019.00	± 587.097

Day 197

Group	Value	95% CI
VAY736	985.50	± 495.652

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline up to end of study, assessed up to approximately 2.4 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

VAY736

Serious: 5/13 (38%)

Deaths: 1/13

Placebo

Serious: 9/16 (56%)

Deaths: 0/16

Total

Serious: 14/29 (48%)

Deaths: 1/29

Serious adverse events (14 terms)

Reaction	System	VAY736	Placebo	Total
Pneumonia	Infections and infestations	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	—	—	—
Aortic valve incompetence	Cardiac disorders	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—
Retinal vein occlusion	Eye disorders	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—
Bronchitis	Infections and infestations	—	—	—
Lower respiratory tract infection	Infections and infestations	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—
Vasculitis	Vascular disorders	—	—	—

Other adverse events (119 terms — click to expand)

Reaction	System	VAY736	Placebo	Total
Injection site pruritus	General disorders	—	—	—
Weight decreased	Investigations	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Bronchitis	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Headache	Nervous system disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Fatigue	General disorders	—	—	—
Injection site erythema	General disorders	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Injection site bruising	General disorders	—	—	—
Lower respiratory tract infection	Infections and infestations	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—
Injection related reaction	Injury, poisoning and procedural complications	—	—	—
Sunburn	Injury, poisoning and procedural complications	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—
Monocyte count increased	Investigations	—	—	—
Urine protein/creatinine ratio increased	Investigations	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Hot flush	Vascular disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Eosinophilia	Blood and lymphatic system disorders	—	—	—
Aortic valve incompetence	Cardiac disorders	—	—	—
Arteriosclerosis coronary artery	Cardiac disorders	—	—	—
Palpitations	Cardiac disorders	—	—	—
Tachycardia	Cardiac disorders	—	—	—
Eustachian tube dysfunction	Ear and labyrinth disorders	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—
Cataract	Eye disorders	—	—	—
Corneal degeneration	Eye disorders	—	—	—

Most-reported serious reactions: Pneumonia, Myocardial infarction, Idiopathic pulmonary fibrosis, Aortic valve incompetence, Vertigo, Retinal vein occlusion, Pancreatitis, Bronchitis.

Data from ClinicalTrials.gov NCT03287414 adverse events section.

Sponsor's own description

The purpose of this study was to investigate the safety, tolerability and efficacy of VAY736 as potential therapy for the treatment of idiopathic pulmonary fibrosis (IPF).

Publications & conference data

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

Idiopathic pulmonary fibrosis: Disease mechanisms and drug development.
Spagnolo P, Kropski JA, Jones MG, Lee JS, et al · · 2021 · cited 448× · PMID 33359599 · DOI 10.1016/j.pharmthera.2020.107798
Targeting fibrosis, mechanisms and cilinical trials.
Zhao M, Wang L, Wang M, Zhou S, et al · · 2022 · cited 352× · PMID 35773269 · DOI 10.1038/s41392-022-01070-3
Regulatory Immune Cells in Idiopathic Pulmonary Fibrosis: Friends or Foes?
van Geffen C, Deißler A, Quante M, Renz H, et al · · 2021 · cited 65× · PMID 33995390 · DOI 10.3389/fimmu.2021.663203
Pulmonary fibrosis from molecular mechanisms to therapeutic interventions: lessons from post-COVID-19 patients.
Giacomelli C, Piccarducci R, Marchetti L, Romei C, et al · · 2021 · cited 48× · PMID 34687672 · DOI 10.1016/j.bcp.2021.114812
Research Progress in the Molecular Mechanisms, Therapeutic Targets, and Drug Development of Idiopathic Pulmonary Fibrosis.
Ma H, Wu X, Li Y, Xia Y. · · 2022 · cited 47× · PMID 35935869 · DOI 10.3389/fphar.2022.963054
Targeting Alveolar Repair in Idiopathic Pulmonary Fibrosis.
Ptasinski VA, Stegmayr J, Belvisi MG, Wagner DE, et al · · 2021 · cited 43× · PMID 34129811 · DOI 10.1165/rcmb.2020-0476tr
Prognosticating Outcomes in Interstitial Lung Disease by Mediastinal Lymph Node Assessment. An Observational Cohort Study with Independent Validation.
Adegunsoye A, Oldham JM, Bonham C, Hrusch C, et al · · 2019 · cited 40× · PMID 30216085 · DOI 10.1164/rccm.201804-0761oc
What have we learned from basic science studies on idiopathic pulmonary fibrosis?
Yanagihara T, Sato S, Upagupta C, Kolb M. · · 2019 · cited 37× · PMID 31511255 · DOI 10.1183/16000617.0029-2019

Verify or expand the search:

Other trials of VAY736

Trials testing the same drug.

NCT05349214 — Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome · Phase 3 · active not recruiting
NCT05350072 — Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome · Phase 3 · active not recruiting
NCT04903197 — Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lympho · Phase 1 · terminated
NCT03827798 — Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 2 · active not recruiting
NCT03656562 — Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients · Phase 2 · completed

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 Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet 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 NCT03287414 (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 Novartis Pharmaceuticals
Last refreshed: 18 June 2024

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/NCT03287414.

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