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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 80 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03287414
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, France, Germany, Ireland, Italy, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions

Arms

Experimental: VAY736

VAY736 administered subcutaneously (s.c.) every 4 weeks

Placebo Comparator: Placebo

Placebo administered subcutaneously (s.c.) every 4 weeks

Interventions

Drug: - VAY736

VAY736 administered subcutaneously (s.c.) every 4 weeks

Drug: - Placebo

Placebo administered s.c. every 4 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Novartis Investigative Site, Birmingham, Alabama

Status

Recruiting

Address

Novartis Investigative Site

Birmingham, Alabama, 35294-0007

Novartis Investigative Site, Los Angeles, California

Status

Recruiting

Address

Novartis Investigative Site

Los Angeles, California, 90095

Novartis Investigative Site, Aurora, Colorado

Status

Recruiting

Address

Novartis Investigative Site

Aurora, Colorado, 80045

Novartis Investigative Site, Miami, Florida

Status

Recruiting

Address

Novartis Investigative Site

Miami, Florida, 33136

Novartis Investigative Site, Chicago, Illinois

Status

Recruiting

Address

Novartis Investigative Site

Chicago, Illinois, 60637

Novartis Investigative Site, Baltimore, Maryland

Status

Recruiting

Address

Novartis Investigative Site

Baltimore, Maryland, 21224

Novartis Investigative Site, Boston, Massachusetts

Status

Recruiting

Address

Novartis Investigative Site

Boston, Massachusetts, 02115

Novartis Investigative Site, Saint Louis, Missouri

Status

Recruiting

Address

Novartis Investigative Site

Saint Louis, Missouri, 63110

Novartis Investigative Site, Lebanon, New Hampshire

Status

Recruiting

Address

Novartis Investigative Site

Lebanon, New Hampshire, 03756

Novartis Investigative Site, Durham, North Carolina

Status

Recruiting

Address

Novartis Investigative Site

Durham, North Carolina, 27710

Novartis Investigative Site, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15213

Novartis Investigative Site, Nashville, Tennessee

Status

Recruiting

Address

Novartis Investigative Site

Nashville, Tennessee, 37203

Novartis Investigative Site, Salt Lake City, Utah

Status

Recruiting

Address

Novartis Investigative Site

Salt Lake City, Utah, 84108

International Sites

Novartis Investigative Site, Calgary, Alberta, Canada

Status

Recruiting

Address

Novartis Investigative Site

Calgary, Alberta, T2N 2T9

Novartis Investigative Site, Quebec, Canada

Status

Recruiting

Address

Novartis Investigative Site

Quebec, , GIV 4G5

Novartis Investigative Site, Besancon Cedex, Doubs, France

Status

Recruiting

Address

Novartis Investigative Site

Besancon Cedex, Doubs, 25030

Novartis Investigative Site, Montpellier cedex 5, Herault, France

Status

Recruiting

Address

Novartis Investigative Site

Montpellier cedex 5, Herault, 34059

Novartis Investigative Site, Bobigny cedex, Seine Saint Denis, France

Status

Recruiting

Address

Novartis Investigative Site

Bobigny cedex, Seine Saint Denis, 93009

Novartis Investigative Site, Marseille, France

Status

Recruiting

Address

Novartis Investigative Site

Marseille, , 13015

Novartis Investigative Site, Paris, France

Status

Recruiting

Address

Novartis Investigative Site

Paris, , 75018

Novartis Investigative Site, Coswig, Germany

Status

Recruiting

Address

Novartis Investigative Site

Coswig, , 01640

Novartis Investigative Site, Hannover, Germany

Status

Recruiting

Address

Novartis Investigative Site

Hannover, , 30625

Novartis Investigative Site, Dublin, Ireland

Status

Active, not recruiting

Address

Novartis Investigative Site

Dublin, , DUBLIN 4

Novartis Investigative Site, Forli, Forli - Cesena, Italy

Status

Recruiting

Address

Novartis Investigative Site

Forli, Forli - Cesena, 47100

Novartis Investigative Site, Milano, MI, Italy

Status

Recruiting

Address

Novartis Investigative Site

Milano, MI, 20123

Novartis Investigative Site, Modena, Italy

Status

Recruiting

Address

Novartis Investigative Site

Modena, , 41124

Novartis Investigative Site, Roma, Italy

Status

Recruiting

Address

Novartis Investigative Site

Roma, , 00168

Novartis Investigative Site, Siena, Italy

Status

Recruiting

Address

Novartis Investigative Site

Siena, , 53100

Novartis Investigative Site, Cambridge, Cambridgeshire, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Cambridge, Cambridgeshire, CB23 3RE

Novartis Investigative Site, High Heaton, Newcastle Upon Tyne, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

High Heaton, Newcastle Upon Tyne, NE7 7DN

Novartis Investigative Site, Nottingham, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Nottingham, , NG5 1PB

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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