NCT01266135

Brief Summary

This study is designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of QAX576 in patients with idiopathic pulmonary fibrosis.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2010

Geographic Reach
2 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

December 19, 2020

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

December 17, 2010

Last Update Submit

December 11, 2020

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Interstitial Lung DiseaseUsual Interstitial PneumoniaFibrosis,Pulmonary Fibrosis,Respiratory Disease,Interstitial Lung Disease,Biological Therapy,Therapeutic Uses,

Outcome Measures

Primary Outcomes (3)

  • To evaluate the safety, tolerability, and effect on lung function of multiple intravenous doses of QAX576 in patients with IPF

    1 year

  • Change in forced vital capacity (FVC) at 52 weeks as compared to baseline

    Measure: FVC was measured using a spirometer according to American Thoracic Society / European Respiratory Society guidelines at screening and week 52 of the treatment period.

    1 year

  • Safety and tolerability of QAX576.

    Measure safety and tolerability as assessed by reported AEs and effects on routine laboratory evaluations.

    1 year

Secondary Outcomes (6)

  • To evaluate the effect of multiple intravenous doses of QAX576 on measures of clinical efficacy

    1 year

  • To determine the pharmacokinetics of of QAX576 by measuring concentrations of QAX576 in blood

    1 year

  • Time to clinical worsening:

    1 year

  • Exacerbation of IPF

    1 year

  • Progression of fibrosis

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Arm 1: QAX576 10 mg/kg

EXPERIMENTAL
Drug: QAX576

Arm 2: Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

QAX576DRUG

QAX576 10 mg/kg intravenous infusion

Arm 1: QAX576 10 mg/kg
PlaceboDRUG

Placebo to QAX576 intravenous infusion

Arm 2: Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF), based on an appropriate clinical definition of IPF as detailed in the ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management Diagnosis must be confirmed by a diagnostic HRCT or surgical lung biopsy.
  • A 6-minute walk test (6MWT) distance ≥50 meters at Screening (use of supplemental oxygen allowed).

You may not qualify if:

  • Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine levels in the range defined as 'smokers' per the local lab.
  • Lung residual volume \> 120% predicted at Screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Novartis Investigative Site

Gainesville, Florida, 32611, United States

Location

Novartis Investigative Site

Orlando, Florida, 32803, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02115, United States

Location

Novartis Investigative Site

Durham, North Carolina, 27710, United States

Location

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15219, United States

Location

Novartis Investigative Site

Nashville, Tennessee, 37203, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78229, United States

Location

Novartis Investigative Site

Cambridge, CB2 2QQ, United Kingdom

Location

Novartis Investigative Site

Leicester, LE3 9QP, United Kingdom

Location

Novartis Investigative Site

London, SW3 6PH, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisLung Diseases, InterstitialFibrosisPulmonary FibrosisRespiration Disorders

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2010

First Posted

December 24, 2010

Study Start

December 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

December 19, 2020

Record last verified: 2015-04

Locations

US(7)GB(3)