QAX576 in Patients With Pulmonary Fibrosis Secondary to Systemic Sclerosis

NCT ID: NCT00581997

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the safety, tolerability, and mechanism of action of multiple doses of QAX576 in patients with pulmonary fibrosis secondary to systemic sclerosis

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Fibrosis Secondary to Systemic Sclerosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pulmonary fibrosis, systemic sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

QAX576

Group Type EXPERIMENTAL

QAX576

Intervention Type DRUG

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

QAX576

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men and women between the ages of 18 and 65 years with a confirmed diagnosis of pulmonary fibrosis secondary to systemic sclerosis
* Both men and women must be willing to use two forms of contraception. Additional information regarding this requirement is available at screening

Exclusion Criteria

* Certain medical conditions may exclude patients from participation.
* Should not have participated in another clinical study within 4 weeks of study start
* Smokers are not eligible for participation
* Blood loss of donation of 400 mL or more within 2 months of study start
* Pregnant women or women who are breast feeding
* Past medical history of clinically significant ECG abnormalities
* Connective tissue disorders other than systemic sclerosis.
* Active infection or history of systemic parasitic infection
* History of immunodeficiency diseases, including a positive HIV test result
* History of drug or alcohol abuse within 12 months of study start
* Any condition that may compromise patient safety
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: PRINCIPAL_INVESTIGATOR

Novartis Pharmaceuticals

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=14398

Results for CQAX576A2201 from the Novartis Clinical Trials website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CQAX576A2201

Identifier Type: -

Identifier Source: org_study_id