Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis

Systemic Sclerosis (also known as Scleroderma) is a chronic, autoimmune disease of the connective tissue generally classified as one of the rheumatic diseases. Systemic Sclerosis causes fibrosis (scar tissue) to be formed in the skin and internal organs. The fibrosis eventually causes the involved skin to harden, limiting mobility, and can also damage other organs. Excess Transforming Growth Factor Beta-1 (TGF-beta1) activity may result in the abnormal fibrosis characteristic of Systemic Sclerosis. An antibody against TGF-beta1 may modify pathologic processes characterized by inappropriate fibrosis. Genzyme Corporation is currently investigating a human monoclonal antibody (CAT-192) that neutralizes active TGF-beta1. This study is being conducted in the U.S. and Europe to evaluate the safety, tolerability, and pharmacokinetics of repeated treatments with CAT-192 in patients with early stage diffuse Systemic Sclerosis.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UCLA-Department of Medicine, Division of Rheumatology, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of diffuse systemic sclerosis
Duration of disease 18 months or less
Modified Rodnan Skin Score in a range as identified by the study protocol
Evidence of worsening disease activity
Ability to attend follow-up assessments for a minimum of 9 months
Agree to delay elective surgery during the trial and up to 9 months after final infusion
Agree to delay reproduction during the trial and up to 9 months after final infusion

Exclusion criteria

Women who are pregnant or lactating
Clinical evidence of other definable connective tissue or autoimmune disease
Severe kidney, heart, lung, or gastrointestinal disease
Treatment with protocol-specified immunosuppressants within 4 weeks of starting the clinical study
Treatment with systemic corticosteroids in a dose greater than 10 mg/day of prednisone or equivalent (inhaled steroids at standard doses are allowed)
Current treatment by photopheresis

Treatment and study plan

Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody

Drug

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Collaborators

Cambridge Antibody Technology

Registry information

Official study title

A Phase 1/2 Double Blind, Placebo Controlled, Randomized, Dose Ranging, Repeat Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CAT-192 Human Anti-TGF-Beta1 Monoclonal Antibody in Patients With Early Stage Diffuse Systemic Sclerosis

Important dates

Study completion: 2003
First posted: Aug 14, 2002
Registry last updated: Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed