ATGFB1-001-01: Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients with Early Stage Diffuse Systemic Sclerosis

This study has been completed.

Sponsored By:	Genzyme Cambridge Antibody Technology
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00043706

Purpose

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.

Condition	Intervention	Phase
Systemic Sclerosis Scleroderma	Drug: Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody	Phase I, Phase II

Study Type: Interventional

Study Design: Treatment

Official 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

Eligibility

Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both

Criteria

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

Location Information

California
UCLA—Department of Medicine, Division of Rheumatology, Los Angeles, California, 90095, United States

Massachusetts
Boston Medical Center, Boston, Massachusetts, 02118, United States

New Jersey
UMDNJ Scleroderma Program, New Brunswick, New Jersey, 08903, United States

Texas
University of Texas - Houston Medical School, Houston, Texas, 77030, United States

More Information

Study ID Numbers: ATGFB1-001-01
ClinicalTrials.gov Identifier: NCT00043706
Health Authority: United States: Food and Drug Administration