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

Systemic Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043706
• Other study ID #: ATGFB1-001-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 12, 2002
• Last updated: March 4, 2015
• Est. completion date: September 2003

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	University of Texas - Houston Medical School	Houston	Texas
United States	UCLA—Department of Medicine, Division of Rheumatology	Los Angeles	California
United States	UMDNJ Scleroderma Program	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company	Cambridge Antibody Technology

Country where clinical trial is conducted

United States,