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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2015
• Main ID: NCT00043706
• Date of registration: 12/08/2002
• Prospective Registration: No
• Primary sponsor: Genzyme, a Sanofi Company
• Public title: Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis
• Scientific 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
• Date of first enrolment: May 2002
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00043706
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Scleroderma

Intervention(s)

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

Secondary ID(s)

ATGFB1-001-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cambridge Antibody Technology