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Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody

Phase 1

Systemic Sclerosis | Monoclonal antibody | Immunology |Sanofi|Trials Updated: Mar 5, 2015

Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2002

Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody target and mechanism

Molecular targetINSR
Target classAgonist
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody clinical trials

Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody · 1 trial · 2 indications

Phase 1 1
NCT00043706Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic SclerosisSystemic Sclerosis
COMPLETED- Analytics
PHASE1COMPLETED
Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis
Systemic SclerosisUnlock trial analytics

Study Design & Arms

PurposeTREATMENT

Interventions

NameTypeDescription
Human Anti-Transforming Growth Factor Beta-1 Monoclonal AntibodyDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

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 d...

Countries:United States
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Frequently asked questions about Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody

What is Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody?

Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody is an investigational monoclonal antibody developed by Sanofi for systemic sclerosis, also known as scleroderma. It was studied in early stage diffuse systemic sclerosis. The compound is also known by the code name CAT-192.

What is Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody used for?

It was studied for the treatment of early stage diffuse systemic sclerosis, a form of scleroderma. The single clinical trial enrolled patients with systemic sclerosis and scleroderma. It is an investigational agent and is not an approved therapy for this or any other indication.

Who makes Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody?

Sanofi, which trades under the ticker SNY, is the developer of Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody. The antibody is also identified by the code name CAT-192.

What phase is Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody in?

Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody is in Phase 1 development. Its only recorded trial, NCT00043706, is a completed Phase 1 study, and no active trials are ongoing. It is an investigational drug and has not been approved by the FDA.

What clinical trials is Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody in?

One clinical trial has evaluated Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody: NCT00043706, a completed Phase 1 study titled Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis. It was conducted in the United States in adults aged 18 years and older.

Is Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody the same as CAT-192?

Yes. CAT-192 is an alternative name for Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody. The Phase 1 trial NCT00043706 refers to the drug as CAT-192, so searches for either name refer to the same Sanofi monoclonal antibody candidate.