Systemic SclerosisPhase 1/2NCT00043706
Safety, Tolerability, and Pharmacokinetics of CAT-192 (Human Anti-TGF-Beta1 Monoclonal Antibody) in Patients With Early Stage Diffuse Systemic Sclerosis
A Phase 1/2 study testing Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody in people with Systemic Sclerosis and Scleroderma, run by Genzyme, a Sanofi Company at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Sclerosis, Scleroderma
- What is being tested?
- Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Start not givento Sep 2003
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boston Medical Center
Boston, Massachusetts, 02118
University of Texas - Houston Medical School
Houston, Texas, 77030
UCLA-Department of Medicine, Division of Rheumatology
Los Angeles, California, 90095
UMDNJ Scleroderma Program
New Brunswick, New Jersey, 08903
About this study
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
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.
- Conditions
- Systemic Sclerosis, Scleroderma
- Being tested
- Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Anti-Transforming Growth Factor Beta-1 Monoclonal AntibodyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2002 (estimated)
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cambridge Antibody Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043706
- Sponsor's protocol ID
- ATGFB1-001-01
- Status last verified
- Mar 2015
- First submitted
- 12 Aug 2002
- Last updated
- 5 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00043706
- Acronym / sponsor ID
- ATGFB1-001-01
- Conditions
- Systemic Sclerosis, Scleroderma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Cambridge Antibody Technology
- Study completion
- Sep 2003 (actual)
- First posted
- 14 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody in people with Systemic Sclerosis and Scleroderma, run by Genzyme, a Sanofi Company at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.