Fresolimumab In Systemic Sclerosis

July 15, 2014 updated by: Robert Lafyatis, Boston University

OPEN LABEL TRIAL OF ANTI-TGF-BETA MAB, FRESOLIMUMAB, IN SYSTEMIC SCLEROSIS - A PHASE ONE BIOMARKER TRIAL

The purpose of this study is to determine if fresolimumab is safe in treating people with systemic sclerosis (scleroderma) and to investigate the effect of fresolimumab in the skin of these individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine; Rheumatology/Arthritis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet ACR criteria for diffuse systemic sclerosis
  • < 24 months since onset of first SSc manifestation other than Raynaud's phenomenon
  • Modified Rodnan Skin Score ≥ 15
  • Male or female adult ( ≥ 18 years of age)
  • Able and willing to give written informed consent and comply with study protocol

Exclusion Criteria:

  • Moderate or severe pulmonary disease w/ FVC < 80% or DLCO < 70% or ground glass and fibrosis > 20% of lung fields by HRCT
  • Treatment with investigational drug within 4 weeks of screening
  • Ongoing use of high dose steroids (> 10mg/day) or unstable steroid dose in past 4 weeks
  • Treatment with immunosuppressive, cytotoxic, or antifibrotic drug within 4 weeks of screening
  • Positive for HIV, HBV, and/or HCV
  • Known active infection (bacterial, viral, fungal, mycobacterial, or other); not including fungal infection of nail beds or any major infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening
  • Patients w/ history of malignancy or premalignant lesion
  • History of keratoacanthoma or squamous cell carcinoma
  • Moderate to severe hepatic impairment
  • SSc renal crisis within 6 months or creatinine > 2.0
  • Lack of IV access for medication administration
  • Moderate or severe cardiac disease with significant arrhythmia, heart failure, or unstable angina
  • Anemia (Hb < 8.5 gm/dL)
  • Thrombocytopenia or blood clotting disorder
  • Patients with organ transplant (including allogeneic bone marrow transplant)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fresolimumab
Drug: Fresolimumab
intravenous fresolimumab 1mg/kg, first 8 patients; 5 mg/kg following 8 patients
Other Names:
  • GC1008
  • anti-TGF-beta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate safety of fresolimumab in patients with scleroderma
Time Frame: 24 weeks
24 weeks
To investigate the effect of fresolimumab on TGF-beta responsive gene expression in skin after treatment with fresolimumab compared to pre-treatment TGF-beta responsive gene expression.
Time Frame: 7 weeks
TGF-beta regulated skin gene expression
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Investigators

  • Principal Investigator: Robert Lafyatis, MD, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 25, 2011

First Submitted That Met QC Criteria

January 26, 2011

First Posted (Estimate)

January 27, 2011

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H30142

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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