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Fresolimumab In Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT01284322
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Robert Lafyatis, Boston University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diffuse Systemic Sclerosis Drug: Fresolimumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OPEN LABEL TRIAL OF ANTI-TGF-BETA MAB, FRESOLIMUMAB, IN SYSTEMIC SCLEROSIS - A PHASE ONE BIOMARKER TRIAL
Study Start Date : January 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate safety of fresolimumab in patients with scleroderma [ Time Frame: 24 weeks ]
  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284322


Locations
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United States, Massachusetts
Boston University School of Medicine; Rheumatology/Arthritis Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
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Principal Investigator: Robert Lafyatis, MD Boston University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Robert Lafyatis, MD, Boston University
ClinicalTrials.gov Identifier: NCT01284322     History of Changes
Other Study ID Numbers: H30142
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
 Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs