Fresolimumab In Systemic Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Lafyatis, Boston University
ClinicalTrials.gov Identifier:
NCT01284322
First received: January 25, 2011
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Diffuse Systemic Sclerosis
Drug: Fresolimumab
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: OPEN LABEL TRIAL OF ANTI-TGF-BETA MAB, FRESOLIMUMAB, IN SYSTEMIC SCLEROSIS - A PHASE ONE BIOMARKER TRIAL

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • To evaluate safety of fresolimumab in patients with scleroderma [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    TGF-beta regulated skin gene expression


Enrollment: 18
Study Start Date: January 2011
Study Completion Date: March 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fresolimumab Drug: Fresolimumab
intravenous fresolimumab 1mg/kg, first 8 patients; 5 mg/kg following 8 patients
Other Names:
  • GC1008
  • anti-TGF-beta

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284322

Locations
United States, Massachusetts
Boston University School of Medicine; Rheumatology/Arthritis Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Robert Lafyatis, MD Boston University
  More Information

No publications provided

Responsible Party: Robert Lafyatis, MD, Boston University
ClinicalTrials.gov Identifier: NCT01284322     History of Changes
Other Study ID Numbers: H30142
Study First Received: January 25, 2011
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Connective Tissue Diseases
Skin Diseases
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014