Fresolimumab In Systemic Sclerosis

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University
• Treatments: Antibodies, Monoclonal

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)