Fresolimumab In Systemic Sclerosis

Boston University

Status and phase

Completed

Phase 1

Conditions

Diffuse Systemic Sclerosis

Treatments

Drug: Fresolimumab

Study type

Interventional

Funder types

Other

Identifiers

NCT01284322

H30142

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)