Fresolimumab In Systemic Sclerosis

Phase 1

Completed

• Conditions: Diffuse Systemic Sclerosis
• Interventions: Drug: Fresolimumab

• Registration Number: NCT01284322
• Lead Sponsor: Boston University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Primary Completion: 2013-06
• Study Completion: 2014-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fresolimumab	Fresolimumab	-

Primary Outcome Measures

Name	Time	Method
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.	7 weeks	TGF-beta regulated skin gene expression
To evaluate safety of fresolimumab in patients with scleroderma	24 weeks

Trial Locations

Locations (1)

Boston University School of Medicine; Rheumatology/Arthritis Center; 🇺🇸 Boston, Massachusetts, United States