Fresolimumab In Systemic Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diffuse Systemic Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fresolimumab

Group Type EXPERIMENTAL

Fresolimumab

Intervention Type DRUG

intravenous fresolimumab 1mg/kg, first 8 patients; 5 mg/kg following 8 patients

Interventions

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Fresolimumab

intravenous fresolimumab 1mg/kg, first 8 patients; 5 mg/kg following 8 patients

Intervention Type DRUG

Other Intervention Names

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GC1008 anti-TGF-beta

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No