Fresolimumab In Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01284322
• Date of registration: 25/01/2011
• Prospective Registration: No
• Primary sponsor: Boston University
• Public title: Fresolimumab In Systemic Sclerosis
• Scientific title: OPEN LABEL TRIAL OF ANTI-TGF-BETA MAB, FRESOLIMUMAB, IN SYSTEMIC SCLEROSIS - A PHASE ONE BIOMARKER TRIAL
• Date of first enrolment: January 2011
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01284322
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Robert Lafyatis, MD
• Affiliation: Boston University

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diffuse Systemic Sclerosis

Intervention(s)

Drug: Fresolimumab

Primary Outcome(s)

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]

To evaluate safety of fresolimumab in patients with scleroderma [Time Frame: 24 weeks]

Secondary ID(s)

H30142

Source(s) of Monetary Support

Please refer to primary and secondary sponsors