Actively Recruiting
Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis
Led by Hospital for Special Surgery, New York · Updated on 2026-03-27
30
Participants Needed
1
Research Sites
361 weeks
Total Duration
On this page
Sponsors
H
Hospital for Special Surgery, New York
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a 52 week, single center, randomized, double-blind, placebo-controlled study. After patients maintain a stable dose of Mycophenolate Mofetil (MMF) for at least 1 month, they will be randomized to treatment with either Belimumab \& Rituximab or placebo.Patients in both groups will be on background MMF for the entirety of the study. Belimumab will be administered subcutaneously and Rituximab intravenously. Placebo injections and infusions will be of normal saline. Randomization will be done in a 2:1 manner to favor the treatment group. It is hypothesized that that Rituximab and Belimumab combination therapy with Mycophenolate Mofetil background therapy will improve fibrosis in SSc skin when compared to treatment with placebo and Mycophenolate Mofetil in a group of patients with early dcSSc.
CONDITIONS
Official Title
Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Diagnosed with systemic sclerosis as defined by 2013 classification criteria
- Diagnosis of diffuse cutaneous systemic sclerosis (dcSSc)
- Disease duration of 3 years or less since first non-Raynaud's symptom
- Modified Rodnan Skin Score (mRSS) greater than 14
You will not qualify if you...
- Unable to provide informed consent
- Disease duration greater than 3 years
- Mixed connective tissue disease or overlap unless dcSSc is dominant
- Limited scleroderma
- Systemic sclerosis-like illness caused by environmental or ingested agents
- Use of anti-fibrotic agents like colchicine, D-penicillamine, or tyrosine kinase inhibitors within 1 month prior
- Corticosteroid use exceeding prednisone 10 mg daily within prior month
- Serious medical conditions such as uncontrollable heart failure, arrhythmia, severe hypertension, severe gastrointestinal issues, liver impairment, high creatinine, active infection, severe diabetes, unstable cardiovascular disease, malignancy, HIV, or severe peripheral vascular disease
- Positive pregnancy test or unwillingness to use effective contraception
- Breastfeeding
- Participation in another investigational drug study within 90 days
- Severe lung disease with DLCO less than 30% or FVC less than 45%
- Grade 3 hypogammaglobulinemia
- Significant IgG deficiency (less than 400 mg/dL)
- IgA deficiency (less than 10 mg/dL)
- Positive HIV test
- Low neutrophil count (less than 1.5 x 10^9/L)
- Evidence of current or past Hepatitis B or positive Hepatitis C antibody
- Active or recent serious infections or chronic infection requiring suppressive therapy
- Prior use of Belimumab, Rituximab, or other B-cell depleting therapies
- Recent use of biologic therapies within specified washout periods
- Significant suicide risk
- Recent drug or alcohol abuse
- History of severe allergic reaction to contrast agents or monoclonal antibodies
- Live vaccines within 30 days prior
- History of malignant neoplasm within 5 years except certain treated skin or cervical cancers
- History of primary immunodeficiency
- Other significant medical or psychiatric conditions
- Non-English speakers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
Research Team
L
Liza Morales
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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