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Monoclonal Antibodies

Belimumab + Rituximab for Systemic Sclerosis

Phase 2

Recruiting

Led By Robert Spiera, MD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of dcSSc, as defined by LeRoy and Medsger

Disease duration of less than or equal to 3 years as defined by the date of onset of the first non-Raynaud's symptom

Must not have

Disease duration of greater than 3 years

Systemic sclerosis-like illness associated with environmental or ingested agents such as toxic rapeseed oil, vinyl chloride, or bleomycin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Summary

This trial will test whether a combination of Belimumab & Rituximab, given on top of standard Mycophenolate Mofetil therapy, can improve fibrosis in early diffuse cutaneous systemic sclerosis (dcSSc) patients.

Who is the study for?

This trial is for adults aged 18-80 with early diffuse cutaneous systemic sclerosis (dcSSc), diagnosed within the last 3 years, and a modified Rodnan Skin Score over 14. Participants must not have used certain drugs like Belimumab or Rituximab before, be free from severe infections or lung disease, and agree to use effective contraception.

What is being tested?

The study tests if combining Belimumab and Rituximab improves skin fibrosis in dcSSc patients compared to placebo. All participants will continue their Mycophenolate Mofetil (MMF) treatment. The active drugs or placebos are given via subcutaneous injections and intravenous infusions over a year.

What are the potential side effects?

Potential side effects include allergic reactions to the medication components, infusion-related reactions such as fever or chills, possible increased risk of infections due to immune system suppression, fatigue, digestive issues, and blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with diffuse cutaneous systemic sclerosis.

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My first non-Raynaud's symptom appeared less than 3 years ago.

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I am between 18 and 80 years old.

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My condition is officially diagnosed as systemic sclerosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition has been diagnosed for over 3 years.

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My condition is linked to exposure to certain toxic substances.

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I have used Belimumab, Rituximab, or similar treatments before.

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I have severe lung disease requiring extra oxygen or have low lung function.

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I have a severe deficiency in my immune system's antibodies.

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I have not used specific biologic drugs within their required washout periods.

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I am on medication for a long-term infection like TB or herpes.

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I have had or currently have Hepatitis B.

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I have been diagnosed with limited scleroderma.

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I have not received any live vaccines in the last 30 days.

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I am unable to understand or sign the consent form.

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My main condition is diffuse systemic sclerosis, not mixed connective tissue disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy Outcome: Change in the ACR Revised CRISS at 12 months

Primary Safety Outcome: The proportion of participants who experience at least one Grade 3 or higher adverse event at or before 12 months

Secondary study objectives

Change in Clinical Disease Activity Index (CDAI): Measures joint tenderness and swelling

Change in Disease Activity Score 28 (DAS-28)

Change in FVC and DLCO

+15 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MMF + Rituximab + BelimumabExperimental Treatment3 Interventions

Two infusions of 1000 mg of Rituximab, two weeks apart, weekly subcutaneous injections of 200 mg of Belimumab, and background MMF, 1000 -1500 mg twice daily for 48 weeks.

Group II: MMF + Placebo + PlaceboPlacebo Group3 Interventions

Two placebo infusions of normal saline, two weeks apart, weekly saline placebo subcutaneous injections, and background MMF, 1000 -1500 mg twice daily for 48 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

MMF

2012

Completed Phase 4

~1580