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New drug cocktail aims to halt scleroderma skin damage

NCT ID NCT03844061

First seen Apr 24, 2026 · Last updated Jun 20, 2026 · Updated 9 times

Summary

This study tests whether combining two immune-suppressing drugs, belimumab and rituximab, can improve skin fibrosis in people with early diffuse systemic sclerosis (a rare autoimmune disease that causes skin hardening). Thirty adults will receive either the drug combo or placebo, alongside standard treatment with mycophenolate mofetil, for 52 weeks. The main goal is to see if the combo improves a composite measure of disease activity and is safe.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Hospital for Special Surgery

    RECRUITING

    New York, New York, 10021, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

belimumab and rituximab (drugs that target the immune system)

What this could lead to

If it works, this combination could offer a new way to slow or improve skin fibrosis in early diffuse systemic sclerosis.

What could go wrong

This is a small, early-phase trial (30 people) with no guarantee of success. The drugs can cause serious infections and infusion reactions.

Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.