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New antibody drug takes aim at autoimmune diseases

NCT ID NCT06647069

Recruiting now Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study tests a new drug called SAR448501 (DR-0201) in 62 adults with lupus or rheumatoid arthritis. The drug is a bispecific antibody designed to target the immune system. The main goal is to check safety and find the right dose, not yet to prove it works. Participants will be followed for about 13 months.

What this could mean

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

Active substance
SAR448501 (also called DR-0201), a bispecific antibody
What this could lead to
If it works, this could point toward a new treatment option for lupus and rheumatoid arthritis that targets the immune system more precisely.
What could go wrong
This is a very early Phase 1 trial with only 62 people, focused on safety and dosing. It may not show clear benefit, and side effects are unknown. Many early-stage drugs do not advance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

congenital lobar emphysema cutaneous lupus erythematosus dermatomyositis diffuse cutaneous systemic sclerosis polymyositis rheumatoid arthritis scleroderma Sjogren syndrome systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

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

CLE CUTANEOUS LUPUS DCSSC DERMATOMYOSITIS DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS POLYMYOSITIS PRIMARY SJÖGREN SYNDROME RHEUMATOID ARTHRITIS (RA) SCLERODERMA SJOGREN'S SYNDROME SLE SLE (SYSTEMIC LUPUS) SSC, DIFFUSE SCLEROSIS SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Investigational Site Number : 001-201

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Investigational Site Number : 001-203

    RECRUITING

    Brisbane, Queensland, 4151, Australia

  • Investigational Site Number : 001-301

    RECRUITING

    Auckland, 0622, New Zealand

  • Investigational Site Number : 001-401

    RECRUITING

    Sarajevo, 71000, Bosnia and Herzegovina

  • Investigational Site Number : 001-801

    RECRUITING

    Pretoria, 0002, South Africa

  • Investigational Site Number : 001-803

    RECRUITING

    Pretoria, 0184, South Africa

  • Investigational Site Number : 001-804

    RECRUITING

    Vereeniging, 1935, South Africa

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