A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Recruiting Phase 1 Interventional Study
Systemic Lupus Erythematosus (SLE) Rheumatoid Arthritis (RA)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
62 (estimated)
Sponsor
Sanofi · Industry
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About This Trial
This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The purpose of the study is to identify possible optimal dose(s) by assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenic…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Diagnosis of SLE and/or RA. American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria should be used. * Contraception during the study intervention period and for at least 140 days after the last administration of study intervent…
Contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610

Contact-US@sanofi.com

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