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RECRUITING
NCT06647069
PHASE1

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

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

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), immunogenicity, and preliminary clinical response of SAR448501/DR-0201. The study duration per participant will be a minimum of approximately 13 months, including a screening period of up to 28 days, a treatment period of 71 days, and a follow-up period of 42 weeks. If necessary, participants will continue to have visits after End of Study (EOS) every 4 weeks until peripheral blood B cells return to at least 80% of either the lower limit of normal (LLN) or the participant's baseline value.

Official title: A Phase 1, Open-label, Multiple Ascending Dose Basket Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Select Autoimmune Rheumatic Diseases

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2025-03-27

Completion Date

2029-06-25

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DRUG

SAR448501

Bispecific antibody

Locations (8)

Investigational Site Number : 001-203

Brisbane, Queensland, Australia

Investigational Site Number : 001-201

Melbourne, Victoria, Australia

Investigational Site Number : 001-402

Mostar, Bosnia and Herzegovina

Investigational Site Number : 001-401

Sarajevo, Bosnia and Herzegovina

Investigational Site Number : 001-301

Auckland, New Zealand

Investigational Site Number : 001-801

Pretoria, South Africa

Investigational Site Number : 001-803

Pretoria, South Africa

Investigational Site Number : 001-804

Vereeniging, South Africa