RecruitingPhase 1NCT06647069

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

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


Sponsor

Sanofi

Enrollment

62 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing DR-0201, a new experimental drug, in patients with active autoimmune diseases including lupus (SLE or cutaneous lupus), primary Sjögren's syndrome, inflammatory muscle diseases (polymyositis/dermatomyositis), or early diffuse systemic sclerosis (a connective tissue disease affecting the skin and organs). **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with one of the following: lupus (SLE or CLE), primary Sjögren's syndrome, polymyositis/dermatomyositis, or diffuse systemic sclerosis diagnosed within the past 3 years - Your disease is active but stable, and your doctor does not expect your treatment to need changing for the next 3–4 months - You are willing to undergo tissue biopsies (skin, salivary gland, or muscle depending on your condition) - You are using effective contraception if of childbearing potential **You may NOT be eligible if...** - Your disease is not one of the specific diagnoses listed - You have lupus or cutaneous lupus with skin scores below the required threshold - You are not willing to undergo biopsies - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSAR448501

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

View Full Details on ClinicalTrials.gov

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NCT06647069


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