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

RECRUITINGPHASE1

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

NCT06647069•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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 intervention: Male participants must agree to refrain from donating or cryopreserving sperm, and either be abstinent or use contraception/barrier. Female participants must use of a highly effective contraceptive measure for all females of childbearing potential. Females of childbearing potential need to have a negative serum pregnancy test within 7 days prior to the first dose.
•Specific to Systemic Lupus Erythematosus (SLE):
•* Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score ≥8 at screening with at least 4 points from clinical features at screening.
•* At least 1 British Isles Lupus Assessment (BILAG) A score or 1 BILAG B score at screening
•* Positive ANA (titer ≥1:80) as documented in the participant's medical history
•* Positive for any of the following as documented in the participant's medical history: antidsDNA, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies
•* Inadequate response to systemic glucocorticoids and to at least 1 therapy other than antimalarials for at least 12 weeks including: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin.
•Specific to Rheumatoid Arthritis (RA):
•\-- Moderate-to-severe disease activity as defined by a 28-joint disease activity score using C reactive protein (DAS28-CRP) \>3.2 at screening.
+5 more criteria

Exclusion Criteria

•Severe manifestation of the selected autoimmune rheumatic diseases under study that could impact participant safety, or is likely to require interventions that will affect investigational drug PD.
•Receipt of super-high potency (eg, clobetasol propionate, betamethasone dipropionate) or high potency (eg, fluocinonide, methylprednisolone aceponate) topical corticosteroids within 28 days prior to screening, had dose changes in other topical corticosteroids within 14 days prior to Day 1, or had dose changes in nonsteroidal topical immunosuppressants within 28 days prior to Day 1.
•Received dose changes of mycophenolate mofetil, methotrexate, leflunomide, calcineurin inhibitors, JAK inhibitors, or azathioprine within 28 days prior to Day 1.
•Receipt of any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide \>20 mg/day, abatacept.
•Receipt of any mAb or experimental immunomodulator within 28 days or 5 published half-lives prior to Day 1, whichever is longer.
•Receipt of rituximab or other B cell depleting biologics within 6 months of Day 1.
•Receipt of rituximab or other B cell depleting biologics without return of CD19 or CD20 count to above the LLN.
•Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, CAR-T or T cell vaccination therapy.
•Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, positive result for HIV infection, splenectomy, or any underlying condition that predisposes the participant to infection.
•History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.
+13 more criteria

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

Key Dates

Start Date

March 27, 2025

Primary Completion Date

June 25, 2029

Completion Date

June 25, 2029

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

Interventions

SAR448501

DRUG

Contacts

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

CONTACT

800-633-1610 Contact-US@sanofi.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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