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A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases
Led by Sanofi · Updated on 2026-03-20
62
Participants Needed
8
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA) using ACR/EULAR criteria
- Use of contraception during the study and for at least 140 days after last dose; negative pregnancy test for females of childbearing potential
- For SLE: SLEDAI-2K score 65 with at least 4 clinical points, at least 1 BILAG A or B score, positive ANA (titer 651:80), positive autoantibodies (anti-dsDNA, anti-Ro, anti-La, or anti-Sm), inadequate response to glucocorticoids and one other therapy for at least 12 weeks
- For RA: moderate-to-severe disease activity (DAS28-CRP >3.2), inadequate response or intolerance to at least 2 DMARDs including one biologic or targeted synthetic DMARD, at least 6 tender and 6 swollen joints at screening
- Methotrexate treatment for at least 12 weeks at stable dose 6425 mg/week or stable conventional DMARDs for at least 28 days
- Compliance with folic acid when taking methotrexate
You will not qualify if you...
- Severe autoimmune disease manifestations affecting safety or investigational drug effects
- Recent use (within 28 days) or dose changes of high potency topical corticosteroids or nonsteroidal topical immunosuppressants
- Dose changes of certain immunosuppressive drugs within 28 days before Day 1
- Use of cyclophosphamide, leflunomide >20 mg/day, or abatacept within 6 months before Day 1
- Use of monoclonal antibodies or experimental immunomodulators within 28 days or 5 half-lives prior to Day 1
- Use of rituximab or other B cell depleting biologics within 6 months without B cell count recovery
- History of bone marrow or stem cell transplantation, lymphoid irradiation, CAR-T or T cell vaccination
- Known primary immunodeficiency, HIV infection, splenectomy, or conditions increasing infection risk
- History of hypersensitivity to monoclonal antibodies or immunoglobulin therapy
- Active or history of serious infections
- Surgery within 28 days prior to Day 1
- Abnormal ECG parameters after rest
- Significant uncontrolled diseases affecting compliance
- History or recent malignant disease except certain skin or cervical cancers
- High dose or recent change in antimalarial drugs
- Use or dose changes of systemic corticosteroids >20 mg/day within 28 days
- Documented liver disease including cirrhosis
- History or risk factors for hypercoagulation, thrombosis, or current anticoagulation
- For SLE: active severe neuropsychiatric SLE or biopsy-proven lupus nephritis or unexplained proteinuria at screening
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Investigational Site Number : 001-203
Brisbane, Queensland, Australia, 4151
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2
Investigational Site Number : 001-201
Melbourne, Victoria, Australia, 3004
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3
Investigational Site Number : 001-402
Mostar, Bosnia and Herzegovina, 88000
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4
Investigational Site Number : 001-401
Sarajevo, Bosnia and Herzegovina, 71000
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5
Investigational Site Number : 001-301
Auckland, New Zealand, 0622
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6
Investigational Site Number : 001-801
Pretoria, South Africa, 0002
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7
Investigational Site Number : 001-803
Pretoria, South Africa, 0184
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8
Investigational Site Number : 001-804
Vereeniging, South Africa, 1935
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Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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