Systemic Lupus Erythematosus (SLE)Phase 1NCT06647069
A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases
A Phase 1 study testing SAR448501 in people with Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA), run by Sanofi at 8 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA)
- What is being tested?
- SAR448501
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 27 Mar 2025to 25 Jun 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Inadequate response or intolerance to at least 2 disease-modifying antirheumatic drugs (DMARDs, at least 1 biologic [bDMARD] or targeted synthetic [tsDMARD]) after a minimum of 12 weeks treatment duration.
- At least 6 tender joints at screening.
- At least 6 swollen joints at screening.
- Methotrexate (MTX) for at least 12 consecutive weeks, and at a stable dose of ≤25 mg/week oral or SC since at least 4 weeks prior to randomization, OR - in case of MTX intolerance - conventional DMARDs at a stable dose for at least 28 days.
- If taking MTX, compliant with folic acid 1 mg daily or 5 mg weekly or greater in combination with MTX.
Who cannot join
- 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.
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- 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.
- Active infection or a history of serious infections as defined in the protocol.
- Surgery within 28 days prior to Day 1.
- 12-lead ECG parameters after 10 minutes resting in supine position NOT in the defined normal ranges.
- Evidence of significant, uncontrolled concurrent disease that could affect compliance with the study (eg, chronic obstructive pulmonary disease).
- Diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of basal cell or squamous epithelial carcinomas of the skin that have been resected or cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline.
- High dose of antimalarial or a change in dose within 28 days prior to Day 1.
- Receipt of systemic corticosteroids >20 mg/day (prednisone or equivalent) or had dose changes of systemic corticosteroids within 28 days prior to Day 1.
- Documented liver disease including documented diagnosis of cirrhosis.
- Participants with a history of hypercoagulation event or thrombosis (such as venous thromboembolism, pulmonary embolism, or stroke), or participants who have known hypercoagulation risk factors (including antiphospholipid syndrome), or participants currently on anticoagulation will be excluded.
- Specific to SLE:
- Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis at screening.
- Known biopsy-proven diagnosis of lupus nephritis (any class) or otherwise unexplained proteinuria (0.5g protein/24h; or urine protein/creatinine ratio >0.5g/g) at screening.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
8 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
8 sites in 5 countries
South Africa3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 001-801
Pretoria, 0002
Hendrihet van Rensburg, (+27)12 343 6844, hendrihet@emmed.co.za
(+27)82 4610031
- Recruiting
Investigational Site Number : 001-803
Pretoria, 0184
Salphy Mogashoa, +27 721974136, mokgadimogashoa@bothokebontle.co.za
- Recruiting
Investigational Site Number : 001-804
Vereeniging, 1935
Charnel Engelbrecht, +27 722743958, charnel.engelbrecht@ctcvaal.co.za
Georgia2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 268-003
Tbilisi, 0141
- Recruiting
Investigational Site Number : 268-001
Tbilisi, 0180
Australia1 site, 1 recruiting
- Recruiting
Investigational Site Number : 001-201
Melbourne, Victoria, 3004
Frances Burns, +613 9076 8592, dermtrials@alfred.org
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
Investigational Site Number : 001-401
Sarajevo, 71000
New Zealand1 site, 1 recruiting
- Recruiting
Investigational Site Number : 001-301
Auckland, 0622
Paul Hamilton, +64 800727669, DR-0201-AIM-001.Taka@momcr.co.nz
About this study
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
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.
- Being tested
- SAR448501
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR448501Drug
Also called DR-0201
Bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| SAR448501 dose escalation | Experimental | SAR448501 will be administered for up to 71 days. Different cohorts with up to 7 dose levels will be included. Receives: Drug: SAR448501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Baseline to Week 52 (End of Study (EOS))
Incidence of potentially clinically significant abnormalities (PCSAs)
PCSAs include laboratory parameters; vital signs; and ECG parameters including heart rate, PR, QRS, QT, QTcF.
Measured: Baseline to Week 52 (EOS)
Secondary outcomes (4)
Assessment of pharmacokinetic (PK) parameters: AUC0-t
Area under the plasma concentration versus time curve calculated using the trapezoidal method during a dosing interval (t)
Measured: Baseline to Week 20
Assessment of pharmacokinetic (PK) parameters: Cmax
Maximum observed plasma concentration
Measured: Baseline to Week 20
Assessment of pharmacokinetic (PK) parameters: Ctrough
Concentration observed before treatment administration during repeated dosing
Measured: Baseline to Week 20
Incidence of anti-drug antibodies (ADAs)
Incidence of ADAs against SAR448501/DR-0201
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start27 Mar 2025
- Primary completion25 Jun 2029 (estimated)
- Study completion25 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647069
- Sponsor's protocol ID
- DR-0201-AIM-001
- Other IDs
- DR0201AIM001, U1111-1328-5055
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org