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Tests treatment safety and results for Systemic Lupus Erythematosus (SLE)
Official title A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases
ClinicalTrials.gov ID: NCT06647069
What this study is testing
What is SAR448501?
SAR448501 is an investigational medicine, being studied as a potential treatment for systemic lupus erythematosus (sle).
Also referred to as DR-0201.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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
You likely can't join if
- Severe manifestation of the selected autoimmune rheumatic diseases under study that could impact participant safety, or is likely to require...
- Receipt of super-high potency (eg, clobetasol propionate, betamethasone dipropionate) or high potency (eg, fluocinonide, methylprednisolone...
- Received dose changes of mycophenolate mofetil, methotrexate, leflunomide, calcineurin inhibitors, JAK inhibitors, or azathioprine within 28 days...
- 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.
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- If taking MTX, compliant with folic acid 1 mg daily or 5 mg weekly or greater in combination with MTX.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Brisbane, Queensland, Australia
- Melbourne, Victoria, Australia
- Sarajevo, Bosnia and Herzegovina
- Auckland, New Zealand
- Pretoria, South Africa
- Vereeniging, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brisbane, Queensland, Australia; Melbourne, Victoria, Australia; Sarajevo, Bosnia and Herzegovina; Auckland, New Zealand; Pretoria, South Africa; Vereeniging, South Africa. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.