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A study to evaluate SAR441566 efficacy and safety in adults with rheumatoid arthritis
EU CTIS ID: 2023-503910-60-00
What this study is testing
To demonstrate that SAR441566, a small molecule specific inhibitor of TNFR1 signaling compared to placebo, plus methotrexate (MTX), is effective in the treatment of moderate-to-severe rheumatoid arthritis (RA) with regards to American College of Rheumatology 20 (ACR20)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months duration
- Moderate-to-severely active RA, defined as: • persistently active disease >= 6 tender and >= 6 swollen joints • high sensitivity C-reactive protein ≥4 mg/L
- Continuous treatment with MTX for at least 12 consecutive weeks prior to randomization and with stable dose/means of administration at least 6 weeks prior to the screening visit. • MTX – 10 to 25 mg/week (or per local labeling requirements for the treatment of RA if the dose range differs) and folic/folinic acid (as part of MTX regimen).
- Inadequate clinical response to MTX at a dose of 10-25 mg/week after proper dose escalation according to local standards .
- BMI within the range [18 – 35] kg/m2 (inclusive)
You likely can't join if
- Immunologic disorder other than RA, with the exception of secondary Sjogren's syndrome associated with RA, and medically controlled diabetes or thyroid disorder as per Investigator's judgement.
- Use of parenteral glucocorticoids or intra-articular glucocorticoids within 4 weeks prior to screening.
- Initiation or change in dose for nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to screening.
- Any condition (other than RA) requiring oral, intravenous, IM, or intra-articular glucocorticoid therapy.
- Uncontrolled polymyalgia rheumatica or fibromyalgia.
- History of recurrent or recent serious infection (eg, pneumonia, septicemia) or infection(s) requiring hospitalization or treatment with IV anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1. Infections(s) requiring oral anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1.
See the full eligibility criteria
Who can join
- Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months duration
- Moderate-to-severely active RA, defined as: • persistently active disease >= 6 tender and >= 6 swollen joints • high sensitivity C-reactive protein ≥4 mg/L
- Continuous treatment with MTX for at least 12 consecutive weeks prior to randomization and with stable dose/means of administration at least 6 weeks prior to the screening visit. • MTX – 10 to 25 mg/week (or per local labeling requirements for the treatment of RA if the dose range differs) and folic/folinic acid (as part of MTX regimen).
- Inadequate clinical response to MTX at a dose of 10-25 mg/week after proper dose escalation according to local standards .
- BMI within the range [18 – 35] kg/m2 (inclusive)
What rules you out
- Immunologic disorder other than RA, with the exception of secondary Sjogren's syndrome associated with RA, and medically controlled diabetes or thyroid disorder as per Investigator's judgement.
- Use of parenteral glucocorticoids or intra-articular glucocorticoids within 4 weeks prior to screening.
- Initiation or change in dose for nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to screening.
- Any condition (other than RA) requiring oral, intravenous, IM, or intra-articular glucocorticoid therapy.
- Uncontrolled polymyalgia rheumatica or fibromyalgia.
- History of recurrent or recent serious infection (eg, pneumonia, septicemia) or infection(s) requiring hospitalization or treatment with IV anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1. Infections(s) requiring oral anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1.
- Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- History of moderate-to-severe congestive heart failure (NYHA Class III or IV), recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would put the participant at risk by participation in the protocol.
- History of solid organ transplant.
- History of alcohol or drug abuse within the past 2 years.
- History of diagnosis of demyelinating disease such as but not limited to: • Multiple Sclerosis, • Acute Disseminated Encephalomyelitis, • Balo’s Disease (Concentric Sclerosis), • Charcot-Marie-Tooth Disease, • Guillain-Barre Syndrome, • human T-lymphotropic virus 1 Associated Myelopathy, • Neuromyelitis Optica (Devic’s Disease).
- Planned surgery during the treatment period.
- Participants who are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care).
- Vaccination with live or live-attenuated virus vaccine within 3 months prior to screening or plan to receive one during the trial including at least 3 months after the last dose of study drug
- Any non-live vaccine (eg, COVID-19) within 14 days prior to randomization or plan to receive one during the trial.
- Participant with personal or family history of long QT syndrome.
- Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 5 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin.
- Previous or current use of biologic therapy or targeted synthetic disease modifying anti-rheumatic drugs (tsDMARD - such as JAK inhibitors) for RA.
- Use of oral glucocorticoid greater than prednisone 10 mg per day or equivalent per day, or a change in dosage within 4 weeks prior to screening. The dose of oral glucocorticoid must remain stable.
The study team makes the final eligibility decision.
Where it's taking place
- Mauritius
- Canada
- Georgia
- Brazil
- South Africa
- United States
- Japan
- India
- Chile
- Mexico
- Argentina
- China
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mauritius; Canada; Georgia; Brazil; South Africa; United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.