Resumen

This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include a run-in period (4 to 6 weeks) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.

Descripción detallada

The overall study duration for each participant will be approximately up to 149 days.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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/m\^2 (inclusive)

Criterios de exclusión

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
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.
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
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Ubicaciones

Investigational Site Number : 0320005

Berazategui, Buenos Aires, Argentina

Investigational Site Number : 0320004

Buenos Aires, Buenos Aires F.D., Argentina

Investigational Site Number : 0320001

Buenos Aires, Buenos Aires F.D., Argentina

Investigational Site Number : 0320003

Buenos Aires, Argentina

Investigational Site Number : 0320007

Buenos Aires, Argentina

Investigational Site Number : 0320006

Mar del Plata, Argentina

Investigational Site Number : 0320002

San Miguel de Tucumán, Argentina

Investigational Site Number : 0320002

San Miguel de Tucumán, Argentina

A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging, Efficacy and Safety Study of SAR441566 Plus Methotrexate in Adults With ModeratetoSevere Rheumatoid Arthritis

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

SAR441566

Placebo

Ubicaciones

Investigational Site Number : 0320005

Investigational Site Number : 0320004

Investigational Site Number : 0320001

Investigational Site Number : 0320003

Investigational Site Number : 0320007

Investigational Site Number : 0320006

Investigational Site Number : 0320002

Investigational Site Number : 0320002

Patrocinadores