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Phase 1b/2 Study of IV Sarilumab in Adult With RA (OPALS)

9 de julio de 2026 actualizado por: Sanofi

A Randomized Open Label, Phase 1b/2 Study to Evaluate Intravenous Administration With Long Dosing Interval Regimens of Sarilumab in Adult Participants With Rheumatoid Arthritis

This is a Phase 1/Phase 2 study with:

  • 5-arms design for Part A;
  • and a single arm for Part B.

The purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 years of age or older.

Study details include:

  • The study duration will be up to 64 weeks.
  • The treatment duration will be up to 6 months for each study phase.

  • Part A has 10 visits, including a post-treatment end of study (EOS) follow-up visit.

    • For participants entering the open label extension to receive the approved 200 mg sarilumab every two weeks (Q2W) dose, there will be 3 additional study visits.
    • For the intra-study sarilumab 200 mg Q2W subcutaneous (SC) arm, participants will be evaluated over the course of 24 weeks plus post-treatment EOS follow-up visit following the schedule of activities (SoA) of Part A from Day -1 to Day 29 (total of 8 visits) and the SoA of Part B from Week 4 to Week 24 (total of 8 visits) and a post-treatment end of study (EOS) follow-up visit at Week 30 (Part B) for a total of 17 visits, including a post-treatment EOS follow-up visit.
  • Part B has 13 visits, including a post-treatment EOS follow-up visit.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

140

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Trial Transparency email recommended (Toll free for US & Canada)
  • Número de teléfono: option 6 800-633-1610
  • Correo electrónico: contact-us@sanofi.com

Ubicaciones de estudio

  • Estados Unidos
    • Florida
      • Hollywood, Florida, Estados Unidos, 33024
        • Reclutamiento
        • Encore Medical Research - Hollywood- Site Number : 8400010
    • Texas
      • Plano, Texas, Estados Unidos, 75023
        • Reclutamiento
        • ClinRx Research - Plano- Site Number : 8400015

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Participant must be 18 years old or the legal age of consent in the jurisdiction in which the study is taking place or older, at the time of signing the informed consent.
  • Diagnosis of RA, according to the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) 2010 RA Classification Criteria with ≥3 months disease duration.
  • ACR Class I to III functional status, based on the 1991 revised criteria
  • Moderate-to-severely active RA, defined as: DAS28-ESR>3.2.
  • Inability to continue treatment with a RA DMARD approved for first line use because of intolerance or inadequate response.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

  • Any prior (within the defined periods below) or concurrent use of immunosuppressive:

    • Janus kinase (JAK) inhibitor (eg, tofacitinib) within 4 weeks of baseline.
    • Cell-depletion agents (eg, anti CD20) without evidence of recovery of B cells to baseline level.
    • Anakinra within 1 week of baseline.
    • Abatacept within 8 weeks of baseline.
    • Tumor necrosis factor (TNF) inhibitors within 2 to 8 weeks.
    • Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline.
    • Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.
  • Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological IL-6 antagonist (prior IL-6 antagonist treatment that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline is not exclusionary).
  • Unstable methotrexate (MTX) dose (if participant is on concomitant MTX).
  • Concurrent use of systemic corticosteroids (CS) of more than 10 mg/day.
  • Pregnant or breastfeeding woman.
  • Exclusion related to tuberculosis (TB): active TB or a history of incompletely treated TB regardless of screening Quantiferon® result.
  • History of invasive opportunistic infections, including but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis despite resolution or John Cunningham virus (progressive multifocal leukoencephalopathy).
  • Uncontrolled diabetes mellitus.
  • History of prior articular or prosthetic joint infection.
  • Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the baseline visit.
  • History of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.
  • History of juvenile idiopathic arthritis or arthritis onset prior to age 16.
  • Severe systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Sarilumab 200 mg Q2W SC - Part A
Participants will receive Sarilumab 200 mg Q2W SC on Day 1 every 2 weeks for 24 weeks.
Droga: Sarilumab, SAR153191 SC

Pharmaceutical form:

solution for injection.

Route of administration: subcutaneous.

Otros nombres:
  • Kevzara®
Experimental: Sarilumab Dose Level 1 (DL1) IV - Part A
Participants will receive Sarilumab DL1 IV. Participants continuing in the open label extension (OLE) arm will receive Sarilumab 200 mg SC Q2W for an additional 20 weeks.
Droga: Sarilumab, SAR153191 SC

Pharmaceutical form:

solution for injection.

Route of administration: subcutaneous.

Otros nombres:
  • Kevzara®
Droga: Sarilumab, SAR153191 IV
Route of administration: intravenous.
Experimental: Sarilumab Dose Level 2 (DL2) IV - Part A
Participants will receive Sarilumab DL2 IV. Participants continuing in the open label extension (OLE) arm will receive Sarilumab 200 mg SC Q2W for an additional 20 weeks.
Droga: Sarilumab, SAR153191 SC

Pharmaceutical form:

solution for injection.

Route of administration: subcutaneous.

Otros nombres:
  • Kevzara®
Droga: Sarilumab, SAR153191 IV
Route of administration: intravenous.
Experimental: Sarilumab Dose Level 3 (DL3) IV - Part A
Participants will receive Sarilumab DL3 IV. Participants continuing in the open label extension (OLE) arm will receive Sarilumab 200 mg SC Q2W for an additional 20 weeks.
Droga: Sarilumab, SAR153191 SC

Pharmaceutical form:

solution for injection.

Route of administration: subcutaneous.

Otros nombres:
  • Kevzara®
Droga: Sarilumab, SAR153191 IV
Route of administration: intravenous.
Experimental: Sarilumab Dose Level 4 (DL4) IV - Part A
Participants will receive Sarilumab DL4 IV. Participants continuing in the open label extension (OLE) arm will receive Sarilumab 200 mg SC Q2W for an additional 20 weeks.
Droga: Sarilumab, SAR153191 SC

Pharmaceutical form:

solution for injection.

Route of administration: subcutaneous.

Otros nombres:
  • Kevzara®
Droga: Sarilumab, SAR153191 IV
Route of administration: intravenous.
Experimental: Selected Sarilumab IV Dose - Part B
Participants will receive Sarilumab selected dose IV.
Droga: Sarilumab, SAR153191 IV
Route of administration: intravenous.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part A: Assessment of Pharmacokinetic (PK) parameters of sarilumab in serum: area under the concentration-time curve [AUClast] for IV doses
Periodo de tiempo: from Baseline up to Week 6
Area under the concentration versus time curve from time zero to time corresponding to the last measurable concentration, tlast.
from Baseline up to Week 6
Part A: Assessment of PK parameters of sarilumab in serum: maximum concentration [Cmax] for IV doses
Periodo de tiempo: from Baseline up to Week 6
Maximum concentration observed.
from Baseline up to Week 6
Part B: Assessment of PK parameters of sarilumab in serum: plasma concentration at steady state (Ctrough ss)
Periodo de tiempo: from Baseline up to Week 30
Concentration observed before treatment administration during repeated dosing at steady state.
from Baseline up to Week 30

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part A: Proportion of participants who experienced adverse events (AEs): treatment-emergent adverse events (TEAEs) up to the post-treatment EOS follow-up visit included
Periodo de tiempo: From Baseline up to Week 32
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse events (TEAEs) are defined as AEs that developed, worsened or became serious during the treatment-emergent period.
From Baseline up to Week 32
Part A: Proportion of participants who experienced potentially clinically significant abnormalities (PCSA) in clinical laboratory evaluations, vital signs, and electrocardiogram (ECG) parameters
Periodo de tiempo: From Baseline up to Week 32

For laboratory variables (hematology, clinical biochemistry, urinalysis, serology and coagulation variables), the proportion of participants with at least 1 PCSA during the treatment-emergent period will be summarized.

For vital signs (heart rate, systolic and diastolic blood pressure, and temperature) and ECG variables (heart rate, PR, QRS, QT and QTcF intervals), the proportion of participants with at least 1 PCSA during the treatment-emergent period will be summarized.
From Baseline up to Week 32
Part A: Proportion of participants with injection site reactions (local tolerability assessments)
Periodo de tiempo: From Baseline up to Week 26
From Baseline up to Week 26
Part B: Assessment of PK parameters of sarilumab in serum: maximum peak plasma drug concentration at steady state (Cmax ss)
Periodo de tiempo: from Baseline up to Week 30
Maximum concentration observed at steady state.
from Baseline up to Week 30
Part B: Area under the curve for the defined interval between doses (TAU) at steady state (AUC0-tau ss)
Periodo de tiempo: from Baseline up to Week 30
Area under the concentration versus time curve calculated using the trapezoidal method during a dose interval (τ) at steady state.
from Baseline up to Week 30
Part B: Proportion of participants who experienced adverse events (AEs): treatment-emergent adverse events (TEAEs) up to the post-treatment EOS follow-up visit included
Periodo de tiempo: From Baseline up to Week 30
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse events (TEAEs) are defined as AEs that developed, worsened or became serious during the treatment-emergent period.
From Baseline up to Week 30
Part B: Proportion of participants who experienced potentially clinically significant abnormalities (PCSA) in clinical laboratory test evaluations, vital signs, and electrocardiogram (ECG) parameters
Periodo de tiempo: From Baseline up to Week 30

For laboratory variables (hematology, clinical biochemistry, urinalysis, serology and coagulation variables), the proportion of participants with at least 1 PCSA during the treatment-emergent period will be summarized.

For vital signs (heart rate, systolic and diastolic blood pressure, and temperature) and ECG variables (heart rate, PR, QRS, QT and QTcF intervals), the proportion of participants with at least 1 PCSA during the treatment-emergent period will be summarized.
From Baseline up to Week 30
Part B: Proportion of participants with injection site reactions (local tolerability assessments)
Periodo de tiempo: From Baseline up to Week 24
From Baseline up to Week 24

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sanofi

Colaboradores

Regeneron Pharmaceuticals

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de julio de 2026

Finalización primaria (Estimado)

26 de octubre de 2028

Finalización del estudio (Estimado)

26 de octubre de 2028

Fechas de registro del estudio

Enviado por primera vez

22 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de julio de 2026

Publicado por primera vez (Actual)

15 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • DRI19694
  • U1111-1337-1202 (Identificador de registro: ICTRP)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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