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

2026년 7월 9일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

140

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Trial Transparency email recommended (Toll free for US & Canada)
  • 전화번호: option 6 800-633-1610
  • 이메일: contact-us@sanofi.com

연구 장소

  • 미국
    • Florida
      • Hollywood, Florida, 미국, 33024
        • 모병
        • Encore Medical Research - Hollywood- Site Number : 8400010
    • Texas
      • Plano, Texas, 미국, 75023
        • 모병
        • ClinRx Research - Plano- Site Number : 8400015

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Sarilumab 200 mg Q2W SC - Part A
Participants will receive Sarilumab 200 mg Q2W SC on Day 1 every 2 weeks for 24 weeks.
의약품: Sarilumab, SAR153191 SC

Pharmaceutical form:

solution for injection.

Route of administration: subcutaneous.

다른 이름들:
  • 케브자라®
실험적: 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.
의약품: Sarilumab, SAR153191 SC

Pharmaceutical form:

solution for injection.

Route of administration: subcutaneous.

다른 이름들:
  • 케브자라®
의약품: Sarilumab, SAR153191 IV
Route of administration: intravenous.
실험적: 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.
의약품: Sarilumab, SAR153191 SC

Pharmaceutical form:

solution for injection.

Route of administration: subcutaneous.

다른 이름들:
  • 케브자라®
의약품: Sarilumab, SAR153191 IV
Route of administration: intravenous.
실험적: 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.
의약품: Sarilumab, SAR153191 SC

Pharmaceutical form:

solution for injection.

Route of administration: subcutaneous.

다른 이름들:
  • 케브자라®
의약품: Sarilumab, SAR153191 IV
Route of administration: intravenous.
실험적: 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.
의약품: Sarilumab, SAR153191 SC

Pharmaceutical form:

solution for injection.

Route of administration: subcutaneous.

다른 이름들:
  • 케브자라®
의약품: Sarilumab, SAR153191 IV
Route of administration: intravenous.
실험적: Selected Sarilumab IV Dose - Part B
Participants will receive Sarilumab selected dose IV.
의약품: Sarilumab, SAR153191 IV
Route of administration: intravenous.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Part A: Assessment of Pharmacokinetic (PK) parameters of sarilumab in serum: area under the concentration-time curve [AUClast] for IV doses
기간: 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
기간: 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)
기간: from Baseline up to Week 30
Concentration observed before treatment administration during repeated dosing at steady state.
from Baseline up to Week 30

2차 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: From Baseline up to Week 24
From Baseline up to Week 24

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sanofi

협력자

Regeneron Pharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 2일

기본 완료 (추정된)

2028년 10월 26일

연구 완료 (추정된)

2028년 10월 26일

연구 등록 날짜

최초 제출

2026년 6월 22일

QC 기준을 충족하는 최초 제출

2026년 7월 9일

처음 게시됨 (실제)

2026년 7월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 9일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DRI19694
  • U1111-1337-1202 (레지스트리 식별자: ICTRP)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

류마티스 관절염에 대한 임상 시험

Sarilumab, SAR153191 SC에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Djibouti

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다