A Study to Investigate Long-term Safety and Tolerability of Frexalimab in Participants With Multiple Sclerosis
A Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Frexalimab in Participants With Multiple Sclerosis.
Study LTS18002 is a global, multicenter, open-label (OL), Phase 3, long-term safety and efficacy extension study.
The purpose of this study is to provide continued access to frexalimab for participants with MS, and to evaluate the long-term safety and efficacy profile of frexalimab. This study will monitor delayed AEs, assess the durability of safety findings and characterize any emerging safety signals that may develop over an extended follow up period.
Study details include:
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The study duration will be up to 4 years.
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The OL treatment duration will be up to 96 weeks (corresponding to approximately 2 years) per participant.
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There is an additional 24 weeks of safety follow up from the last dose of OL frexalimab for all participants (safety follow-up period/EOS: 4, 12 and 24 weeks after last investigational medicinal product(IMP) or OL frexalimab administration).
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The number of visits over the 2-year duration will be dependent on subgroup assignment which is based on parent study from which the participant has entered the LTS18002 :
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ACT16877, EFC17504, EFC18098, and ASY22814 participants
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Will have on-site visits every 12 weeks (9 visits)
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Additionally, there will be 16 on-site visits for OL frexalimab administration (Week 4, 8, 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, and 92) for all participants EXCEPT those entering from EFC18098 (frexalimab open label administration is conducted at home via SC large volume (OBDS VT) device)
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There will be 3 follow up visits beginning 4 weeks after the last administration of OL frexalimab
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Home administration is allowed for participants from ACT16877, based on Investigator judgement, participant/caregiver training and local availability. Home nurse services are mandatory for at-home administration.
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Home nurse services for at home administration may be considered for EFC17504 participants after Week 24 administration of OL frexalimab, based on availability. Participants that have initiated OL frexalimab via home administration during the parent study may continue to receive it in this manner.
- NOTE: For participants from EFC17504, all on-site visits including monthly IMP administrations will include safety labs (biochemistry, hematology liver chemistry, and immunoglobulins) and physical exams
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EFC17919A/B participants
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Will have on site visits every 12 weeks (9 visits)
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Will have a total of 16 visits for OL frexalimab administration (Week 4, 8, 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, and 92)
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Additionally, there will be up to 3 visits for administration of DB treatment (until results become available and randomization assignment availability).
- Home nurse services for at home administration may be considered for EFC17919A/B participants after Week 24 administration of OL frexalimab, based on availability.
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NOTE: all on-site visits including monthly IMP administrations will include safety labs (biochemistry, hematology liver chemistry, and immunoglobulins) and physical exams.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Trial Transparency email recommended (Toll free for US & Canada)
- 전화번호: option 6 800-633-1610
- 이메일: Contact-US@sanofi.com
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants with relapsing multiple sclerosis(RMS) or non-relapsing secondary progressive multiple sclerosis(nrSPMS) who completed, on IMP, the Phase 2 ACT16877 study, or one of the four Phase 3 frexalimab studies in MS indication (EFC17919A and EFC17919B, EFC17504, EFC18098), or planned Phase 2 biomarker ASY22814.
Exclusion Criteria:
- If IMP discontinuation criteria are met as per guidance
- The participant is at risk for or has a persistent chronic, active (including fever ≥38°C and clinically unstable), recurring systemic infection or opportunistic infections (eg, PML See Appendix in protocol) as judged by the Investigator.
- Notably low immunoglobulin G(IgG) levels, defined as a level that is 20% below the LLN, and/or notably low IgM level, defined as a level 10% below the LLN.
- Participants who developed clinically relevant cardiovascular, hepatic, endocrine, neuropsychiatric or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the extension study, as judged by the Investigator.
- Clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment.
- Continued need for/chronic use of a prohibited concomitant medication.
- Suicidal risk as per C-SSRS: if a participant scores "yes" on items 4 or 5 of the Suicidal Ideation Section, or "yes" on any item of the Suicidal Behavior Section.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Frexalimab SC (OL)
Participants will be administered frexalimab subcutaneous |
Pharmaceutical form:Solution for injection-Route of administration:SC
다른 이름들:
Pharmaceutical form:Solution for infusion-Route of administration:IV
다른 이름들:
Route of administration:IV |
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실험적: Frexalimab IV (OL)
Participants will be administered frexalimab intravenously |
Pharmaceutical form:Solution for injection-Route of administration:SC
다른 이름들:
Pharmaceutical form:Solution for infusion-Route of administration:IV
다른 이름들:
Route of administration:IV |
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실험적: Frexalimab (DB)
For EFC17919A/B parent study participants: at Opt-in visit participants will continue to be administered f rexalimab through unblinding visit. Participants will receive placebo tablet once daily until the unblinding visit. |
Pharmaceutical form:Solution for injection-Route of administration:SC
다른 이름들:
Pharmaceutical form:Solution for infusion-Route of administration:IV
다른 이름들:
Route of administration:IV Pharmaceutical form:Tablet-Route of administration:Oral Route of administration:oral Route of administration:oral |
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활성 비교기: Teriflunomide (DB)
For EFC17919A/B parent study participants: at Opt-in visit participants will continue to receive teriflunomide tablet. The placebo will be administered to participants at the same infusion rate and duration as for frexalimab from the opt-in visit until availability of results and unblinding. |
Route of administration:IV Route of administration:oral Route of administration:oral Pharmaceutical form:Solution for infusion-Route of administration:IV Pharmaceutical form:Tablet-Route of administration:Oral |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants with Adverse Events(AEs)
기간: up to to approximately 2.5 years since last participant in
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Number of participants with Adverse Events(AEs), serious adverse event(SAEs), AEs leading to permanent study intervention discontinuation, adverse event of special interest(AESIs), local tolerability, clinically significant abnormalities in laboratory tests, Columbia-Suicide Severity Rating Scale(C-SSRS) |
up to to approximately 2.5 years since last participant in
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participants from EFC17919A, EFC17919B, and EFC17504 studies only: time to onset of 6-month composite confirmed disability worsening(cCDW) for RMS or composite confirmed disability progression(cCDP) for nrSPMS
기간: up to to approximately 2.5 years since last participant in
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up to to approximately 2.5 years since last participant in
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Time to onset of individual components of the composite, confirmed over 3 months or 6 months EDSS for all prior study participants 9-HPT, T25FW test (participants rolling over from EFC17504, EFC17919A, and EFC17919B)
기간: up to to approximately 2.5 years since last participant in
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up to to approximately 2.5 years since last participant in
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Progression independent of relapse activity defined as the time to onset of 6-month cCDW
기간: up to to approximately 2.5 years since last participant in
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Progression independent of relapse activity defined as the time to onset of 6-month cCDW, defined by either no prior relapse or an onset more than 90 days after the start date of the last Investigator reported relapse (participants rolling over from EFC17919A and EFC17919B) |
up to to approximately 2.5 years since last participant in
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Number of new and/or enlarging T2-hyperintense lesions per year as detected by MRI
기간: up to to approximately 2.5 years since last participant in
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up to to approximately 2.5 years since last participant in
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Total number of new GdE T1 lesions per year as detected by MRI
기간: up to to approximately 2.5 years since last participant in
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up to to approximately 2.5 years since last participant in
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Change from baseline at scheduled visits in total volume of T2-hyperintense lesions as detected by brain MRI
기간: up to to approximately 2.5 years since last participant in
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up to to approximately 2.5 years since last participant in
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ARR assessed by confirmed protocol defined relapses
기간: up to to approximately 2.5 years since last participant in
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up to to approximately 2.5 years since last participant in
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antidrug antibodys(ADAs) incidence
기간: up to to approximately 2.5 years since last participant in
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up to to approximately 2.5 years since last participant in
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Change from baseline in serum immunoglobulin(Ig) levels
기간: up to to approximately 2.5 years since last participant in
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up to to approximately 2.5 years since last participant in
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- LTS18002
- 2026-525688-41 (레지스트리 식별자: CTIS)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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
미국 FDA 규제 기기 제품 연구
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