재발성 다발성 경화증 환자에서 IMU-838의 효능, 안전성 및 내약성을 평가하기 위한 연구 (ENSURE-1)
재발성 다발성 경화증이 있는 성인(ENSURE-1)에서 IMU-838 대 위약의 효능, 안전성 및 내약성을 평가하기 위한 다기관, 무작위, 이중맹검 3상 연구
Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1)
연구 개요
상세 설명
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU-838 in adult patients with RMS. The study will consist of the following periods:
Screening Period: Approximately 28 days Main Treatment Period: Up to 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Tbilisi, 그루지야
- LTD Aversi Clinic
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Tbilisi, 그루지야, 0141
- 1st Uni Clinic of Tbilisi LEPL
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Tbilisi, 그루지야
- Eristavi Experimental Center
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Tbilisi, 그루지야
- J.S.C. Curatio Clinic
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Tbilisi, 그루지야
- Khechinashvili University Hospital
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Tbilisi, 그루지야
- LTD New Hospitals
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Tbilisi, 그루지야
- MediClub Georgia LLC
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Tbilisi, 그루지야
- Sarajishvili Neurology Institute
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Tbilisi, 그루지야
- JSC "Jerarsi"
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Tbilisi, 그루지야
- Pineo Medical Ecosystem LTD
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Münster, 독일, 48149
- University Hospital Muenster, Institute Translational Neurology dept. Neurology
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Barnaul, 러시아 제국, 656045
- City Hospital #5, Barnaul
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Barnaul, 러시아 제국, 656906
- Profimed LLC
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Bryansk, 러시아 제국, 241033
- Bryansk Regional Hospital 1
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Chelyabinsk, 러시아 제국, 454021
- Regional Clinical Hospital 3
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Krasnoyarsk, 러시아 제국, 660037
- Federal Siberian Scientific and Clinical Centre of Federal Medical and Biological Agency
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Kursk, 러시아 제국, 305007
- Kursk Regional Clinical Hospital
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Nizhny Novgorod, 러시아 제국, 603076
- Medis LLC
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Novosibirsk, 러시아 제국, 630004
- Sibneiromed LLC
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Novosibirsk, 러시아 제국, 630007
- SDMCH SDMC of FMBA of Russia
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Perm, 러시아 제국, 614045
- Perm State Medical University n.a. Acad. E. A. Vagner
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Samara, 러시아 제국, 443095
- Samara regional clinical hospital n. a. V. L. Seredavin
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Yekaterinburg, 러시아 제국, 620102
- Sverdlovsk Regional Clinical Hospital #1
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Beirut, 레바논
- Hotel Dieu de France Hospital
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Hamra, 레바논, 1107-2020
- AUB Medical Center
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Kaunas, 리투아니아, 50161
- Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos
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Culiacán, 멕시코, 80020
- Neurociencias Estudios Clínicos S.C
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Guadalajara, 멕시코, 44670
- Instituto Jalisciense de Metabolismo, SC
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Mexico City, 멕시코, 14050
- Unidad de Investigación en Salud de Chihuahua S.C.
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Mexico City, 멕시코
- Clinstile SA de CV
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Mexico City, 멕시코, 03310
- Grupo medico camino SC
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Mexico City, 멕시코, 06700
- Consultorio Médico Expert Brain Clinic
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Morelia, 멕시코, 58000
- Centro de Morelia
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Veracruz, 멕시코, 91900
- Sociedad de Metabolismo y Corazon, S.C.
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Veracruz, 멕시코, 91900
- Faicic de RL de CV
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Nikšić, 몬테네그로
- General Hospital Niksic
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Podgorica, 몬테네그로
- Clinical Center of Montenegro
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Chisinau, 몰도바
- Instititute of Emergency Medicine
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Chisinau, 몰도바
- Medico-Sanitary Public Institution, Institute of Neurology and Neurosurgery "Diomid Gherman"
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Chisinau, 몰도바
- The Diomid Gherman Institute of Neurology and Neurosurgery
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Arizona
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Phoenix, Arizona, 미국, 85004
- Xenoscience, Inc., 21st Century Neurology
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California
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West Hollywood, California, 미국, 90048
- Regina Berkovich MD, PhD Inc. MS Neurology
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Florida
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Bradenton, Florida, 미국, 34205
- Bradenton Research Center
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Naples, Florida, 미국, 34105
- Collier Neurologic Specialists
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Ormond Beach, Florida, 미국, 32174
- Neurology Associates of Ormond Beach
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Illinois
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Northbrook, Illinois, 미국, 60062
- Consultants in Neurology, Ltd
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Skopje, 북 마케도니아
- Hospital "8 mi Septemvri"
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Skopje, 북 마케도니아
- University Clinic of Neurology
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Blagoevgrad, 불가리아, 2700
- MHAT Puls AD
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Burgas, 불가리아, 8000
- MHAT "Heart and Brain", EAD
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Pleven, 불가리아, 5800
- MC Exacta Medica OOD
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Pleven, 불가리아, 5800
- MHAT Avis Medica
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Pleven, 불가리아, 5800
- UMHAT Dr.Georgi Stranski EAD
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Pleven, 불가리아
- Heart and Brain University Hospital
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Pleven, 불가리아
- MC Vita 1
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Plovdiv, 불가리아, 4002
- UMHAT Sveti Georgi
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Plovdiv, 불가리아, 4001
- UMHAT "Kaspela"EOOD
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Plovdiv, 불가리아, 4002
- UMHAT "Pulmed" Ltd
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Rousse, 불가리아
- UMHAT "Medica Ruse"
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Sofia, 불가리아, 1431
- UMHAT "Alexandrovska"
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Sofia, 불가리아, 1431
- UMHAT "Alexandrovska" EAD
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Sofia, 불가리아
- Military Medical Academy
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Sofia, 불가리아, 1606
- Military Medical Academy MHAT
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Sofia, 불가리아, 1000
- CCB Medical Institute Ministry of Interior
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Sofia, 불가리아, 1000
- Diagnostic and Consultative Center Neoclinic
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Sofia, 불가리아, 1000
- UMHAT "Sveti Ivan Rilski" EAD
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Sofia, 불가리아, 1113
- MHATNP "Sveti Naum", EAD
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Sofia, 불가리아, 1113
- MHATNPsy Sveti Naum EAD
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Sofia, 불가리아, 1618
- MHAT "Sveta Sofia" EOOD
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Sofia, 불가리아
- UMHAT"Tsaritsa Yoanna -ISUL
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Sofia, 불가리아
- UMHATEM N.Pirogov
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Varna, 불가리아
- UMHAT "Sveta Marina" EAD, First Clinic of Neurological Diseases
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Tirana, 알바니아, 1005
- Klinika Mjekesore Nuova, Neurology Clinic
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Tirana, 알바니아
- Hygeia Hospital Tirana
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Algiers, 알제리, 16000
- University Hospital Center Mustapha Pacha, Algiers
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Annaba, 알제리, 23000
- University Hospital Center Ibn Sina, Annaba
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Oran, 알제리, 31000
- University Hospital Center of Oran
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Amman, 요르단, 11942
- Jordan University Hospital
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Amman, 요르단, 11196
- Istiklal Hospital
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Amman, 요르단
- TSH Advanced Clinical Center
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Irbid, 요르단
- Irbid Speciality Hospital
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Chernihiv, 우크라이나, 14029
- Communal Non-Commercial Enterprise "Chernihiv Regional Hospital",Department of Neurology
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Chernivtsi, 우크라이나, 58023
- Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital"
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Chernivtsi, 우크라이나
- Chernihiv Regional Hospital
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Ivano-Frankivsk, 우크라이나, 76008
- Regional Clinical Hospital
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Ivano-Frankivsk, 우크라이나, 76493
- Neuro Global, LLC
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Khmelnytskyi, 우크라이나
- Khmelnytsky regional hospital of war veterans
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Kiev, 우크라이나
- Clinical Hospital #15 of the Podilskyi District of the Kyiv City
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Kyiv, 우크라이나, 3037
- "Medbud"
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Kyiv, 우크라이나, 4212
- SMART medical center
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Kyiv, 우크라이나
- Kyiv City Hospital 4
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Odesa, 우크라이나
- Odesa Regional Clinical Hospital, Department of Neurosurgery
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Poltava, 우크라이나
- Medical and diagnostic center of a LLC "Medcontinent", neurology and rehabilitation center
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Ternopil, 우크라이나, 46027
- Ternopil Psycho-Neuro Hospital
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Uzhhorod, 우크라이나
- Regional Clinical Center for Neurosurgery and Neurology
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Bangalore, 인도, 560092
- Medstar Speciality Hospital
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Mangalore, 인도, 575002
- Mallikatte, Kadri
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Nagpur, 인도
- Jasleen Hospital
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New Delhi, 인도, 110060
- Sir Ganga Ram Hospital
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Pune, 인도, 411001
- Ruby Hospital
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Shimla, 인도, 171006
- Atal Institute of Medical Super Specialities (AIMSS)
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Varanasi, 인도, 221005
- Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi
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Lublin, 폴란드, 20-064
- NZOZ Neuromed M. i M. Nastaj Sp. P.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Male or female patient (age ≥18 to ≤55 years).
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Patients with an established diagnosis of MS according to 2017 McDonald Criteria.
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Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014.
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Active disease as defined by Lublin 2014 evidenced prior to Screening by:
- At least 2 relapses in the last 24 months before randomization, or
- At least 1 relapse in the last 12 months before randomization, or
- A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior to randomization.
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Willingness and ability to comply with the protocol.
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Written informed consent given prior to any study-related procedure.
Exclusion Criteria:
- Patients with non-active secondary progressive MS and primary progressive MS.
- Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis.
- Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associated encephalomyelitis
- Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease)
- Use of experimental/investigational drug (with the exception ofCOVID-19 vaccines approved by emergency use authorization) and/or participation in drug clinical studies within 6 months prior to Screening
- Previous or current use of MS treatments lifelong, or within a pre-specified time period.
- Use of the pre-specified concomitant medications.
- Clinically significantly abnormal and pre-specified lab values.
- History of chronic systemic infections within 6 months before the date of informed consent.
- Diagnosis or suspected liver function impairment, which may cause fluctuating liver function tests during this study.
- Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis.
- History or clinical diagnosis of gout.
- History or presence of any major medical or psychiatric illness
- Substantial medical condition that could create undue risk to the patient, could affect adherence with the study protocol or could undesirably affect study outcomes
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: IMU-838
IMU-838 (vidofludimus calcium), a small molecule inhibitor of DHODH. Formulation: Tablets with 15 or 30 mg IMU-838 for once daily oral intake in the morning. |
Patients are randomized to IMU-838 or placebo in ratio 1:1
다른 이름들:
|
|
위약 비교기: Placebo
Matching placebo, as described for the test product, identical number of tablets as given for IMU-838. |
Patients are randomized to IMU-838 or placebo in ratio 1:1
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse
기간: 72 weeks
|
Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks. |
72 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Effect of IMU-838 versus placebo on volume of new T2 lesions
기간: 72 weeks
|
To evaluate the effect of IMU-838 versus placebo on volume of new T2 lesions. Mean difference between IMU-838- and placebo in changes of the volume of new MRI T2 lesions over 24-weeks of treatment in the double-blind period. |
72 weeks
|
|
Effect of IMU-838 versus placebo on disability progression
기간: 72 weeks
|
To evaluate the effect of IMU-838 versus placebo on disability progression. Survival analysis of time to 12-week confirmed disability progression, as measured on Expanded Disability Status Scale during the double-blind period, censored at maximum 72-weeks. |
72 weeks
|
|
Effect of IMU-838 versus placebo on cognitive performance
기간: 72 weeks
|
To evaluate the effect of IMU-838 versus placebo on cognitive performance. Survival analysis of time to confirmed clinically relevant changes on Symbol Digit Modalities Test during the double-blind period, censored at maximum 72-weeks. |
72 weeks
|
|
Effect of IMU-838 versus placebo on whole brain atrophy
기간: 72 weeks
|
To evaluate the effect of IMU-838 versus placebo on whole brain atrophy. Difference in the mean of the percentage change on the whole brain volume between IMU-838 and placebo during the 72-weeks double-blind period. |
72 weeks
|
|
Safety of IMU-838 versus placebo
기간: 72 weeks
|
To evaluate safety and tolerability of IMU-838 versus placebo by assessing rates of Treatment Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, changes in levels of pre-specified laboratory parameters, vital signs and ECG parameters and rates and reasons for study discontinuations. |
72 weeks
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Robert J. Fox, MD, Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- P3-IMU-838-RMS-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .