Multiple Sclerosis Clinical Trial

Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

Summary

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-2)

View Full Description

Full Description

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: 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or female patient (age ≥18 to ≤55 years).
Patients with an established diagnosis of MS according to 2017 McDonald Criteria.
Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014.

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.
Willingness and ability to comply with the protocol.
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 of COVID-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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1050

Study ID:

NCT05201638

Recruitment Status:

Recruiting

Sponsor:

Immunic AG

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There are 68 Locations for this study

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HonorHealth Research Institute - Bob Bove Neuroscience Institute
Scottsdale Arizona, 85251, United States More Info
Todd Levine, Dr.
Contact
Neuro of Central Florida
Altamonte Springs Florida, 32714, United States More Info
Alicia Cabrera, Dr.
Contact
Healthcare Innovations
Coral Springs Florida, 33067, United States More Info
Sonia Kalirao, Dr.
Contact
Homestead Associates
Miami Florida, 33032, United States More Info
Angel Carrasco, Dr.
Contact
Premier Clinical Research
Miami Florida, 33122, United States More Info
Diego Rielo, Dr.
Contact
Baptist Health Lexington
Nicholasville Kentucky, 40356, United States More Info
James Winkley, Dr.
Contact
Boston Clinical Trials
Boston Massachusetts, 02131, United States More Info
Deborah Green-LaRoche, Dr.
Contact
Heratsi Hospital Complex 1
Yerevan , 0025, Armenia More Info
Yekaterina Hovhannisyan, Dr.
Contact
Erebouni Medical Center
Yerevan , 0087, Armenia More Info
Nune Yeghiazaryan, Dr.
Contact
UCC of Rep of Srpska
Banja Luka , , Bosnia and Herzegovina More Info
Sanja Grgic, Prof.
Contact
Cantonal Hospital Bihac Dr. Irfan Ljubijankic
Bihać , 77000, Bosnia and Herzegovina More Info
Muhamed Lepuzanovic, Dr.
Contact
University Clinical Center of Sarajevo
Sarajevo , 71000, Bosnia and Herzegovina More Info
Admir Mehicevic, Dr.
Contact
University Clinical Center Sarajevo
Sarajevo , 71000, Bosnia and Herzegovina More Info
Enra Suljic, Dr.
Contact
University Clinical Center Tuzla
Tuzla , 75000, Bosnia and Herzegovina More Info
Aida Sehanovic, Dr.
Contact
Astra Clinic
Tallinn , , Estonia More Info
Katrin Gross-Paju, Dr.
Contact
Post-Graduation Institute of Medical Education and Research (PGIMER)
Chandigarh , 16001, India More Info
Dheeraj Khurana, Dr.
Contact
Fortis Memorial Research Institute
Gurugramam , 12200, India More Info
Praveen Gupta, Dr.
Contact
Dr Ram Manohar Lohia Institute of Medical Sciences
Lucknow , 22601, India More Info
Abdul Qavi, Dr.
Contact
All India Institute of Medical Sciences
New Delhi , 11002, India More Info
Manjari Triphathi, Dr.
Contact
GB Pant Institute of Postgraduate Medical Education and Research
New Delhi , 11005, India More Info
Debashish Chowdhury, Dr.
Contact
SRI Guru Ram Das Institute of Medical Sciences and Research
Punjabi Bagh , 14300, India More Info
Dinesh Kumar, Dr.
Contact
DKS PGI
Raipur , 49200, India More Info
Abhijeet Kohat, Dr.
Contact
Centro de Investig. Médicas
Lima , 15801, Peru More Info
Wenzel Duenas Pacheco, Dr.
Contact
NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"
Katowice , 40123, Poland More Info
Marek Smilowski, Dr.
Contact
Neuro-Medic Janusz Zbrojkiewicz
Katowice , 40686, Poland More Info
Janusz Zbrojkiewicz, Dr.
Contact
NZOZ Neuromed
Lublin , 20-06, Poland More Info
Marcin Nastaj, Dr.
Contact
Indywidualna Praktyka Lekarska prof. Konrad Rejdak
Lublin , 20-41, Poland More Info
Konrad Rejdak, Prof
Contact
Instytut Zdrowia Boczarska
Oświęcim , 32-60, Poland More Info
Magdalena Boczarska-Jedynak, Dr.
Contact
NZOZ Hertmanowskiej
Plewiska , 62-06, Poland More Info
Adriana Chelminiak, Dr.
Contact
NZOZ Neuro-Kard
Poznań , 61-85, Poland More Info
Jan Ilkowski, Dr.
Contact
Centrum Medyczne NeuroProtect
Warsaw , 01684, Poland More Info
Maciej Czarnecki, Dr.
Contact
FutureMeds Warszawa Centrum
Warsaw , , Poland More Info
Bartosz Otak, Dr.
Contact
Centrum Med. Ibismed
Zabrze , , Poland More Info
Monika Adamczyk-Sowa, Prof.
Contact
SC Sana Monitoring SRL
Bucharest , 01102, Romania More Info
Mirela Chiru, Dr.
Contact
Elias University Emergency Hospital
Bucharest , 01146, Romania More Info
Christina Panea, Dr.
Contact
Spitalul clinic CF Constanta
Constanţa , 90012, Romania More Info
Ana-Maria Ionescu, Dr.
Contact
Asociatia Comunitatea Oamenilor
Craiova , 20015, Romania More Info
Iuliu Trifan, Dr.
Contact
Clubul Sanatatii SRL
Câmpulung , 11510, Romania More Info
Emilian S. Manescu, Dr.
Contact
Aria Clinic SRL
Sibiu , 55005, Romania More Info
Catalin C. Mutu, Dr.
Contact
Neuro Therapy
Timişoara , 30042, Romania
Spit Jud Branzeu TIM Neuro
Timişoara , 30072, Romania More Info
Mihaela Simu, Prof.
Contact
Klinicko bolnicki centar Dr Dragisa Misovic - Dedinje
Belgrade , 11000, Serbia More Info
Dragana Kuljic Obradovic, Dr.
Contact
Klinicko bolnicki centar Zvezdara
Belgrade , 11000, Serbia More Info
Vera Cvijanovic, Dr.
Contact
Opsta bolnica Medicinski sistem Beograd
Belgrade , 11000, Serbia More Info
Miodrag Vujcic, Dr.
Contact
Vojnomedicinska akademija
Belgrade , 11000, Serbia More Info
Evica Dincic, Dr.
Contact
Univerzitetski Klinicki centar Kragujevac
Kragujevac , 34000, Serbia More Info
Tatjana Boskovic Matic, Prof.
Contact
Univerzitetski Klinicki centar Kragujevac
Kragujevac , 34000, Serbia More Info
Svetlana Miletic Drakulic, Dr.
Contact
Univerzitetski Klinicki centar Nis
Niš , 18000, Serbia More Info
Slobodan Vojinovic, Prof.
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Hsptl Sveti Vracevi
Novi Kneževac , , Serbia More Info
Jovana Stijovic, Dr.
Contact
General Hospital Uzice
Užice , 31000, Serbia More Info
Mira Gavric Kezic, Dr.
Contact
Klinicko Bolnicki centar Zemun
Zemun , 11080, Serbia More Info
Dusica Smiljanic-Miljkovic, Dr.
Contact
Opsta bolnica Djordje Jovanovic Zrenjanin
Zrenjanin , 23000, Serbia More Info
Julijana Filipov, Dr.
Contact
Acibadem Adana Hospital
Adana , 01130, Turkey More Info
Cem Ortacbayram, Dr.
Contact
Adana Baskent Hospital
Adana , 01250, Turkey More Info
Basak Karakurum Goksel, Prof.
Contact
Baskent University Ankara Hospital
Ankara , 06490, Turkey More Info
Munire Kilinc Toprak, Prof.
Contact
Bezmialem Vakif University Hospital
Istanbul , 34093, Turkey More Info
Gulsen Akman-Demir, Prof.
Contact
T.C. Ministry of Health Istanbul Haseki Training and Research Hospital
Istanbul , 34250, Turkey More Info
Belgin Balci, Prof.
Contact
Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital
Istanbul , 34785, Turkey More Info
Serkan Demir, Prof.
Contact
Marmara University Pendik Training and Research Hospital
Istanbul , 34899, Turkey More Info
Gulin Sunter, Prof
Contact
Haydar Pasa Num. EAH
Istanbul , , Turkey More Info
Recai Türkoğlu, Prof.
Contact
Kocaeli University Research and Application Hospital
Kocaeli , 41000, Turkey More Info
Husnu Efendi, Prof.
Contact
T.C. Ministry of Health Kutahya Provincial Directorate of Health Kutahya University of Health Sciences Evliya Celebi Training and Research Hospital
Kütahya , 43100, Turkey More Info
Sibel Canbaz Kabay, Prof.
Contact
Manisa Celal Bayar University Hafsa Sultan Hospital
Manisa , 45030, Turkey More Info
Hikmet Yilmaz, Prof.
Contact
19 Mayis University Medical Faculty Hospital Health Application and Research Center
Samsun , 55200, Turkey More Info
Murat Terzi, Prof.
Contact
Namik Kemal Uni Hospital
Tekirdağ , 59100, Turkey More Info
Aysun Ünal, Prof.
Contact
Zonguldak Bulent Ecevit University Health Practice and Research Hospital
Zonguldak , 67000, Turkey More Info
Bilge Piri Cinar, Prof.
Contact
Communal noncommercial enterprise "First Cherkasy City Hospital"
Cherkasy , 18009, Ukraine
MS Diagnosis Treatment Center
Cherkasy , , Ukraine More Info
Valentyna Drobotenko, Dr.
Contact
Chernihiv City Hospital 4
Chernihiv , , Ukraine More Info
Larysa Kadina, Dr.
Contact
Municipal Institution "Dnipropetrovsk Regional Rehabilitation Hospital" of Dnipropetrovsk Regional Council"
Dnipro , 49000, Ukraine More Info
Roman Khaitov, Dr.
Contact
Ukrainian State Research Institute of Medico-Social Problems of Disability
Dnipro , 49027, Ukraine
"University Clinic" of Dnipro State Medical University, Department of Neurology
Dnipro , 49038, Ukraine
Dnipro City Hospital 6
Dnipro , , Ukraine More Info
Larysa Zakharova, Dr.
Contact
Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1
Kremenchuk , 39623, Ukraine More Info
Iryna Piskunova, Dr.
Contact
State Institution "National Research Center for Radiation Medicine of the National Academy of Medical Sciences of Ukraine
Kyiv , 03115, Ukraine More Info
Olena Kolosynska, Prof.
Contact
1 Private Clinic Medical Center
Kyiv , , Ukraine More Info
Iryna Ihnatenko, Dr.
Contact
Dopomoga Plus medical center
Kyiv , , Ukraine
Volyn Reg Clin Hospital
Luts'k , 43005, Ukraine
Lviv Regional Central Hospital
Lviv , 79010, Ukraine
5 City Clin Hospital
Lviv , 79013, Ukraine
Communal institution "City Clinical Hospital №3" of Poltava City Council
Poltava , 36000, Ukraine More Info
Svetlana Ivashchenko, Dr.
Contact
City Clinical Hospital 2
Rivne , , Ukraine
Sumy Reg Clinical Hospital
Sumy , , Ukraine More Info
Oleksii Kmyta, Dr.
Contact
Salutem
Vinnytsia , 21018, Ukraine More Info
Sergii Moskovko, Dr.
Contact
LCC Medical center INET-09
Zaporizhzhya , 69001, Ukraine
Zaporizhia Med
Zaporizhzhya , , Ukraine
Zaporizhia Regional Clinic Hospital
Zaporizhzhya , , Ukraine
Zaporizhzhya City Hospital 6
Zaporizhzhya , , Ukraine
Zaporizhzhya Hospital 9
Zaporizhzhya , , Ukraine
Royal Devon Uni NHS
Exeter , EX2 5, United Kingdom More Info
Timothy Harrower, Dr.
Contact
Royal Hallamshire Hospital
Sheffield , , United Kingdom More Info
Azza Ismail, Dr.
Contact

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1050

Study ID:

NCT05201638

Recruitment Status:

Recruiting

Sponsor:


Immunic AG

How clear is this clinincal trial information?

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