A 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)

Who is this study for? Adults with relapsing multiple sclerosis
What treatments are being studied? IMU-838
Status: Recruiting
Location: See all (91) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
HonorHealth Research Institute - Bob Bove Neuroscience Institute
RECRUITING
Scottsdale
Florida
Neuro of Central Florida
RECRUITING
Altamonte Springs
Healthcare Innovations
RECRUITING
Coral Springs
Homestead Associates
RECRUITING
Miami
Premier Clinical Research
RECRUITING
Miami
Kentucky
Baptist Health Lexington
RECRUITING
Nicholasville
Massachusetts
Boston Clinical Trials
RECRUITING
Boston
Other Locations
Armenia
Erebouni Medical Center
RECRUITING
Yerevan
Heratsi Hospital Complex 1
RECRUITING
Yerevan
Bosnia and Herzegovina
UCC of Rep of Srpska
RECRUITING
Banja Luka
Cantonal Hospital Bihac Dr. Irfan Ljubijankic
RECRUITING
Bihać
University Clinical Center of Sarajevo
RECRUITING
Sarajevo
University Clinical Center Sarajevo
RECRUITING
Sarajevo
University Clinical Center Tuzla
RECRUITING
Tuzla
Estonia
Astra Clinic
RECRUITING
Tallinn
India
Post-Graduation Institute of Medical Education and Research (PGIMER)
RECRUITING
Chandigarh
Fortis Memorial Research Institute
RECRUITING
Gurugramam
Dr Ram Manohar Lohia Institute of Medical Sciences
RECRUITING
Lucknow
All India Institute of Medical Sciences
RECRUITING
New Delhi
GB Pant Institute of Postgraduate Medical Education and Research
RECRUITING
New Delhi
SRI Guru Ram Das Institute of Medical Sciences and Research
RECRUITING
Punjābi Bāgh
DKS PGI
RECRUITING
Raipur
Peru
Centro de Investig. Médicas
RECRUITING
Lima
Poland
Neuro-Medic Janusz Zbrojkiewicz
RECRUITING
Katowice
NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis
RECRUITING
Katowice
Indywidualna Praktyka Lekarska prof. Konrad Rejdak
RECRUITING
Lublin
NZOZ Neuromed
RECRUITING
Lublin
Instytut Zdrowia Boczarska
RECRUITING
Oświęcim
NZOZ Hertmanowskiej
RECRUITING
Plewiska
NZOZ Neuro-Kard
RECRUITING
Poznan
Centrum Medyczne NeuroProtect
RECRUITING
Warsaw
FutureMeds Warszawa Centrum
RECRUITING
Warsaw
Centrum Med. Ibismed
RECRUITING
Zabrze
Romania
Elias University Emergency Hospital
RECRUITING
Bucharest
SC Sana Monitoring SRL
RECRUITING
Bucharest
Clubul Sanatatii SRL
RECRUITING
Campulung Muscel
Spitalul clinic CF Constanta
RECRUITING
Constanța
Asociatia Comunitatea Oamenilor
RECRUITING
Craiova
Aria Clinic SRL
RECRUITING
Sibiu
Neuro Therapy
WITHDRAWN
Timișoara
Spit Jud Branzeu TIM Neuro
RECRUITING
Timișoara
Serbia
Klinicko bolnicki centar Dr Dragisa Misovic - Dedinje
RECRUITING
Belgrade
Klinicko bolnicki centar Zvezdara
RECRUITING
Belgrade
Opsta bolnica Medicinski sistem Beograd
RECRUITING
Belgrade
Vojnomedicinska akademija
RECRUITING
Belgrade
Univerzitetski Klinicki centar Kragujevac
RECRUITING
Kragujevac
Univerzitetski Klinicki centar Kragujevac
RECRUITING
Kragujevac
Univerzitetski Klinicki centar Nis
RECRUITING
Niš
Hsptl Sveti Vracevi
RECRUITING
Novi Kneževac
General Hospital Uzice
RECRUITING
Užice
Klinicko Bolnicki centar Zemun
RECRUITING
Zemun
Opsta bolnica Djordje Jovanovic Zrenjanin
RECRUITING
Zrenjanin
Turkey
Acibadem Adana Hospital
RECRUITING
Adana
Adana Baskent Hospital
RECRUITING
Adana
Baskent University Ankara Hospital
RECRUITING
Ankara
Bezmialem Vakif University Hospital
RECRUITING
Istanbul
Haydar Pasa Num. EAH
RECRUITING
Istanbul
Marmara University Pendik Training and Research Hospital
RECRUITING
Istanbul
Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital
RECRUITING
Istanbul
T.C. Ministry of Health Istanbul Haseki Training and Research Hospital
RECRUITING
Istanbul
Kocaeli University Research and Application Hospital
RECRUITING
Kocaeli
T.C. Ministry of Health Kutahya Provincial Directorate of Health Kutahya University of Health Sciences Evliya Celebi Training and Research Hospital
RECRUITING
Kütahya
Manisa Celal Bayar University Hafsa Sultan Hospital
RECRUITING
Manisa
19 Mayis University Medical Faculty Hospital Health Application and Research Center
RECRUITING
Samsun
Namik Kemal Uni Hospital
RECRUITING
Tekirdağ
Zonguldak Bulent Ecevit University Health Practice and Research Hospital
RECRUITING
Zonguldak
Ukraine
Communal noncommercial enterprise First Cherkasy City Hospital
ACTIVE_NOT_RECRUITING
Cherkasy
MS Diagnosis Treatment Center
RECRUITING
Cherkasy
Chernihiv City Hospital 4
RECRUITING
Chernihiv
Dnipro City Hospital 6
RECRUITING
Dnipro
Municipal Institution Dnipropetrovsk Regional Rehabilitation Hospital of Dnipropetrovsk Regional Council
RECRUITING
Dnipro
Ukrainian State Research Institute of Medico-Social Problems of Disability
ACTIVE_NOT_RECRUITING
Dnipro
University Clinic of Dnipro State Medical University, Department of Neurology
ACTIVE_NOT_RECRUITING
Dnipro
Communal Non-Commercial Medical Enterprise O.T.Bohayevskyi Kremenchuk City Hospital #1
RECRUITING
Kremenchuk
1 Private Clinic Medical Center
RECRUITING
Kyiv
Dopomoga Plus medical center
ACTIVE_NOT_RECRUITING
Kyiv
State Institution National Research Center for Radiation Medicine of the National Academy of Medical Sciences of Ukraine
RECRUITING
Kyiv
Volyn Reg Clin Hospital
ACTIVE_NOT_RECRUITING
Lutsk
5 City Clin Hospital
ACTIVE_NOT_RECRUITING
Lviv
Lviv Regional Central Hospital
ACTIVE_NOT_RECRUITING
Lviv
Communal institution City Clinical Hospital №3 of Poltava City Council
RECRUITING
Poltava
City Clinical Hospital 2
ACTIVE_NOT_RECRUITING
Rivne
Sumy Reg Clinical Hospital
RECRUITING
Sumy
Salutem
RECRUITING
Vinnytsia
LCC Medical center INET-09
ACTIVE_NOT_RECRUITING
Zaporizhzhya
Zaporizhia Med
ACTIVE_NOT_RECRUITING
Zaporizhzhya
Zaporizhia Regional Clinic Hospital
ACTIVE_NOT_RECRUITING
Zaporizhzhya
Zaporizhzhya City Hospital 6
ACTIVE_NOT_RECRUITING
Zaporizhzhya
Zaporizhzhya Hospital 9
ACTIVE_NOT_RECRUITING
Zaporizhzhya
United Kingdom
Royal Devon Uni NHS
RECRUITING
Exeter
Royal Hallamshire Hospital
RECRUITING
Sheffield
Contact Information
Primary
Andreas Muehler, MD
info@imux.com
+49 89 2080 477 00
Time Frame
Start Date: 2022-01-12
Estimated Completion Date: 2032-10
Participants
Target number of participants: 1050
Treatments
Experimental: 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.
Placebo_comparator: Placebo
Matching placebo, as described for the test product, identical number of tablets as given for IMU-838.
Authors
R. F.
Sponsors
Leads: Immunic AG

This content was sourced from clinicaltrials.gov

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