Clinical trial NCT05134441: Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
Official title: 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-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: Immunic AG
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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-1)

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

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:

  1. At least 2 relapses in the last 24 months before randomization, or
  2. At least 1 relapse in the last 12 months before randomization, or
  3. 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 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

Primary outcomes:
measure: To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse
timeFrame: 72 weeks
Secondary outcomes:
measure: Effect of IMU-838 versus placebo on volume of new T2 lesions
timeFrame: 72 weeks
measure: Effect of IMU-838 versus placebo on disability progression
timeFrame: 72 weeks
measure: Effect of IMU-838 versus placebo on cognitive performance
timeFrame: 72 weeks
measure: Effect of IMU-838 versus placebo on whole brain atrophy
timeFrame: 72 weeks
measure: Safety of IMU-838 versus placebo
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Xenoscience, Inc., 21st Century Neurology
state: Arizona
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research, LLC
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Northbrook
country: United States
facility: Consultants in Neurology, Ltd
state: Illinois
city: Tirana
country: Albania
facility: Klinika Mjekesore Nuova, Neurology Clinic
city: Tirana
country: Albania
facility: Hygeia Hospital Tirana
city: Blagoevgrad
country: Bulgaria
facility: MHAT Puls AD
city: Burgas
country: Bulgaria
facility: MHAT "Heart and Brain", EAD
city: Pleven
country: Bulgaria
facility: MC Exacta Medica OOD
city: Pleven
country: Bulgaria
facility: MHAT Avis Medica
city: Pleven
country: Bulgaria
facility: UMHAT Dr.Georgi Stranski EAD
city: Pleven
country: Bulgaria
facility: Heart and Brain University Hospital
city: Pleven
country: Bulgaria
facility: MC Vita 1
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi
city: Ruse
country: Bulgaria
facility: UMHAT "Medica Ruse"
city: Sofia
country: Bulgaria
facility: CCB Medical Institute Ministry of Interior
city: Sofia
country: Bulgaria
facility: Diagnostic and Consultative Center Neoclinic
city: Sofia
country: Bulgaria
facility: UMHAT "Sveti Ivan Rilski" EAD
city: Sofia
country: Bulgaria
facility: MHATNP "Sveti Naum", EAD
city: Sofia
country: Bulgaria
facility: MHATNPsy Sveti Naum EAD
city: Sofia
country: Bulgaria
facility: UMHAT "Alexandrovska" EAD
city: Sofia
country: Bulgaria
facility: UMHAT "Alexandrovska"
city: Sofia
country: Bulgaria
facility: Military Medical Academy MHAT
city: Sofia
country: Bulgaria
facility: MHAT "Sveta Sofia" EOOD
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: UMHAT"Tsaritsa Yoanna -ISUL
city: Sofia
country: Bulgaria
facility: UMHATEM N.Pirogov
city: Varna
country: Bulgaria
facility: UMHAT "Sveta Marina" EAD, First Clinic of Neurological Diseases
city: Bogotá
country: Colombia
facility: Clínica Colsanitas S.A. Sede Clínica Universitaria Colombia
city: Puerto Colombia
country: Colombia
facility: Neurocountry Portoazul S.A.S.
city: Tbilisi
country: Georgia
facility: 1st Uni Clinic of Tbilisi LEPL
city: Tbilisi
country: Georgia
facility: Eristavi Experimental Center
city: Tbilisi
country: Georgia
facility: J.S.C. Curatio Clinic
city: Tbilisi
country: Georgia
facility: Katsiashvili Emergency Center
city: Tbilisi
country: Georgia
facility: Khechinashvili University Hospital
city: Tbilisi
country: Georgia
facility: LTD Aversi Clinic
city: Tbilisi
country: Georgia
facility: LTD New Hospitals
city: Tbilisi
country: Georgia
facility: MediClub Georgia LLC
city: Tbilisi
country: Georgia
facility: Pineo Medical Ecosystem LTD
city: Tbilisi
country: Georgia
facility: Sarajishvili Neurology Institute
city: Athens
country: Greece
facility: Athens Medical Center
city: Thessaloníki
country: Greece
facility: Thessaloniki Hosptl
city: Gandhinagar
country: India
facility: Kanoria Hospital & Research Centre
city: Mangalore
country: India
facility: Mallikatte, Kadri
city: Nagpur
country: India
facility: Jasleen Hospital
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Pune
country: India
facility: Ruby Hospital
city: Shimla
country: India
facility: Indira Gandhi Medical College & Hospital
city: Varanasi
country: India
facility: Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi
city: Amman
country: Jordan
facility: TSH Advanced Clinical Center
city: Irbid
country: Jordan
facility: Irbid Speciality Hospital
city: Beirut
country: Lebanon
facility: Hotel Dieu de France Hospital
city: Hamra
country: Lebanon
facility: AUB Medical Center
city: Kaunas
country: Lithuania
facility: Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos
city: Klaipėda
country: Lithuania
facility: Klaipedos Universitetine Ligonine - Klaipedos Issetines Sklerozes Centra
city: Culiacán
country: Mexico
facility: Neurociencias Estudios Clínicos S.C
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Metabolismo, SC
city: Mexico City
country: Mexico
facility: Grupo medico camino SC
city: Mexico City
country: Mexico
facility: Cliditer S.A de C.V
city: Mexico City
country: Mexico
facility: Unidad de Investigación en Salud de Chihuahua S.C.
city: Mexico City
country: Mexico
facility: Clinstile SA de CV
city: Morelia
country: Mexico
facility: Centro de Morelia
city: Veracruz
country: Mexico
facility: Faicic de RL de CV
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon, S.C.
city: Chisinau
country: Moldova, Republic of
facility: Instititute of Emergency Medicine
city: Chisinau
country: Moldova, Republic of
facility: Medico-Sanitary Public Institution, Institute of Neurology and Neurosurgery "Diomid Gherman"
city: Chisinau
country: Moldova, Republic of
facility: The Diomid Gherman Institute of Neurology and Neurosurgery
city: Nikšić
country: Montenegro
facility: General Hospital Niksic
city: Podgorica
country: Montenegro
facility: Clinical Center of Montenegro
city: Skopje
country: North Macedonia
facility: Hospital "8 mi Septemvri"
city: Skopje
country: North Macedonia
facility: University Clinic of Neurology
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Chernivtsi
country: Ukraine
facility: Chernihiv Regional Hospital
city: Ivano-Frankivs'k
country: Ukraine
facility: Regional Clinical Hospital
city: Ivano-Frankivs'k
country: Ukraine
facility: Neuro Global, LLC
city: Khmelnytskyi
country: Ukraine
facility: Khmelnytsky regional hospital of war veterans
city: Kiev
country: Ukraine
facility: Clinical Hospital #15 of the Podilskyi District of the Kyiv City
city: Kiew
country: Ukraine
facility: Kyiv City Hospital 4
city: Kyiv
country: Ukraine
facility: "Medbud"
city: Kyiv
country: Ukraine
facility: SMART medical center
city: Odesa
country: Ukraine
facility: Odesa Regional Clinical Hospital, Department of Neurosurgery
city: Poltava
country: Ukraine
facility: Medical and diagnostic center of a LLC "Medcontinent", neurology and rehabilitation center
city: Ternopil'
country: Ukraine
facility: Ternopil Psycho-Neuro Hospital
city: Uzhhorod
country: Ukraine
facility: Regional Clinical Center for Neurosurgery and Neurology
Study officials:
affiliation: Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
name: Robert J. Fox, MD
role: PRINCIPAL_INVESTIGATOR
References: