Clinical trial NCT05201638: 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-2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Immunic AG
Sponsor class: INDUSTRY
First posted: 2022-01-21
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-2)

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: 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 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

Primary outcomes:
measure: To evaluate efficacy of IMU-838 versus placebo based on 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: Scottsdale
country: United States
facility: HonorHealth Research Institute - Bob Bove Neuroscience Institute
state: Arizona
city: Altamonte Springs
country: United States
facility: Neuro of Central Florida
state: Florida
city: Coral Springs
country: United States
facility: Healthcare Innovations
state: Florida
city: Miami
country: United States
facility: Homestead Associates
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research
state: Florida
city: Nicholasville
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Yerevan
country: Armenia
facility: Heratsi Hospital Complex 1
city: Yerevan
country: Armenia
facility: Erebouni Medical Center
city: Banja Luka
country: Bosnia and Herzegovina
facility: UCC of Rep of Srpska
city: Bihać
country: Bosnia and Herzegovina
facility: Cantonal Hospital Bihac Dr. Irfan Ljubijankic
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinical Center of Sarajevo
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinical Center Sarajevo
city: Tuzla
country: Bosnia and Herzegovina
facility: University Clinical Center Tuzla
city: Tallinn
country: Estonia
facility: Astra Clinic
city: Chandigarh
country: India
facility: Post-Graduation Institute of Medical Education and Research (PGIMER)
city: Gurugramam
country: India
facility: Fortis Memorial Research Institute
city: Lucknow
country: India
facility: Dr Ram Manohar Lohia Institute of Medical Sciences
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: New Delhi
country: India
facility: GB Pant Institute of Postgraduate Medical Education and Research
city: Punjabi Bagh
country: India
facility: SRI Guru Ram Das Institute of Medical Sciences and Research
city: Raipur
country: India
facility: DKS PGI
city: Lima
country: Peru
facility: Centro de Investig. Médicas
city: Katowice
country: Poland
facility: NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"
city: Katowice
country: Poland
facility: Neuro-Medic Janusz Zbrojkiewicz
city: Lublin
country: Poland
facility: NZOZ Neuromed
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska prof. Konrad Rejdak
city: Oświęcim
country: Poland
facility: Instytut Zdrowia Boczarska
city: Plewiska
country: Poland
facility: NZOZ Hertmanowskiej
city: Poznań
country: Poland
facility: NZOZ Neuro-Kard
city: Warsaw
country: Poland
facility: Centrum Medyczne NeuroProtect
city: Warsaw
country: Poland
facility: FutureMeds Warszawa Centrum
city: Zabrze
country: Poland
facility: Centrum Med. Ibismed
city: Bucharest
country: Romania
facility: SC Sana Monitoring SRL
city: Bucharest
country: Romania
facility: Elias University Emergency Hospital
city: Constanţa
country: Romania
facility: Spitalul clinic CF Constanta
city: Craiova
country: Romania
facility: Asociatia Comunitatea Oamenilor
city: Câmpulung
country: Romania
facility: Clubul Sanatatii SRL
city: Sibiu
country: Romania
facility: Aria Clinic SRL
city: Timişoara
country: Romania
facility: Neuro Therapy
city: Timişoara
country: Romania
facility: Spit Jud Branzeu TIM Neuro
city: Belgrade
country: Serbia
facility: Klinicko bolnicki centar Dr Dragisa Misovic - Dedinje
city: Belgrade
country: Serbia
facility: Klinicko bolnicki centar Zvezdara
city: Belgrade
country: Serbia
facility: Opsta bolnica Medicinski sistem Beograd
city: Belgrade
country: Serbia
facility: Vojnomedicinska akademija
city: Kragujevac
country: Serbia
facility: Univerzitetski Klinicki centar Kragujevac
city: Kragujevac
country: Serbia
facility: Univerzitetski Klinicki centar Kragujevac
city: Niš
country: Serbia
facility: Univerzitetski Klinicki centar Nis
city: Novi Kneževac
country: Serbia
facility: Hsptl Sveti Vracevi
city: Užice
country: Serbia
facility: General Hospital Uzice
city: Zemun
country: Serbia
facility: Klinicko Bolnicki centar Zemun
city: Zrenjanin
country: Serbia
facility: Opsta bolnica Djordje Jovanovic Zrenjanin
city: Adana
country: Turkey
facility: Acibadem Adana Hospital
city: Adana
country: Turkey
facility: Adana Baskent Hospital
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University Hospital
city: Istanbul
country: Turkey
facility: T.C. Ministry of Health Istanbul Haseki Training and Research Hospital
city: Istanbul
country: Turkey
facility: Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
city: Istanbul
country: Turkey
facility: Haydar Pasa Num. EAH
city: Kocaeli
country: Turkey
facility: Kocaeli University Research and Application Hospital
city: Kütahya
country: Turkey
facility: T.C. Ministry of Health Kutahya Provincial Directorate of Health Kutahya University of Health Sciences Evliya Celebi Training and Research Hospital
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University Hafsa Sultan Hospital
city: Samsun
country: Turkey
facility: 19 Mayis University Medical Faculty Hospital Health Application and Research Center
city: Tekirdağ
country: Turkey
facility: Namik Kemal Uni Hospital
city: Zonguldak
country: Turkey
facility: Zonguldak Bulent Ecevit University Health Practice and Research Hospital
city: Cherkasy
country: Ukraine
facility: Communal noncommercial enterprise "First Cherkasy City Hospital"
city: Cherkasy
country: Ukraine
facility: MS Diagnosis Treatment Center
city: Chernihiv
country: Ukraine
facility: Chernihiv City Hospital 4
city: Dnipro
country: Ukraine
facility: Municipal Institution "Dnipropetrovsk Regional Rehabilitation Hospital" of Dnipropetrovsk Regional Council"
city: Dnipro
country: Ukraine
facility: Ukrainian State Research Institute of Medico-Social Problems of Disability
city: Dnipro
country: Ukraine
facility: "University Clinic" of Dnipro State Medical University, Department of Neurology
city: Dnipro
country: Ukraine
facility: Dnipro City Hospital 6
city: Kremenchuk
country: Ukraine
facility: Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1
city: Kyiv
country: Ukraine
facility: State Institution "National Research Center for Radiation Medicine of the National Academy of Medical Sciences of Ukraine
city: Kyiv
country: Ukraine
facility: 1 Private Clinic Medical Center
city: Kyiv
country: Ukraine
facility: Dopomoga Plus medical center
city: Luts'k
country: Ukraine
facility: Volyn Reg Clin Hospital
city: Lviv
country: Ukraine
facility: Lviv Regional Central Hospital
city: Lviv
country: Ukraine
facility: 5 City Clin Hospital
city: Poltava
country: Ukraine
facility: Communal institution "City Clinical Hospital №3" of Poltava City Council
city: Rivne
country: Ukraine
facility: City Clinical Hospital 2
city: Sumy
country: Ukraine
facility: Sumy Reg Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: Salutem
city: Zaporizhzhya
country: Ukraine
facility: LCC Medical center INET-09
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhia Med
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhia Regional Clinic Hospital
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya City Hospital 6
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya Hospital 9
city: Exeter
country: United Kingdom
facility: Royal Devon Uni NHS
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
name: Robert J. Fox, MD
role: PRINCIPAL_INVESTIGATOR
References: