Clinical trial • Phase II • Neurology

Vidofludimus calcium for Progressive multiple sclerosis

Phase II trial of Vidofludimus calcium for Progressive multiple sclerosis.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Progressive multiple sclerosis
Trial Stage
Phase II
Drug Modality
Small molecule|Other

Key dates

Initial CTIS Submission Date
14-08-2024
First CTIS Authorization Date
12-09-2024

Trial design

Randomised, placebo for imu-838 tablets (matching placebo). dosing schedule (placebo matched to imu-838): 22.5 mg tablet once daily in the morning for first 7 days, then matching tablet once daily (placebo) thereafter to mirror imu-838 45 mg maintenance dose.-controlled Phase II trial in Netherlands, Poland, Germany and others.

Randomised
Yes
Comparator
Placebo for IMU-838 Tablets (matching placebo). Dosing schedule (placebo matched to IMU-838): 22.5 mg tablet once daily in the morning for first 7 days, then matching tablet once daily (placebo) thereafter to mirror IMU-838 45 mg maintenance dose.
Target Sample Size
237
Trial Duration For Participant
840

Eligibility

Recruits 237 Vulnerable population flag is selected in the registry. Written informed consent must be given by the patient before any study-related procedure (no children; age eligibility 18 to 65 years). The record does not specify assent or proxy consent procedures..

Pregnancy Exclusion
If of childbearing potential, must have a negative pregnancy test at SV1 (blood test) and before the first IMP intake at Day 1 (urine test).
Vulnerable Population
Vulnerable population flag is selected in the registry. Written informed consent must be given by the patient before any study-related procedure (no children; age eligibility 18 to 65 years). The record does not specify assent or proxy consent procedures.

Inclusion criteria

  • {"criterion_text":"- 1. Adult patients, age 18 to 65 years (inclusive). 2. No evidence of relapse in the last 24 months before randomization, AND Patients diagnosed with either a) SPMS, in patients showing evidence of Gd+ MRI lesions (active SPMS) in the brain or spinal cord, or without Gd+ MRI lesions (non-active SPMS) in the last 12 months, OR b) PPMS according to 2017 revised McDonald Criteria and the 2013 revised classification of disease courses with a disease duration of the progressive disease of ≤10 years"}
  • {"criterion_text":"- 3. EDSS score at screening between 3.0 to 6.5 (both inclusive)"}
  • {"criterion_text":"- 4. Evidence of disability worsening not temporarily related to a relapse in the last 24 months before randomization, adjudicated by a central independent reviewer, and documented as: a) An increase of EDSS of at least 1.0 point with Screening EDSS of up to 5.5 (inclusive) and 0.5 point for Screening EDSS 6.0 or 6.5 (as documented in patient files in the last 24 months before randomization), OR b) A 20% worsening (or more) in 25-foot walk time or 9-hole peg test time in either hand (as documented in patient files in the last 24 months before randomization), OR c) A written summary of the clinical evidence of disability worsening in the previous 24 months before randomization through a retrospective assessment of disease worsening from patient files."}
  • {"criterion_text":"- 5. Female patients: a) Must be of non-childbearing potential, i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before SV1) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or b) If of childbearing potential, must have a negative pregnancy test at SV1 (blood test) and before the first IMP intake at Day 1 (urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method (see below) together with a barrier method between study consent and 30 days after the last intake of the IMP. c) Highly effective forms of birth control are those with a failure rate of less than 1% per year and include: i) Oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation. ii) Oral, injectable, or implantable progestogen-only hormonal contraceptives associated with inhibition of ovulation. iii) Intrauterine device or intrauterine hormone-releasing system. iv) Bilateral tubal occlusion. v) Vasectomized partner (i.e., the patient's male partner underwent effective surgical sterilization before the female patient entered the clinical study. And is the sole sexual partner of the female patient during the clinical study). vi) Sexual abstinence (acceptable only if it is the patient's usual form of birth control/lifestyle choice; periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception). d) Barrier methods of contraception include: i) Condom. ii) Occlusive cap (diaphragm or cervical/vault caps) with spermicidal gel/film/cream/suppository."}
  • {"criterion_text":"- 6. Male patients must agree not to father a child or to donate sperm starting at SV1, throughout the clinical study, and for 30 days after the last intake of the IMP. Male patients must also: a) Abstain from sexual intercourse with a female partner (acceptable only if it is the patient's usual form of birth control/lifestyle choice), or b) Use adequate barrier contraception during treatment with the IMP and until at least 30 days after the last intake of the IMP, and Note: Simultaneous use of male and female condoms with or without any other contraception methods is not permitted. c) If they have a female partner of childbearing potential, the partner should use a highly effective contraceptive method as outlined in inclusion criterion 4. d) If they have a pregnant partner, they must use condoms while taking the IMP to avoid exposure of the fetus to the IMP."}
  • {"criterion_text":"- 7. Willingness and ability to comply with the protocol."}
  • {"criterion_text":"- 8. Written informed consent given by the patient before the beginning of any study-related procedure. For more information, please refer to Clinical Study Protocol."}

Exclusion criteria

  • {"criterion_text":"- MS-related exclusion criteria: 1. Any disease other than MS that may better explain the signs and symptoms, including a history of complete transverse myelitis. 2. Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica spectrum disorders (NMOSD) or myelin oligodendrocyte glycoprotein (MOG)-associated encephalomyelitis (i.e., presence of aquaporin-4 antibodies or anti-MOG antibodies). 3. Any MRI finding, atypical for MS, including but not limited to a longitudinally extensive spinal cord lesion. 4. Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease)."}
  • {"criterion_text":"- Therapy-related exclusion criteria: 5. Any previous or current use of the following MS treatments: a) alemtuzumab or belimumab, including their biosimilars, b) cladribine, c) total lymphoid irradiation, and d) bone marrow or stem cell transplantation. 6. Any use of the following MS treatments before the date of randomization (see table in study protocol) 7. Any use of adrenocorticotrophic hormone (ACTH) or occasional use of systemic corticosteroids (oral or intravenous) 30 days before SV2. 8. Use of any investigational product within 8 weeks or 5× the respective PK half-life before the date of informed consent, whichever is longer, and throughout the study. For some investigational products, prolonged biological effects beyond 8 weeks should be considered. For more information, please refer to Clinical Study Protocol."}
  • {"criterion_text":"- Exclusion Criteria for the OLE Period: Patients meeting any of the following criteria will be ineligible to participate in the OLE Period of the study: 1. Any ongoing, clinically significant (as assessed by the Investigator) treatment-emergent AE or laboratory abnormality (including blood biochemistry and urinalysis) that can jeopardize the patient's safety, in agreement with the medical monitor. 2. Significant study or treatment non-compliance (<80% or >125%) during the MT period, and/or inability or unwillingness to follow instructions by study personnel. 3. The lack of interpretable BL or EoMT MRI or the omission of more than one other MRI during the MT. 4. Use of experimental/investigational drug (except for COVID-19 vaccines approved by emergency use authorization or similar expanded access schemes) and/or participation in another clinical study of an investigational drug throughout the duration of the OLE treatment period."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Annualized rate of percent brain volume change (PBVC) during MT period.","definition_or_measurement_approach":"Measured by quantitative MRI analysis for whole brain atrophy using the Structural Image Evaluation using Normalization of Atrophy (SIENA) method during the Main Treatment (MT) period."}

Secondary endpoints

  • {"endpoint_text":"- Time to 24-week confirmed disability worsening as assessed on a composite of EDSS, 9-Hole Peg Test (9-HPT), or Timed 25-foot Walk (T25-FW) (24wCDW-Comp) during the MT period","definition_or_measurement_approach":"Time-to-event assessed as time to 24-week confirmed disability worsening based on a composite of EDSS, 9-HPT, or T25-FW during the Main Treatment period."}

Recruitment

Planned Sample Size
237
Recruitment Window Months
85
Consent Approach
Written informed consent must be given by the patient before any study-related procedure. Participants are adults (18-65). Consent documents (SIS and ICF) are provided in multiple country-specific languages (available documents include English, Dutch, Polish, Bulgarian, Czech, German, Romanian, Ukrainian, Russian). No separate assent process for minors is provided (trial enrols adults only).

Geography

Total Number Of Sites
41
Total Number Of Participants
230

Netherlands

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
604
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Alrijne Ziekenhuis Leiden Poli Neurologie, t.a.v. C. Holthuijsen
Department Name
Poli Neurologie
Contact Person Name
Elske Hoitsma
Contact Person Email
msresearch@alrijne.nl
Site Name
Amsterdam UMC Stichting
Department Name
Poli Neurologie
Contact Person Name
Eva Strijbis
Contact Person Email
e.strijbis@amsterdamumc.nl

Poland

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
600
Number Of Sites
14
Number Of Participants
102

Sites

Site Name
Neuro-Medic Sp. z o.o.
Department Name
unknown
Contact Person Name
Janusz Zbrojkiewicz
Contact Person Email
jzbrojkiewicz@op.pl
Site Name
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej
Department Name
unknown
Contact Person Name
Justyna Hryniewicz
Contact Person Email
j.dhryniewicz@gmail.com
Site Name
EMC Instytut Medyczny S.A.
Department Name
Unknown
Contact Person Name
Monika Susz-Kolodynska
Contact Person Email
badania.kliniczne@emc-sa.pl
Site Name
Ilkowski I Partnerzy sp.p. Lekarzy
Department Name
unknown
Contact Person Name
Jan Ilkowski
Contact Person Email
jan.ilkowski@neurokard.pl
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
Department Name
unknown
Contact Person Name
Marcin Nastaj
Contact Person Email
marcinnastaj@gmail.com
Site Name
EMC Instytut Medyczny S.A. (Poznan)
Department Name
Unknown
Contact Person Name
Alicja Kalinowska-Lyszczarz
Contact Person Email
alicjakal@yahoo.com
Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Department Name
unknown
Contact Person Name
Agnieszka Adamczak-Ratajczak
Contact Person Email
biuro@cr-center.pl
Site Name
Indywidualna Praktyka Lekarska Prof. dr hab. n. med. Konrad Rejdak
Department Name
Private Practice
Contact Person Name
Konrad Rejdak
Contact Person Email
konrad.rejdak@umlub.pl
Site Name
Wk Medical Service Sp. z o.o.
Department Name
unknown
Contact Person Name
Katarzyna Kubiak-Balcerewicz
Contact Person Email
recepcja@warszawskaklinika.pl
Site Name
Resmedica Sp. z o.o.
Department Name
unknown
Contact Person Name
Elzbieta Jasinska
Site Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Department Name
unknown
Contact Person Name
Magdalena Boczarska-Jedynak
Contact Person Email
info@instytutboczarska.pl
Site Name
Ma-Lek Clinical Sp. z o.o.
Department Name
unknown
Contact Person Name
Maciej Maciejowski
Contact Person Email
m.m@ctsm.pl
Site Name
Neurocentrum Bydgoszcz Sp. z o.o.
Department Name
MS Treatment Clinic
Contact Person Name
Robert Bonek
Contact Person Email
r.bonek@ncbydgoszcz.pl
Site Name
Euromedis Sp. z o.o.
Department Name
unknown
Contact Person Name
Marcin Ratajczak
Contact Person Email
marcin.ratajczak@euromedis.pl

Germany

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
594
Number Of Sites
6
Number Of Participants
13

Sites

Site Name
DataMed Klinische Studien GmbH
Department Name
unknown
Contact Person Name
Gereon Nelles
Contact Person Email
g.nelles@neuromed-campus.de
Site Name
Neuro Centrum Science GmbH
Department Name
unknown
Contact Person Name
Gerd Reifschneider
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik für Neurologie
Contact Person Name
Tjalf Ziemssen
Contact Person Email
Tjalf.Ziemssen@ukdd.de
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik und Poliklinik für Neurologie
Contact Person Name
Matthias Grothe
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Neurologie MNR-Klinik
Contact Person Name
Marc Pawlitzki
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
unknown
Contact Person Name
Christoph Heesen
Contact Person Email
heesen@uke.de

Bulgaria

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
603
Number Of Sites
16
Number Of Participants
95

Sites

Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD (Pleven)
Department Name
Clinic of Neurology Diseases
Contact Person Name
Plamen Bozhinov
Contact Person Email
psbozhinov@yahoo.com
Site Name
Medical Institute Ministry Of Interior
Department Name
Clinic of Neurology Diseases
Contact Person Name
Kosta Kostov
Contact Person Email
drkostov@abv.bg
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Clinic of Neurology Diseases for Movement Disorders, Department of Parkinson's Diseases
Contact Person Name
Ivan Milanov
Contact Person Email
prof.ivan.milanov@gmail.com
Site Name
Alexandrovska University Hospital
Department Name
Clinic of Neurology Diseases
Contact Person Name
Ivaylo Tarnev
Contact Person Email
itournev@emhpf.org
Site Name
Diagnostic And Consultative Center Neoclinic EAD
Department Name
Outpatient Department for Neurology Diseases
Contact Person Name
Rosen Ikonomov
Contact Person Email
drros@abv.bg
Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD (Burgas)
Department Name
Second Department of Neurology Diseases
Contact Person Name
Ivan Dimitrov
Site Name
Multiprofile Hospital For Active Treatment - Shumen AD
Department Name
Department of Neurology Diseases
Contact Person Name
Nikolay Georgiev
Contact Person Email
georgiev_ns@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Pulmed Ltd.
Department Name
Department of Neurology Diseases
Contact Person Name
Yuliya Kostadinova
Contact Person Email
drjulia@abv.bg
Site Name
Mbal Lyulin EAD
Department Name
Department of Neurology Diseases
Contact Person Name
Aneliya Bocheva
Contact Person Email
d_rbelcheva@yahoo.com
Site Name
Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie Medika Ruse OOD
Department Name
Department of Neurology Diseases
Contact Person Name
Rositsa Krasteva
Contact Person Email
rosikrasteva@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Department of Neurology Diseases
Contact Person Name
Mariya Dimitrova
Contact Person Email
dr.m.i.dimitrova@gmail.com
Site Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Department Name
Department of Neurology Diseases
Contact Person Name
Sasho Kastrev
Contact Person Email
kastrev@hotmail.com
Site Name
MBAL Sveta Marina EAD
Department Name
First Clinic of Neurology Diseases
Contact Person Name
Ara Kaprelyan
Contact Person Email
arakapri07@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Clinic of Neurology Diseases
Contact Person Name
Penko Shotekov
Contact Person Email
shotekov@abv.bg
Site Name
Military Medical Academy
Department Name
Clinic of Neurology Diseases
Contact Person Name
Stratina Stratieva
Contact Person Email
stratina@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Neurology Clinic
Contact Person Name
Maya Danovska
Contact Person Email
mdanovska@yahoo.com

Czechia

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
607
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Neurologická klinika
Contact Person Name
Zbysek Pavelek
Contact Person Email
zbysekpavelek@email.cz
Site Name
Krajska zdravotni a.s.
Department Name
unknown
Contact Person Name
Marta Vachova
Contact Person Email
marta.vachova@kzcr.eu

Romania

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
614
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Neurology Clinic
Contact Person Name
Lacramioara Perju-Dumbrava
Contact Person Email
lperjud@umfcluj.ro

Sponsor

Primary sponsor

Full Name
Immunic AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Syneos Health UK Limited
Responsibilities
sponsorDuties codes: [1,12,5]
Name
Worldwide Clinical Trials Holdings Inc.
Responsibilities
sponsorDuties codes: [8]
Name
FGK Clinical Research GmbH
Responsibilities
sponsorDuties codes: [11]
Name
Verum.De GmbH
Responsibilities
sponsorDuties codes: [1]

Third parties

  • {"country":"Romania","full_name":"Clinical Trial Center S.R.L.","duties_or_roles":"sponsorDuties codes: [1,12]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Syneos Health UK Limited","duties_or_roles":"sponsorDuties codes: [1,12,5]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"SCRATCH Pharmacovigilance GmbH & Co. KG","duties_or_roles":"sponsorDuties codes: [8]","organisation_type":"Pharmaceutical company"}
  • {"country":"Bulgaria","full_name":"Resbiomed OOD","duties_or_roles":"sponsorDuties codes: [1,12]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Poland","full_name":"Verum.De Polska Sp. z o.o.","duties_or_roles":"sponsorDuties codes: [1,12]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"IMGM Laboratories GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Worldwide Clinical Trials Holdings Inc.","duties_or_roles":"sponsorDuties codes: [8]","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Siena Imaging S.r.l.","duties_or_roles":"sponsorDuties codes: [15]; value: MRI post processing, central MRI reading/data analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Mde Healthcare Services Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: Patient Travel Reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Metronomia Clinical Research GmbH","duties_or_roles":"sponsorDuties codes: [10,15,6]; value for 15: eCRF development","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Keosys","duties_or_roles":"sponsorDuties codes: [15]; value: Technical MRI qualification of participating sites, set up of portal for upload of MRI images","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"Molecular Signature Diagnostics GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: Patient and clinical outcome scores","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"GBA Central Lab Services GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Verum.De GmbH","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PharmaLex Belgium","duties_or_roles":"sponsorDuties codes: [15]; value: PK data analysis and modelling","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"FGK Clinical Research GmbH","duties_or_roles":"sponsorDuties codes: [11]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"MENAL Gesellschaft fuer medizinische und naturwissenschaftliche Laboranalytik mbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Quanterix Corp.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"MVZ Medizinisches Labor Nord MLN GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
IMU-838 22.5 mg tablet
Active Substance
Vidofludimus calcium
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus = 1
Starting Dose
22.5 mg
Dose Levels
22.5 mg; 45 mg
Frequency
Once daily in the morning (22.5 mg for first 7 days, then uptitration to 45 mg from Day 8)
Maximum Dose
45 mg
Dose Escalation Increase
Initial 22.5 mg once daily (Days 1-7) then increase to 45 mg once daily from Day 8
Investigational Product Name
IMU-838 45 mg tablet
Active Substance
Vidofludimus calcium
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus = 1
Starting Dose
22.5 mg (titrated to 45 mg)
Dose Levels
22.5 mg; 45 mg
Frequency
Once daily in the morning (titration: 22.5 mg first 7 days then 45 mg thereafter)
Maximum Dose
45 mg
Dose Escalation Increase
Initial 22.5 mg then increased to 45 mg
Investigational Product Name
Placebo for IMU-838 Tablets
Modality
Other
Frequency
Matched to active dosing (placebo tablets once daily; 22.5 mg equivalent placebo for first 7 days then matching placebo thereafter)

Related trials

Other published trials that may interest you.