Clinical trial • Phase III • Neurology
Vidofludimus calcium for Relapsing multiple sclerosis
Phase III trial of Vidofludimus calcium for Relapsing multiple sclerosis.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Relapsing multiple sclerosis
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 03-09-2024
- First CTIS Authorization Date
- 15-10-2024
Trial design
Randomised, placebo for imu-838 tablets (matching placebo with identical appearance/labeling); dosing schedule matched to imu-838: 15 mg tablet once daily days 1–7 then 30 mg tablet once daily starting day 8 (placebo administered on same schedule to maintain blinding).-controlled Phase III trial in Germany, Lithuania, Bulgaria and others.
- Randomised
- Yes
- Comparator
- Placebo for IMU-838 Tablets (matching placebo with identical appearance/labeling); dosing schedule matched to IMU-838: 15 mg tablet once daily Days 1–7 then 30 mg tablet once daily starting Day 8 (placebo administered on same schedule to maintain blinding).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 736
- Trial Duration For Participant
- 504
Stratification factors
- EDSS (≤2.5 vs >2.5)
- Age (<40 vs ≥40 years)
Eligibility
Recruits 736 Vulnerable population flag selected (isVulnerablePopulationSelected = true). Participants must be able to read and understand provided information and provide written informed consent prior to any trial-related procedure; no description of assent or consent by proxy for minors is provided..
- Pregnancy Exclusion
- if of childbearing potential, must have a negative pregnancy test at SV1 (blood test) and before the first IMP intake (Day 1 blood or urine test).
- Vulnerable Population
- Vulnerable population flag selected (isVulnerablePopulationSelected = true). Participants must be able to read and understand provided information and provide written informed consent prior to any trial-related procedure; no description of assent or consent by proxy for minors is provided.
Inclusion criteria
- {"criterion_text":"- 1. Male or female patient (age ≥18 to ≤55 years) 2. Patients with an established diagnosis of MS according to 2017 McDonald Criteria [41] 3. Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014. Patients are eligible for this trial if their disease modifying treatment has failed due to efficacy, safety, or tolerability issues, if they have contraindications or no access to treatment, or if they refuse the offered MS treatment.\n- 4. Active disease as defined by Lublin 2014 evidenced prior to Screening by: a. At least 2 relapses(a) in the last 24 months before randomization, or b. At least 1 relapse(a) in the last 12 months before randomization, or c. A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior to randomization. (a) Relapses and/or Gd+ MRI lesions must have been assessed and documented by a physician in the patient files.\n- 5. EDSS score between 0 and 5.5 (inclusive) at SV1.\n- 6. 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 (Day 1 blood or 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 trial consent and 30 days after the last intake of the IMP. c.highly effective forms of birth control are those with a failure rate 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 trial and is the sole sexual partner of the female patient during the clinical trial). 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.\n- 7. Male patients must agree not to father a child or to donate sperm starting at SV1, throughout the clinical trial, 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 c. if they have a female partner of childbearing potential, the partner should use a highly effective contraceptive method as outlined in inclusion criterion 5. d. if they have a pregnant partner, they must use condoms while taking the IMP to avoid exposure of the fetus to the IMP.\n- 8. Willingness and ability to comply with the protocol. 9. Patients are able to read and understand the given information about the trial (including their language capabilities) and provide written informed consent prior to any trial-related procedure.\n- Inclusion criteria for the EP: 1.Completed full visit schedule of the MP up to 72 weeks of (with the V8/EOMP completed and no more than 1 regular study visit omitted), independent of the patient's treatment: a.Double-blind treatment, or b.active treatment option (ATO) within MP, or c.Rescue treatment outside this trial (observational phase) but with double-blind treatment of at least 24 weeks in this trial and approved by the sponsor. 2. Performed a full and complete Week 72 visit (Visit 8; which also serves as an EOMP visit and includes the Visit 8 MRI examination)."}
Exclusion criteria
- {"criterion_text":"- Exclusion Criteria for the Main Period of the Trial: 1. Patients with non-active secondary progressive MS and primary progressive MS. 2. Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis. 3. Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associated encephalomyelitis. 4. Any MRI finding, which puts in question the MS diagnosis, including but not limited to a longitudinally extensive spinal cord lesion. 5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or adequately treated cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of full remission at the current time. 6. Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease). 7. An MS relapse ending within 30 days before SV1 and/or during the Screening Period (until Day 1). 8. Any corticosteroid treatment for relapse given within 30 days before SV2. Please refer to protocol for further exclusion criteria (Therapy, immune response, other medical history and concomitant disease as well as general exclusion criteria).\n- Exclusion Criteria for the EP: 1. Any ongoing, clinically significant (as assessed by the investigator) TEAE (started after intake of IMP) or laboratory abnormality (including blood chemistry and urinalysis) that, upon discretion of the investigator, should prohibit further treatment with trial medication in this trial(a). 2. Significant treatment non-compliance (defined as having taken <70% of trial medication) or trial non-compliance during the MP (as assessed by the investigator, in consultation with the medical monitor), and/or inability or unwillingness to follow instructions by trial personnel. 3. Multiple significant protocol deviations during the MP that are assessed by the investigator, in consultation with the medical monitor, to negatively affect further patient cooperation in this trial. 4. Use of experimental/investigational drug (with the exception of COVID-19 vaccines) and/or participation in another clinical trial of an investigational drug throughout the duration of the EP. 5. Any treatment mentioned in the Therapy Exclusion Criteria 9, 10, 11, 12, and 13. (a) If a TEAE(s) is the reason for exclusion from the EP open-label treatment period, the eligibility can be re-assessed up to 12 weeks following the last treatment in the MP."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Time to first confirmed relapse, as determined by the Independent Neurology Evaluation Committee (INEC), relapse occurred after the start of treatment administration and before the end of the main period (EOMP)","definition_or_measurement_approach":"Time to first confirmed relapse determined by the Independent Neurology Evaluation Committee (INEC); relapse must occur after start of treatment administration and before end of main period (EOMP)."}
Secondary endpoints
- {"endpoint_text":"- Key secondary efficacy: 1) Total number of new and/or enlarging T2-MRI lesions from baseline (BL, SV2) until Week 48","definition_or_measurement_approach":"Total number of new and/or enlarging T2 MRI lesions measured from baseline (SV2) until Week 48."}
Recruitment
- Planned Sample Size
- 736
- Recruitment Window Months
- 70
- Consent Approach
- Written informed consent provided by the participant prior to any trial-related procedure; participants must be able to read and understand the trial information. Multiple language ICF/SIS documents are available (documents listed for English, Bulgarian, Lithuanian, Polish, German, Russian and Ukrainian). Reconsent and withdrawal forms are provided; specific age-based assent not applicable (adult-only population).
Geography
- Total Number Of Sites
- 26
- Total Number Of Participants
- 314
Germany
- Earliest CTIS Part Ii Submission Date
- 16-09-2024
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 582
- Number Of Sites
- 1
- Number Of Participants
- 50
Sites
- Site Name
- Universitaet Muenster
- Department Name
- Klinik für Neurologie mit Institut für Translational Neurologie
- Contact Person Name
- Luisa Klotz
- Contact Person Email
- luisa.klotz@ukmuenster.de
Lithuania
- Earliest CTIS Part Ii Submission Date
- 16-09-2024
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 582
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- Neurology department
- Contact Person Name
- Renata Balnyte
- Contact Person Email
- renatabalnyte@gmail.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 16-09-2024
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 583
- Number Of Sites
- 23
- Number Of Participants
- 224
Sites
- Site Name
- Medical Center Exacta Medica OOD
- Department Name
- Office of Nervous Diseases
- Contact Person Name
- Albena Antimova
- Contact Person Email
- a.antimova@mail.bg
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Neurology Clinic
- Contact Person Name
- Penko Shotekov
- Contact Person Email
- shotekov@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment Avis Medika OOD
- Department Name
- Department of Nervous Diseases
- Contact Person Name
- Hristo Lilovski
- Contact Person Email
- hristolilovski@gmail.com
- Site Name
- Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
- Department Name
- Clinic of nervous diseases for movement disorders, Department for Multiple Sclerosis
- Contact Person Name
- Ivan Milanov
- Contact Person Email
- prof.ivan.milanov@gmail.com
- Site Name
- Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
- Department Name
- Department of Nervous Diseases
- Contact Person Name
- Sasho Kastrev
- Contact Person Email
- kastrev@hotmail.com
- Site Name
- Multi-profile Hospital for Active Treatment Heart and Brain EAD
- Department Name
- Second department of neurological diseases
- Contact Person Name
- Ivan Dimitrov
- Contact Person Email
- indimitrov@yahoo.com
- Site Name
- Multi-profile Hospital for Active Treatment Heart and Brain EAD
- Department Name
- Clinic of Neurology Diseases
- Contact Person Name
- Plamen Bozhinov
- Contact Person Email
- psbozhinov@yahoo.com
- Site Name
- Alexandrovska University Hospital
- Department Name
- Neurology Clinic
- Contact Person Name
- Ivaylo Tarnev
- Contact Person Email
- itournev@emhpf.org
- Site Name
- MBAL Sveta Marina EAD
- Department Name
- First Clinic of Neurology Diseases
- Contact Person Name
- Ara Kaprelyan
- Contact Person Email
- arakapri07@yahoo.co.uk
- Site Name
- Medical Center Vita 1 Ltd.
- Department Name
- Neurology Office
- Contact Person Name
- Plamen Petkov
- Contact Person Email
- pn.petkov@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
- Department Name
- Clinic for Intensive treatment of neurological diseases
- Contact Person Name
- Paraskeva Stamenova
- Contact Person Email
- par.stamenova@gmail.com
- Site Name
- Multispecialty hospital for active treatment Sveta Sofia EOOD
- Department Name
- Department of neurological diseases
- Contact Person Name
- Emil Olevski
- Contact Person Email
- emil_olevski@abv.bg
- Site Name
- Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
- Department Name
- Clinic for intensive treatment of nervous diseases
- Contact Person Name
- Evgenia Vasileva-Ruscheva
- Contact Person Email
- prof.evgenia.ruscheva@gmail.com
- Site Name
- Diagnostic And Consultative Center Neoclinic EAD
- Department Name
- Office of Nervous Diseases
- Contact Person Name
- Rosen Ikonomov
- Contact Person Email
- drros@abv.bg
- Site Name
- Military Medical Academy
- Department Name
- Clinic of Neurology Diseases
- Contact Person Name
- Stratieva Stratina
- 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
- Site Name
- Military Medical Academy
- Department Name
- Clinic of Nervous Disease
- Contact Person Name
- Hristina Dimitrova
- Contact Person Email
- drhrisi@abv.bg
- Site Name
- Alexandrovska University Hospital
- Department Name
- Neurology Clinic
- Contact Person Name
- Latchezar Traykov
- Contact Person Email
- traykov_l@yahoo.fr
- 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 Kaspela EOOD
- Department Name
- Department of Neurology Diseases
- Contact Person Name
- Anastasiya Trenova
- Contact Person Email
- atrenova@yahoo.com
- Site Name
- University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
- Department Name
- Department of Neurology Diseases
- Contact Person Name
- Maria Dimitrova
- Contact Person Email
- dr.m.i.dimitrova@gmail.com
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Neurology Clinic
- Contact Person Name
- Georgi Slavov
- Contact Person Email
- dr.georgi.slavov@gmail.com
- Site Name
- Medical Institute Ministry Of Interior
- Department Name
- Clinic of Nervous Diseases
- Contact Person Name
- Kosta Kostov
- Contact Person Email
- drkostov@abv.bg
Poland
- Earliest CTIS Part Ii Submission Date
- 16-09-2024
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 582
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
- Contact Person Name
- Marcin Nastaj
- Contact Person Email
- marcinnastaj@gmail.com
Sponsor
Primary sponsor
- Full Name
- Immunic AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- FGK Clinical Research GmbH
- Responsibilities
- code 11
- Name
- Worldwide Clinical Trials Holdings Inc.
- Responsibilities
- codes 1,10,11,12,2,6,7,8,9
- Name
- WCG Clinical - Trifecta
- Responsibilities
- code 15; Patient and clinical outcome scores
Third parties
- {"country":"Germany","full_name":"FGK Clinical Research GmbH","duties_or_roles":"code 11","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Suvoda LLC","duties_or_roles":"code 3","organisation_type":"Industry"}
- {"country":"Germany","full_name":"SCRATCH Pharmacovigilance GmbH & Co. KG","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"France","full_name":"Keosys","duties_or_roles":"code 15; Technical MRI qualification of participating sites, set up of portal for upload of MRI images","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"MENAL Gesellschaft fuer medizinische und naturwissenschaftliche Laboranalytik mbH","duties_or_roles":"code 15; PK data analysis and modelling","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Worldwide Clinical Trials Holdings Inc.","duties_or_roles":"codes 1,10,11,12,2,6,7,8,9","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical - Trifecta","duties_or_roles":"code 15; Patient and clinical outcome scores","organisation_type":"SME"}
- {"country":"Bulgaria","full_name":"Resbiomed OOD","duties_or_roles":"codes 1,12","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"MVZ Medizinisches Labor Nord MLN GmbH","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Italy","full_name":"Siena Imaging S.r.l.","duties_or_roles":"codes 15 (MRI post processing, central MRI reading/data analysis) and 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Autocruitment LLC","duties_or_roles":"code 15; Screening patients services for Bulgaria, Lithuania, Poland, and Romania","organisation_type":"Industry"}
- {"country":"Bulgaria","full_name":"Resbiomed OOD (additional listing in thirdParties)","duties_or_roles":"codes 1,12","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- IMU-838 15 mg tablets
- Active Substance
- Vidofludimus calcium
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised
- Starting Dose
- 15 mg once daily (Days 1–7)
- Dose Levels
- 15 mg; 30 mg
- Frequency
- Once daily
- Maximum Dose
- 30 mg
- Dose Escalation Increase
- Initial 15 mg once daily (Days 1–7) then increase to 30 mg once daily (from Day 8)
- Investigational Product Name
- IMU-838 30 mg tablet
- Active Substance
- Vidofludimus calcium
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised
- Starting Dose
- 30 mg once daily (from Day 8)
- Dose Levels
- 15 mg; 30 mg
- Frequency
- Once daily
- Maximum Dose
- 30 mg
- Dose Escalation Increase
- Initial 15 mg once daily (Days 1–7) then 30 mg once daily
- Investigational Product Name
- Placebo for IMU-838 Tablets
- Modality
- Other
- Routes Of Administration
- Oral (matching placebo)
- Route
- Oral
- Starting Dose
- Placebo matching 15 mg once daily (Days 1–7)
- Dose Levels
- Placebo matched to 15 mg then 30 mg schedule
- Frequency
- Once daily
- Dose Escalation Increase
- Placebo given on same schedule: initial placebo '15 mg' equivalent Days 1–7 then '30 mg' equivalent from Day 8
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