Relapsing Multiple Sclerosis MedDRA version: 27.0 Level: PT Classification code 10080700 Term: Relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: vidofludimus calcium
Product Code: IMU-838
Pharmaceutical Form: Tablet
INN or Proposed INN: Vidofludimus calcium
CAS Number: 1354012-90-0
Current Sponsor code: IM90838
Other descriptive
Sponsors
Immunic AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for the Main period of the Trial: 1. Male or female patient (age =18 to =55 years) 2. Patients with an established diagnosis of MS according to 2017 McDonald Criteria 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. 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. 5. EDSS score between 0 and 5.5 (inclusive) at SV1. 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. ii.occlusive cap (diaphragm or cervical/vault caps) with spermicidal gel/film/cream/suppository. 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 ha
Exclusion criteria
Exclusion criteria: 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. Exclusion Criteria for the Extension Period of the Trial, Open-Label Treatment: 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 approved by emergency use authorization) and/or participation in another clinical trial of an investigational drug throughout the duration of the EP open-label treatment period. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the effect of IMU-838 versus placebo on volume of new T2 lesions; To evaluate the effect of IMU-838 versus placebo on disability progression; To evaluate the effect of IMU-838 versus placebo on cognitive performance; To evaluate the effect of IMU-838 versus placebo on whole brain atrophy; Please refer to the study protocol for further secondary objective.;Primary end point(s): 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), censored at a maximum of 72 weeks, Visit 8 (V8)/EOMP;Timepoint(s) of evaluation of this end point: at least 2 weeks, maximum 72 weeks;Main Objective: To demonstrate the efficacy of IMU-838 versus placebo in adult patients with active RMS in delaying the occurrences of relapses based on time to first relapse (T2FR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary efficacy: 1)Changes in total volume of new T2-lesions from baseline (BL SV2) MRI until Week 24 MRI; 2)Time to 12-week confirmed disability worsening (12wCDW) as assessed on Expanded Disability Status Scale (EDSS);; as defined in this protocol during the MP (censored until at Week 72/EOMP visit but with confirmation potentially done within EP, if applicable); 3)Time to confirmed clinically relevant changes in Symbol Digit Modalities Test (SDMT) in the MP (censored Week 72/EOMP; 4)Annualized rate of percentage changes in whole brain volume from BL MRI to until V8/EOMP MRI; Please refer to protocol for secondary efficacy, safety, and exploratory endpoints.;Timepoint(s) of evaluation of this end point: Please refer to section 7 of the clinical study Protocol | — |
Countries
Albania, Algeria, Bulgaria, Colombia, Georgia, Germany, Greece, India, Jordan, Lebanon, Lithuania, Mexico, Moldova, Republic of, Montenegro, North Macedonia, Poland, Spain, Ukraine, United States
Contacts
Public ContactAndreas Muehler
Immunic AG
Outcome results
None listed