VIDOFLUDIMUS CALCIUM for Relapsing multiple sclerosis

Stratification factors

• EDSS (≤2.5, >2.5)
• Age (<40, ≥40)

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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 5. EDSS score between 0 and 5.5 (inclusive) at SV1."}
• {"criterion_text":"- 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. ii.occlusive cap (diaphragm or cervical/vault caps) with spermicidal gel/film/cream/suppository."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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 study medication in this trial(a). 2.Significant treatment non-compliance (defined as having taken <70% of study medication) or study 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 study 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 study. 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. 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."}

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":"Determined by the Independent Neurology Evaluation Committee (INEC); relapse must occur after start of treatment administration and before 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":"MRI assessment of new and/or enlarging T2 lesions from baseline (BL, SV2) to Week 48 (central MRI assessment described in protocol)."}

Methods

• Screening patients services provided by Autocruitment LLC for Bulgaria, Lithuania, Poland, and Romania (as stated in third-party duties).
• Patient identification/screening at investigator sites (site lists and start of recruitment dates provided per country).

Romania

Earliest CTIS Part Ii Submission Date

12-09-2024

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

587

Number Of Sites

3

Number Of Participants

60

Poland

Earliest CTIS Part Ii Submission Date

12-09-2024

Latest Decision Or Authorization Date

21-04-2026

Processing Time Days

586

Number Of Sites

9

Number Of Participants

209

Estonia

Earliest CTIS Part Ii Submission Date

12-09-2024

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

587

Number Of Sites

1

Number Of Participants

20

Germany

Earliest CTIS Part Ii Submission Date

12-09-2024

Latest Decision Or Authorization Date

21-04-2026

Processing Time Days

586

Number Of Sites

1

Number Of Participants

50

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

multiple operational responsibilities (codes 2,6,7,8,9,10,11,12 listed)

Name

Suvoda LLC

Responsibilities

eClinical/electronic data capture support (code 3 listed)

Name

Autocruitment LLC

Responsibilities

Screening patients services for Bulgaria, Lithuania, Poland, and Romania

Name

WCG Clinical

Responsibilities

Patient and clinical outcome scores

Third parties

• {"country":"Italy","full_name":"Siena Imaging S.r.l.","duties_or_roles":"MRI post processing, central MRI reading/data analysis","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"FGK Clinical Research GmbH","duties_or_roles":"code 11","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Suvoda LLC","duties_or_roles":"code 3","organisation_type":"Industry"}
• {"country":"United States","full_name":"Worldwide Clinical Trials Holdings Inc.","duties_or_roles":"codes 10,11,12,2,6,7,8,9 (multiple operational responsibilities)","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Keosys","duties_or_roles":"Technical MRI qualification of participating sites, set up of portal for upload of MRI images","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Autocruitment LLC","duties_or_roles":"Screening patients services for Bulgaria, Lithuania, Poland, and Romania","organisation_type":"Industry"}
• {"country":"Germany","full_name":"MVZ Medizinisches Labor Nord MLN GmbH","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"SCRATCH Pharmacovigilance GmbH & Co. KG","duties_or_roles":"Pharmacovigilance Services; code 8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"MENAL Gesellschaft fuer medizinische und naturwissenschaftliche Laboranalytik mbH","duties_or_roles":"PK data analysis and modelling","organisation_type":"Pharmaceutical company"}
• {"country":"Bulgaria","full_name":"Resbiomed OOD","duties_or_roles":"code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical","duties_or_roles":"Patient and clinical outcome scores","organisation_type":"SME"}