Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Not authorised
Participants planned
210
Countries
1
Sites
1
Multiple sclerosis
Comparison of the effectiveness of Trilac vs Lacidofil vs control group in reducing the clinical activity of multiple sclerosis.
Key facts
- Sponsor
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2025-10-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Medical Research Agency
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
Comparison of the effectiveness of Trilac vs Lacidofil vs control group in reducing the clinical activity of multiple sclerosis.
Secondary objectives 5
- Comparison of the impact of Trilac vs Lacidofil vs control group on the radiological activity of multiple sclerosis.
- Comparison of the impact of Trilac vs Lacidofil vs control group on the level of disability.
- Comparison of the impact of Trilac and Lacidofil vs control group on quality of life.
- Comparison of the impact of Trilac vs Lacidofil vs control group on pain perception and fatigue.
- Safety assessment of Trilac vs Lacidofil vs control group.
Conditions and MedDRA coding
Multiple sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10063399 | Relapsing-remitting multiple sclerosis | 100000004852 |
| 20.1 | PT | 10028245 | Multiple sclerosis | 100000004852 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Multiple sclerosis diagnosed according to McDonald's criteria from 2017.
- Age 18-45 years inclusive.
- Consent to participate in the study.
- No steroids treatment in the past 3 months.
- Minimum of 6 months history of MS treatment with ozanimod or ofatumumab.
Exclusion criteria 11
- Unable or not willing to comply with the protocol regulations.
- Participation in other clinical trial during the participation in this trial.
- Elapsed time of less than 5 half-lives since the last administration of investigational medicinal product in another clinical trial, as of the date of patient randomization (visit 0).
- Antibiotics, oral or intravenous immunosuppressive in the past 3 months.
- History of chronic infectious disease (e.g., TBC, HIV, HBV, HCV, etc.).
- Active or history of cancer within the past 5 years, except for basal-cell carcinoma of the skin and carcinoma in situ of cervix in patients who have received radical treatment.
- Pregnancy or lactation.
- Primary multiple sclerosis.
- Known allergic reaction to one of the probiotics: Trilac or Lacidofil.
- History of other immunomodulatory MS treatment than ozanimod or ofatumumab.
- Lack of consent for using highly effective contraception during treatment with ozanimod or ofatumumab and at least for 3 months after last administration of ozanimod or at least for 6 months after last administration of ofatumumab (for women of childbearing potential only).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Annualized Relapse Rate (ARR) at the end of month 12 and 24.
Secondary endpoints 10
- Percentage of patients with no clinical evidence of disease activity (NEDA) [Time Frame: Baseline month 12, month 24] NEDA is defined by no confirmed MS relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening.
- Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months [Time Frame: 24-month period].
- The mean number of new or enlarging hyperintense T2-weighted brain MRI lesions per scan based on the cumulative number of new or enlarging T2 lesions since baseline over 24 months. [Time Frame: 24-month period].
- Mean Number of Gadolinium Enhancing Brain Lesions at Month 12, Month 24 [Time Frame: 24-month period].
- The number of gadolinium-enhancing (GdE) lesions at 12 month and 24 months. [Time Frame: 24-month period]
- Change in mental health evaluated by the GHQ-28 questionnaire in MS patients receiving Trilac vs Lacidofil vs the control group.
- Difference in severity of feeling pain measured by VAS scale in MS patients receiving Trilac vs Lacidofil vs the control group.
- Difference in severity of fatigue in MS patients receiving Trilac vs Lacidofil vs the control group. Fatigue will be evaluated by Fatigue Analogue Scale.
- Change in quality of life measured by SF-36 questionnaire in MS patients receiving Trilac vs Lacidofil vs the control group.
- Percentage of adverse events.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB187907 · Substance
- Active substance
- Lactobacillales
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 8000000000 CFU/g colony forming unit(s)/gram
- Max total dose
- 2928000000000 CFU/g colony forming unit(s)/gram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2019924 · Product
- Active substance
- Lactobacillus Helveticus
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 10000000000 CFU/g colony forming unit(s)/gram
- Max total dose
- 3660000000000 CFU/g colony forming unit(s)/gram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07FA — ANTIDIARRHEAL MICROORGANISMS
- Marketing authorisation
- R/2350
- MA holder
- LALLEMAND SAS
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 7
Zeposia 0.23 mg hard capsules Zeposia 0.46 mg hard capsules
PRD9257549 · Product
- Active substance
- Ozanimod
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0.92 mg milligram(s)
- Max total dose
- 0.92 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AE02 — -
- Marketing authorisation
- EU/1/20/1442/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9257552 · Product
- Active substance
- Ozanimod
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.92 mg milligram(s)
- Max total dose
- 0.92 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AE02 — -
- Marketing authorisation
- EU/1/20/1442/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9257562 · Product
- Active substance
- Ozanimod
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.92 mg milligram(s)
- Max total dose
- 0.92 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AE02 — -
- Marketing authorisation
- EU/1/20/1442/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kesimpta 20 mg solution for injection in pre-filled syringe
PRD8833232 · Product
- Active substance
- Ofatumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ORAL
- Max daily dose
- 2.86 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AG12 — -
- Marketing authorisation
- EU/1/21/1532/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kesimpta 20 mg solution for injection in pre-filled syringe
PRD8833236 · Product
- Active substance
- Ofatumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ORAL
- Max daily dose
- 2.86 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AG12 — -
- Marketing authorisation
- EU/1/21/1532/002
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kesimpta 20 mg solution for injection in pre-filled pen
PRD8833240 · Product
- Active substance
- Ofatumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ORAL
- Max daily dose
- 2.86 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AG12 — -
- Marketing authorisation
- EU/1/21/1532/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kesimpta 20 mg solution for injection in pre-filled pen
PRD8833244 · Product
- Active substance
- Ofatumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- ORAL
- Max daily dose
- 2.86 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AG12 — -
- Marketing authorisation
- EU/1/21/1532/004
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Sponsor organisation
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Address
- Ul. Szaserow 128
- City
- Warsaw
- Postcode
- 04-141
- Country
- Poland
Scientific contact point
- Organisation
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Contact name
- Wojciech Szypowski
Public contact point
- Organisation
- Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
- Contact name
- Klinika Neurologiczna WIM-PIB
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Not authorised | 210 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 20 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2025-520955-10_for publication | 1.1 |
| Protocol (for publication) | D1_Protocol EU CT 2025-520955-10_tc_ for publication | 1.1 |
| Protocol (for publication) | D1_Protocol synopsis EU CT 2025-520955-10_PL | 1.1 |
| Protocol (for publication) | D1_Protocol synopsis EU CT 2025-520955-10_PL_tc | 1.1 |
| Protocol (for publication) | D4_ Patient facing documents_Dzienniczek badanego produktu leczniczego | 1.0 |
| Protocol (for publication) | D4_ Patient facing documents_Karta Indentyfikacyjna Pacjenta | 1.0 |
| Protocol (for publication) | D4_ Patient facingdocuments_kwestionariusz_FAS_for publication | 1 |
| Protocol (for publication) | D4_ Patient facingdocuments_kwestionariusz_GHQ28_for publication | 1 |
| Protocol (for publication) | D4_ Patient facingdocuments_kwestionariusz_SF 36_for publication | 2 |
| Protocol (for publication) | D4_ Patient facingdocuments_kwestionariusz_VAS_for publication | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Procedura swiadomej zgody | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ogoszenie | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_tc | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF ciaza | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF do dalszych badan naukowych niezwiazanych bezposrednio z protokoem | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF do dalszych badan naukowych niezwiazanych bezposrednio z protokoem_tc | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF do przyszych celow naukowych_ABM | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lacidofil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Trilac | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-26 | Poland | Not acceptable 2025-10-13
|
2025-10-20 |