Overview
Sponsor-declared trial summary
Non-infectious uveitis
To evaluate the efficacy of Escherichia coli Nissle 1917 (ECN) in patients with autoimmune uveitis
Key facts
- Sponsor
- Vseobecna Fakultni Nemocnice V Praze
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20], Diseases [C] - Eye Diseases [C11]
- Trial duration
- 2 Jun 2023 → ongoing
- Decision date (initial)
- 2024-12-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Czech Health Research Council (AZV MZ ČR NU23-05-00133)
External identifiers
- EU CT number
- 2024-517946-32-00
- EudraCT number
- 2021-002850-96
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the efficacy of Escherichia coli Nissle 1917 (ECN) in patients with autoimmune uveitis
Secondary objectives 4
- To assess changes in best-corrected visual acuity (BCVA)
- To evaluate uveitis activity using SUN criteria
- To assess changes in optical coherence tomography (OCT) parameters
- To verify the safety and tolerability of ECN
Conditions and MedDRA coding
Non-infectious uveitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10075690 | Autoimmune uveitis | 100000004853 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Principal inclusion criteria: Adults ≥ 18 and < 65 years of age with autoimmune anterior, intermediate, posterior or pan-uveitis, who experienced flare-up of uveitis within 6 months prior to baseline visit
Exclusion criteria 1
- Principal exclusion criteria: Uveitis of infectious etiology, active uveitis requiring an increase in systemic therapy or initiation of biological treatment, etc. (See study protocol for full list)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to first disease relapse from the baseline visit (V2)
Secondary endpoints 4
- Severity of first relapse according to the SUN system
- Total number of relapses during the study
- Changes in BCVA
- Changes in OCT parameters
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD4943542 · Product
- Active substance
- Escherichia Coli Strain Nissle 1917
- Pharmaceutical form
- GASTRO-RESISTANT CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 4 billion CFU billion colony forming units
- Max total dose
- 4 billion CFU billion colony forming units
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07FA — ANTIDIARRHEAL MICROORGANISMS
- Marketing authorisation
- 49/442/00-C
- MA holder
- ARDEYPHARM GMBH
- MA country
- Czech Republic
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vseobecna Fakultni Nemocnice V Praze
- Sponsor organisation
- Vseobecna Fakultni Nemocnice V Praze
- Address
- U Nemocnice 499/2, Nove Mesto Nove Mesto
- City
- Prague
- Postcode
- 128 00
- Country
- Czechia
Scientific contact point
- Organisation
- Vseobecna Fakultni Nemocnice V Praze
- Contact name
- Prof. MUDr. Jarmila Heissigerová, Ph.D., MBA
Public contact point
- Organisation
- Vseobecna Fakultni Nemocnice V Praze
- Contact name
- Mgr. Martina Racková, MBA
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 9 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2023-06-02 | 2023-06-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Study Protocol_VFN-MIU-2021-01_v3_25April2022_clean | 3 |
| Protocol (for publication) | VFN-MIU-2021-01_Protocol_Amendment_01_Signed | 1 |
| Recruitment arrangements (for publication) | 1_Nabor_a_inf_souhlas | 1 |
| Subject information and informed consent form (for publication) | Inform souhlas_VFN-MIU-2021-01_v3_25-4-2022_clean | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | Mutaflor_SmPC_Summary_of_Product_Characteristics_ | 1 |
| Synopsis of the protocol (for publication) | Synopsis_Protocol VFN-MIU-2021-01_ver3_25April2022 | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Czechia | Acceptable 2024-10-23
|
2024-12-09 |