Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
140
Countries
1
Sites
1
Ulcerative colitis
Comparing pre-post treatment clinical findings in correlation with changes in commensal microbiota composition and function
Key facts
- Sponsor
- Pirkanmaan hyvinvointialue
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2026-03-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
Comparing pre-post treatment clinical findings in correlation with changes in commensal microbiota composition and function
Conditions and MedDRA coding
Ulcerative colitis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- 6-16 years old with established diagnosis of atypical UC (presenting right-sided colitis, backwash ileitis, or rectal sparing, and/or positive atypical pANCA or PR3-ANCA) with confirmed PSC in MRCP (PSC-UC) or without detectable PSC (aUC-non-PSC), and children with typical UC without PSC
- Has nor received OVT preciously, but patients and/or their guardians has given an informed consent to commence OVT for at least 3 months for treating PSC-UC or aUC-non-PSC
- Able to swallow capsules
- Do not have active infection (such as clostridium or other bacteria) if the clinical stool screening before starting OVT
- No new interventions (medications or new conventional therapies) for treating IBD was given within the past 4 weeks before starting OVT • May use contraceptives or other medications that are not antibiotics
- May use contraceptives or other medications that are not antibiotics
- For healthy participant: no symptoms or suspicion of inflammatory bowel diseases but are scheduled for endoscopy for other reasons
Exclusion criteria 7
- PSC without UC; Crohn’s disease type of inflammatory bowel diseases.
- Under the age of 6 years old
- Is unable to swallow capsules
- Had a previous allergic reactions to vancomycin (such as vancomycin allergy) and/or other related antibiotics similar to vancomycin
- Presence of malignant disease or potential need for liver transplantation within the following 12 months
- Pregnancy
- For healthy controls: presence of chronic illness requiring long-term medications, use of antibiotics within the past 6 months
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Suolen tervehtyminen (remissio eli lapsi on oireeton ja ulosteen kalprotektiini on alle 100)
- Miltä suolen bakteeristo näyttää ennen vankomysiinihoitoa tai tavanomaista hoitoa tulehduksen aikana ja remissiossa hoidon aloittamisen jälkeen
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Vancomycin Xellia 250 mg, kapseli, kova
PRD377905 · Product
- Active substance
- Vancomycin Hydrochloride
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 548 g gram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07AA09 — VANCOMYCIN
- Marketing authorisation
- 11661
- MA holder
- XELLIA PHARMACEUTICALS APS
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vancomycin Xellia 125 mg, kapseli, kova
PRD377900 · Product
- Active substance
- Vancomycin Hydrochloride
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 548 g gram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07AA09 — VANCOMYCIN
- Marketing authorisation
- 11660
- MA holder
- XELLIA PHARMACEUTICALS APS
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pirkanmaan hyvinvointialue
- Sponsor organisation
- Pirkanmaan hyvinvointialue
- Address
- Elamanaukio 2
- City
- Tampere
- Postcode
- 33520
- Country
- Finland
Scientific contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Laura Räisänen
Public contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Saara Ojala
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 140 | 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 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-524543-12-00 | 1 |
| Protocol (for publication) | D1_Protocol_2025-524543-12-00_Redacted | 3.0 |
| Protocol (for publication) | D4_Patient facing document_PedsQL FI | 1 |
| Protocol (for publication) | D4_PUCAI_kyselylomake | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_clean | 3 |
| Subject information and informed consent form (for publication) | L1_Notification_Guardian_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_12-14v | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_12-14v_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-16v | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-17v_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_alle 12v | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_alle 12v_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_huoltaja | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_huoltaja_redacted | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Vankomysiini_Xellia | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Vankomysiini_Xellia | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-08 | Finland | Acceptable 2026-03-13
|
2026-03-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-31 | Finland | Acceptable 2026-03-13
|
2026-03-31 |