Trials Sponsors Conditions Drugs Pricing

Conditions

Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

The primary endpoint of this study is the proportion of subjects in clinical remission according to the modified Mayo score at week 12 compared to the day of screening (remission defined as the proportion of subjects with Mayo subscores of 0 for rectal bleeding, 0 or 1 for stool frequency, and 0 or 1 for endoscopy [modified excluding friability]).

Interventions

TregType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Established diagnosis of active UC, with minimum time from diagnosis of ≥ 3 months and confirmed by endoscopy extending 15 cm or more above the anal verge, with a mMayo score of 5-9, including an endoscopic subscore of ≥ 2 (modified to exclude friability from grade 1), WHO performance status of 0, 1 or 2
age ≥ 18 years

You may not qualify if:

Sponsors & Collaborators

Universitaetsklinikum Erlangen AöR
Type not reportedlead

Study Sites (2)

Universitaetsklinikum Erlangen AöR

Erlangen, 91054, Germany

Markus Neurath091318535204 markus.neurath@uk-erlangen.de

Charite Universitaetsmedizin Berlin KöR

Berlin, 12203, Germany

Britta Siegmund030450514342 britta.siegmund@charite.de

Central Study Contacts

Prof. Dr. Caroline Voskens

091318535000 caroline.bosch-voskens@uk-erlangen.de

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

May 22, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-520628-11-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 06:11:22 UTC

Documents

D1_Protocol_ER-TREG-02_redacted

Multi-center, single-arm, phase II clinical trial evaluating efficacy and in-vivo homing of adoptively transferred autologous ex-vivo expanded regulatory T cells in adults with ulcerative colitis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

Locations