Clinical trial • Phase III • Gastroenterology

GRT-001 for Ulcerative colitis

Phase III trial of GRT-001 for Ulcerative colitis. Randomised, placebo (dose/schedule not specified)-controlled, adaptive. 40 participants.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Ulcerative colitis
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
23-01-2026
First CTIS Authorization Date
15-04-2026

Trial design

Randomised, placebo (dose/schedule not specified)-controlled, adaptive Phase III trial across 1 site in Germany.

Randomised
Yes
Comparator
Placebo (dose/schedule not specified)
Adaptive
True, dose-escalation design stated; specific escalation rules, interim analyses or stopping rules not provided in the record
Target Sample Size
40

Eligibility

Recruits 40 No vulnerable population selected (isVulnerablePopulationSelected: false); population: Healthy volunteers (male and female). No consent/assent procedures or age-specific consent information provided in the record..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false); population: Healthy volunteers (male and female). No consent/assent procedures or age-specific consent information provided in the record.

Recruitment

Planned Sample Size
40
Recruitment Window Months
10

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Germany

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
16
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Charite Research Organisation GmbH
Contact Person Name
Stanislav Ignatenko
Number Of Participants
40

Sponsor

Primary sponsor

Full Name
Granite Bio AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
GRT-001
Routes Of Administration
Subcutaneous
Route
Subcutaneous

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