ABTECT-1: A potential new treatment for UC

The ABTECT-1 Study is being done to learn more about an investigational medication, called Obefazimod or ‘ABX464’, and its effect in people with ulcerative colitis (UC). UC causes inflammation in the lining of the colon (large
intestine). The main symptoms of UC are pain and recurring diarrhoea, which may contain blood and/or mucus.
This study aims to check:
- if 2 different doses of the study medication work in controlling the symptoms of UC
- how safe the investigational medication is.

Category
Trial Status
Recruiting
Trial Phase
Phase 3 Drug Trial
ERM Project ID
100622
Trial contact details
Contact Person
Sharyn Grossman
What you need to know

Who can take part?

To participate, you must:
- Be 18-75 years of age
- Have UC diagnosis confirmed by endoscopy & histology
- Have had previous treatment for UC (confirm requirements with study team)
- Have test results within expected ranges
- Not have an additional condition that may impact your UC treatment
- Not have failed 5-ASA only therapy
- Have planned surgery
- Not be taking probiotics

What is involved for me?

- Take one tablet, daily
- Colonoscopy with biopsy
- Blood tests
- Daily diary completion
- Vital Signs
- ECG
- Questionnaires
- Eye exam
- Stool tests
- Optional Cardiac testing

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