The study is designed to investigate efficacy and safety of KBL697 in patients with mild to moderate active ulcerative colitis. KBL697 has been developed as a potential new treatment for ulcerative colitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
Proportion of Patients with Clinical Remission
Proportion of Patients with Clinical Remission at Week 8
Time frame: Week 8
Change from baseline in Partial Mayo Score
Change from baseline in Partial Mayo Score at Week 8 Minimum value: 0, Maximum value: 9, higher score mean a worse outcome
Time frame: Week 8
Portion of patients with Endoscopic subscore change
Portion of patients with endoscopic subscore decrease to ≥ 1 at Week 8
Time frame: Week 8
Change from baseline in C-reactive Protein
Change from baseline in concentration of C-reactive Protein
Time frame: Week 8
Change from baseline in Fecal Calprotectin
Change from baseline in concentration of fecal Calprotectin
Time frame: Week 8
Changes from baseline in Inflammatory Bowel Disease Questionnaire score
Changes from baseline in Inflammatory Bowel Disease Questionnaire score Minimum value: 0, Maximum value: 224, higher score mean a worse outcome
Time frame: Week 8
Change from baseline in Histologic Disease Activity
Change from baseline in histologic disease activity measured by Geboes score
Time frame: Week 8
Safety measure through incidence of treatment-emergent adverse events (TEAEs)
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Occurrence of TEAEs, treatment-related TEAEs, TEAEs by severity (mild/moderate/severe), serious TEAEs, TEAEs leading to dose adjustment, treatment termination, or death will be summarized by actual treatment groups respectively.
Time frame: Week 12