Ulcerative Colitis (UC)
Conditions
Brief summary
To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.
Detailed description
This is a phase 2 randomized,double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI112 induction and maintenance therapy in subjects with moderate to severe active ulcerative colitis
Interventions
DRUGPeriod 1 IBI112 Placebo
Intravenous Injection
DRUGPeriod 2 IBI112 dose 3
Subcutaneous injections
DRUGPeriod 1 IBI112 dose 1
Intravenous Injection
DRUGPeriod 1 IBI112 dose 2
Intravenous Injection
DRUGPeriod 2 IBI112 dose 4
Intravenous Injection
DRUGPeriod 2 IBI112 Placebo
Subcutaneous injections
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of ulcerative colitis at least 3 months ago, including endoscopy evidence supporting UC and histopathological evidence supporting UC diagnosis; 2. Patients with moderate to severe ulcerative colitis, defined as modified Mayo Score ≥4 and endoscopic score ≥2; 3. Subject must have received at least one prior treatment or first use of a biological agent:
Exclusion criteria
1. Diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, uncertain colitis, etc., or crohn's disease; 2. UC lesions were limited to rectum or involved colon \< 15cm; 3. Evidence of toxic hirschsprung's disease was found during screening; 4. History or evidence of atypical hyperplasia of the colon, adenomatous polyps (not removed before entering the study) or gastrointestinal tumors;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of IBI112 in inducing clinical remission in patients with moderately to severely active ulcerative colitis (UC) | week 12 | Percentage of subjects who achieved clinical remission at week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of participants achieving symptomatic relief at Week 12. | week 12 | Symptomatic relief is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. |
| The proportion of participants achieving endoscopic remission at Week 12. | week 12 | Endoscopic remission is defined as an endoscopic subscore of 0 or 1 within the modified Mayo score. |
| The proportion of participants achieving mucosal healing at Week 12. | week 12 | Mucosal healing is defined as endoscopic remission, which means an endoscopic subscore of 0 or 1 within the modified Mayo score, and central Geboes histopathological index remission. |
| The proportion of participants achieving clinical remission at Week 52 during the maintenance treatment period. | week 52 | — |
| The proportion of participants achieving clinical response at Week 52 during the maintenance treatment period. | week 52 | — |
| The proportion of participants achieving a clinical response at Week 12. | week 12 | Clinical response is defined as a relative decrease from baseline in the modified Mayo score of ≥30% and ≥2 points, along with a relative decrease in the rectal bleeding subscore of ≥1 point or an absolute subscore of 0 or 1. |
| The proportion of participants achieving mucosal healing at Week 52 during the maintenance treatment period. | week 52 | — |
| The proportion of participants achieving endoscopic remission at Week 52 during the maintenance treatment period. | week 52 | — |
| The change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) scores at Week 12, Week 52 during the maintenance treatment period, and Weeks 24 and 64 during the extension treatment period. | Week 12, Week 52，Weeks 24 and 64 | — |
| The change from baseline in the 36-item Short Form Health Survey (SF-36) scores at Week 12, Week 52 during the maintenance treatment period, and Weeks 24 and 64 during the extension treatment period. | Week 12, Week 52，Weeks 24 and 64 | — |
| The proportion of participants achieving symptomatic relief at Week 52 during the maintenance treatment period. | week 52 | — |
Countries
China
Outcome results
None listed