Ulcerative Colitis
Conditions
Interventions
Study sites: The National Hospital of Sri Lanka, Colombo North Teaching Hospital, National Hospital, Galle, Jaffna Teaching Hospital, Colombo South Teaching Hospital, Kandy Teaching Hospital,
Randomi
Sponsors
Alvotech Swiss AG
Eligibility
Inclusion criteria
Inclusion criteria: 1 Males and females 2 Aged 18 to 80 years (Minimum 18 years and Maximum 80 years). 3 Female participants not pregnant or breastfeeding and using effective contraception if of childbearing potential. 4 Male participants using effective contraception or abstaining if they have female partners of childbearing potential. 5 Diagnosis of ulcerative colitis (UC) established at least 3 months prior to baseline endoscopy, confirmed by clinical, endoscopic, and histopathological evidence. 6 Moderate to severe UC with a Mayo Score of 6 to 12 with an endoscopic subscore greater than or equal to 2 within 14 days prior to the first dose of IP. 7 Evidence of UC extending beyond the rectum (greater than or equal to 15 cm from the anal verge) confirmed by endoscopy at least 3 months prior the baseline endoscopy 8 Documented surveillance colonoscopy for those with long-standing colitis for those of >8 years duration or left-sided colitis of >12 years or colorectal cancer risk factors. 9 History of inadequate response, loss of response, or intolerance to corticosteroids or immunomodulators.
Exclusion criteria
Exclusion criteria: 1. Evidence of severe UC complications (e.g., toxic megacolon), significant bowel surgery, or ileostomy/colostomy. 2. Prior treatment with TNF antagonists or other biological therapies for UC. 3. Recent use of certain nonbiologic therapies or topical treatments within specified timeframes. 4. Recent infections, need for surgery, or history of colonic polyps or mucosal dysplasia. 5. Chronic hepatitis B/C, active or latent TB, or immunodeficiency. 6. Recent live vaccination (except influenza), significant extra-intestinal infection, or neurological disorders. 7. Recent surgery or planned major surgery, history of malignancy (with specific exceptions). 8. Clinically significant lab abnormalities, recent alcohol/drug dependence, or active psychiatric issues. 9. Employment or close familial ties to study personnel or inability to comply with study procedures. 10. Evidence of or treatment for Clostridium difficile infection within 60 days or other intestinal pathogen (eg, Salmonella, Escherichia coli, etc.) within 30 days prior to baseline endoscopy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Response defined as a reduction in the complete Mayo Clinic score of at least 3 points and at least 30% from the baseline score with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. [Week 6] | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Response defined as a reduction of the partial Mayo Clinic score (reduction of less than or equal to 2 points and less than or equal to 25% from baseline). [Weeks 14, 22, 30, 38, and 46] Clinical Response defined as a reduction in the complete Mayo Clinic score of at least 3 points and at least 30% from the baseline score with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. [ Week 52] Clinical Remission defined as a reduction of the complete Mayo Score of =2 points and no individual subscore >1 point, and an endoscopic subscore of 0 or 1. [ Week 6 and Week 52] Clinical Remission: For this endpoint, moderately to severely active UC is defined as an mMCSa of 5 to 9 at Baseline. The mMCS is the 3 components of the Mayo Clinic score excluding the PGA. [ Week 52] Mucosal healing assessed as a Mayo endoscopic subscore =1 [normal/inactive disease or mild disease]. [ Week 6 and Week 52] Glucocorticoid-free remission in subjects receiving glucocorticoids at baseline (discontinuation of oral corticosteroids, followed by full Clinical Remission [by complete Mayo Clinic score] at Week 52). [ Week 52] Albumin levels [ Baseline, Week 6, and Week 52. ] CRP levels [ Baseline, Week 6, and Week 52.] Incidence, nature, and severity of adverse events (AEs), graded according to the current version of the common terminology criteria for adverse events (CTCAE); clinical laboratory assessments (hematology, clinical biochemistry, coagulation, inflammatory markers such as the erythrocyte sedimentation rate, urinalysis, and urine microscopy), vital signs, ECG, physical examination findings, targeted physical examination findings, infusion drug-related reactions, and injection site reactions. [ Throughout the study.] Titer and frequency of antidrug antibody (ADA) [ Baseline, Weeks 2, 6, 14, 22, 30, 38, 46 and 52.] Frequency of neutralizing antibody (Nab) [ Baseline, Weeks 2, 6, 14, 22, 30, 38 | — |
Countries
Argentina,Bosnia and Herzegovina,Colombia,Georgia,India,Mexico,Peru,Serbia,Sri Lanka,Ukraine
Contacts
Public ContactProf. Arjuna De Silva
Consultant Physician
Outcome results
None listed