K51 NULL NULL
Conditions
Interventions
Subjects will receive AVT16 300 mg IV once at Week 0, Week 2, Week 6, and every 8 weeks until Week 46 (14, 22, 30, 38, 46). - Subjects will receive Entyvio 300 mg IV once at Week 0, Week 2, Week 6, an
Sponsors
Alvotech Swiss AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each subject must meet all of the following criteria to be enrolled in this study: 1. Male or female subjects aged 18 to 80 years inclusive at the time of signing the informed consent form (ICF) who are voluntarily able to give informed consent. 2. Female subjects are eligible to participate if they are not pregnant, not breastfeeding, and at least ONE of the following conditions applies: a. Is not a woman of childbearing potential (WOCBP), defined as: i. Surgically sterile, or ii. Postmenopausal b. Is a WOCBP who agrees to use a highly effective method of contraception consistently and correctly from screening (signing the ICF) until at least 15 weeks after the last IP administration. 3. Nonsterilized male subjects with female partners of childbearing potential are eligible to participate if they agree to one of the options established by the protocol from screening (signing the ICF) until at least 15 weeks after investigational product administration. 4. Diagnosis of ulcerative colitis established 5. Moderately to severely active ulcerative colitis 6. Evidence of ulcerative colitis 7. Subjects with extensive colitis or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during screening). 8.Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or another known risk factor must be up to date on colorectal cancer surveillance (may be performed during screening). 9. Demonstrated, over the previous 5-year period, an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below: a. Corticosteroids i. Signs and symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to prednisone 30 mg daily orally for 2 weeks or IV for 1 week OR ii. Two failed attempts to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally OR iii. History of intolerance of corticosteroids (including, but not limited to Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection). b. Immunomodulators i. Signs and symptoms of persistently active disease despite a history of at least one 8-week regimen of oral azathioprine (=1.5 mg/kg) or 6-mercaptopurine (=0.75 mg/kg) OR ii. History of intolerance of at least one immunomodulator (including, but not limited to, nausea/vomiting, abdominal pain, pancreatitis, liver function tests [LFT] abnormalities, lymphopenia, thiopurine methyltransferase [TPMT] genetic mutation, infection). 10. May be receiving a therapeutic dose of the following drugs: a. Oral 5-aminosalicylic acid (5-ASA) compounds provided b. Oral corticosteroid therapy c. Probiotics (eg, Culturelle, Saccharomyces boulardii) provided d. Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea. e. Azathioprine or 6-mercaptopurine
Exclusion criteria
Exclusion criteria: Subjects will be excluded if any of the following criteria apply at any time from screening up to Day 0 prior to IP administration: Gastrointestinal Exclusion Criteria 1. Evidence of abdominal abscess or toxic megacolon or fulminant stage of disease during the screening period. 2. Extensive colonic resection, subtotal, or total colectomy. 3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. 4. Prior treatment with TNF antagonist and/or any other biological therapy for UC. 5. Have received any of the following for the treatment of underlying disease: a. other than those permitted in the study if last dose was given prior to the baseline endoscopy. b. 6. Use of topical (rectal) treatment with within prior to baseline endoscopy. 7. Evidence of or treatment for infection within or other intestinal pathogen within prior to baseline endoscopy. 8. Currently require or are anticipated to require surgical intervention for ulcerative colitis during the study. 9. History or evidence of adenomatous colonic polyps that have not been removed. 10. History or evidence of any grade of colonic mucosal dysplasia. 11. Diagnosis of Crohn’s colitis or indeterminate colitis. Infectious Disease Exclusion Criteria 12. Chronic hepatitis B or C infection. 13. Active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following: a. History of TB. b. A positive diagnostic TB test within 1 month of enrollment defined as: i. a positive QuantiFERON® test or 2 successive indeterminate QuantiFERON tests. c. Chest X-ray within 3 months of enrollment in which active or latent pulmonary TB cannot be excluded. Note: Subjects with an indeterminate QuantiFERON test are allowed if they have all of the following: a. No evidence of active TB on chest radiograph within 3 months prior to the first dose of IP. b. Documented history of 3 weeks of prophylaxis initiation prior to receiving IP in accordance with local recommendations and intends to complete its entire course during the study. c. No known exposure to active TB after most recent prophylaxis. d. Asymptomatic at screening and baseline. Investigators should check with the medical monitor before enrolling such subjects. 14. Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, HIV infection, organ transplantation). 15. Any live vaccinations within 30 days prior to IP administration except for an influenza vaccine. 16. Clinically significant extra-intestinal infection (eg, pneumonia, pyelonephritis) within 30 days prior to baseline endoscopy. General Exclusion Criteria 17. Previous exposure to vedolizumab. 18. Female subjects who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 0 prior to IP administration. 19. Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety. 20. Have had any surgical procedure requiring general anesthesia within 30 days prior to baseline endoscopy or are planning to undergo major surgery during the study period. 21. Any history of malignancy, except for the following: (a) adequately treated nonmetastatic basal cell skin cancer; (b) any other type of nonmelanoma skin cancer that has been
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Mayo Clinic score (Subject Diary, endoscopy and physician assessment) NAME OF THE RESULT: Clinical Response at Week 6 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Baseline and Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Mayo Clinic score (Subject Diary, endoscopy and physician assessment) NAME OF THE RESULT: Clinical Response at Week 6 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Baseline and Week 6;Partial Mayo Clinic score (Subject Diary and physician assessment) NAME OF THE RESULT: Clinical response at Weeks 14, 22, 30, 38 and 46 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 14, 22, 30, 38 y 46;Complete Mayo Clinic score (Subject Diary, endoscopy and physician assessment) NAME OF THE RESULT: Clinical Response at Week 52 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 52;Complete Mayo Clinic Score (Subject Diary, endoscopy and physician assessment) NAME OF THE RESULT: Clinical Remision at Week 6 and Week 52 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 6 and week 52;Modified Mayo Clinic score (mMCS) (Subject Diary and endoscopy) NAME OF THE RESULT: Clinical Remission at Week 52 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 52;Endoscopy NAME OF THE RESULT: Mucosal healing at Week 6 and Week 52 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 6 and week 52;Registration of Glucocorticoid use and Complete Mayo Clinic score (Subject Diary, endoscopy and physician assessment). NAME OF THE RESULT: To further compare the efficacy of AVT16 with Entyvio. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From baseline through Week 52;Albumin Test NAME OF THE RESULT: Albumin levels PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Baseline, week 6 and week 52;C-reactive Protein (CRP) Test NAME OF THE RESULT | — |
Countries
Argentina, Bosnial and Herzegovina, Bulgaria, Colombia, Croatia, Czech Republic, Georgia, Greece, Hungary, India, Italy, Latvia, Mexico, Peru, Poland, Romania, Serbia, Slovakia, Spain, Sri Lanka, Ukraine
Contacts
Public ContactJUANITA ACHING
PPD PERU S.A.C.
Outcome results
None listed