Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: PB016: Stage 1: Induction Period â?? after 1:1 randomization, intravenous infusions of either PB016 or Entyvio® at a dose of 300 mg at Weeks 0 and 2.
Stage 2: Maintenance Period â?? f
Sponsors
Polpharma Biologics S.A.
Worldwide Clinical Trials India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. At Screening, females of childbearing potential must be non-pregnant and non-lactating; or females should be of non-childbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year post menopausal [amenorrhea duration of 12 consecutive months]) non-pregnancy will be confirmed for all females of childbearing potential by a serum pregnancy test conducted at Screening.2.Female patients of childbearing potential, with a fertile male sexual partner, must use adequate contraception from Screening until 18 weeks after the last dose of study drug. Adequatecontraception is defined as using hormonal contraceptives or an intrauterine device, combined with at least one of the following forms of contraception: a diaphragm or cervical cap, or a condom. Total abstinence from heterosexual activity, inaccordance with the lifestyle of the patient, is acceptable.3. Male patients who are sexually active with women of childbearing potential agree they will use adequate contraception from Screening until 90 days after the last dose of study drug if not surgically sterilized at least 6 months before Screening (with a post-vasectomy semen analysis negative for sperm). Male patients must not donate sperm until 90 days after the last dose of study drug. Adequate contraception for the male patient and his female partner of childbearing potential is defined as using hormonal contraceptives or an intrauterine device, combined with at least one of the following forms of contraception: a diaphragm or cervical cap, or a condom. Total abstinence from heterosexual activity, in accordance with the lifestyle of the patient, is acceptable.4. Diagnosis of moderate to severe UC established at least 6 months prior to Screening by clinical and endoscopic evidence, corroborated by a histopathology report and confirmed by the Investigator.5. Moderately to severely active UC as determined by a complete Mayo score of 6 to 12 with an endoscopic sub-score is more than or equal to 2, confirmed by a central reader within 28 days prior to randomization.6. Evidence of UC extending proximal to the rectum (is greater than or equal to 15 cm of involved colon).7. Patients with extensive colitis or pancolitis of greater than 8 years duration or left-sided colitis of greater than 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. Patients with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age greater than 45 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during Screening).
Exclusion criteria
Exclusion criteria: 1. Previous exposure to vedolizumab (Entyvio® or any other investigational vedolizumab containing product). 2. Female patients 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 study drug administration 3. Within 30 days prior to randomization, has received any of the following for the treatment of underlying disease: a. Non-biologic therapies (e.g., cyclosporine, thalidomide) other than those specifically listed in Inclusion Criterion 8. b. A non-biologic investigational therapy c. An approved non-biologic therapy in an investigational protocol 4. Has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives prior to randomization (whichever is longer) 5. Has had prior exposure to approved or investigational anti-integrin antibodies (e.g., natalizumab, efalizumab, etrolizumab, AMG-181, anti-MAdCAM-1 antibodies) or antiCD20 antibodies (e.g., rituximab) 6. Evidence of abdominal abscess or toxicmegacolon at the Screening Visit. 7. Extensive colonic resection, subtotal or total colectomy 8. History of ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine 9. Diagnosis of Crohnâ??s disease, microscopic colitis, ischemic colitis or indeterminate colitis. 10. Had any surgical procedure requiring general anesthesia within 30 days prior to randomization or the patient currently requires or is anticipated to require surgical intervention for UC during the study 11. Has any identified congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation). 12. Has any live vaccination within 30 days prior to Screening or is planning to receive any live vaccination during participation in the study 13. Has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks prior to randomization unless taken on stable dose for at least 2 weeks before randomization 14. Has any unstable or uncontrolled cardiovascular disorder, heart failure moderate to severe (New York Heart Association Class III or IV), any pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the Investigator, would confound the study results or compromise patient safety 15. Has received total parenteral nutrition or albumin in the last 30 days prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate similarity of effect of induction treatment with IV formulations of PB016 & Entyvio® on clinical response rate at 6 weeksTimepoint: Clinical response rate, defined as the proportion of patients with a reduction in complete Mayo score of greater than or equal to 3 points & greater than or equal to 30% from Baseline with an accompanying decrease in rectal bleeding (RB) sub-score of greater than or equal to 1 point or absolute RB sub-score of less than or equal to 1 point, at Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate similarity of effect of maintenance treatment with IV formulations of PB016 & Entyvio® on clinical response rate at 52 weeksTimepoint: Clinical response rate at Week 52;To demonstrate similarity of effect of IV PB016 & Entyvio® on partial Mayo scoreTimepoint: Change from Baseline in partial Mayo score at Weeks 2, 6, 14, 22, 30, 38, 46, & 52;To demonstrate similarity of effect of IV PB016 & Entyvio® on clinical remission rateTimepoint: Clinical remission rate, defined as the proportion of patients with complete Mayo score of less than or equal to 2 points & no individual sub-score 1 point, at Weeks 6, and 52.;To demonstrate similarity of effect of IV PB016 & Entyvio® on mucosal healing rateTimepoint: Mucosal healing rate, defined as the proportion of patients with a Mayo endoscopic sub-score of less than or equal to 1 point, at Weeks 6, and 52;To demonstrate similarity of effect of IV PB016 & Entyvio® on corticosteroid-free remission rateTimepoint: Corticosteroid-free remission rate, defined as the proportion of patients using oral corticosteroids at Baseline who have discontinued corticosteroids & are in clinical remission at Week 52;To demonstrate similarity of IV PB016 and Entyvio® on immunogenicityTimepoint: Number of patients with anti-drug antibodies (ADAs) & neutralizing antibodies (NAb) at Baseline and at Weeks 2, 6, 14, 30, and 52 | — |
Countries
Albania, Australia, Bosnia and Herzegovina, Brazil, Bulgaria, Czech Republic, Georgia, Hungary, India, Israel, Latvia, Poland, Romania, Slovakia, South Africa, Turkey
Contacts
Public ContactShamim Anwar
Worldwide Clinical Trials India Pvt. Ltd,
Outcome results
None listed