Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®

Inclusion Criteria

• •Age ≥18 and ≤75 years at Screening.
• •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.
• •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. Adequate contraception 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.
• •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.
• •Diagnosis of moderate to severe UC
• •Evidence of UC extending proximal to the rectum (≥15 cm of involved colon).
• •Patients with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>45 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during Screening).
• •Demonstrated an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents:
• •Corticosteroids, Immunomodulators, TNFα antagonists
• •Able to participate in all aspects of this clinical study, including collection of tissue biopsies.
• •Male or female patient who is voluntarily able to give informed consent.
• •Known active TB.
• •Has any identified congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
• •Has a history of hypersensitivity or allergies to the ingredients of Entyvio®.