Comparing a new biosimilar treatment for ulcerative colitis to an existing medication

A Randomized, Double-blind, Multicenter Phase 3 Study in Patients With Moderately to Severely Active Ulcerative Colitis (UC) to Compare the Efficacy, Safety and Immunogenicity of PB016 and Entyvio® for the Induction and Maintenance of Clinical Response and Remission

This study is testing a new treatment for ulcerative colitis to see if it works as well and is safe compared to an existing medication called Entyvio.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 750 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Polpharma Biologics S.A. (Industry-sponsored)
• Drugs / interventions: vedolizumab
• Locations: 1 site (Tbilisi)
• Trial ID: NCT05771155 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, randomized, parallel arm, double-blind study involving approximately 750 participants with moderately to severely active ulcerative colitis. Participants will be randomly assigned to receive either the proposed biosimilar PB016 or the established medication Entyvio® over a 54-week period, with doses administered intravenously. The study aims to evaluate the efficacy, safety, and immunogenicity of PB016 compared to Entyvio®, with a structured follow-up to monitor safety outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with moderately to severely active ulcerative colitis.

Not a fit: Patients who are not within the specified age range or who have mild ulcerative colitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective alternative treatment for patients with ulcerative colitis, potentially at a lower cost.

How similar studies have performed: Other studies have shown success with similar biosimilar approaches, indicating potential for this treatment to be effective.

Eligibility criteria

(Selected) 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.

(Selected) Exclusion Criteria:

* Previous exposure to vedolizumab (Entyvio® or any other investigational vedolizumab containing product).
* 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.
* Has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives prior to randomization (whichever is longer).
* Evidence of abdominal abscess or toxic megacolon at the Screening Visit.
* Extensive colonic resection, subtotal or total colectomy.
* History of ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
* History or evidence of colonic mucosal dysplasia.
* Diagnosis of Crohn's disease, microscopic colitis, ischemic colitis or indeterminate colitis.
* 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.
* Has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia.
* Has any of the following:

Evidence of a serious active or clinically significant infection requiring medical treatment or that in the opinion of the Investigator would confound the study results, during Screening or has been hospitalized or treated for such infection within 60 days of Baseline (e.g., sepsis, cytomegalovirus, listeriosis or opportunistic infections such as PML).

OR Evidence of or received treatment for C. difficile infection within 60 days, or other intestinal pathogen within 30 days prior to Screening. Rescreening of treated patients with no clinical signs and subsequent negative test results can be allowed at the Investigator's discretion.

OR Other current or recent (within 30 days prior to Screening) clinically significant infection (e.g., pneumonia, pyelonephritis).

* Chronic hepatitis B or C infection. Patients with positive viral serology at Screening for infection with hepatitis B (HBV), or hepatitis C virus (HCV) may be eligible if polymerase chain reaction test is negative, and the patient receives standard of care antiviral prophylaxis (if applicable).
* 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®.

Where this trial is running

Tbilisi

• Todua Clinic LLC — Tbilisi, Georgia (Recruiting)

Study contacts

• Study coordinator: Monika Fus-Szewczyk, Dr.

Conditions Ulcerative Colitis; ulcerative colitis; vedolizumab; biosimilar