BridgeMD
New treatment option for Crohn's Disease
Official title A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease
ClinicalTrials.gov ID: NCT05837897
What this study is testing
What is Vedolizumab IV?
Vedolizumab IV is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for crohn's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China. Participants will receive an injection of Vedolizumab 300 mg at scheduled weeks 0, 2, and 6, and starting at week 14, every 8 weeks over 58 weeks or starting at week 18, every 4 weeks over 54 weeks.
- Phase 3: a large, late-stage study
- Time commitment: about 58 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence corroborated by a...
- The participant has moderately to severely active CD as determined by a 2-component patient-reported outcome (PRO2) score of 14 to 34 points and a...
- The participant has CD involvement of the ileum and/or colon, at a minimum.
- A participant with extensive colitis or pancolitis of \>8 years duration or limited colitis of \>12 years duration must have documented evidence that...
- A participant with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk...
You likely can't join if
- I. Gastrointestinal (GI) Exclusion Criteria:
- The participant has evidence of abdominal abscess at the initial screening visit.
- The participant has had extensive colonic resection, subtotal or total colectomy.
- The participant has a history of \>3 small bowel resections or diagnosis of short bowel syndrome.
- The participant has received tube feeding, defined formula diets, or parenteral alimentation within 21 days before administration of the first dose...
- The participant has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or evidence of fixed stenosis, or small bowel...
See the full eligibility criteria
Who can join
- The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence corroborated by a histopathology report. Cases of CD established at least 6 months before...
- The participant has moderately to severely active CD as determined by a 2-component patient-reported outcome (PRO2) score of 14 to 34 points and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥6 (or ≥4...
- The participant has CD involvement of the ileum and/or colon, at a minimum.
- A participant with extensive colitis or pancolitis of \>8 years duration or limited colitis of \>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months before...
- A participant with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be...
- The participant has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
- Corticosteroids.
- Immunomodulators.
- TNF-α antagonists.
What rules you out
- I. Gastrointestinal (GI) Exclusion Criteria:
- The participant has evidence of abdominal abscess at the initial screening visit.
- The participant has had extensive colonic resection, subtotal or total colectomy.
- The participant has a history of \>3 small bowel resections or diagnosis of short bowel syndrome.
- The participant has received tube feeding, defined formula diets, or parenteral alimentation within 21 days before administration of the first dose of study drug.
- The participant has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or evidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.
- Within 30 days before randomization, the participant has received any of the following for the treatment of underlying disease:
- Nonbiologic therapies (eg, cyclosporine, thalidomide) other than those specifically listed in the Permitted Medications and Treatments section.
- An approved or investigational nonbiologic therapy in an investigational protocol.
- The participant has received traditional Chinese medication (TCMs) within 30 days before randomization.
- The participant has had previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or abrilumab (AMG-181), or mucosal vascular addressin cell...
- The participant has had previous exposure to vedolizumab.
- The participant has used topical (rectal) treatment with 5-aminosalicylic acid (5-ASA), corticosteroid enemas/suppositories or traditional Chinese medications for CD treatment within 2 weeks of the administration of the...
- The participant requires currently or is anticipated to require surgical intervention for CD during the study.
- The participant has a history or evidence of adenomatous colonic polyps that have not been removed.
- The participant has a history or evidence of colonic mucosal dysplasia including low or high-grade dysplasia, as well as indeterminate for dysplasia. II. Infectious Disease Exclusion Criteria
- The participant has evidence of active infection during the screening period.
- The participant has evidence of treatment for Clostridioides difficile (C difficile) infection or other intestinal pathogen within, 28 days before first dose of study drug.
- The participant has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection.
- The participant has active or latent tuberculosis (TB).
- The participant has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
- The participants has received any live vaccinations within 30 days before screening.
- The participant has a clinically significant active infection (eg, pneumonia, pyelonephritis, or coronavirus disease 2019 [COVID-19]) within 30 days before screening or during screening, or has an ongoing chronic...
- The participant has had any surgical procedure requiring general anesthesia within 30 days before enrollment or is planning to undergo major surgery during the study period.
- The participant has any history of malignancy, except for the following: (a) adequately-treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and has not recurred...
- The participant has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Wuhu, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Lanzhou, Gansu, China
- Foshan, Guangdong, China
- Guangzhou, Guangdong, China
- Huizhou, Guangdong, China
- Qingyuan, Guangdong, China
- Shenzhen, Guangdong, China
- Zhuhai, Guangdong, China
- Shijiazhuang, Hebei, China
- Haerbin, Heilongjiang, China
- Nanyang, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Changzhou, Jiangsu, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Xuzhou, Jiangsu, China
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 58 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Wuhu, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Lanzhou, Gansu, China; Foshan, Guangdong, China and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.