This trial will evaluate the efficacy, safety, and tolerability of a new drug for treating adults with IBD over a period of 26 weeks and 30 months.
- Crohn's Disease
- Ulcerative Colitis
2 Primary · 20 Secondary · Reporting Duration: Weeks 0, 4, 8, 10, 12, 16, 20, 24 and 26
4 Treatment Groups
TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)
1 of 4
TEV-48574 Dose Regimen A for Crohn's Disease (CD)
1 of 4
TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)
1 of 4
TEV-48574 Dose Regimen B for Crohn's Disease (CD)
1 of 4
128 Total Participants · 4 Treatment Groups
Primary Treatment: TEV-48574 Dose Regimen A for Ulcerative Colitis (UC) · No Placebo Group · Phase 2
Who is running the clinical trial?
Age 18 - 75 · All Participants · 4 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
Are individuals aged thirty and over eligible to join this trial?
"Conforming to the eligibility criteria for this trial, the youngest permitted participant is 18 years old and the oldest accepted patient is 75." - Anonymous Online Contributor
Has the FDA cleared TEV-48574 Dose Regimen A for Crohn's Disease (CD) treatments?
"Considering the evidence gathered in Phase 2 trials, TEV-48574 Dose Regimen A for Crohn's Disease (CD) received a safety score of two. This signifies that there are some data points indicating its security but insufficient proof to suggest efficacy." - Anonymous Online Contributor
Are there any vacancies for test subjects in this trial?
"Affirmative. Clinicaltrials.gov holds evidence that this medical experiment is still enrolling participants, with the first post dating back to November 1st 2023 and the last edit made on February 2nd2023. This clinical trial aims to recruit 128 individuals from one single location." - Anonymous Online Contributor
How many people have enrolled in this investigation thus far?
"Affirmative. The information posted on clinicaltrials.gov affirms that this medical trial is presently recruiting individuals for participation. It was initially listed on the 11th of January 2021 and most recently amended on the 2nd of February 2021. This study seeks to enrol 128 patients from a single site." - Anonymous Online Contributor
Is there a way to join this clinical trial?
"This trial seeks 128 individuals diagnosed with ulcerative colitis, aged between 18 and 75. The specific requirements for enrolment include demonstrating clinical response or remission during the 14-week TV48574-IMM-20036 DRF study as well a negative β-human chorionic gonadotropin test result for women of childbearing potential, who must also practice effective contraception methods. Moreover, male participants in such partnerships are expected to use condoms post initial IMP administration until completion of the research project. More details can be acquired by contacting the lead investigator directly." - Anonymous Online Contributor