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TEV-48574 Dose Regimen A for Ulcerative Colitis (UC) for Crohn's Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Teva Investigational Site 15357, Kissimmee, FLCrohn's Disease+1 MoreTEV-48574 Dose Regimen A - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
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Study Summary

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.

Eligible Conditions
  • Crohn's Disease
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 20 Secondary · Reporting Duration: Weeks 0, 4, 8, 10, 12, 16, 20, 24 and 26

Up to Week 24
Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events
Up to Week 26
Number of Participants Who Experience Adverse Events
Number of participants who report the use of concomitant medications
Number of participants with infusion device-related adverse events and malfunctions
Week 24
Number of participants with moderate to severe CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease
Number of participants with moderate to severe CD with Endoscopic remission as defined by SES-CD score
Number of participants with moderate to severe CD with a Histologic response as defined by Global Histologic Activity score
Number of participants with moderate to severe CD with an Endoscopic response as defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD)
Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score
Number of participants with moderate to severe UC who show clinical remission as defined by the Mayo score
Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score
Number of participants with moderate to severe UC with Histological remission defined as Geboes index score ≤3.1
Number of participants with moderate to severe UC with Histological remission defined as a Robarts Histopathology Index of ≤5
Number of participants with moderate to severe UC with a clinical response as defined by Mayo score
Week 0
Number of participants with moderate to severe CD in clinical remission as defined by CDAI score
Number of participants with moderate to severe CD in clinical remission as defined by PRO2 score
Number of participants with moderate to severe CD with a clinical response as defined by PRO2 score
Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index
Number of participants with moderate to severe UC in Clinical remission based on PRO2 score
Week 0
Number of ADA positive participants with the presence of neutralizing ADA
Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)
Week 0
Number of participants with moderate to severe UC with a clinical response based on patient-reported outcome (PRO2)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
Vancomycin
2
Dupilumab
2
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Trial Design

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

Experimental Treatment

128 Total Participants · 4 Treatment Groups

Primary Treatment: TEV-48574 Dose Regimen A for Ulcerative Colitis (UC) · No Placebo Group · Phase 2

TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)
Drug
Experimental Group · 1 Intervention: TEV-48574 Dose Regimen A · Intervention Types: Drug
TEV-48574 Dose Regimen A for Crohn's Disease (CD)
Drug
Experimental Group · 1 Intervention: TEV-48574 Dose Regimen A · Intervention Types: Drug
TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)
Drug
Experimental Group · 1 Intervention: TEV-48574 Dose Regiment B · Intervention Types: Drug
TEV-48574 Dose Regimen B for Crohn's Disease (CD)
Drug
Experimental Group · 1 Intervention: TEV-48574 Dose Regiment B · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 0, 4, 8, 10, 12, 16, 20, 24 and 26

Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
244 Previous Clinical Trials
3,482,755 Total Patients Enrolled
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
87 Previous Clinical Trials
35,769 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
There may be more requirements to participate. Please contact the researcher for more information.
References

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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