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Monoclonal Antibodies

TEV-48574 for Inflammatory Bowel Disease

Phase 2
Recruiting
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Maintenance Period- Participants who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 4, 8, 16, 28, 44, and 48
Awards & highlights

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.

Who is the study for?
This trial is for adults with moderate to severe Ulcerative Colitis or Crohn's Disease who showed improvement in a previous 14-week study. Women must not be pregnant, should test negative for pregnancy, and use effective birth control. Men with partners of childbearing potential must use condoms.Check my eligibility
What is being tested?
The trial tests two different long-term dosing regimens of TEV-48574, administered every four weeks by injection under the skin. It aims to determine the effectiveness, safety, tolerability, and immune response over up to 66 weeks per participant.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions related to TEV-48574 injections which could include typical drug-related intolerances such as injection site reactions or systemic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I showed improvement or remission at week 14 of my previous study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 4, 8, 16, 28, 44, and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 4, 8, 16, 28, 44, and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with moderate to severe Crohn's disease (CD) who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease
Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score
Secondary outcome measures
Number of ADA positive participants with the presence of neutralizing ADA
Number of Participants Who Experience Adverse Events
Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)
+9 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)Experimental Treatment1 Intervention
Administered by subcutaneous infusion for participants with UC
Group II: TEV-48574 Dose Regimen B for Crohn's Disease (CD)Experimental Treatment1 Intervention
Administered by subcutaneous infusion for participants with CD
Group III: TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)Experimental Treatment1 Intervention
Administered by subcutaneous infusion for participants with UC
Group IV: TEV-48574 Dose Regimen A for Crohn's Disease (CD)Experimental Treatment1 Intervention
Administered by subcutaneous infusion for participants with CD

Find a Location

Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
251 Previous Clinical Trials
3,485,160 Total Patients Enrolled
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
93 Previous Clinical Trials
38,555 Total Patients Enrolled

Media Library

TEV-48574 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05668013 — Phase 2
Crohn's Disease Research Study Groups: TEV-48574 Dose Regimen A for Ulcerative Colitis (UC), TEV-48574 Dose Regimen A for Crohn's Disease (CD), TEV-48574 Dose Regimen B for Ulcerative Colitis (UC), TEV-48574 Dose Regimen B for Crohn's Disease (CD)
Crohn's Disease Clinical Trial 2023: TEV-48574 Highlights & Side Effects. Trial Name: NCT05668013 — Phase 2
TEV-48574 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05668013 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~144 spots leftby Jul 2031