What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis that modulate the immune response include biologics (e.g., infliximab, adalimumab), immunomodulators (e.g., azathioprine, 6-mercaptopurine), and newer agents like vedolizumab. These treatments can have side effects such as increased risk of infections, infusion reactions, and potential development of antibodies against the drugs. Immunomodulators may cause bone marrow suppression, liver toxicity, and increased risk of certain cancers. Corticosteroids, often used for flare-ups, can lead to weight gain, osteoporosis, hypertension, and diabetes. 5-aminosalicylates (5-ASA) are generally well-tolerated but can cause headaches, nausea, and rarely, kidney issues.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of Ulcerative Colitis, focusing on modulating the immune response. These include biologics such as infliximab (Remicade), adalimumab (Humira), and vedolizumab (Entyvio), which target specific components of the immune system to reduce inflammation. Additionally, immunosuppressive agents like azathioprine and 6-mercaptopurine have been used to maintain remission in UC patients. These treatments aim to control the overactive immune response characteristic of UC, similar to the investigational drug TEV-48574.

What other types of research exist?

Promising novel alternatives to TEV-48574 for Ulcerative Colitis patients include: <ol> <li>Vedolizumab (subcutaneous formulation) - Shown to be effective in a phase 3 study for moderate to severe UC.</li> <li></li> </ol> Ontamalimab - A fully-human monoclonal antibody targeting MAdCAM-1, demonstrated long-term efficacy and safety in the TURANDOT II study. 3. Ustekinumab - Effective in elderly patients with inflammatory bowel disease, including UC, as per recent studies.

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Monoclonal Antibodies

TEV-48574 for Ulcerative Colitis and Crohn's Disease (RELIEVE UCCD Trial)

Phase 2

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 4, 8, 12 and 14

Summary

This trial is testing a new medication called TEV-48574 on adults with moderate to severe Ulcerative Colitis or Crohn's Disease. The goal is to see if it can reduce inflammation and improve their symptoms.

Who is the study for?

Adults with moderate to severe Ulcerative Colitis or Crohn's Disease for at least 3 months can join. They must be able to understand the study and follow its rules. Women not of childbearing potential and men (even if vasectomized) with partners who can bear children must use contraception during the study.

What is being tested?

The trial is testing TEV-48574, a new treatment for IBD, against a placebo. The main goal is to see if it helps achieve clinical remission in UC or endoscopic response in CD after 14 weeks. Participants will also be checked for safety, tolerability, dose response, and immune reaction.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for general safety and tolerability which may include common drug-related adverse events such as allergic reactions, gastrointestinal issues, fatigue or infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 4, 8, 12 and 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, weeks 4, 8, 12 and 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 4, 8, 12 and 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Crohn Disease

Number of participants with moderate to severe UC who show clinical remission as defined by the Mayo score

Secondary study objectives

Number of Participants Who Experience Adverse Events

Number of participants with moderate to severe CD in clinical remission as defined by CDAI score

Cadmium

+8 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: TEV-48574 Dose B (UC)Experimental Treatment1 Intervention

Dose regimen B administered by Subcutaneous infusion for participants with UC

Group II: TEV-48574 Dose B (CD)Experimental Treatment1 Intervention

Dose regimen B administered by subcutaneous infusion for participants with CD

Group III: TEV-48574 Dose A (UC)Experimental Treatment1 Intervention

Dose regimen A administered by subcutaneous infusion for participants with UC

Group IV: TEV-48574 Dose A (CD)Experimental Treatment1 Intervention

Dose regimen A administered by subcutaneous infusion for participants with CD

Group V: Placebo UCPlacebo Group1 Intervention

Matching Placebo

Group VI: Placebo CDPlacebo Group1 Intervention

Matching Placebo

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Ulcerative Colitis (UC) include biologics, immunomodulators, and targeted therapies. Biologics such as infliximab and adalimumab work by inhibiting tumor necrosis factor-alpha (TNF-α), a cytokine involved in systemic inflammation. Immunomodulators like azathioprine and 6-mercaptopurine suppress the immune system to reduce inflammation. Targeted therapies, such as the investigational drug TEV-48574, aim to modulate specific components of the immune response, potentially offering more precise control of inflammation with fewer side effects. These treatments are vital for UC patients as they help induce and maintain remission, reduce symptoms, and improve overall quality of life.