What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, such as anti-TNF agents (infliximab, adalimumab), ustekinumab, and vedolizumab, have several known side effects. Anti-TNF agents can cause infections, including bacterial, viral, and fungal infections, and may increase the risk of malignancy. Ustekinumab, which targets IL-12 and IL-23, commonly causes infections and nasopharyngitis. Vedolizumab, an anti-integrin antibody, can lead to headaches, arthralgias, and nasopharyngitis. All these treatments require careful monitoring for adverse effects, particularly infections.

What prior FDA approvals exist?

Several biologic agents have been FDA-approved for the treatment of Crohn's Disease, targeting various inflammatory pathways. Anti-TNF agents such as infliximab, adalimumab, and certolizumab pegol are commonly used to reduce inflammation by inhibiting tumor necrosis factor-alpha. Vedolizumab, an anti-integrin agent, targets the alpha-4-beta-7 integrin to prevent immune cells from migrating to the gut. Ustekinumab, an anti-IL 12/23 agent, blocks interleukin-12 and interleukin-23 to reduce inflammation. These treatments are similar to the investigational drug TEV-48574, which is likely a monoclonal antibody targeting an inflammatory pathway in IBD.

What other types of research exist?

Promising novel alternatives to TEV-48574 for Crohn's Disease patients include: 1) Risankizumab, an interleukin-23 antibody, which has shown efficacy and acceptable safety in phase 2 studies. 2) Anti-IL-12/23p40 antibodies, which have been assessed for maintaining remission in Crohn's Disease. 3) Ustekinumab, another IL-12/23 inhibitor, which can be used alone or in combination with an immunomodulator for patients who do not respond to initial biologic therapy.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years after start of ol period

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called TEV-48574, given as a shot periodically, in adults with inflammatory bowel disease. It aims to see how well the drug works, how safe it is, and how the body reacts to it.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years after start of ol period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years after start of ol period

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years after start of ol period for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

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 study objectives

Number of participants who experience adverse events in the double-blind period

Number of participants who experience adverse events in the open-label (OL) period

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

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

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 Crohn's Disease include biologic agents like anti-TNF antibodies (e.g., infliximab, adalimumab) and other monoclonal antibodies targeting specific inflammatory pathways. These biologics work by neutralizing pro-inflammatory cytokines such as TNF-alpha, thereby reducing inflammation and preventing tissue damage. TEV-48574, likely a monoclonal antibody, would function similarly by targeting specific molecules involved in the inflammatory process. Additionally, immunomodulators like thiopurines (azathioprine, 6-mercaptopurine) and methotrexate suppress the immune response to maintain remission. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment strategy tailored to their disease severity and response to therapy.

Human therapeutic antibodies.Review article: biological agents in the treatment of Crohn's disease.