What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis, such as thiopurines, infliximab, adalimumab, vedolizumab, and 5-aminosalicylic acid (5-ASA) agents, have various side effects. Thiopurines can cause nausea, vomiting, and allergic reactions. Infliximab and adalimumab, which are anti-TNF agents, may lead to infections, infusion reactions, and potential development of antibodies against the drug. Vedolizumab, another biologic agent, can cause headaches, joint pain, and increased risk of infections. 5-ASA agents, like mesalamine, may result in headaches, nausea, and abdominal pain. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of moderate to severe Ulcerative Colitis include biologic agents such as infliximab and adalimumab (anti-TNF agents), vedolizumab (an integrin receptor antagonist), and ustekinumab (an interleukin inhibitor). Additionally, tofacitinib, a Janus kinase (JAK) inhibitor, has been approved for this indication. These treatments, like the investigational drug ABBV-668, aim to reduce inflammation and manage symptoms in patients with moderate to severe UC.

What other types of research exist?

Promising novel alternatives to ABBV-668 for treating moderate to severe ulcerative colitis in 2024 include: <ol> <li>Ustekinumab (Stelara) - An anti-IL 12/23 antibody approved for moderately to severely active ulcerative colitis.</li> <li></li> </ol> Vedolizumab (Entyvio) - An integrin receptor antagonist used for induction and maintenance of remission in ulcerative colitis. 3. Tofacitinib (Xeljanz) - An oral Janus kinase (JAK) inhibitor for moderate to severe ulcerative colitis. 4. Risankizumab - An anti-IL-23 antibody showing promise in clinical trials for ulcerative colitis. 5. Ozanimod (Zeposia) - An S1P receptor modulator recently approved for moderate to severe ulcerative colitis.

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ABBV-668 for Ulcerative Colitis

Phase 2

Recruiting

Research Sponsored by AbbVie

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 approximately 56 weeks

Awards & highlights

Summary

This trial tests ABBV-668, an experimental drug, on adults with moderate to severe ulcerative colitis. Participants will take capsules regularly over several months. The study will check if the drug is safe and effective by monitoring side effects and disease activity.

Who is the study for?

Adults with moderate to severe Ulcerative Colitis (UC) for at least 3 months, who haven't responded well to standard treatments like aminosalicylates or corticosteroids. They should have an active UC with certain scores on the Adapted Mayo scale and endoscopy results. People with Crohn's disease or limited inflammation only in the rectum can't join.

What is being tested?

The trial is testing ABBV-668 oral capsules' safety and effectiveness for UC treatment. Participants will take these capsules twice daily for 16 weeks, followed by a month of follow-up, while their health is monitored through medical assessments and questionnaires.

What are the potential side effects?

Specific side effects of ABBV-668 are not listed but may include typical drug reactions such as digestive issues, allergic responses, fatigue, headaches, or other symptoms that will be closely monitored throughout the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 56 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 56 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 56 weeks 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 Adverse Events (AEs)

Percentage of Participants Achieving Endoscopic Improvement

Secondary outcome measures

Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score

Percentage of Participants Achieving Clinical Response per Adapted Mayo Score

Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo score

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ABBV-668Experimental Treatment1 Intervention

Participants will receive ABBV-668 twice daily approximately at same time each day for 52 weeks.

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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

The most common treatments for Ulcerative Colitis (UC) include 5-aminosalicylates (5-ASAs), corticosteroids, immunomodulators, and biologic therapies. 5-ASAs, such as mesalamine, reduce inflammation in the colon by inhibiting the production of inflammatory chemicals. Corticosteroids, like prednisone, suppress the immune system to quickly reduce inflammation but are typically used short-term due to side effects. Immunomodulators, such as azathioprine, alter the immune response to maintain remission. Biologic therapies, including anti-TNF agents like infliximab, target specific proteins involved in the inflammatory process. These treatments are crucial for UC patients as they help manage symptoms, induce and maintain remission, and prevent complications. ABBV-668, an investigational drug, is being studied for its potential to treat moderate to severe UC, highlighting ongoing efforts to find more effective and safer treatment options.

Novel topical therapies for distal colitis.

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Who is running the clinical trial?

AbbVieLead Sponsor

1,004 Previous Clinical Trials

513,694 Total Patients Enrolled

32 Trials studying Ulcerative Colitis

22,336 Patients Enrolled for Ulcerative Colitis

ABBVIE INC.Study DirectorAbbVie

430 Previous Clinical Trials

156,058 Total Patients Enrolled

18 Trials studying Ulcerative Colitis

17,222 Patients Enrolled for Ulcerative Colitis

Media Library

ABBV-668 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05570006 — Phase 2

Ulcerative Colitis Research Study Groups: ABBV-668

Ulcerative Colitis Clinical Trial 2023: ABBV-668 Highlights & Side Effects. Trial Name: NCT05570006 — Phase 2

ABBV-668 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05570006 — Phase 2

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