ABBV-668 for Ulcerative Colitis

No longer recruiting at 46 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Crohn's disease, IBD-U, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial tests a new drug, ABBV-668, to determine its safety and effectiveness for people with moderate to severe ulcerative colitis (UC). UC causes inflammation and bleeding in the colon and rectum. Participants will take ABBV-668 tablets twice daily for a year and attend regular check-ups to monitor their health and any side effects. Those who have had UC for at least three months and haven't found relief with other treatments may be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in UC treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, since the trial involves a new treatment, it's possible that changes to your medication might be required. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that ABBV-668 is likely to be safe for humans?

Research shows that ABBV-668 is currently being tested for safety in people with ulcerative colitis (UC). Detailed information on tolerance and specific side effects is not yet available.

Since ABBV-668 is in a Phase 2 trial, earlier tests have suggested it might be safe for humans, but researchers continue to gather more safety data. This phase is crucial for determining the right dose and identifying any side effects.

Participants in this trial will take ABBV-668 orally twice a day for a year. Regular check-ups will monitor their health and assess the treatment's effectiveness. This approach ensures that any side effects are closely observed and managed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for UC?

ABBV-668 is unique because it offers a new approach to treating ulcerative colitis. Unlike standard treatments such as mesalamine or corticosteroids, which primarily focus on reducing inflammation, ABBV-668 may target the condition through a novel mechanism of action, potentially providing relief to patients who do not respond well to existing therapies. Researchers are excited about ABBV-668 because it could offer a more effective and longer-lasting solution by being administered twice daily, aiming for consistent therapeutic effects over a prolonged period. This innovative method of treatment might significantly improve the quality of life for those with this chronic condition.

What evidence suggests that ABBV-668 might be an effective treatment for ulcerative colitis?

Research has shown that ABBV-668, the investigational treatment in this trial, may help treat moderate to severe ulcerative colitis (UC). In earlier studies, 69.2% of patients responded well to the treatment after eight weeks. Additionally, 30.8% of patients experienced significant improvement in their symptoms, known as clinical remission. These results suggest that ABBV-668 could help reduce inflammation and symptoms in UC patients. While more research is needed, these early findings are promising for those considering this treatment option. ^{1 2 3 5 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have not responded well to certain medications for my condition.

I have been diagnosed with ulcerative colitis for over 3 months and have biopsy results to prove it.

My ulcerative colitis is active with a moderate to severe score.

Exclusion Criteria

I have been diagnosed with Crohn's disease or IBD-U.

My inflammation is only in the rectum, confirmed by an endoscopy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral capsules of ABBV-668 twice daily for 52 weeks

52 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-668

Trial Overview 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.

How Is the Trial Designed?

Group I: ABBV-668 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Upadacitinib has been shown to be effective as both an induction and maintenance therapy for patients with moderately to severely active ulcerative colitis, based on results from three phase 3 clinical trials.

The trials demonstrated significant improvements in clinical remission rates and symptom control, highlighting upadacitinib's potential as a valuable treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In active UC, upadacitinib induced and maintained remission. Forbes, GM.[2022]

In a study of 228 patients with mildly and moderately active ulcerative colitis (UC), sulfasalazine (SASP) demonstrated a short-term clinical remission rate of 71.8% after 6 weeks of treatment, indicating its efficacy in managing symptoms.

SASP was found to be safe, with only 16.4% of patients experiencing adverse reactions, none of which were severe enough to require discontinuation of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and therapeutic efficacy of sulfasalazine in patients with mildly and moderately active ulcerative colitis. Chen, QK., Yuan, SZ., Wen, ZF., et al.[2019]

Tofacitinib is the first Janus kinase inhibitor approved for treating moderate-to-severely active ulcerative colitis, specifically for patients who have not responded to conventional therapies.

Despite advancements in treatment options, 25-40% of ulcerative colitis patients still do not respond to therapies, highlighting the need for effective alternatives like tofacitinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is tofacitinib a game-changing drug for ulcerative colitis? Magro, F., Estevinho, MM.[2021]

Citations

1. clinicaltrials.eu clinicaltrials.eu/inn/abbv-668/

ABBV-668: A Promising New Drug for Ulcerative Colitis ... Efficacy and Safety Study in Ulcerative Colitis Patients: This study is evaluating how safe and effective ABBV-668 is in treating adults with moderate to severe ...

2. ctv.veeva.com ctv.veeva.com/study/study-of-abbv-668-oral-capsules-to-assess-adverse-events-and-change-in-disease-activity-in-adult-par

Study of ABBV-668 Oral Capsules to Assess Adverse Events ... This study will assess how safe and effective ABBV-668 is in treating adult participants with UC. Adverse events and change in disease activity ...

3. withpower.com withpower.com/trial/phase-2-colitis-ulcerative-10-2022-a68d5

ABBV-668 for Ulcerative Colitis · Info for Participants Upadacitinib has been shown to be effective as both an induction and maintenance therapy for patients with moderately to severely active ulcerative colitis, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10441644/

Emerging Therapies for Ulcerative Colitis 60 Dose B was considered the maximum effective dose with a week 8 clinical response rate of 69.2% and clinical remission rate of 30.8%. These data support ...

5. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M21-446

Study of ABBV-668 Oral Capsules to Assess Adverse ... Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis.

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05570006/

Trial | NCT05570006 This study will assess how safe and effective ABBV-668 is in treating adult participants with UC. Adverse events and change in disease activity will be assessed ...