ABBV-668 for Ulcerative Colitis

Recruiting at 42 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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug ABBV-668 for ulcerative colitis?

Research shows that similar drugs like upadacitinib and tofacitinib, which are Janus kinase inhibitors (a type of medication that blocks certain signals in the body that cause inflammation), have been effective in treating ulcerative colitis, suggesting that ABBV-668 might also be effective. ^{1 2 3 4 5}

How is the drug ABBV-668 different from other ulcerative colitis treatments?

ABBV-668 is unique because it is based on the active component 5-aminosalicylic acid (5-ASA), which has shown to be more effective and safer than traditional treatments like sulfasalazine (SASP) for ulcerative colitis, particularly in reducing intestinal erosion and shortening. ^{6 7 8 9 10}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Sequential Use of High-Dose Tofacitinib After Infliximab Salvage Therapy in Acute Severe Ulcerative Colitis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Mucosal healing with oral tacrolimus is associated with favorable medium- and long-term prognosis in steroid-refractory/dependent ulcerative colitis patients. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Upadacitinib Salvage Therapy for Infliximab experienced patients with Acute Severe Ulcerative Colitis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Is tofacitinib a game-changing drug for ulcerative colitis? [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Determination of the active moiety of BX661A, a new therapeutic agent for ulcerative colitis, by studying its therapeutic effects on ulcerative colitis induced by dextran sulfate sodium in rats. [2013]

7. China pubmed.ncbi.nlm.nih.gov

[The effects of bifidobacterium on the intestinal mucosa of the patients with ulcerative colitis]. [2014]

8. Germany pubmed.ncbi.nlm.nih.gov

Pharmacological mechanism of Shenlingbaizhu formula against experimental colitis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Anti-inflammatory activity of probiotic Bifidobacterium: enhancement of IL-10 production in peripheral blood mononuclear cells from ulcerative colitis patients and inhibition of IL-8 secretion in HT-29 cells. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Characteristics and therapeutic efficacy of sulfasalazine in patients with mildly and moderately active ulcerative colitis. [2019]