Oral NX-13 for Ulcerative Colitis

Recruiting at 45 trial locations

Overseen By Dawn Louro, VP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Severe colitis, Crohn's, toxic megacolon, others

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

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment for people with moderate to severe ulcerative colitis. The goal is to see if this treatment can reduce inflammation and improve symptoms. The study includes a period to monitor the effects over time.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What makes the drug NX-13 unique for treating ulcerative colitis?

NX-13 is an oral treatment for ulcerative colitis, which may offer advantages over traditional infusion therapies by being easier to use and more acceptable to patients. It is part of a new wave of small molecule therapies that are being developed to target specific pathways involved in the disease. ^{1 2 3 4 5}

Research Team

AbbVie

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for adults aged 18-75 with moderate to severe ulcerative colitis diagnosed at least 90 days prior. Participants must have a Mayo Score of ≥5 indicating active disease. Not eligible are those with fulminant colitis, toxic megacolon, Crohn's disease, infections, or conditions likely requiring hospitalization or surgery within 12 weeks.

Inclusion Criteria

I am between 18 and 75 years old.

I was diagnosed with ulcerative colitis over 90 days ago, confirmed by a tissue test.

RBS ≥ 1.

Exclusion Criteria

I have been diagnosed with a specific type of colitis.

My doctor thinks I might need hospital care or surgery for my ulcerative colitis soon.

I have a bacterial or parasitic stomach or intestine infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive either 250 mg or 750 mg of NX-13 or placebo daily for the induction phase

12 weeks

Weekly visits (in-person)

Long-Term Extension

Participants may continue to receive the study drug in a long-term extension period

Up to 365 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NX-13 250mg
• NX-13 750mg
• NX-13 Placebo

Trial Overview The study tests two doses of NX-13 (250mg and 750mg) against a placebo in people with ulcerative colitis. It's a Phase 2 trial that includes an initial treatment phase followed by long-term extension to assess the drug's effectiveness and safety over time.

Participant Groups

Group I: NX-13 750mg Experimental Treatment 1 Intervention

Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.

Group II: NX-13 250mg Experimental Treatment 1 Intervention

Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.

Group III: NX-13 Placebo Placebo Group 1 Intervention

Subjects will take study drug by ingesting three tablets per day, recommended at the same time daily for consistency. Subjects in a NX-13 group will receive either 250 mg or 750 mg of NX-13 in 3 tablets and subjects in the placebo group will receive matching placebo.

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

Landos Biopharma Inc.

Lead Sponsor

Trials

9

Recruited

530+

Findings from Research

In a study on mice with acute ulcerative colitis induced by dextran sulfate sodium, rIL-25 showed a dose-dependent effect, where a dose of 0.4 microg improved colitis symptoms, while 0.2 microg worsened the condition.

At the highest dose of 0.8 microg, rIL-25 not only reversed diarrhea but also demonstrated a protective role by inhibiting the production of the inflammatory cytokine IFN-gamma and enhancing the anti-inflammatory cytokine IL-10.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential dose effects of recombinant IL-25 on the development of dextran sulfate sodium-induced colitis. Mchenga, SS., Wang, D., Janneh, FM., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Differential dose effects of recombinant IL-25 on the development of dextran sulfate sodium-induced colitis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Once daily oral mesalamine compared to conventional dosing for induction and maintenance of remission in ulcerative colitis: a systematic review and meta-analysis. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Small molecule oral targeted therapies in ulcerative colitis. [2020]

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

Placebo-controlled trial of ulcerative colitis with oral 4-aminosalicylic acid. [2019]

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

Once-daily Mesalamine Formulation for Maintenance of Remission in Ulcerative Colitis: A Randomized, Placebo-controlled Clinical Trial. [2016]