Oral NX-13 for Ulcerative Colitis

No longer recruiting at 53 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called NX-13 for individuals with moderate to severe ulcerative colitis (UC), a condition that causes inflammation and sores in the colon. Researchers aim to determine if different doses of NX-13 can reduce UC symptoms compared to a placebo. Participants will take three tablets daily of either NX-13 or a placebo. Those diagnosed with UC for at least 90 days and experiencing frequent symptoms, such as blood in their stool, might be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that NX-13 is generally safe and well-tolerated. In a previous study, participants taking NX-13 experienced quick improvements in their symptoms and in what doctors observed inside the colon. Importantly, the treatment did not cause serious side effects.

NX-13 reduces inflammation, the body's response to injury or irritation, through a unique process. This was tested in both animals and people. Earlier studies examined different doses of NX-13, similar to those planned for this new trial. The results were positive, suggesting that the treatment could be a promising option for people with ulcerative colitis.

As this treatment undergoes further testing, past research provides some confidence in its safety for humans. However, ongoing trials will continue to monitor and confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about NX-13 because it represents a novel approach to treating ulcerative colitis. Unlike existing treatments that often focus on suppressing the immune system or reducing inflammation, NX-13 targets the gut microbiome, aiming to restore balance and improve gut health. This new mechanism of action could potentially offer benefits with fewer side effects and address the condition more holistically. Additionally, NX-13 is taken orally, which is convenient compared to some current therapies that require injections or infusions.

What evidence suggests that this trial's treatments could be effective for ulcerative colitis?

Research has shown that NX-13 may help treat ulcerative colitis. Participants in earlier studies often noticed rapid improvement in their symptoms. One study found that patients had lower total Mayo scores, a measure of ulcerative colitis severity. Additionally, NX-13 was generally safe and well tolerated. This trial will test different dosages of NX-13, specifically 250 mg and 750 mg, against a placebo. These early results suggest that NX-13 could be a promising option for managing moderate to severe ulcerative colitis symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

AbbVie

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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

RBS ≥ 1.

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

ES ≥ 2 within 14 days prior to randomization

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37952114/

Results of a Phase 1b Study - PubMed - NIH Conclusions: NX-13 was generally safe and well tolerated with early signs of rapid symptom and endoscopic improvement. This novel mechanism of ...

2. academic.oup.com academic.oup.com/ecco-jcc/article/18/5/762/7408692

Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of ... Clinical outcomes of patients treated with NX-13 or placebo. NX-13-treated patients experienced reductions in total Mayo score [A] and higher ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04862741

Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in ... This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13.

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/landoss-nx-13-shows-symptom-relief-in-phase-ib-ulcerative-colitis-trial/

Landos's NX-13 shows symptom relief in Phase Ib ... The majority of the subjects treated with the drug reported consistent and rapid clinical improvement in symptoms, as measured by rectal ...

5. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=NX-13-201

Study to Evaluate the Clinical Activity and Safety of Oral NX ... Phase 2 induction study with a long-term extension (LTE) period in participants with moderate to severe ulcerative colitis (UC).

6. clinicaltrials.eu clinicaltrials.eu/inn/nx-13/

NX-13: A Promising New Treatment for Ulcerative Colitis NX-13 shows promise as a potential new treatment option for patients with ulcerative colitis. If the ongoing clinical trials demonstrate that NX-13 is safe and ...