Oral NX-13 for Ulcerative Colitis
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.12345Why 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.12346
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive either 250 mg or 750 mg of NX-13 or placebo daily for the induction phase
Long-Term Extension
Participants may continue to receive the study drug in a long-term extension period
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
3
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
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
Published Research Related to This Trial
Citations
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 ...
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 ...
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 ...
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).
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 ...
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