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1,3,5-Tris(6-Methylpyridin-2-Yloxy)Benzene

This article discusses the ongoing clinical trials of NX-13, a novel drug being tested for the treatment of moderate to severe ulcerative colitis. NX-13 contains the active substance 1,3,5-Tris(6-Methylpyridin-2-Yloxy)Benzene and is being evaluated for its safety, tolerability, and effectiveness in managing this chronic inflammatory bowel disease.

Table of Contents

What is NX-13?

NX-13 is a new medication being studied for the treatment of moderate to severe ulcerative colitis. Ulcerative colitis is a type of inflammatory bowel disease that causes inflammation and sores (ulcers) in the lining of the large intestine (colon) and rectum[1]. The active ingredient in NX-13 is a chemical compound called 1,3,5-TRIS(6-METHYLPYRIDIN-2-YLOXY)BENZENE.

How NX-13 Works

While the exact mechanism of action is not fully described in the trial information, NX-13 is being developed as an oral medication for ulcerative colitis. It is designed to target the underlying inflammation in the colon that causes the symptoms of ulcerative colitis[1].

Clinical Trial Details

NX-13 is currently being studied in a Phase 2 clinical trial. This trial is designed to evaluate how well NX-13 works and how safe it is for people with moderate to severe ulcerative colitis. Here are some key details about the trial:

  • It is a randomized, double-blind, placebo-controlled study. This means that participants are randomly assigned to receive either NX-13 or a placebo, and neither the participants nor the researchers know who is receiving which treatment[1].
  • The trial consists of a 12-week induction period followed by a 40-week long-term extension period[1].
  • The main goal is to assess the clinical activity of oral NX-13 compared to placebo[1].

Who Can Participate in the NX-13 Trial?

The trial is looking for participants who meet specific criteria, including:

  • Adults aged 18 to 75 years[1]
  • Diagnosed with ulcerative colitis for at least 3 months before screening[1]
  • Have moderate to severe disease activity[1]
  • Have not responded well to, lost response to, or cannot tolerate at least one conventional or biologic therapy for ulcerative colitis[1]

There are also several exclusion criteria, such as having certain other medical conditions or taking specific medications, which might prevent someone from participating in the trial[1].

Potential Benefits of NX-13

The trial aims to measure several potential benefits of NX-13, including:

  • Clinical remission: This means that the symptoms of ulcerative colitis have significantly improved or disappeared[1].
  • Clinical response: This refers to a noticeable improvement in symptoms[1].
  • Endoscopic response and remission: These measure improvements in the appearance of the colon lining when viewed through an endoscope[1].
  • Symptomatic remission: This focuses on the improvement of specific symptoms like rectal bleeding and stool frequency[1].

Safety Considerations

As with any new medication, safety is a crucial aspect of the NX-13 trial. The researchers will be closely monitoring:

  • The proportion of participants who experience side effects (called treatment-emergent adverse events or TEAEs)[1]
  • Any serious adverse events that occur during the trial[1]
  • Changes in laboratory test results, vital signs, and ECGs (heart tests) over time[1]

It’s important to note that while NX-13 shows promise, it is still an experimental medication. More research is needed to fully understand its effectiveness and safety profile for treating ulcerative colitis[1].

Aspect Details
Drug Name NX-13 (1,3,5-Tris(6-Methylpyridin-2-Yloxy)Benzene)
Condition Treated Moderate to Severe Ulcerative Colitis
Trial Phase Phase 2
Trial Design Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter
Duration 12-week induction period + 40-week long-term extension
Primary Endpoint Change from baseline in Modified Mayo Score (MMS) at Week 12
Key Secondary Endpoints Safety, tolerability, clinical remission, clinical response, endoscopic response, endoscopic remission, symptomatic remission
Administration Oral tablets, maximum daily dose 750 mg
Eligibility Adults 18-75 years with moderate to severe ulcerative colitis, inadequate response to previous therapies

FAQ

  • What is NX-13 and how does it work? NX-13 is a new drug containing the active substance 1,3,5-Tris(6-Methylpyridin-2-Yloxy)Benzene. It is being tested as a potential treatment for moderate to severe ulcerative colitis. While the exact mechanism is not fully explained in the trial data, it is designed to target the inflammation associated with ulcerative colitis.
  • Who is eligible to participate in the NX-13 clinical trial? Eligible participants are adults aged 18 to 75 with moderate to severe ulcerative colitis who have not responded well to, lost response to, or cannot tolerate at least one conventional or biologic therapy. They must meet specific disease activity criteria and have no severe complications or certain other medical conditions.
  • How is the NX-13 clinical trial structured? The trial consists of a 12-week induction period followed by a 40-week long-term extension (LTE) period. Participants are randomly assigned to receive either NX-13 at different doses or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who is receiving the actual drug or placebo.
  • What are the main goals of the NX-13 clinical trial? The primary goal is to assess the clinical activity of NX-13 compared to placebo by measuring changes in the Modified Mayo Score at Week 12. Secondary goals include evaluating safety, tolerability, clinical remission, clinical response, endoscopic response, endoscopic remission, and symptomatic remission.
  • How is NX-13 administered in the trial? NX-13 is administered orally in tablet form. Participants are required to swallow 3 whole tablets per day without crushing, breaking, or chewing. The maximum daily dose being tested is 750 mg.

Ongoing Clinical Trials on 1,3,5-Tris(6-Methylpyridin-2-Yloxy)Benzene

  • Study of Oral NX-13 for Patients with Moderate to Severe Ulcerative Colitis

    Not recruiting

    2 1
    Investigated drugs:
    Belgium Italy Poland

Glossary

  • Ulcerative Colitis: A chronic inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine (colon) and rectum.
  • Modified Mayo Score (MMS): A scoring system used to assess the severity of ulcerative colitis, taking into account factors such as stool frequency, rectal bleeding, and endoscopic findings.
  • Endoscopic Subscore (ES): A component of the Mayo Score that evaluates the appearance of the colon lining during an endoscopic examination.
  • Rectal Bleeding Subscore (RBS): A component of the Mayo Score that measures the severity of rectal bleeding in ulcerative colitis patients.
  • Clinical Remission: A state where the symptoms of ulcerative colitis are significantly reduced or absent, typically defined by specific criteria in clinical trials.
  • Endoscopic Remission: The absence of visible inflammation or ulceration in the colon when examined through an endoscope.
  • Symptomatic Remission: The absence or significant reduction of ulcerative colitis symptoms, particularly rectal bleeding and stool frequency.
  • Induction Period: The initial phase of treatment in a clinical trial, typically aimed at achieving rapid improvement in disease symptoms.
  • Long-Term Extension (LTE): An extended phase of a clinical trial that follows the initial treatment period, designed to assess long-term safety and efficacy.
  • Placebo: An inactive substance that looks like the drug being tested but contains no active medication, used as a control in clinical trials.

References

  1. http://clinicaltrials.eu/trial/study-of-oral-nx-13-for-patients-with-moderate-to-severe-ulcerative-colitis/