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

What is this study about?

This clinical trial is focused on studying the effects of a new treatment for Ulcerative Colitis, a condition that causes inflammation and sores in the digestive tract. The treatment being tested is called NX-13, which is taken as a tablet. The study will compare the effects of NX-13 with a placebo to understand its clinical activity and safety in people with moderate to severe forms of this disease.

The purpose of the study is to evaluate how well NX-13 works and how safe it is for participants. The study will involve multiple doses and will be conducted over a period of time, allowing researchers to observe any changes in the condition of the participants. Participants will be randomly assigned to receive either the NX-13 tablets or a placebo, and neither the participants nor the researchers will know who is receiving which treatment during the study.

Throughout the study, participants will have regular check-ups to monitor their health and any side effects. The study aims to provide valuable information on the potential benefits and risks of using NX-13 as a treatment for Ulcerative Colitis, contributing to the development of new therapies for this condition.

1 initial visit and consent

Upon joining the study, you will attend an initial visit where you will be asked to provide informed consent. This means you agree to participate in the study after understanding all the details, risks, and benefits.

During this visit, your eligibility will be confirmed based on criteria such as age, medical history, and current health status.

2 screening procedures

You will undergo various screening procedures to ensure you meet the study requirements. This may include a colonoscopy to confirm the diagnosis of ulcerative colitis and rule out other conditions.

Additional tests may include blood tests and a review of your medical history.

3 randomization and treatment assignment

Once you pass the screening, you will be randomly assigned to receive either the study medication NX-13 or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

4 treatment phase

You will take the assigned treatment orally in the form of a tablet. The dosage and frequency will be provided by the study team.

This phase will last for a specified period, during which you will be required to attend regular study visits and complete e-diaries to monitor your health and any symptoms.

5 follow-up visits

Throughout the study, you will have scheduled follow-up visits to assess your health and the effects of the treatment.

These visits will include physical examinations, laboratory tests, and possibly additional colonoscopies to evaluate the condition of your ulcerative colitis.

6 end of treatment and extension phase

At the end of the initial treatment period, your response to the medication will be evaluated.

If eligible, you may enter a long-term extension phase where you continue to receive the study medication and attend regular follow-up visits.

7 study completion

Upon completing the study, you will have a final visit to assess your overall health and gather any remaining data.

You will be informed about the next steps and any additional follow-up that may be necessary.

Who Can Join the Study?

Must be between 18 to 75 years old at the time of giving consent.
Women of childbearing potential must agree to use highly effective birth control methods, such as:
- Combined hormonal contraception (oral, intravaginal, transdermal)
- Progestogen-only hormonal contraception (oral, injectable, implantable)
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion (blocking of fallopian tubes)
- Partner with a vasectomy
- Sexual abstinence
Must also agree not to try to become pregnant for at least 30 days after the last dose of the study medication.
Must be able to give informed consent and attend study visits.
Must have been diagnosed with Ulcerative Colitis (UC) for at least 3 months before screening, confirmed by specific medical tests.
Must have had a colonoscopy within 12 months before the study to check for abnormal growths in the colon if they have had certain types of colitis for a long time. If not, a colonoscopy will be done during screening.
Must have moderate to severe disease activity, as defined by specific medical criteria.
Must have had an inadequate response, loss of response, or intolerance to at least one of the following treatments:
- Conventional therapies like oral 5-ASA compounds and systemic glucocorticosteroids
- Biologic therapies like anti-TNF, anti-integrin, or anti-IL-12/23 monoclonal antibodies
- Advanced therapies like JAK inhibitors or S1P receptor modulators
Eligible male participants must either be surgically sterile (vasectomy) for at least 3 months before screening or agree to use a condom with spermicide and not try to conceive for at least 30 days after the last dose of the study medication.
Eligible female participants must be nonpregnant, confirmed by a pregnancy test, and not breastfeeding.
Female participants who cannot have children must be surgically sterile or postmenopausal (no menstrual periods for at least 1 year).

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to any of the ingredients in the study medication cannot participate.
Patients with other significant health conditions that might interfere with the study results are not eligible.
Pregnant or breastfeeding women are excluded from the study.
Patients who have participated in another clinical trial within the last 30 days are not allowed to join.
Individuals with a history of substance abuse or addiction may not participate.
Patients who are unable to comply with the study procedures or follow-up visits are not eligible.
Anyone who has had a major surgery within the last 3 months is excluded.
Patients with a history of certain infections, such as tuberculosis, are not eligible.
Individuals with a compromised immune system, which means their body’s defense against infections is weakened, cannot participate.
Patients who are currently taking medications that might interfere with the study drug are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
IRCCS Humanitas Research Hospital	Rozzano	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Amicare Sp. z o.o. S.K.	Lodz	Poland
Ospedale San Raffaele S.r.l.	Milan	Italy
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.	Wroclaw	Poland
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.	Wloclawek	Poland
H-T. Centrum Medyczne Sp. z o.o.	Tychy	Poland
Gastromed Sp. z o.o.	Torun	Poland
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Sonomed Sp. z o.o.	Szczecin	Poland
Vitamed Galaj I Cichomski Sp. j.	Bydgoszcz	Poland
Vita Longa Sp. z o.o.	Katowice	Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Endoskopia Sp. z o.o.	Sopot	Poland
Planetmed Sp. z o.o.	Wroclaw	Poland
Rivermed Sp. z o.o.	Poznan	Poland
Amamhvg Sp z ozkr Scgo	Opoczno	Poland
Neoscva Rokjkx Kkqqbhu	Bytom	Poland
Ocytcsj Bixni Khxfbwtaupj Cundgporf Sdoi Eul Grejeqtztrbei Mxshpebpcj Tstoewa	Bydgoszcz	Poland
Wfl Wjtjqy Ise Pitqv Pdkrpndo Kcdqwwb	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	04.09.2023
Italy	Not recruiting	04.09.2023
Poland	Not recruiting	04.09.2023

Trial locations

Investigated drugs:

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

NX-13 is an experimental medication being tested for its potential to help people with moderate to severe ulcerative colitis, a condition that causes inflammation and sores in the colon. This medication is taken by mouth and is designed to reduce inflammation in the digestive tract, which may help alleviate symptoms like abdominal pain and diarrhea. The study aims to see how well NX-13 works in improving the condition and to ensure it is safe for long-term use.

Ulcerative Colitis – Ulcerative Colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. The disease typically begins in the rectum and may extend continuously to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation can lead to frequent and urgent bowel movements. Over time, the disease can cause complications such as severe bleeding or perforation of the colon.

Trial ID:

2022-503005-38-00

Protocol code:

NX-13-201/M25-484

Trial Phase:

Therapeutic exploratory (Phase II)

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

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