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ENC1018 Capsules for Moderate-to-severe Active Ulcerative Colitis (UC) Treatment

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Study Aim

This trial examines how ENC1018 capsules affect people with moderate-to-severe ulcerative colitis, focusing on any side effects and the drug's absorption in the body.

What is being tested

ENC1018 capsule administration group

Drug
Who is being recruted

Colitis+5

+ Colitis, Ulcerative

+ Colonic Diseases

From 18 to 75 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorTang-Du Hospital
Study ContactXin Wang
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a new medicine, ENC1018, for patients who have moderate-to-severe ulcerative colitis, which is a condition that causes inflammation in the colon. The study is looking to understand how safe this medication is, how it moves through the body, and whether it helps reduce the symptoms of ulcerative colitis. By testing this new treatment, the study hopes to find a more effective way to manage this challenging condition and improve the quality of life for those affected. Participants in the study will take ENC1018 capsules once each day for 14 days. These capsules are taken orally, and participants must fast for at least two hours before and after taking the medication to ensure accurate results. Over the course of the study, which lasts up to 49 days, participants will stay in the hospital during the treatment period so that doctors can closely monitor their health. Blood and stool samples will be collected to evaluate how the medicine is processed in the body. This careful monitoring helps ensure the safety of participants and the reliability of the study results.

Official TitleAn Open-label, Single-arm, Single-center Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of ENC1018 Capsules in Patients With Moderate-to-severe Active Ulcerative Colitis (UC)
NCT07062185
Principal SponsorTang-Du Hospital
Study ContactXin Wang
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ColitisColitis, UlcerativeColonic DiseasesDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

6 inclusion criteria required to participate
Aged between 18 and 75 years, male or female.
Ulcerative colitis has been diagnosed at least 3 months before screening, and the diagnosis must be confirmed by endoscopy or radiology and histology.
Have moderate to severe active ulcerative colitis, defined as a modified Mayo score ≥6.
Poor response or intolerance to at least one conventional therapy (aminosalicylic acids, corticosteroids, or immunomodulators) or biologics (anti-TNF, anti-α4β7 integrin, or anti-IL-12/23 antibody drugs) as determined by the investigator.
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12 exclusion criteria prevent from participating
Diagnosed with undefined colitis, infectious colitis, ischemic colitis, fulminant colitis, toxic megacolon, or other chronic intestinal diseases other than UC such as Crohn's disease (CD), intestinal tuberculosis, radiation enteritis, and intestinal belcet's disease.
Never received any previous treatment for UC.
Participated in any other clinical trial within 3 months prior to screening (except those who have only participated in clinical trial screening without using the experimental drug).
Subjects with a history of alcohol or drug abuse and complete abstinence for less than 6 months before enrollment.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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