Ulcerative Colitis (UC)NCT07062185
A Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ENC1018 Capsules in Patients With Moderate-to-severe Active Ulcerative Colitis (UC)
A study testing ENC1018 capsule administration group in people with Ulcerative Colitis (UC), run by Tang-Du Hospital.
Trial summary
This is an open-label, single-arm, single-center study to evaluate the safety, pharmacokinetics, and efficacy signal of ENC1018 capsules in patients with moderate-to-severe active ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- ENC1018 capsule administration group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- If subjects are taking oral aminosalicylic acids or oral glucocorticoids, their doses must remain stable for at least 2 weeks prior to enrollment and for the duration of the study.
- Voluntarily sign the informed consent and be willing to follow the research procedures and complete the test in accordance with the protocol.
Who cannot join
- 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.
- Received any live vaccine within 6 weeks prior to enrollment or planned to receive any live vaccine during the study period or within 6 weeks after the last use of the investigational drug.
- Experienced major trauma or major surgery within 4 weeks before enrollment;
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- Have any other gastrointestinal diseases that may affect the absorption of oral drugs or have undergone gastrectomy or gastric bypass surgery.
- Assessed by investigator as needing or receiving total parenteral nutrition and/or total enteral nutrition.
- Allergy to the test drug or its ingredients.
- Surgical treatment for ulcerative colitis, including but not limited to ostomy, ileal pocket anal anastomosis, and intestinal resection, is required during prior or anticipated study.
- Pregnant and lactating women; Or women of childbearing age who have positive blood pregnancy test results during screening; Or had a birth plan throughout the trial period and within 3 months after the end of the study; Or unwilling to use one or more types of physical contraception during the trial and for three months after the end of the study.
- The investigator believes that participation in this study is not appropriate for other reasons; Or other conditions that may confuse or interfere with the safety, tolerability, or pharmacokinetic evaluation of the investigational drug.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An 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)
This is an open-label, single-arm, single-center study to evaluate the safety, pharmacokinetics, and efficacy signal of ENC1018 capsules in patients with moderate-to-severe active ulcerative colitis (UC).
Read the detailed description
The study will enroll about 10 diagnosed patients with moderate-to-severe active UC. Each patient will receive an oral dose of ENC1018 capsules once daily for 14 consecutive days after enrollment. Before each dose, patients must fast for at least 2 hours to remain in a fasting state, and no food should be consumed for at least 2 hours after dosing. The entire study period includes a screening phase of up to 3 weeks, a 14-day treatment period, and a 2-week follow-up period. The total duration of the trial is up to 49 days, and patients will be hospitalized during the treatment period. Blood and fecal samples will be collected during the study for PK evaluation.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- ENC1018 capsule administration group
- Keywords
- ENC1018, moderate to severe active Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENC1018 capsule administration groupDrug
ENC1018 capsules were taken orally once a day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| ENC1018 capsule administration group | Experimental | Not described Receives: Drug: ENC1018 capsule administration group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE) and Serious Adverse Events (SAE);
Measured: Day 1 - Day 28
Tmax of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC).
Measured: Day 1 - Day 17
Cmax of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC).
Measured: Day 1 - Day 17
AUC of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC).
Measured: Day 1 - Day 17
Secondary outcomes (6)
Fecal PK parameters of ENC1018 and its major metabolites: cumulative excretion amount (Ae);
Measured: Day 1- Day 17
Changes in partial Mayo scores (excluding endoscopy scores from the complete modified Mayo score) from baseline;
Measured: Day 1- Day 28
Changes in the pharmacodynamic biomarker hsCRP and fecal calcarein from baseline.
Measured: Day 1- Day 28
Fecal PK parameters of ENC1018 and its major metabolites: excretion fraction (Fe);
Measured: Day 1- Day 17
Changes in defecation frequency (SF) scores from baseline;
Measured: Day 1- Day 28
Changes in blood in the stool (RB) scores from baseline;
Measured: Day 1- Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang xin, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062185
- Sponsor's protocol ID
- ENC1018-UC-01
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 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)
- ClinicalTrials.gov ID
- NCT07062185
- Acronym / sponsor ID
- ENC1018-UC-01
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- ENC1018, moderate to severe active Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-arm, single-center study to evaluate the safety, pharmacokinetics, and efficacy signal of ENC1018 capsules in patients with moderate-to-severe active ulcerative colitis (UC).
Detailed description
The study will enroll about 10 diagnosed patients with moderate-to-severe active UC. Each patient will receive an oral dose of ENC1018 capsules once daily for 14 consecutive days after enrollment. Before each dose, patients must fast for at least 2 hours to remain in a fasting state, and no food should be consumed for at least 2 hours after dosing. The entire study period includes a screening phase of up to 3 weeks, a 14-day treatment period, and a 2-week follow-up period. The total duration of the trial is up to 49 days, and patients will be hospitalized during the treatment period. Blood and fecal samples will be collected during the study for PK evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENC1018 capsule administration group | Experimental | Drug: ENC1018 capsule administration group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- If subjects are taking oral aminosalicylic acids or oral glucocorticoids, their doses must remain stable for at least 2 weeks prior to enrollment and for the duration of the study.
Key exclusion criteria (12 listed)
- 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.
- Received any live vaccine within 6 weeks prior to enrollment or planned to receive any live vaccine during the study period or within 6 weeks after the last use of the investigational drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENC1018 capsule administration groupENC1018 capsules were taken orally once a day for 14 days. | Drug | ENC1018 capsule administration group |
Primary outcome
Adverse events (AE) and Serious Adverse Events (SAE);
Time frame: Day 1 - Day 28
Tmax of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC).
Time frame: Day 1 - Day 17
Cmax of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC).
Time frame: Day 1 - Day 17
AUC of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC).
Time frame: Day 1 - Day 17
6 secondary outcomes
Fecal PK parameters of ENC1018 and its major metabolites: cumulative excretion amount (Ae);
Time frame: Day 1- Day 17
Changes in partial Mayo scores (excluding endoscopy scores from the complete modified Mayo score) from baseline;
Time frame: Day 1- Day 28
Changes in the pharmacodynamic biomarker hsCRP and fecal calcarein from baseline.
Time frame: Day 1- Day 28
Fecal PK parameters of ENC1018 and its major metabolites: excretion fraction (Fe);
Time frame: Day 1- Day 17
Changes in defecation frequency (SF) scores from baseline;
Time frame: Day 1- Day 28
Changes in blood in the stool (RB) scores from baseline;
Time frame: Day 1- Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing ENC1018 capsule administration group in people with Ulcerative Colitis (UC), run by Tang-Du Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Wang (029-84777551, wangx@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE) and Serious Adverse Events (SAE); (time frame: Day 1 - Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.