Moderately to Severely Active Ulcerative ColitisPhase 3NCT04176588
A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study testing Etrasimod in people with Moderately to Severely Active Ulcerative Colitis, run by Everstar Therapeutics Limited at 1 site in China.
Trial summary
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis. Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderately to Severely Active Ulcerative Colitis
- What is being tested?
- Etrasimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 341 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2019to Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- A documented of diagnosis with UC at least 3 months prior to screening.
- Have active UC confirmed by endoscopy with ≥ 10 cm rectal involved.
Who cannot join
- Have severe extensive colitis
- Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
- Diagnosis of microscopic colitis, ischemic colitis, infection colitis or colonic mucosal dysplasia
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fourth Military Medical University, PLA
Xi’an, Shanxi, 710032
About this study
Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Etrasimod for Induction and Maintenance Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3
- Being tested
- Etrasimod, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtrasimodDrug
Drug:Etrasimod Tablet other name:APD334
PlaceboDrug
Drug:placebo Tablet
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Etrasimod 2mg | Experimental | 2mg/tablet, administratered orally, once daily Receives: Drug: Etrasimod |
| Placebo Comparator: Placebo | Placebo comparator | matching tablet, administratered orally, once daily Receives: Drug: Placebo |
| Etrasimod 2mg (optional open-label extension period) | Experimental | 2mg/tablet, administratered orally, once daily Receives: Drug: Etrasimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS)
Clinical remission per mMS(endoscopy, rectal bleeding, stool frequency), ranging from 0-9 (normal to severe)
Measured: induction period week 12
Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS)
Clinical remission per mMS, ranging from 0-9 (normal to severe)
Measured: Maintenance period week 40
Secondary outcomes (6)
Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore
Endoscopic improvement per endoscopy subscore, ranging from 0 to 3 (normal to severe)
Measured: induction period week 12
Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS)
Clinical response per mMS, ranging from 0 to 9 (normal to severe).
Measured: induction period Week 12
Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore
Endoscopic improvement per endoscopy subscore, ranging from 0 to 3 (normal to severe)
Measured: Maintenance period Week 40
Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS)
Clinical response per mMS, ranging from 0 to 9 (normal to severe)
Measured: Maintenance period Week 40
Proportion of Subjects who achieve symptomatic response over time
Symptomatic response per paritial Mayo score(rectal bleeding, stool frequency), ranging from 0-6(normal to severe)
Measured: Open label treatment period up to 40 Weeks
Proportion of Subjects who achieve Symptomatic Remission over time
Symptomatic remission per paritial Mayo score, ranging from 0-6(normal to severe)
Measured: Open label treatment period up to 40 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start10 Sep 2019
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Moderately to Severely Active Ulcerative ColitisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Everstar Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kaichun Wu, Principal investigator, The First Affiliated Hospital of Fourth Military Medical University, PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176588
- Sponsor's protocol ID
- ES101002
- Status last verified
- Jan 2024
- First submitted
- 22 Nov 2019
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu K, Zheng C, Cao Q, Ding Y, Gao X, Zhong J, Chiu CT, Zhang H, Wang X, Wang B, Liang J, Liu X, Zhou Y, Xu B, Kim TO, Shen X, Chen D, Chen W, Liu Y, Shen J, Liu F, Ding X, Zhan Q, Chou JW, Zeng S, Lin Y, Ying L, Chen X; ENLIGHT UC Study Group. Etrasimod as induction and maintenance treatment for patients with moderately to severely active ulcerative colitis in East Asia (ENLIGHT UC): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet Gastroenterol Hepatol. 2025 Dec;10(12):1089-1103. doi: 10.1016/S2468-1253(25)00198-0. Epub 2025 Sep 30.
PubMed 41043449Vermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol. 2025 Jan 8;12(1):e001516. doi: 10.1136/bmjgast-2024-001516.
PubMed 39778975
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Etrasimod for Induction and Maintenance Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04176588
- Acronym / sponsor ID
- ES101002
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Everstar Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 25 Nov 2019 (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.
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Etrasimod 2mg | Experimental | Drug: Etrasimod2mg/tablet, administratered orally, once daily |
| Placebo Comparator: Placebo | Placebo comparator | Drug: Placebomatching tablet, administratered orally, once daily |
| Etrasimod 2mg (optional open-label extension period) | Experimental | Drug: Etrasimod2mg/tablet, administratered orally, once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A documented of diagnosis with UC at least 3 months prior to screening.
- Have active UC confirmed by endoscopy with ≥ 10 cm rectal involved.
Key exclusion criteria (3 listed)
- Have severe extensive colitis
- Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
- Diagnosis of microscopic colitis, ischemic colitis, infection colitis or colonic mucosal dysplasia
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 |
|---|---|---|
| EtrasimodDrug:Etrasimod Tablet other name:APD334 | Drug | Etrasimod 2mg (optional open-label extension period), Experimental: Etrasimod 2mg |
| PlaceboDrug:placebo Tablet | Drug | Placebo Comparator: Placebo |
Primary outcome
Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS)
Time frame: induction period week 12
Clinical remission per mMS(endoscopy, rectal bleeding, stool frequency), ranging from 0-9 (normal to severe)
Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS)
Time frame: Maintenance period week 40
Clinical remission per mMS, ranging from 0-9 (normal to severe)
6 secondary outcomes
Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore
Time frame: induction period week 12
Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS)
Time frame: induction period Week 12
Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore
Time frame: Maintenance period Week 40
Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS)
Time frame: Maintenance period Week 40
Proportion of Subjects who achieve symptomatic response over time
Time frame: Open label treatment period up to 40 Weeks
Proportion of Subjects who achieve Symptomatic Remission over time
Time frame: Open label treatment period up to 40 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 41043449Wu K, Zheng C, Cao Q, Ding Y, Gao X, Zhong J, Chiu CT, Zhang H, Wang X, Wang B, Liang J, Liu X, Zhou Y, Xu B, Kim TO, Shen X, Chen D, Chen W, Liu Y, Shen J, Liu F, Ding X, Zhan Q, Chou JW, Zeng S, Lin Y, Ying L, Chen X; ENLIGHT UC Study Group. Etrasimod as induction and maintenance treatment for patients with moderately to severely active ulcerative colitis in East Asia (ENLIGHT UC): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet Gastroenterol Hepatol. 2025 Dec;10(12):1089-1103. doi: 10.1016/S2468-1253(25)00198-0. Epub 2025 Sep 30.
- Derived from this study: PubMed 39778975Vermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol. 2025 Jan 8;12(1):e001516. doi: 10.1136/bmjgast-2024-001516.
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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. This study is not recruiting at the moment.
Kaichun Wu principal investigator
The First Affiliated Hospital of Fourth Military Medical University, PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etrasimod in people with Moderately to Severely Active Ulcerative Colitis, run by Everstar Therapeutics Limited at 1 site in China.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS) (time frame: induction period week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04176588, which also lists 2 linked publications.
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 9 Jan 2024.