Ulcerative ColitisPhase 2NCT02447302
Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
A Phase 2 study testing Etrasimod in people with Ulcerative Colitis, run by Arena Pharmaceuticals at 134 sites in 21 countries.
Trial summary
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- 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
- 156 participants
- Where
- 134 sitesin 21 countries
- Study dates
- 15 Oct 2015to 14 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score
- Evidence of colonic ulcerative colitis activity on endoscopy
Who cannot join
- Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide), a non-biologic investigational therapy or an approved non-biologic therapy in an investigational protocol
- Within 60 days prior to randomization, receipt of any of the following: Infliximab, adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or approved biologic agent
- Any prior exposure to natalizumab, efalizumab, or rituximab
Trial locations and contacts
134 sites in 21 countries.
134 sites in 21 countries
United States30 sites
Arena 1119
Birmingham, Alabama, 35294
Arena 1131
Chicago, Illinois, 60611
Arena 1112
Cincinnati, Ohio, 45267
Arena 1136
DeSoto, Texas, 75115
Arena 1133
Dothan, Alabama, 36305
Arena 1105
Germantown, Tennessee, 38138
Arena 1109
Great Neck, New York, 11021
Arena 1102
Hermitage, Tennessee, 37076
Arena 1139
Hoffman Estates, Illinois, 60169
Arena 1107
Hollywood, Florida, 33021
Arena 1121
Houston, Texas, 77030
Arena 1138
Miami, Florida, 33134
Arena 1123
Naples, Florida, 34102
Arena 1103
Ogden, Utah, 84405
Arena 1141
Orlando, Florida, 32825
Arena 1117
Pittsburgh, Pennsylvania, 15219
Arena 1106
Port Orange, Florida, 32127
Arena 1118
Raleigh, North Carolina, 27612
Arena 1130
Richmond, Virginia, 23298
Arena 1128
Roanoke, Virginia, 24014
Arena 1114
Rochester, New York, 14642
Arena 1115
Seattle, Washington, 98101
Arena 1101
Seattle, Washington, 98195
Arena 1137
Sweetwater, Florida, 33172
Arena 1116
Temple, Texas, 76508
Arena 1143
Thousand Oaks, California, 91360
Arena 1142
Traverse City, Michigan, 49686
Arena 1111
Troy, Michigan, 48098
Arena 1127
Urbana, Illinois, 61801
Arena 1108
Wauwatosa, Wisconsin, 53226
Ukraine12 sites
Arena 1424
Chernivtsi, 3110
Arena 1445
Ivano-Frankivsk, 07601
Arena 1454
Kharkiv, 6100
Arena 1459
Kharkiv, 61039
Arena 1466
Kiev, 01030
Arena 1408
Kyiv, 01030
Arena 1502
Kyiv, 01133
Arena 1506
Kyiv, 02091
Arena 1414
Odesa, 65025
Arena 1433
Uzhhorod, 88000
Arena 1416
Vinnytsia, 21018
Arena 1501
Vinnytsia, 21029
Russia10 sites
Arena 1440
Kazan', 420029
Arena 1500
Krasnoyarsk, 660022
Arena 1504
Novosibirsk, 630091
Arena 1419
Rostov-on-Don, 197022
Arena 1452
Ryazan, 197022
Arena 1498
Saint Petersburg, 191015
Arena 1467
Saint Petersburg, 195257
Arena 1448
Saint Petersburg, 344007
Arena 1447
Saint Petersburg, 603126
Arena 1465
Samara, 111539
Poland9 sites
Arena 1439
Bydgoszcz, 85-681
Arena 1486
Elblag, 03-580
Arena 1495
Kielce, 25-364
Arena 1451
Krakow, 31-009
Arena 1438
Lodz, 90-302
Arena 1458
Poznan, 61-485
Arena 1428
Rzeszów, 35-068
Arena 1456
Sopot, 81-756
Arena 1494
Wroclaw, 54-144
France7 sites
Arena 1443
Amiens, 80054
Arena 1418
Clichy, 92110
Arena 1437
Lille, 59037
Arena 1476
Paris, 75010
Arena 1480
Pierre-Bénite, 693110
Arena 1423
Saint-Etienne, 42055
Arena 1457
Vandœuvre-lès-Nancy, 54511
Germany7 sites
Arena 1479
Hamburg, 20249
Arena 1422
Hamburg
Arena 1470
Hanover, 30625
Arena 1446
Kiel, 24105
Arena 1489
Leipzig, 04103
Arena 1497
Oldenburg, 26123
Arena 1444
Ulm, 89073
Hungary7 sites
Arena 1478
Békéscsaba, 5600
Arena 1471
Budapest, 1062
Arena 1492
Budapest, 1062
Arena 1431
Budapest, 1076
Arena 1505
Debrecen, 4025
Arena 1474
Debrecen, 4032
Arena 1477
Szombathely, 9700
Romania7 sites
Arena 1441
Bucharest, 050098
Arena 1491
Bucharest, 10719
Arena 1406
Bucharest
Arena 1436
Iași, 700506
Arena 1420
Oradea, 410159
Arena 1405
Timișoara, 300002
Arena 1493
Timișoara, 300736
South Korea7 sites
Arena 1613
Busan, 49241
Arena 1614
Daegu, 42415
Arena 1610
Incheon, 21565
Arena 1612
Seoul, 05505
Arena 1611
Seoul, 06519
Arena 1608
Suwon, 16247
Arena 1615
Wŏnju, 26426
Bulgaria6 sites
Arena 1421
Rousse, 7002
Arena 1409
Sofia, 1407
Arena 1410
Sofia, 1407
Arena 1417
Sofia, 1407
Arena 1407
Sofia, 1797
Arena 1425
Varna, 9010
Canada6 sites
Arena 1210
Bridgewater, Nova Scotia, B4V 3N2
Arena 1208
Greater Sudbury, Ontario, P3E 1H5
Arena 1209
Greater Sudbury, Ontario, P3E 6C3
Arena 1206
London, Ontario, N6A 4G5
Arena 1204
Toronto, Ontario, M5G 1X5
Arena 1202
Winnipeg, Manitoba, R3A 1R9
Spain6 sites
Arena 1403
Barcelona, 08022
Arena 1460
Barcelona, 08036
Arena 1481
Madrid, 28046
Arena 1430
Pontevedra, 36071
Arena 1432
Santiago de Compostela, 15706
Arena 1469
Seville, 41007
Israel5 sites
Arena 1705
Beersheba, 84101
Arena 1702
Haifa, 31096
Arena 1706
Holon, 58100
Arena 1704
Jerusalem, 91031
Arena 1703
Petah Tikva, 49100
Australia3 sites
Arena 1604
Kingswood, 2747
Arena 1605
Randwick, 2031
Arena 1607
Subiaco, 6008
Belgium3 sites
Arena 1472
Edegem, 2650
Arena 1464
Kortrijk, 8500
Arena 1473
Leuven, 3000
United Kingdom3 sites
Arena 1302
London, E1 1BB
Arena 1304
Torquay, TQ2 7AA
Arena 1303
Wolverhampton, WV10 0QP
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Etrasimod, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtrasimodDrug
Also called APD334
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Etrasimod Low Dose | Experimental | Oral, low dose, daily for 12 Weeks Receives: Drug: Etrasimod |
| Etrasimod High Dose | Experimental | Oral, high dose, daily for 12 weeks Receives: Drug: Etrasimod |
| Placebo | Placebo comparator | Oral, placebo, daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Adapted Mayo Score (MCS) at Week 12
The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Measured: Baseline and Week 12
Secondary outcomes (3)
Percentage of Participants Who Achieved Endoscopic Improvement at Week 12
For determination of the endoscopic subscore of the MCS, a flexible proctosigmoidoscopy, performed with a videoendoscope following a cleansing prep (oral or rectal cathartic) was performed at screening (within 10 days prior to administration of the first dose of study drug) and the Week 12 visit. This efficacy procedure assessed endoscopic mucosal appearance. The results were rated on a scale from 0 to 3, indicating normal to severe. Endoscopic improvement was defined as Mayo endoscopic subscore (using findings of flexible proctosigmoidoscopy) of ≤1 point. Multiple imputation method was used to handle missing data.
Measured: Week 12
Change From Baseline in 2-component MCS at Week 12
The 2-component MCS was used to measure disease activity of ulcerative colitis. It consisted of 2 subscores (rectal bleeding and findings on endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The 2-component MCS was calculated as the sum of the 2 subscores, and the overall score value ranged from 0 to 6, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Measured: Baseline and Week 12
Change From Baseline in Total Mayo Score (TMS) at Week 12
The TMS was used to measure disease activity of ulcerative colitis. It consisted of 4 subscores [stool frequency, rectal bleeding, findings of endoscopy (flexible proctosigmoidoscopy), and Physician's Global Assessment (PGA) score], each of which was rated on a scale from 0 to 3, indicating normal to severe. The TMS was calculated as the sum of the 4 subscores, and the overall score values ranged from 0 to 12, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study start15 Oct 2015
- Primary completion14 Feb 2018
- Study completion14 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arena Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arena CT.gov Administrator, Study director, Arena Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447302
- Sponsor's protocol ID
- APD334-003
- Other IDs
- 2015-001942-28, 2015
- Status last verified
- Mar 2021
- First submitted
- 13 May 2015
- Last updated
- 5 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Vermeire 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 39778975Lees CW, Torres J, Leung Y, Vermeire S, Fellmann M, Modesto I, McDonnell A, Lazin K, Keating M, Goetsch M, Wu J, Loftus EV Jr. Non-serious adverse events in patients with ulcerative colitis receiving etrasimod: an analysis of the phase II OASIS and phase III ELEVATE UC 52 and ELEVATE UC 12 clinical trials. Ther Adv Gastroenterol. 2024 Nov 7;17:17562848241293643. doi: 10.1177/17562848241293643. eCollection 2024.
PubMed 39526078Yarur AJ, Chiorean MV, Panes J, Jairath V, Zhang J, Rabbat CJ, Sandborn WJ, Vermeire S, Peyrin-Biroulet L. Achievement of Clinical, Endoscopic, and Histological Outcomes in Patients with Ulcerative Colitis Treated with Etrasimod, and Association with Faecal Calprotectin and C-reactive Protein: Results From the Phase 2 OASIS Trial. J Crohns Colitis. 2024 Jun 3;18(6):885-894. doi: 10.1093/ecco-jcc/jjae007.
PubMed 38245818Sandborn WJ, Peyrin-Biroulet L, Zhang J, Chiorean M, Vermeire S, Lee SD, Kuhbacher T, Yacyshyn B, Cabell CH, Naik SU, Klassen P, Panes J. Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):550-561. doi: 10.1053/j.gastro.2019.10.035. Epub 2019 Nov 9.
PubMed 31711921
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02447302
- Acronym / sponsor ID
- APD334-003
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Arena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 14 Feb 2018 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Posted 5 Apr 2021
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 ulcerative colitis.
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 |
|---|---|---|
| Etrasimod Low Dose | Experimental | Drug: EtrasimodOral, low dose, daily for 12 Weeks |
| Etrasimod High Dose | Experimental | Drug: EtrasimodOral, high dose, daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboOral, placebo, daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score
- Evidence of colonic ulcerative colitis activity on endoscopy
Key exclusion criteria (3 listed)
- Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide), a non-biologic investigational therapy or an approved non-biologic therapy in an investigational protocol
- Within 60 days prior to randomization, receipt of any of the following: Infliximab, adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or approved biologic agent
- Any prior exposure to natalizumab, efalizumab, or rituximab
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 |
|---|---|---|
| EtrasimodAlso: APD334 | Drug | Etrasimod High Dose, Etrasimod Low Dose |
| Placebo | Drug | Placebo |
Primary outcome
Change From Baseline in Adapted Mayo Score (MCS) at Week 12
Time frame: Baseline and Week 12
The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
3 secondary outcomes
Percentage of Participants Who Achieved Endoscopic Improvement at Week 12
Time frame: Week 12
Change From Baseline in 2-component MCS at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Total Mayo Score (TMS) at Week 12
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Derived from this study: PubMed 39526078Lees CW, Torres J, Leung Y, Vermeire S, Fellmann M, Modesto I, McDonnell A, Lazin K, Keating M, Goetsch M, Wu J, Loftus EV Jr. Non-serious adverse events in patients with ulcerative colitis receiving etrasimod: an analysis of the phase II OASIS and phase III ELEVATE UC 52 and ELEVATE UC 12 clinical trials. Ther Adv Gastroenterol. 2024 Nov 7;17:17562848241293643. doi: 10.1177/17562848241293643. eCollection 2024.
- Derived from this study: PubMed 38245818Yarur AJ, Chiorean MV, Panes J, Jairath V, Zhang J, Rabbat CJ, Sandborn WJ, Vermeire S, Peyrin-Biroulet L. Achievement of Clinical, Endoscopic, and Histological Outcomes in Patients with Ulcerative Colitis Treated with Etrasimod, and Association with Faecal Calprotectin and C-reactive Protein: Results From the Phase 2 OASIS Trial. J Crohns Colitis. 2024 Jun 3;18(6):885-894. doi: 10.1093/ecco-jcc/jjae007.
- Derived from this study: PubMed 31711921Sandborn WJ, Peyrin-Biroulet L, Zhang J, Chiorean M, Vermeire S, Lee SD, Kuhbacher T, Yacyshyn B, Cabell CH, Naik SU, Klassen P, Panes J. Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):550-561. doi: 10.1053/j.gastro.2019.10.035. Epub 2019 Nov 9.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Arena CT.gov Administrator study director
Arena Pharmaceuticals
134 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etrasimod in people with Ulcerative Colitis, run by Arena Pharmaceuticals at 134 sites in 21 countries.
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: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 134 sites in United States, Ukraine, Russia, Poland, France and 16 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Adapted Mayo Score (MCS) at Week 12 (time frame: Baseline and Week 12). 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 NCT02447302, which also lists 4 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 5 Apr 2021.