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Ulcerative ColitisPhase 2NCT02536404

Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis

A Phase 2 study testing Etrasimod in people with Ulcerative Colitis, run by Arena Pharmaceuticals at 127 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment. 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
127 sitesin 21 countries
Study dates
25 Jan 2016to 1 Nov 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

  • Participants who completed the APD334-003 (NCT02447302) study

Who cannot join

  • Participants who did not complete the APD334-003 study

Trial locations and contacts

127 sites in 21 countries.

127 sites in 21 countries

United States31 sites

  • Arena 1119

    Birmingham, Alabama, 35294

  • Arena 1113

    Chevy Chase, Maryland, 20815

  • 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

Other trials in United States

Ukraine12 sites

  • Arena 1424

    Chernivtsi, 03110

  • Arena 1445

    Ivano-Frankivsk, 76018

  • Arena 1454

    Kharkiv, 06100

  • Arena 1459

    Kharkiv, 61039

  • Arena 1466

    Kiev, 01030

  • Arena 1411

    Kiev, 04201

  • Arena 1408

    Kyiv, 01030

  • Arena 1506

    Kyiv, 02091

  • Arena 1414

    Odesa, 65025

  • Arena 1433

    Uzhhorod, 88018

  • Arena 1416

    Vinnytsia, 21018

  • Arena 1501

    Vinnytsia, 21029

Other trials in Ukraine

Poland9 sites

  • Arena 1439

    Bydgoszcz, 85-681

  • Arena 1486

    Elblag, 82-300

  • Arena 1495

    Kielce, 25-364

  • Arena 1451

    Krakow, 31-009

  • Arena 1438

    Lodz, 90-302

  • Arena 1458

    Poznan, 60-856

  • Arena 1428

    Rzeszów, 35-068

  • Arena 1456

    Sopot, 81-756

  • Arena 1494

    Wroclaw, 54-144

Other trials in Poland

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

Other trials in France

Germany7 sites

  • Arena 1479

    Hamburg, 20249

  • Arena 1422

    Hamburg, 22559

  • Arena 1470

    Hanover, 30625

  • Arena 1446

    Kiel, 24105

  • Arena 1489

    Leipzig, 04103

  • Arena 1497

    Oldenburg, 26123

  • Arena 1444

    Ulm, 89073

Other trials in Germany

Hungary7 sites

  • Arena 1478

    Békéscsaba, 5600

  • Arena 1431

    Budapest, 1036

  • Arena 1471

    Budapest, 1062

  • Arena 1492

    Budapest, 1062

  • Arena 1505

    Debrecen, 4025

  • Arena 1474

    Debrecen, 4032

  • Arena 1477

    Szombathely, 9700

Other trials in Hungary

Romania7 sites

  • Arena 1491

    Bucharest, 010719

  • Arena 1406

    Bucharest, 020125

  • Arena 1441

    Bucharest, 050098

  • Arena 1436

    Iași, 700506

  • Arena 1420

    Oradea, 410159

  • Arena 1405

    Timișoara, 300002

  • Arena 1493

    Timișoara, 300736

Other trials in Romania

Bulgaria6 sites

  • Arena 1421

    Rousse, 1407

  • Arena 1417

    Sofia, 1407

  • Arena 1410

    Sofia, 1527

  • Arena 1409

    Sofia, 1784

  • Arena 1407

    Sofia, 1797

  • Arena 1425

    Varna, 9010

Other trials in Bulgaria

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

Other trials in Canada

Russia6 sites

  • Arena 1500

    Krasnoyarsk, 660022

  • Arena 1504

    Novosibirsk, 630091

  • Arena 1419

    Rostov-on-Don, 344022

  • Arena 1498

    Saint Petersburg, 191015

  • Arena 1448

    Saint Petersburg, 191186

  • Arena 1465

    Samara, 443063

Other trials in Russia

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, 41071

Other trials in Spain

Israel5 sites

  • Arena 1705

    Beersheba, 84101

  • Arena 1702

    Haifa, 31096

  • Arena 1706

    Holon, 58100

  • Arena 1704

    Jerusalem, 91031

  • Arena 1703

    Petah Tikva, 49100

Other trials in Israel

Australia3 sites

  • Arena 1604

    Kingswood, 2747

  • Arena 1605

    Randwick, 2031

  • Arena 1607

    Subiaco, 6008

Other trials in Australia

Belgium3 sites

  • Arena 1472

    Edegem, 2650

  • Arena 1464

    Kortrijk, 8500

  • Arena 1473

    Leuven, 3000

Other trials in Belgium

South Korea3 sites

  • Arena 1614

    Daegu, 42415

  • Arena 1610

    Incheon, 21565

  • Arena 1615

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

United Kingdom3 sites

  • Arena 1302

    London, E1 1BB

  • Arena 1304

    Torquay, TQ2 7AA

  • Arena 1303

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Latvia2 sites

  • Arena 1462

    Riga, 1002

  • Arena 1475

    Riga, 1006

Other trials in Latvia

Austria1 site

  • Arena 1490

    Vienna, 1090

Other trials in Austria

Czechia1 site

  • Arena 1455

    Prague, 140 59

Other trials in Czechia

Lithuania1 site

  • Arena 1484

    Vilnius, 8661

Other trials in Lithuania

New Zealand1 site

  • Arena 1601

    Christchurch, 8011

Other trials in New Zealand

About this study

The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.

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 groups in NCT02536404
Study groupRoleWhat they receive
Etrasimod 2 mgExperimentalNot described
Receives: Drug: Etrasimod
PlaceboActive comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)

    A TEAE was defined as any adverse event (AE) that occurred after the first dose of study drug in the APD334-005 (NCT02536404) study, including any AE that started in Study APD334-003 (NCT02447302) and was ongoing, worsened, or ended in Study APD334-005. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events.

    Measured: Up to Week 48 (up to 30 days following discontinuation of the study drug)

Secondary outcomes (4)

  1. Proportion of Participants Who Achieved Clinical Response

    A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

    Measured: Week 46 (extension study APD334-005)

  2. Proportion of Participants Who Achieved Clinical Response at Week 12 in APD334-003 and Maintained Clinical Response at Week 46 in APD334-005

    A participant was considered to have achieved clinical response if he/she met the criteria of clinical remission or met criteria of clinical response. Clinical remission was defined as individual subscores of the 3-component Mayo Clinic score as follows: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared to APD334-003 baseline. Clinical response was defined as a decrease in 3-component Mayo Clinic score of ≥ 2 points and at least 30% with either a decrease of rectal bleeding of ≥ 1 or rectal bleeding score of 0 or 1 at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

    Measured: Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)

  3. Proportion of Participants Who Achieved Clinical Remission

    A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

    Measured: Week 46 (extension study APD334-005)

  4. Proportion of Participants Who Achieved Clinical Remission at Week 12 in APD334-003 and Also Maintained Clinical Remission at Week 46 in APD334-005

    A participant was considered to have achieved clinical remission if he/she had: (1) an endoscopy score (using flexible proctosigmoidoscopy) of 0 or 1, (2) a rectal bleeding score of 0, and (3) a stool frequency score of 0 or 1 with a decrease of ≥ 1 point at Week 46 compared with baseline of study APD334-003. A score of 0 = normal and 1 = mild disease.

    Measured: Week 12 (core study APD334-003) and Week 46 (extension study APD334-005)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2015 (estimated)
  2. Study start25 Jan 2016
  3. Primary completion1 Nov 2018
  4. Study completion1 Nov 2018

Resources

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
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02536404
Sponsor's protocol ID
APD334-005
Status last verified
Nov 2021
First submitted
24 Aug 2015
Last updated
26 Nov 2021
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 39778975

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 127 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 1 inclusion and 1 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 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, Ukraine, Poland, France, Germany 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. 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 26 Nov 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?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) (time frame: Up to Week 48 (up to 30 days following discontinuation of the study drug)). 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 NCT02536404, which also lists 1 linked publication.

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 26 Nov 2021.

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