Ulcerative ColitisPhase 2NCT05287126
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
A Phase 2 study testing Etrasimod in people with Ulcerative Colitis, run by Pfizer at 47 sites in 5 countries.
Trial summary
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Read more about this study
- Who is it for?
- Ages 12 to 17 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?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 47 sitesin 5 countries
- Study dates
- 16 Dec 2022to 10 Jul 2033
- Phase
- Phase 2
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active
- Participants are permitted to be receiving a therapeutic dose of select UC therapies
Who cannot join
- Severe extensive colitis
- Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Trial locations and contacts
47 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
47 sites in 5 countries
United States22 sites, 22 recruiting
- Recruiting
ACT-Midwest G1
Abilene, Texas, 79606
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
- Recruiting
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
Cook Children's Health Care System-Dodson Specialty Clinics
Fort Worth, Texas, 76104
- Recruiting
Cook Children's Medical Center
Fort Worth, Texas, 76104
- Recruiting
Valley View Wellness Medical Center
Garden Grove, California, 92845
- Not yet recruiting
Arkansas Children's (IP Address)
Little Rock, Arkansas, 72202
- Not yet recruiting
Arkansas Children's
Little Rock, Arkansas, 72202
- Not yet recruiting
Loma Linda Children's Hospital
Loma Linda, California, 92354
- Not yet recruiting
Loma Linda University Clinical Trial Center
Loma Linda, California, 92354
- Not yet recruiting
Loma Linda University Eye Institute
Loma Linda, California, 92354
- Not yet recruiting
Loma Linda University Medical Center
Loma Linda, California, 92354
- Not yet recruiting
Loma Linda University Pediatric Clinics
Loma Linda, California, 92354
- Recruiting
Arnold Palmer Hospital - Center for Digestive Health and Nutrition
Orlando, Florida, 32806
- Recruiting
William Beaumont Hospital/Corewell Health - East
Royal Oak, Michigan, 48073
- Recruiting
William Beaumont Hospitals Reference Laboratory
Royal Oak, Michigan, 48073
- Not yet recruiting
Loma Linda University Children's Hospital Pediatric Specialty Clinics
San Bernardino, California, 92408
- Recruiting
University of California San Francisco,
San Francisco, California, 94158
- Recruiting
University of California San Francisco
San Francisco, California, 94158
- Recruiting
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
San Francisco, California, 94158
Japan11 sites, 11 recruiting
- Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
- Recruiting
Kinki University - Nara Hospital
Ikoma, Nara, 630-0293
- Recruiting
Tsujinaka Hospital - Kashiwanoha
Kashiwa, Chiba, 277-0871
- Recruiting
Japanese Red Cross Kyoto Daini Hospital
Kyoto, 602-8026
- Recruiting
Gunma University Hospital
Maebashi, Gunma, 371-8511
- Recruiting
Ishii Eye Clinic
Nagareyama-shi, Chiba, 270-0116
- Recruiting
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, 663-8501
- Recruiting
Saga University Hospital
Saga, 849-8501
- Recruiting
Saitama Prefectural Children's Medical Center
Saitama-shi, Saitama, 330-8777
- Recruiting
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329 0498
- Recruiting
Toyama Prefectural Central Hospital
Toyama, 930-8550
Poland8 sites, 8 recruiting
- Recruiting
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, 40-600
- Recruiting
Uniwersytecki Szpital Dziecięcy w Krakowie
Krakow, 30-663
- Recruiting
Twoja Przychodnia - Szczecińskie Centrum Medyczne
Szczecin, 71-434
- Recruiting
WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship, 04-501
- Recruiting
Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)
Warsaw, Masovian Voivodeship, 04-730
- Recruiting
Centrum Zdrowia MDM
Warsaw, 00-189
- Recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
- Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-369
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Reina Sofia
Córdoba, 14004
- Recruiting
Consorci Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208
- Recruiting
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, 15706
Slovakia2 sites, 2 recruiting
- Recruiting
Detska fakultna nemocnica Kosice
Košice, 040 11
- Recruiting
K.M. Management, spol. s r.o.
Nitra, 949 01
About this study
Official title: An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).
- Conditions
- Ulcerative Colitis
- Being tested
- Etrasimod
- Keywords
- Pharmacokinetics, Adolescents, Active Ulcerative Colitis, APD334
- 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
Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Etrasimod | Experimental | Not described Receives: Drug: Etrasimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52
Measured: Week 52
Secondary outcomes (16)
Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)
Measured: 4 hours (± 15 minutes) post-dose
Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod
Measured: pre-dose and 4 hours (±15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12
Measured: Week 12
Proportion of Participants Achieving Endoscopic Improvement at Week 12
Measured: Week 12
Proportion of Participants Achieving Endoscopic Improvement at Week 52
Measured: Week 52
Proportion of Participants Achieving Symptomatic Remission at Week 12
Measured: Week 12
Proportion of Participants Achieving Symptomatic Remission at Week 52
Measured: Week 52
Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12
Measured: Week 12
Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52
Measured: Week 52
Proportion of Participants Achieving Clinical Response at Week 12
Measured: Week 12
Proportion of Participants Achieving Clinical Response at Week 52
Measured: Week 52
Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12
Measured: Week 12
Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52
Measured: Week 52
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12
Measured: Week 12
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52
Measured: Week 52
Number and Severity of Adverse Events
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start16 Dec 2022
- Primary completion16 Jun 2029 (estimated)
- Study completion10 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arena is a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287126
- Sponsor's protocol ID
- APD334-207
- Other IDs
- C5041010, 2022-500345-25-00
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05287126
- Acronym / sponsor ID
- APD334-207
- Conditions
- Ulcerative Colitis
- Keywords
- Pharmacokinetics, Adolescents, Active Ulcerative Colitis, APD334
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Arena is a wholly owned subsidiary of Pfizer
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 16 Jun 2029 (estimated)
- Study completion
- 10 Jul 2033 (estimated)
- First posted
- 18 Mar 2022 (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 the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etrasimod | Experimental | Drug: Etrasimod |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active
- Participants are permitted to be receiving a therapeutic dose of select UC therapies
Key exclusion criteria (3 listed)
- Severe extensive colitis
- Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
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: APD334Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment. | Drug | Etrasimod |
Primary outcome
Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52
Time frame: Week 52
16 secondary outcomes
Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)
Time frame: 4 hours (± 15 minutes) post-dose
Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod
Time frame: pre-dose and 4 hours (±15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12
Time frame: Week 12
Proportion of Participants Achieving Endoscopic Improvement at Week 12
Time frame: Week 12
Proportion of Participants Achieving Endoscopic Improvement at Week 52
Time frame: Week 52
Proportion of Participants Achieving Symptomatic Remission at Week 12
Time frame: Week 12
Proportion of Participants Achieving Symptomatic Remission at Week 52
Time frame: Week 52
Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12
Time frame: Week 12
Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52
Time frame: Week 52
Proportion of Participants Achieving Clinical Response at Week 12
Time frame: Week 12
Proportion of Participants Achieving Clinical Response at Week 52
Time frame: Week 52
Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12
Time frame: Week 12
Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52
Time frame: Week 52
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12
Time frame: Week 12
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52
Time frame: Week 52
Number and Severity of Adverse Events
Time frame: Up to Week 52
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 27 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
47 sites in 5 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 Pfizer at 47 sites in 5 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Japan, Poland, Spain, Slovakia. 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?
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 Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 (time frame: Week 52). 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 27 Oct 2026.