Colitis, UlcerativePhase 2ELEVATE-UCkidsNCT07470879
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
A Phase 2 study testing Etrasimod in people with Colitis, Ulcerative, run by Pfizer at 46 sites in 10 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 pediatrics participants (≥ 2 years up to < 12 years of age). Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Colitis, Ulcerative
- 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
- 24 participants
- Where
- 46 sitesin 10 countries
- Study dates
- 28 May 2026to 18 Aug 2034
- 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 2 to 11 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
46 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
46 sites in 10 countries
United States10 sites, 10 recruiting
- Recruiting
Investigational Drug Services - Riley Hospital
Indianapolis, Indiana, 46202
- Recruiting
IU Health North Hospital
Indianapolis, Indiana, 46202
- Recruiting
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
- Recruiting
Fink Children's Ambulatory Care Center
New York, New York, 10016
- Recruiting
Kimmel Pavilion - NYU Langone
New York, New York, 10016
- Recruiting
NYU Grossman School of Medicine
New York, New York, 10016
- Recruiting
NYU Langone Health (Tisch Hospital)
New York, New York, 10016
- Recruiting
NYU Langone Inflammatory Bowel Disease Center
New York, New York, 10016
- Recruiting
NYU Langone Radiology - Tisch Hospital
New York, New York, 10016
- Recruiting
NYU Medical Science Building (MSB)
New York, New York, 10016
Israel7 sites, 7 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, Northern District, 3109601
- Recruiting
Carmel Medical Center
Haifa, Northern District, 3436212
- Recruiting
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9013102
- Recruiting
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001
- Recruiting
Sheba Medical Center
Ramat Gan, Central District, 5262100
- Recruiting
Kaplan Medical Center
Rehovot, Central District, 7610001
- Recruiting
Yitzhak Shamir Medical Center
Tsrifin, Central District, 70300
United Kingdom5 sites, 5 recruiting
- Recruiting
Bristol Royal Hospital for Children
Bristol, BS2 8BJ
- Recruiting
Alder Hey Children's Hospital
Liverpool, L14 5AB
- Recruiting
King's College Hospital
London, London, CITY of, SE5 9RL
- Recruiting
Evelina London Children's Hospital
London, SE1 7EH
- Recruiting
Sheffield Children's Hospital
Sheffield, S10 2TH
Australia4 sites, 4 recruiting
- Recruiting
Queensland Children's Hospital
Brisbane, Queensland, 4101
- Recruiting
Monash Health
Clayton, Victoria, 3168
- Recruiting
Perth Children's Hospital
Perth, Western Australia, 6009
- Recruiting
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Canada4 sites, 4 recruiting
- Not yet recruiting
University of Alberta
Edmonton, Alberta, T6G 1C9
- Recruiting
CHU de Québec - Université Laval
Québec, Quebec, G1V4G2
- Recruiting
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R3A 1S1
- Recruiting
Children's Hospital Research Institute of Manitoba
Winnipeg, Manitoba, R3E 3P4
Germany4 sites, 4 recruiting
- Recruiting
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
- Recruiting
Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin Albert-Schweitzer-Campus 1
Münster, North Rhine-Westphalia, 48149
- Recruiting
Universitaetsklinikum Tuebingen
Tübingen, 72076
- Recruiting
HELIOS Klinikum Wuppertal
Wuppertal, 42283
Poland4 sites, 4 recruiting
- Recruiting
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero
Katowice, 40-600
- Recruiting
Centrum Zdrowia MDM
Warsaw, Masovian Voivodeship, 00-189
- Recruiting
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw, Masovian Voivodeship, 04-501
- Recruiting
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, 04-730
Italy3 sites, 3 recruiting
- Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Lombardy, 24127
- Recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, Tuscany, 50139
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Japan3 sites, 3 recruiting
- Recruiting
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861-8520
- Recruiting
Saitama Prefectural Children's Medical Center
Saitama-shi, Saitama, 330-8777
- Recruiting
Juntendo University Hospital
Tokyo, 113-8431
France2 sites, 2 recruiting
- Recruiting
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, 69500
- Recruiting
Hôpital Universitaire Necker Enfants Malades
Paris, 75015
About this study
Official title: A PHASE 2 OPEN-LABEL, SINGLE ARM STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS, AND SAFETY OF ETRASIMOD IN PEDIATRIC 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 pediatrics participants (≥ 2 years up to < 12 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
- Colitis, Ulcerative
- Being tested
- Etrasimod
- Keywords
- ulcerative, colitis, ulcerative colitis, etrasimod, pediatrics
- Medical subject headings
- Colitis, Ulcerative, Ulcer, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtrasimodDrug
Also called APD334
Once daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| Etrasimod | Experimental | Etrasimod by mouth, once daily up to 52 weeks Receives: Drug: Etrasimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52
Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.
Measured: Week 52
Secondary outcomes (17)
Number and percent of enrolled participants with clinical remission based on MMS at Week 12
Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.
Measured: Week 12
Number and percent of enrolled participants with clinical response based on MMS score components at Week 12
Clinical response was defined as a ≥2-point and ≥30% decrease from baseline in MMS, and a ≥1-point decrease from baseline in RB subscore or an absolute RB subscore ≤ 1. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.
Measured: Week 12
Number and percent of enrolled participants with clinical response based on MMS score components at Week 52
Clinical response was defined as a ≥2-point and ≥30% decrease from baseline in MMS, and a ≥1-point decrease from baseline in RB subscore or an absolute RB subscore ≤ 1. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.
Measured: Week 52
Number and percent of enrolled participants endoscopic improvement based on MMS score components at Week 12
Endoscopic improvement defined as ES ≤1 (excluding friability). These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.
Measured: Week 12
Number and percent of enrolled participants endoscopic improvement based on MMS score components at Week 52
Endoscopic improvement defined as ES ≤1 (excluding friability). These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.
Measured: Week 52
Number and percent of enrolled participants Clinical remission at Week 12 and who had not been receiving corticosteroids for ≥2 weeks immediately prior to Week 12
Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Number of weeks off corticosteroids prior to week 12 visit will be used to determine end point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.
Measured: Week 12
Number and percent of enrolled participants Clinical remission at Week 52 and who had not been receiving corticosteroids for ≥12 weeks immediately prior to Week 52
Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Number of weeks off corticosteroids prior to week 52 visit will be used to determine end point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.
Measured: Week 52
Number and percent of enrolled participants Symptomatic remission at all time points up to Week 52
Symptomatic remission was defined as SF subscore = 0 or 1 and an RB subscore = 0. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.
Measured: Week 52
Number and percent of enrolled participants Pediatric Ulcerative Colitis Activity Index (PUCAI) clinical remission from baseline to Week 260
Clinical remission by PUCAI is defined as a score <10. These assessments will be conducted at each visit. These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.
Measured: Baseline, through Week 260
Number and percent of enrolled participants PUCAI clinical response from baseline to Week 260
Clinical response by PUCAI is defined as a score ≥ 20 point reduction from baseline. These assessments will be conducted at each visit.These results will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.
Measured: Baseline, through Week 260
Number and percentage of participants reporting a positive taste/palatability score
The responses to taste acceptability questionnaire on etrasimod tablets and granules will be summarized using count and percentage for SAS
Measured: Week 2
Number and percentage of participants reporting a positive taste/palatability score
The responses to taste acceptability questionnaire on etrasimod tablets and granules will be summarized using count and percentage for SAS
Measured: Week 12
Change from baseline in Z-Scores height and weight
These assessments will be conducted at each visit. The values and change from baseline will be summarized using number of observations, mean, standard deviation, minimum and maximum values by visit for SAS.
Measured: Baseline through Week 260
Number of Participants with Treatment Emergent Treatment-Related Adverse Events (AEs), including Serious Adverse Events (SAEs) and AEs leading to discontinuation.
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to etrasimod was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: Baseline up to 28 days after last dose of study intervention
Number of Participants with Clinically Significant Findings in Laboratory Examinations
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); Hepatobiliary biochemistry: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Albumin, Alkaline Phosphatase, Total Bilirubin ; Renal Function Tests: Blood Urea Nitrogen (BUN), Creatinine, Creatinine Kinase, Uric Acid ; Electrolytes: Sodium, Potassium; Glucose; Urine analysis: (decimal logarithm of reciprocal of hydrogen ion activity )[pH], Specific gravity. Clinically significant laboratory abnormality findings were based on investigator discretion.
Measured: Baseline up to 28 days after last dose of study intervention
Number of Participants with Clinically Significant Change in Vital Signs
Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and body weight. Number of participants with clinically significant change in any vital sign parameter compared to baseline were reported. Clinically significant change in vital signs criteria were based on investigator's discretion.
Measured: Baseline up to week 260
Plasma concentration verses time of study intervention
Samples collected prior to daily dosing of study intervention for measurement of plasma concentrations of etrasimod will be analyzed using a validated analytical method in compliance with applicable SOPs.
Measured: Baseline, Weeks 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start28 May 2026
- Primary completion8 Sep 2030 (estimated)
- Study completion18 Aug 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470879
- Sponsor's protocol ID
- C5041018
- Other IDs
- APD334-208, 2025-523100-77-00, 2025
- Acronym
- ELEVATE-UCkids
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2026
- Last updated
- 26 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 2 OPEN-LABEL, SINGLE ARM STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS, AND SAFETY OF ETRASIMOD IN PEDIATRIC PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
- ClinicalTrials.gov ID
- NCT07470879
- Acronym / sponsor ID
- ELEVATE-UCkids / C5041018
- Conditions
- Colitis, Ulcerative
- Keywords
- ulcerative, colitis, ulcerative colitis, etrasimod, pediatrics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 28 May 2026 (actual)
- Primary completion
- 8 Sep 2030 (estimated)
- Study completion
- 18 Aug 2034 (estimated)
- First posted
- 13 Mar 2026 (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 pediatrics participants (≥ 2 years up to < 12 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: EtrasimodEtrasimod by mouth, once daily up to 52 weeks |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 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 (1 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: APD334Once daily by mouth | Drug | Etrasimod |
Primary outcome
Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52
Time frame: Week 52
Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point (SF= 1 or 0), ES=1 or 0 and RB=0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. will be summarized by the number and percentage of participants achieving the response, along with a two-sided 95% CI.
17 secondary outcomes
Number and percent of enrolled participants with clinical remission based on MMS at Week 12
Time frame: Week 12
Number and percent of enrolled participants with clinical response based on MMS score components at Week 12
Time frame: Week 12
Number and percent of enrolled participants with clinical response based on MMS score components at Week 52
Time frame: Week 52
Number and percent of enrolled participants endoscopic improvement based on MMS score components at Week 12
Time frame: Week 12
Number and percent of enrolled participants endoscopic improvement based on MMS score components at Week 52
Time frame: Week 52
Number and percent of enrolled participants Clinical remission at Week 12 and who had not been receiving corticosteroids for ≥2 weeks immediately prior to Week 12
Time frame: Week 12
Number and percent of enrolled participants Clinical remission at Week 52 and who had not been receiving corticosteroids for ≥12 weeks immediately prior to Week 52
Time frame: Week 52
Number and percent of enrolled participants Symptomatic remission at all time points up to Week 52
Time frame: Week 52
Number and percent of enrolled participants Pediatric Ulcerative Colitis Activity Index (PUCAI) clinical remission from baseline to Week 260
Time frame: Baseline, through Week 260
Number and percent of enrolled participants PUCAI clinical response from baseline to Week 260
Time frame: Baseline, through Week 260
Number and percentage of participants reporting a positive taste/palatability score
Time frame: Week 2
Number and percentage of participants reporting a positive taste/palatability score
Time frame: Week 12
Change from baseline in Z-Scores height and weight
Time frame: Baseline through Week 260
Number of Participants with Treatment Emergent Treatment-Related Adverse Events (AEs), including Serious Adverse Events (SAEs) and AEs leading to discontinuation.
Time frame: Baseline up to 28 days after last dose of study intervention
Number of Participants with Clinically Significant Findings in Laboratory Examinations
Time frame: Baseline up to 28 days after last dose of study intervention
Number of Participants with Clinically Significant Change in Vital Signs
Time frame: Baseline up to week 260
Plasma concentration verses time of study intervention
Time frame: Baseline, Weeks 2 and 4
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 26 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.
Related trials for Colitis, Ulcerative
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.
Pfizer CT.gov Call Center study director
Pfizer
46 sites in 10 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 Colitis, Ulcerative, run by Pfizer at 46 sites in 10 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: looking for participants now, as of the sponsor's last update on 26 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 46 sites in United States, Israel, United Kingdom, Australia, Canada and 5 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?
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?
Number and percent of enrolled participants with clinical remission based on 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 26 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.