search
Back to results

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Etrasimod
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Pharmacokinetics, Adolescents, Active Ulcerative Colitis, APD334

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Sites / Locations

  • Valley View Wellness Medical CenterRecruiting
  • Childrens Hospital of Orange CountyRecruiting
  • University of California San Francisco,Recruiting
  • University of California San FranciscoRecruiting
  • University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)Recruiting
  • IHS Health ResearchRecruiting
  • Arnold Palmer Hospital - Center for Digestive Health and NutritionRecruiting
  • Nemours Children's HospitalRecruiting
  • Kissimmee Endoscopy CenterRecruiting
  • Children's Center for Digestive Health Care, LLCRecruiting
  • University of Chicago Medical CenterRecruiting
  • Boston Children's HospitalRecruiting
  • Beaumont HospitalRecruiting
  • William Beaumont HospitalRecruiting
  • Dartmouth Hitchcock Medical CenterRecruiting
  • University of Rochester Medical Center Clinical Research CenterRecruiting
  • University of Rochester Medical CenterRecruiting
  • University Hospitals Cleveland Medical Center Rainbow Babies & Children's HospitalRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Tennessee Eye CareRecruiting
  • East Tennessee Children's HospitalRecruiting
  • Statcare PulmonaryRecruiting
  • GI for KidsRecruiting
  • TennovaRecruiting
  • DCT - Midwest GI
  • Landeskrankenhaus SalzburgRecruiting
  • Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)Recruiting
  • Uniwersytecki Szpital Dziecięcy w KrakowieRecruiting
  • Twoja Przychodnia - Szczecińskie Centrum MedyczneRecruiting
  • Centrum Zdrowia MDMRecruiting
  • WIP Warsaw IBD Point Profesor KierkusRecruiting
  • Instytut Centrum Zdrowia Matki PolkiRecruiting
  • Consorci Corporacio Sanitaria Parc TauliRecruiting
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitari Vall d'HebronRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Etrasimod

Arm Description

Outcomes

Primary Outcome Measures

Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52

Secondary Outcome Measures

Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)
Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod
Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12
Proportion of Participants Achieving Endoscopic Improvement at Week 12
Proportion of Participants Achieving Endoscopic Improvement at Week 52
Proportion of Participants Achieving Symptomatic Remission at Week 12
Proportion of Participants Achieving Symptomatic Remission at Week 52
Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12
Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52
Proportion of Participants Achieving Clinical Response at Week 12
Proportion of Participants Achieving Clinical Response at Week 52
Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12
Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at 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.

Full Information

First Posted
March 10, 2022
Last Updated
October 5, 2023
Sponsor
Pfizer
Collaborators
Arena is a wholly owned subsidiary of Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT05287126
Brief Title
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
Official Title
An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
November 25, 2025 (Anticipated)
Study Completion Date
December 19, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Arena is a wholly owned subsidiary of Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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), or until marketing authorization is obtained in the participant's country, whichever comes first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Pharmacokinetics, Adolescents, Active Ulcerative Colitis, APD334

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Etrasimod
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Etrasimod
Other Intervention Name(s)
APD334
Intervention Description
Etrasimod tablet by mouth, once daily up to 52 weeks of treatment.
Primary Outcome Measure Information:
Title
Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)
Time Frame
4 hours (± 15 minutes) post-dose
Title
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
Title
Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12
Time Frame
Week 12
Title
Proportion of Participants Achieving Endoscopic Improvement at Week 12
Time Frame
Week 12
Title
Proportion of Participants Achieving Endoscopic Improvement at Week 52
Time Frame
Week 52
Title
Proportion of Participants Achieving Symptomatic Remission at Week 12
Time Frame
Week 12
Title
Proportion of Participants Achieving Symptomatic Remission at Week 52
Time Frame
Week 52
Title
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
Title
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
Title
Proportion of Participants Achieving Clinical Response at Week 12
Time Frame
Week 12
Title
Proportion of Participants Achieving Clinical Response at Week 52
Time Frame
Week 52
Title
Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12
Time Frame
Week 12
Title
Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52
Time Frame
Week 52
Title
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12
Time Frame
Week 12
Title
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52
Time Frame
Week 52
Title
Number and Severity of Adverse Events
Description
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Time Frame
Up to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Valley View Wellness Medical Center
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Francisco,
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Name
IHS Health Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Name
Arnold Palmer Hospital - Center for Digestive Health and Nutrition
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Nemours Children's Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Name
Kissimmee Endoscopy Center
City
Windermere
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Center for Digestive Health Care, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Rochester Medical Center Clinical Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Eye Care
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Name
East Tennessee Children's Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Individual Site Status
Recruiting
Facility Name
Statcare Pulmonary
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37919
Country
United States
Individual Site Status
Recruiting
Facility Name
GI for Kids
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennova
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Individual Site Status
Recruiting
Facility Name
DCT - Midwest GI
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Landeskrankenhaus Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-730
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Dziecięcy w Krakowie
City
Krakow
ZIP/Postal Code
30-663
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia - Szczecińskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Zdrowia MDM
City
Warsaw
ZIP/Postal Code
00-635
Country
Poland
Individual Site Status
Recruiting
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warsaw
ZIP/Postal Code
00-728
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Centrum Zdrowia Matki Polki
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
Consorci Corporacio Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=APD334-207
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

We'll reach out to this number within 24 hrs