A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05287126
• Other study ID #: APD334-207
• Secondary ID: C50410102021-003
• Status: Recruiting
• Phase: Phase 2
• Start date: December 16, 2022
• Est. completion date: August 7, 2031

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 7, 2031
• Est. primary completion date: July 14, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Etrasimod
Etrasimod tablet by mouth, once daily up to 52 weeks of treatment.

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Salzburg	Salzburg
Belgium	University Hospitals Leuven	Leuven
Belgium	UZ Leuven	Leuven
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Kinki University - Nara Hospital	Ikoma City	Nara
Japan	Tsujinaka Hospital - Kashiwanoha	Kashiwa	Chiba
Japan	Japanese Red Cross Kyoto Daini Hospital	Kyoto
Japan	Ishii Eye Clinic	Nagareyama-shi	Chiba
Japan	Hyogo Medical University Hospital	Nishinomiya	Hyogo
Japan	Saga University Hospital	Saga
Japan	Saitama Prefectural Children's Medical Center	Saitama-shi	Saitama
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Toyama Prefectural Central Hospital	Toyama
Poland	Uniwersytecki Szpital Dzieciecy w Krakowie	Krakow
Poland	Instytut Centrum Zdrowia Matki Polki	Lodz	Lódzkie
Poland	Twoja Przychodnia - Szczecinskie Centrum Medyczne	Szczecin
Poland	Centrum Zdrowia MDM	Warsaw
Poland	Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)	Warsaw	Mazowieckie
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warsaw
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Reina Sofia	Cordoba
Spain	Consorci Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona
Spain	Hospital Clinico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruna
United States	Advance Clinical Trial PLLC	Abilene	Texas
United States	DCT - Midwest GI	Abilene	Texas
United States	Children's Center for Digestive Health Care, LLC	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital	Cleveland	Ohio
United States	Valley View Wellness Medical Center	Garden Grove	California
United States	IHS Health Research	Kissimmee	Florida
United States	East Tennessee Children's Hospital	Knoxville	Tennessee
United States	GI for Kids	Knoxville	Tennessee
United States	Statcare Pulmonary	Knoxville	Tennessee
United States	Tennessee Eye Care	Knoxville	Tennessee
United States	Tennova	Knoxville	Tennessee
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Arkansas Children's	Little Rock	Arkansas
United States	Arkansas Children's (IP Address)	Little Rock	Arkansas
United States	Childrens Hospital of Orange County	Orange	California
United States	Arnold Palmer Hospital - Center for Digestive Health and Nutrition	Orlando	Florida
United States	Nemours Children's Hospital	Orlando	Florida
United States	University of Rochester Medical Center	Rochester	New York
United States	University of Rochester Medical Center Clinical Research Center	Rochester	New York
United States	Beaumont Hospital	Royal Oak	Michigan
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University of California San Francisco	San Francisco	California
United States	University of California San Francisco,	San Francisco	California
United States	University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)	San Francisco	California
United States	Kissimmee Endoscopy Center	Windermere	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Arena is a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Japan,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52		Week 52
Secondary	Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)		4 hours (± 15 minutes) post-dose
Secondary	Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod		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
Secondary	Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12		Week 12
Secondary	Proportion of Participants Achieving Endoscopic Improvement at Week 12		Week 12
Secondary	Proportion of Participants Achieving Endoscopic Improvement at Week 52		Week 52
Secondary	Proportion of Participants Achieving Symptomatic Remission at Week 12		Week 12
Secondary	Proportion of Participants Achieving Symptomatic Remission at Week 52		Week 52
Secondary	Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for = 2 weeks Prior to Week 12		Week 12
Secondary	Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for = 12 weeks Prior to Week 52		Week 52
Secondary	Proportion of Participants Achieving Clinical Response at Week 12		Week 12
Secondary	Proportion of Participants Achieving Clinical Response at Week 52		Week 52
Secondary	Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12		Week 12
Secondary	Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52		Week 52
Secondary	Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12		Week 12
Secondary	Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52		Week 52
Secondary	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.	Up to Week 52

External Links

•   To obtain contact information for a study center near you, click here.