Clinical trial NCT05287126: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Pharmacokinetics
Adolescents
Active Ulcerative Colitis
APD334
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Arena is a wholly owned subsidiary of Pfizer
First posted: 2022-03-18
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)
timeFrame: 4 hours (± 15 minutes) post-dose
measure: Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod
timeFrame: 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
measure: Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12
timeFrame: Week 12
measure: Proportion of Participants Achieving Endoscopic Improvement at Week 12
timeFrame: Week 12
measure: Proportion of Participants Achieving Endoscopic Improvement at Week 52
timeFrame: Week 52
measure: Proportion of Participants Achieving Symptomatic Remission at Week 12
timeFrame: Week 12
measure: Proportion of Participants Achieving Symptomatic Remission at Week 52
timeFrame: Week 52
measure: Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12
timeFrame: Week 12
measure: Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52
timeFrame: Week 52
measure: Proportion of Participants Achieving Clinical Response at Week 12
timeFrame: Week 12
measure: Proportion of Participants Achieving Clinical Response at Week 52
timeFrame: Week 52
measure: Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12
timeFrame: Week 12
measure: Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52
timeFrame: Week 52
measure: Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12
timeFrame: Week 12
measure: Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52
timeFrame: Week 52
measure: Number and Severity of Adverse Events
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's (IP Address)
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Children's
state: Arkansas
city: Garden Grove
country: United States
facility: Valley View Wellness Medical Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda Children's Hospital
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Clinical Trial Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Eye Institute
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Pediatric Clinics
state: California
city: San Bernardino
country: United States
facility: Loma Linda University Children's Hospital Pediatric Specialty Clinics
state: California
city: San Francisco
country: United States
facility: University of California San Francisco,
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: San Francisco
country: United States
facility: University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
state: California
city: Orlando
country: United States
facility: Arnold Palmer Hospital - Center for Digestive Health and Nutrition
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Abilene
country: United States
facility: Advance Clinical Trial PLLC
state: Texas
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital - Kashiwanoha
state: Chiba
city: Nagareyama-shi
country: Japan
facility: Ishii Eye Clinic
state: Chiba
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Nishinomiya
country: Japan
facility: Hyogo Medical University Hospital
state: Hyogo
city: Ikoma City
country: Japan
facility: Kinki University - Nara Hospital
state: Nara
city: Saitama-shi
country: Japan
facility: Saitama Prefectural Children's Medical Center
state: Saitama
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daini Hospital
city: Saga
country: Japan
facility: Saga University Hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Warsaw
country: Poland
facility: Instytut "Pomnik - Centrum Zdrowia Dziecka" (IPCZD) (The Children's Memorial Health Institute)
state: Mazowieckie
city: Krakow
country: Poland
facility: Uniwersytecki Szpital Dziecięcy w Krakowie
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecińskie Centrum Medyczne
city: Warsaw
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
state: Łódzkie
city: Bratislava
country: Slovakia
facility: Narodny ustav detskych chorob
state: Bratislavský KRAJ
city: Bratislava
country: Slovakia
facility: Cliniq s.r.o.
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
state: A Coruna
city: Sabadell
country: Spain
facility: Consorci Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Cordoba
country: Spain
facility: Hospital Reina Sofia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: