Clinical trial NCT05156125: VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Colitis, Ulcerative
Keywords: S1P; sphingosine 1 phosphate receptor;
Ventyx; Oppilan;
moderate or severe ulcerative colitis
Lead sponsor: Oppilan Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 189 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily.

The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.

Detailed description: This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of VTX002 in subjects with moderately to severely active UC following daily oral administration of VTX002 as a tablet. Approximately 189 eligible subjects will be randomized in a 1:1:1 ratio to receive VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily (approximately 63 subjects per treatment group).

The study consists of a 28-day Screening Period, a 13-week double-blind Induction Treatment Period (including 7 days of titration followed by 12 weeks of treatment at the assigned dose), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.

Objectives Primary Objective

• Assess the efficacy of VTX002 when administered for 13 weeks on clinical remission

Secondary Objectives

* Assess the efficacy of VTX002 when administered for 13 weeks on endoscopic changes, symptomatic response and remission, histology, and mucosal healing
* Assess the safety and tolerability of VTX002
* Assess the pharmacokinetics (PK) of VTX002

Long-Term and Open-Label Extension Objectives

* Assess the efficacy of VTX002 through the LTE and OLE Treatment Periods on endoscopic changes, symptomatic response and remission, histology, and mucosal healing
* Assess the safety of VTX002 through the LTE and OLE Treatment Periods

Eligibility criteria: Inclusion Criteria:

* Diagnosed with UC ≥ 3 months prior to Screening.
* Active UC confirmed by endoscopy

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: Clinical Remission at 13 Weeks
timeFrame: Day 1 of Induction treatment period to Week 13
Secondary outcomes:
measure: Endoscopic Improvement at Week 13
timeFrame: Day 1 of Induction Treatment Period to Week 13
measure: Symptomatic Remission at Week 13
timeFrame: Day 1 of Induction Treatment Period to Week 13
measure: Histologic Remission at Week 13
timeFrame: Day 1 of Induction Treatment Period to Week 13
measure: Endoscopic Improvement-Histologic Remission at Week 13
timeFrame: Day 1 of Induction Treatment Period to Week 13
measure: PK of VTX002
timeFrame: Weeks 1, 4, 8, and 13 of the Induction Treatment Period
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Local Site # 840030
state: California
city: Lancaster
country: United States
facility: Local Site # 840026
state: California
city: San Diego
country: United States
facility: Local Site # 840040
state: California
city: Ventura
country: United States
facility: Local Site # 840001
state: California
city: Kissimmee
country: United States
facility: Local Site # 840049
state: Florida
city: Miami
country: United States
facility: Local Site # 840006
state: Florida
city: Atlanta
country: United States
facility: Local Site # 840018
state: Georgia
city: New Albany
country: United States
facility: Local Site # 840046
state: Indiana
city: Shreveport
country: United States
facility: Local Site # 840042
state: Louisiana
city: Ypsilanti
country: United States
facility: Local Site # 840044
state: Michigan
city: Dayton
country: United States
facility: Local Site # 840043
state: Ohio
city: Oklahoma City
country: United States
facility: Local Site # 840010
state: Oklahoma
city: Myrtle Beach
country: United States
facility: Local Site # 840045
state: South Carolina
city: Garland
country: United States
facility: Local Site # 840013
state: Texas
city: Lubbock
country: United States
facility: Local Site # 8400039
state: Texas
city: McAllen
country: United States
facility: Local Site # 840033
state: Texas
city: San Marcos
country: United States
facility: Local Site # 840007
state: Texas
city: Southlake
country: United States
facility: Local Site # 840016
state: Texas
city: Tyler
country: United States
facility: Local Site # 840028
state: Texas
city: Ruse
country: Bulgaria
facility: Local Site # 100002
city: Ruse
country: Bulgaria
facility: Local Site # 100005
city: Hradec Králové
country: Czechia
facility: Local Site # 203002
city: Slaný
country: Czechia
facility: Local Site # 203001
city: Ústí Nad Labem
country: Czechia
facility: Local Site # 203004
city: Caen
country: France
facility: Local Site # 250004
city: Nantes
country: France
facility: Local Site # 250001
city: Vandœuvre-lès-Nancy
country: France
facility: Local Site # 250003
city: Tbilisi
country: Georgia
facility: Local Site # 268001
city: Tbilisi
country: Georgia
facility: Local Site # 268002
city: Tbilisi
country: Georgia
facility: Local Site # 268003
city: Tbilisi
country: Georgia
facility: Local Site # 268004
city: Tbilisi
country: Georgia
facility: Local Site # 268005
city: Tbilisi
country: Georgia
facility: Local Site # 268006
city: Berlin
country: Germany
facility: Local Site # 276005
city: Brandenburg an der Havel
country: Germany
facility: Local Site # 276008
city: Duisburg
country: Germany
facility: Local Site # 276007
city: Halle
country: Germany
facility: Local Site # 276009
city: Nordhausen
country: Germany
facility: Local Site # 276003
city: Budapest
country: Hungary
facility: Local Site # 348001
city: Budapest
country: Hungary
facility: Local Site # 348003
city: Békéscsaba
country: Hungary
facility: Local Site # 348004
city: Székesfehérvár
country: Hungary
facility: Local Site # 348002
city: Ahmedabad
country: India
facility: Local Site # 356001
city: Jaipur
country: India
facility: Local Site # 356003
city: Sūrat
country: India
facility: Local Site # 356005
city: Milan
country: Italy
facility: Local Site # 380009
city: Negrar
country: Italy
facility: Local Site # 380001
city: Pavia
country: Italy
facility: Local Site # 380004
city: Rome
country: Italy
facility: Local Site # 380008
city: San Giovanni Rotondo
country: Italy
facility: Local Site # 380002
city: Daegu
country: Korea, Republic of
facility: Local Site # 410003
city: Seoul
country: Korea, Republic of
facility: Local Site # 410002
city: Wŏnju
country: Korea, Republic of
facility: Local Site # 410004
city: Panevėžys
country: Lithuania
facility: Local Site # 440002
city: Vilnius
country: Lithuania
facility: Local Site # 440001
city: Bydgoszcz
country: Poland
facility: Local Site # 616010
city: Jelenia Góra
country: Poland
facility: Local Site # 616012
city: Lublin
country: Poland
facility: Local Site # 616015
city: Oświęcim
country: Poland
facility: Local Site # 616004
city: Piotrków Trybunalski
country: Poland
facility: Local Site # 616011
city: Poznań
country: Poland
facility: Local Site # 616008
city: Rzeszów
country: Poland
facility: Local Site # 616014
city: Sosnowiec
country: Poland
facility: Local Site # 616007
city: Warsaw
country: Poland
facility: Local Site # 616003
city: Warsaw
country: Poland
facility: Local Site # 616006
city: Wrocław
country: Poland
facility: Local Site # 616002
city: Wrocław
country: Poland
facility: Local Site # 616009
city: Wrocław
country: Poland
facility: Local Site # 616013
city: Łódź
country: Poland
facility: Local Site # 616001
city: Łódź
country: Poland
facility: Local Site # 616017
city: Belgrade
country: Serbia
facility: Local Site # 688002
city: Belgrad
country: Serbia
facility: Local Site # 688003
city: Belgrad
country: Serbia
facility: Local Site # 688004
city: Zrenjanin
country: Serbia
facility: Local Site # 688001
city: Košice
country: Slovakia
facility: Local Site # 703001
city: Prešov
country: Slovakia
facility: Local Site # 703003
city: Šahy
country: Slovakia
facility: Local Site # 703002
Study officials:
affiliation: Ventyx Biosciences, Inc
name: Snehal Naik, PhD
role: STUDY_DIRECTOR
References: