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VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

Primary Purpose

Colitis, Ulcerative

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VTX002
VTX002
Placebo
Sponsored by
Oppilan Pharma Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring S1P; sphingosine 1 phosphate receptor;, Ventyx; Oppilan;, moderate or severe ulcerative colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Site # 840030
  • Local Site # 840026
  • Local Site # 840040
  • Local Site # 840001
  • Local Site # 840049
  • Local Site # 840006
  • Local Site # 840018
  • Local Site # 840046
  • Local Site # 840042
  • Local Site # 840044
  • Local Site # 840043
  • Local Site # 840010
  • Local Site # 840045
  • Local Site # 840013
  • Local Site # 8400039
  • Local Site # 840033
  • Local Site # 840007
  • Local Site # 840016
  • Local Site # 840028
  • Local Site # 100002
  • Local Site # 100005
  • Local Site # 203002
  • Local Site # 203001
  • Local Site # 203004
  • Local Site # 250004
  • Local Site # 250001
  • Local Site # 250003
  • Local Site # 268001
  • Local Site # 268002
  • Local Site # 268003
  • Local Site # 268004
  • Local Site # 268005
  • Local Site # 268006
  • Local Site # 276005
  • Local Site # 276008
  • Local Site # 276007
  • Local Site # 276009
  • Local Site # 276003
  • Local Site # 348001
  • Local Site # 348003
  • Local Site # 348004
  • Local Site # 348002
  • Local Site # 356001
  • Local Site # 356003
  • Local Site # 356005
  • Local Site # 380009
  • Local Site # 380001
  • Local Site # 380004
  • Local Site # 380008
  • Local Site # 380002
  • Local Site # 410003
  • Local Site # 410002
  • Local Site # 410004
  • Local Site # 440002
  • Local Site # 440001
  • Local Site # 616010
  • Local Site # 616012
  • Local Site # 616015
  • Local Site # 616004
  • Local Site # 616011
  • Local Site # 616008
  • Local Site # 616014
  • Local Site # 616007
  • Local Site # 616003
  • Local Site # 616006
  • Local Site # 616002
  • Local Site # 616009
  • Local Site # 616013
  • Local Site # 616001
  • Local Site # 616017
  • Local Site # 688002
  • Local Site # 688003
  • Local Site # 688004
  • Local Site # 688001
  • Local Site # 703001
  • Local Site # 703003
  • Local Site # 703002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

VTX002 Dose A

VTX002 Dose B

Placebo

Arm Description

VTX002 Dose A tablet administered orally once daily

VTX002 Dose B tablet administered orally once daily

Placebo tablet administered orally once daily

Outcomes

Primary Outcome Measures

Clinical remission at 13 weeks
The proportion of subjects with clinical remission at Week 13 using modified Mayo score (MMS) defined as stool frequency (SF) subscore = 0 or 1, rectal bleeding (RB) subscore = 0, and endoscopic subscore (ES) ≤ 1 (excluding friability)

Secondary Outcome Measures

Endoscopic improvement at Week 13
The proportion of subjects with endoscopic improvement at Week 13 ES ≤ 1 (excluding friability)
Symptomatic remission at Week 13
The proportion of subjects with symptomatic remission at Week 13 as defined as SF subscore = 0 or 1 and RB subscore = 0
Histologic remission at Week 13
The proportion of subjects with histologic remission at Week 13 as defined as Geboes Index score < 2.0. Histology will also be assessed by the Robarts Histopathology Index and Nancy Index
Endoscopic improvement-histologic remission at Week 13
The proportion of subjects with mucosal healing at Week 13 as defined as ES ≤ 1 (excluding friability) and histologic remission measured by a Geboes Index score < 2.0

Full Information

First Posted
December 1, 2021
Last Updated
September 28, 2023
Sponsor
Oppilan Pharma Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05156125
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oppilan Pharma Ltd

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
S1P; sphingosine 1 phosphate receptor;, Ventyx; Oppilan;, moderate or severe ulcerative colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study will employ a double-blind design. Subjects, Investigators, study center staff, persons performing the assessments, central endoscopy readers and the Sponsor are to remain blinded to the identity of the Induction Period treatment from the time of randomization until the interim database lock for the study.
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VTX002 Dose A
Arm Type
Experimental
Arm Description
VTX002 Dose A tablet administered orally once daily
Arm Title
VTX002 Dose B
Arm Type
Experimental
Arm Description
VTX002 Dose B tablet administered orally once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
VTX002
Other Intervention Name(s)
OPL-002
Intervention Description
Dose A tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
VTX002
Other Intervention Name(s)
OPL-002
Intervention Description
Dose B Tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Tablet for VTX002 administered orally once daily
Primary Outcome Measure Information:
Title
Clinical remission at 13 weeks
Description
The proportion of subjects with clinical remission at Week 13 using modified Mayo score (MMS) defined as stool frequency (SF) subscore = 0 or 1, rectal bleeding (RB) subscore = 0, and endoscopic subscore (ES) ≤ 1 (excluding friability)
Time Frame
Day 1 of Induction treatment period to week 13
Secondary Outcome Measure Information:
Title
Endoscopic improvement at Week 13
Description
The proportion of subjects with endoscopic improvement at Week 13 ES ≤ 1 (excluding friability)
Time Frame
Day 1 of Induction Treatment Period to week 13
Title
Symptomatic remission at Week 13
Description
The proportion of subjects with symptomatic remission at Week 13 as defined as SF subscore = 0 or 1 and RB subscore = 0
Time Frame
Day 1 of Induction Treatment Period to week 13
Title
Histologic remission at Week 13
Description
The proportion of subjects with histologic remission at Week 13 as defined as Geboes Index score < 2.0. Histology will also be assessed by the Robarts Histopathology Index and Nancy Index
Time Frame
Day 1 of Induction Treatment Period to week 13
Title
Endoscopic improvement-histologic remission at Week 13
Description
The proportion of subjects with mucosal healing at Week 13 as defined as ES ≤ 1 (excluding friability) and histologic remission measured by a Geboes Index score < 2.0
Time Frame
Day 1 of Induction Treatment Period to week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chohee Yun, MD
Organizational Affiliation
Ventyx Biosciences, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Local Site # 840030
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Local Site # 840026
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Local Site # 840040
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Local Site # 840001
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Local Site # 840049
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34744
Country
United States
Facility Name
Local Site # 840006
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Local Site # 840018
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Local Site # 840046
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Local Site # 840042
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Local Site # 840044
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Local Site # 840043
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Local Site # 840010
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73101
Country
United States
Facility Name
Local Site # 840045
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Local Site # 840013
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Local Site # 8400039
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Local Site # 840033
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Local Site # 840007
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Local Site # 840016
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Local Site # 840028
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Local Site # 100002
City
Ruse
Country
Bulgaria
Facility Name
Local Site # 100005
City
Ruse
Country
Bulgaria
Facility Name
Local Site # 203002
City
Hradec Králové
Country
Czechia
Facility Name
Local Site # 203001
City
Slaný
Country
Czechia
Facility Name
Local Site # 203004
City
Ústí Nad Labem
Country
Czechia
Facility Name
Local Site # 250004
City
Caen
Country
France
Facility Name
Local Site # 250001
City
Nantes
Country
France
Facility Name
Local Site # 250003
City
Vandœuvre-lès-Nancy
Country
France
Facility Name
Local Site # 268001
City
Tbilisi
Country
Georgia
Facility Name
Local Site # 268002
City
Tbilisi
Country
Georgia
Facility Name
Local Site # 268003
City
Tbilisi
Country
Georgia
Facility Name
Local Site # 268004
City
Tbilisi
Country
Georgia
Facility Name
Local Site # 268005
City
Tbilisi
Country
Georgia
Facility Name
Local Site # 268006
City
Tbilisi
Country
Georgia
Facility Name
Local Site # 276005
City
Berlin
Country
Germany
Facility Name
Local Site # 276008
City
Brandenburg an der Havel
Country
Germany
Facility Name
Local Site # 276007
City
Duisburg
Country
Germany
Facility Name
Local Site # 276009
City
Halle
Country
Germany
Facility Name
Local Site # 276003
City
Nordhausen
Country
Germany
Facility Name
Local Site # 348001
City
Budapest
Country
Hungary
Facility Name
Local Site # 348003
City
Budapest
Country
Hungary
Facility Name
Local Site # 348004
City
Békéscsaba
Country
Hungary
Facility Name
Local Site # 348002
City
Székesfehérvár
Country
Hungary
Facility Name
Local Site # 356001
City
Ahmedabad
Country
India
Facility Name
Local Site # 356003
City
Jaipur
Country
India
Facility Name
Local Site # 356005
City
Sūrat
Country
India
Facility Name
Local Site # 380009
City
Milan
Country
Italy
Facility Name
Local Site # 380001
City
Negrar
Country
Italy
Facility Name
Local Site # 380004
City
Pavia
Country
Italy
Facility Name
Local Site # 380008
City
Rome
Country
Italy
Facility Name
Local Site # 380002
City
San Giovanni Rotondo
Country
Italy
Facility Name
Local Site # 410003
City
Daegu
Country
Korea, Republic of
Facility Name
Local Site # 410002
City
Seoul
Country
Korea, Republic of
Facility Name
Local Site # 410004
City
Wŏnju
Country
Korea, Republic of
Facility Name
Local Site # 440002
City
Panevėžys
Country
Lithuania
Facility Name
Local Site # 440001
City
Vilnius
Country
Lithuania
Facility Name
Local Site # 616010
City
Bydgoszcz
Country
Poland
Facility Name
Local Site # 616012
City
Jelenia Góra
Country
Poland
Facility Name
Local Site # 616015
City
Lublin
Country
Poland
Facility Name
Local Site # 616004
City
Oświęcim
Country
Poland
Facility Name
Local Site # 616011
City
Piotrków Trybunalski
Country
Poland
Facility Name
Local Site # 616008
City
Poznań
Country
Poland
Facility Name
Local Site # 616014
City
Rzeszów
Country
Poland
Facility Name
Local Site # 616007
City
Sosnowiec
Country
Poland
Facility Name
Local Site # 616003
City
Warsaw
Country
Poland
Facility Name
Local Site # 616006
City
Warsaw
Country
Poland
Facility Name
Local Site # 616002
City
Wrocław
Country
Poland
Facility Name
Local Site # 616009
City
Wrocław
Country
Poland
Facility Name
Local Site # 616013
City
Wrocław
Country
Poland
Facility Name
Local Site # 616001
City
Łódź
Country
Poland
Facility Name
Local Site # 616017
City
Łódź
Country
Poland
Facility Name
Local Site # 688002
City
Belgrade
Country
Serbia
Facility Name
Local Site # 688003
City
Belgrad
Country
Serbia
Facility Name
Local Site # 688004
City
Belgrad
Country
Serbia
Facility Name
Local Site # 688001
City
Zrenjanin
Country
Serbia
Facility Name
Local Site # 703001
City
Košice
Country
Slovakia
Facility Name
Local Site # 703003
City
Prešov
Country
Slovakia
Facility Name
Local Site # 703002
City
Šahy
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

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