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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: VTX002; Drug: VTX002; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Ruse, Bulgaria
    • Local Site # 100002
  • Ruse, Bulgaria
    • Local Site # 100005
• Czechia
  • Hradec Králové, Czechia
    • Local Site # 203002
  • Slaný, Czechia
    • Local Site # 203001
  • Ústí Nad Labem, Czechia
    • Local Site # 203004
• France
  • Caen, France
    • Local Site # 250004
  • Nantes, France
    • Local Site # 250001
  • Vandœuvre-lès-Nancy, France
    • Local Site # 250003
• Georgia
  • Tbilisi, Georgia
    • Local Site # 268001
  • Tbilisi, Georgia
    • Local Site # 268002
  • Tbilisi, Georgia
    • Local Site # 268003
  • Tbilisi, Georgia
    • Local Site # 268004
  • Tbilisi, Georgia
    • Local Site # 268005
  • Tbilisi, Georgia
    • Local Site # 268006
• Germany
  • Berlin, Germany
    • Local Site # 276005
  • Brandenburg an der Havel, Germany
    • Local Site # 276008
  • Duisburg, Germany
    • Local Site # 276007
  • Halle, Germany
    • Local Site # 276009
  • Nordhausen, Germany
    • Local Site # 276003
• Hungary
  • Budapest, Hungary
    • Local Site # 348001
  • Budapest, Hungary
    • Local Site # 348003
  • Békéscsaba, Hungary
    • Local Site # 348004
  • Székesfehérvár, Hungary
    • Local Site # 348002
• India
  • Ahmedabad, India
    • Local Site # 356001
  • Jaipur, India
    • Local Site # 356003
  • Sūrat, India
    • Local Site # 356005
• Italy
  • Milan, Italy
    • Local Site # 380009
  • Negrar, Italy
    • Local Site # 380001
  • Pavia, Italy
    • Local Site # 380004
  • Rome, Italy
    • Local Site # 380008
  • San Giovanni Rotondo, Italy
    • Local Site # 380002
• Korea, Republic of
  • Daegu, Korea, Republic of
    • Local Site # 410003
  • Seoul, Korea, Republic of
    • Local Site # 410002
  • Wŏnju, Korea, Republic of
    • Local Site # 410004
• Lithuania
  • Panevėžys, Lithuania
    • Local Site # 440002
  • Vilnius, Lithuania
    • Local Site # 440001
• Poland
  • Bydgoszcz, Poland
    • Local Site # 616010
  • Jelenia Góra, Poland
    • Local Site # 616012
  • Lublin, Poland
    • Local Site # 616015
  • Oświęcim, Poland
    • Local Site # 616004
  • Piotrków Trybunalski, Poland
    • Local Site # 616011
  • Poznań, Poland
    • Local Site # 616008
  • Rzeszów, Poland
    • Local Site # 616014
  • Sosnowiec, Poland
    • Local Site # 616007
  • Warsaw, Poland
    • Local Site # 616003
  • Warsaw, Poland
    • Local Site # 616006
  • Wrocław, Poland
    • Local Site # 616002
  • Wrocław, Poland
    • Local Site # 616009
  • Wrocław, Poland
    • Local Site # 616013
  • Łódź, Poland
    • Local Site # 616001
  • Łódź, Poland
    • Local Site # 616017
• Serbia
  • Belgrad, Serbia
    • Local Site # 688003
  • Belgrad, Serbia
    • Local Site # 688004
  • Belgrade, Serbia
    • Local Site # 688002
  • Zrenjanin, Serbia
    • Local Site # 688001
• Slovakia
  • Košice, Slovakia
    • Local Site # 703001
  • Prešov, Slovakia
    • Local Site # 703003
  • Šahy, Slovakia
    • Local Site # 703002
• United States
  • California
    • Garden Grove, California, United States, 92845
      • Local Site # 840030
    • Lancaster, California, United States, 93534
      • Local Site # 840026
    • San Diego, California, United States, 92123
      • Local Site # 840040
    • Ventura, California, United States, 93003
      • Local Site # 840001
  • Florida
    • Kissimmee, Florida, United States, 34744
      • Local Site # 840049
    • Miami, Florida, United States, 33165
      • Local Site # 840006
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Local Site # 840018
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Local Site # 840046
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Local Site # 840042
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Local Site # 840044
  • Ohio
    • Dayton, Ohio, United States, 45415
      • Local Site # 840043
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73101
      • Local Site # 840010
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Local Site # 840045
  • Texas
    • Garland, Texas, United States, 75044
      • Local Site # 840013
    • Lubbock, Texas, United States, 79424
      • Local Site # 8400039
    • McAllen, Texas, United States, 78503
      • Local Site # 840033
    • San Marcos, Texas, United States, 78666
      • Local Site # 840007
    • Southlake, Texas, United States, 76092
      • Local Site # 840016
    • Tyler, Texas, United States, 75701
      • Local Site # 840028

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VTX002 Dose A; VTX002 Dose A tablet administered orally once daily	Drug: VTX002; Dose A tablet administered orally once daily; Other Names: OPL-002; Drug: VTX002; Dose B Tablet administered orally once daily; Other Names: OPL-002
Experimental: VTX002 Dose B; VTX002 Dose B tablet administered orally once daily	Drug: VTX002; Dose A tablet administered orally once daily; Other Names: OPL-002; Drug: VTX002; Dose B Tablet administered orally once daily; Other Names: OPL-002
Placebo Comparator: Placebo; Placebo tablet administered orally once daily	Drug: Placebo; Placebo Tablet for VTX002 administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 1 of Induction treatment period to week 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic improvement at Week 13	The proportion of subjects with endoscopic improvement at Week 13 ES ≤ 1 (excluding friability)	Day 1 of Induction Treatment Period to week 13
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	Day 1 of Induction Treatment Period to week 13
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	Day 1 of Induction Treatment Period to week 13
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	Day 1 of Induction Treatment Period to week 13

Collaborators and Investigators

• Sponsor: Oppilan Pharma Ltd
• Investigators: Study Director: Chohee Yun, MD, Ventyx Biosciences, Inc

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): August 30, 2023
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: S1P; sphingosine 1 phosphate receptor;; Ventyx; Oppilan;; moderate or severe ulcerative colitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: VTX002-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No