VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
- Registration Number
- NCT05156125
- Lead Sponsor
- Oppilan Pharma Ltd
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 213
- Diagnosed with UC ≥ 3 months prior to Screening.
- Active UC confirmed by endoscopy
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VTX002 Dose A VTX002 VTX002 Dose A tablet administered orally once daily VTX002 Dose B VTX002 VTX002 Dose B tablet administered orally once daily Placebo Placebo Placebo tablet administered orally once daily
- Primary Outcome Measures
Name Time Method Clinical Remission at 13 Weeks Day 1 of Induction treatment period to Week 13 The percentage of participants with clinical remission at Week 13. Clinical remission was based on the modified Mayo score (MMS), which is a composite score of participant-reported symptoms and endoscopies which were assessed by a central reader. Clinical remission was defined as stool frequency (SF) subscore = 0 or 1, rectal bleeding (RB) subscore = 0, and endoscopic subscore (ES) ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
- Secondary Outcome Measures
Name Time Method Endoscopic Improvement at Week 13 Day 1 of Induction Treatment Period to Week 13 The percentage of participants with endoscopic improvement at Week 13. Endoscopic improvement was assessed from endoscopies assessed by a central reader. Endoscopic improvement was defined as ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).
Symptomatic Remission at Week 13 Day 1 of Induction Treatment Period to Week 13 The percentage of participants with symptomatic remission at Week 13. Symptomatic remission was measured using participant-reported symptoms and was defined as SF subscore = 0 or 1 and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
Histologic Remission at Week 13 Day 1 of Induction Treatment Period to Week 13 The percentage of participants with histologic remission at Week 13. Histologic remission was assessed using the Geboes Index score and defined for this outcome measure as a Geboes score \< 2.0. The Geboes score grading system is a validated score for evaluating histologic disease activity in ulcerative colitis and is graded on a scale of 0 to 5. A higher Geboes score indicates more severe disease.
Endoscopic Improvement-Histologic Remission at Week 13 Day 1 of Induction Treatment Period to Week 13 The percentage of participants with endoscopic improvement-histologic remission at Week 13. This outcome measure was assessed by endoscopic histologic scores and defined as ES ≤ 1 (excluding friability) and a Geboes Index score \< 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in ulcerative colitis and is graded on a scale of 0 to 5. A higher Geboes score indicates more severe disease.
PK of VTX002 Weeks 1, 4, 8, and 13 of the Induction Treatment Period Plasma concentrations of VTX002 in samples obtained predose at Weeks 1, 4, 8, and 13 in the Induction Treatment Period
Trial Locations
- Locations (77)
Local Site # 616011
🇵🇱Piotrków Trybunalski, Poland
Local Site # 616006
🇵🇱Warsaw, Poland
Local Site # 703002
🇸🇰Šahy, Slovakia
Local Site # 840018
🇺🇸Atlanta, Georgia, United States
Local Site # 840042
🇺🇸Shreveport, Louisiana, United States
Local Site # 840006
🇺🇸Miami, Florida, United States
Local Site # 840040
🇺🇸San Diego, California, United States
Local Site # 840010
🇺🇸Oklahoma City, Oklahoma, United States
Local Site # 616004
🇵🇱Oświęcim, Poland
Local Site # 616012
🇵🇱Jelenia Góra, Poland
Local Site # 410003
🇰🇷Daegu, Korea, Republic of
Local Site # 410004
🇰🇷Wŏnju, Korea, Republic of
Local Site # 440002
🇱🇹Panevėžys, Lithuania
Local Site # 616015
🇵🇱Lublin, Poland
Local Site # 616013
🇵🇱Wrocław, Poland
Local Site # 410002
🇰🇷Seoul, Korea, Republic of
Local Site # 616001
🇵🇱Łódź, Poland
Local Site # 616014
🇵🇱Rzeszów, Poland
Local Site # 616017
🇵🇱Łódź, Poland
Local Site # 688001
🇷🇸Zrenjanin, Serbia
Local Site # 840030
🇺🇸Garden Grove, California, United States
Local Site # 840001
🇺🇸Ventura, California, United States
Local Site # 840026
🇺🇸Lancaster, California, United States
Local Site # 840049
🇺🇸Kissimmee, Florida, United States
Local Site # 840046
🇺🇸New Albany, Indiana, United States
Local Site # 840043
🇺🇸Dayton, Ohio, United States
Local Site # 840044
🇺🇸Ypsilanti, Michigan, United States
Local Site # 840013
🇺🇸Garland, Texas, United States
Local Site # 840045
🇺🇸Myrtle Beach, South Carolina, United States
Local Site # 840033
🇺🇸McAllen, Texas, United States
Local Site # 8400039
🇺🇸Lubbock, Texas, United States
Local Site # 840007
🇺🇸San Marcos, Texas, United States
Local Site # 100002
🇧🇬Ruse, Bulgaria
Local Site # 203001
🇨🇿Slaný, Czechia
Local Site # 840028
🇺🇸Tyler, Texas, United States
Local Site # 840016
🇺🇸Southlake, Texas, United States
Local Site # 100005
🇧🇬Ruse, Bulgaria
Local Site # 203002
🇨🇿Hradec Králové, Czechia
Local Site # 203004
🇨🇿Ústí Nad Labem, Czechia
Local Site # 250004
🇫🇷Caen, France
Local Site # 250001
🇫🇷Nantes, France
Local Site # 250003
🇫🇷Vandœuvre-lès-Nancy, France
Local Site # 268001
🇬🇪Tbilisi, Georgia
Local Site # 268002
🇬🇪Tbilisi, Georgia
Local Site # 268005
🇬🇪Tbilisi, Georgia
Local Site # 276005
🇩🇪Berlin, Germany
Local Site # 276007
🇩🇪Duisburg, Germany
Local Site # 268006
🇬🇪Tbilisi, Georgia
Local Site # 276008
🇩🇪Brandenburg an der Havel, Germany
Local Site # 276003
🇩🇪Nordhausen, Germany
Local Site # 348001
🇭🇺Budapest, Hungary
Local Site # 348003
🇭🇺Budapest, Hungary
Local Site # 348004
🇭🇺Békéscsaba, Hungary
Local Site # 356001
🇮🇳Ahmedabad, India
Local Site # 356003
🇮🇳Jaipur, India
Local Site # 348002
🇭🇺Székesfehérvár, Hungary
Local Site # 356005
🇮🇳Sūrat, India
Local Site # 380001
🇮🇹Negrar, Italy
Local Site # 380009
🇮🇹Milan, Italy
Local Site # 380004
🇮🇹Pavia, Italy
Local Site # 440001
🇱🇹Vilnius, Lithuania
Local Site # 380008
🇮🇹Rome, Italy
Local Site # 616010
🇵🇱Bydgoszcz, Poland
Local Site # 380002
🇮🇹San Giovanni Rotondo, Italy
Local Site # 616008
🇵🇱Poznań, Poland
Local Site # 616007
🇵🇱Sosnowiec, Poland
Local Site # 616009
🇵🇱Wrocław, Poland
Local Site # 616003
🇵🇱Warsaw, Poland
Local Site # 616002
🇵🇱Wrocław, Poland
Local Site # 688002
🇷🇸Belgrade, Serbia
Local Site # 688003
🇷🇸Belgrad, Serbia
Local Site # 688004
🇷🇸Belgrad, Serbia
Local Site # 703003
🇸🇰Prešov, Slovakia
Local Site # 276009
🇩🇪Halle, Germany
Local Site # 268003
🇬🇪Tbilisi, Georgia
Local Site # 268004
🇬🇪Tbilisi, Georgia
Local Site # 703001
🇸🇰Košice, Slovakia