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NCT05156125 Clinical Trial

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

Colitis, Ulcerative Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05156125
Other study ID # VTX002-201
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 30, 2021
Est. completion date August 31, 2026

Study information
Verified date September 2023
Source Oppilan Pharma Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Active, not recruiting
Enrollment 213
Est. completion date August 31, 2026
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• VTX002
Dose A tablet administered orally once daily
• VTX002
Dose B Tablet administered orally once daily
• Placebo
Placebo Tablet for VTX002 administered orally once daily

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

Sponsors (1)
Lead Sponsor Collaborator
Oppilan Pharma Ltd

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  France,  Georgia,  Germany,  Hungary,  India,  Italy,  Korea, Republic of,  Lithuania,  Poland,  Serbia,  Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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