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

NCT05156125 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: VTX002-201
• Study Type: interventional
• Target: 213
• Locations: 14 countries
• Sites: 77

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.

Conditions

Colitis, Ulcerative

Keywords

S1P; sphingosine 1 phosphate receptor;; Ventyx; Oppilan;; moderate or severe ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Clinical Remission at 13 Weeks

  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.

  Day 1 of Induction treatment period to Week 13

Secondary Outcomes (5)

• Endoscopic Improvement at Week 13

  Day 1 of Induction Treatment Period to Week 13

• Symptomatic Remission at Week 13

  Day 1 of Induction Treatment Period to Week 13

• Histologic Remission at Week 13

  Day 1 of Induction Treatment Period to Week 13

• Endoscopic Improvement-Histologic Remission at Week 13

  Day 1 of Induction Treatment Period to Week 13

• PK of VTX002

  Weeks 1, 4, 8, and 13 of the Induction Treatment Period

Study Arms (3)

VTX002 Dose A

EXPERIMENTAL

VTX002 Dose A tablet administered orally once daily

Drug: VTX002

VTX002 Dose B

EXPERIMENTAL

VTX002 Dose B tablet administered orally once daily

Drug: VTX002

Placebo

PLACEBO COMPARATOR

Placebo tablet administered orally once daily

Drug: Placebo

Interventions

VTX002 DRUG

Dose A tablet administered orally once daily

Also known as: OPL-002

VTX002 Dose A

Placebo DRUG

Placebo Tablet for VTX002 administered orally once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oppilan Pharma Ltd: lead

Study Sites (77)

Local Site # 840030

Garden Grove, California, 92845, United States

Location

Local Site # 840026

Lancaster, California, 93534, United States

Location

Local Site # 840040

San Diego, California, 92123, United States

Location

Local Site # 840001

Ventura, California, 93003, United States

Location

Local Site # 840049

Kissimmee, Florida, 34744, United States

Location

Local Site # 840006

Miami, Florida, 33165, United States

Location

Local Site # 840018

Atlanta, Georgia, 30342, United States

Location

Local Site # 840046

New Albany, Indiana, 47150, United States

Location

Local Site # 840042

Shreveport, Louisiana, 71105, United States

Location

Local Site # 840044

Ypsilanti, Michigan, 48197, United States

Location

Local Site # 840043

Dayton, Ohio, 45415, United States

Location

Local Site # 840010

Oklahoma City, Oklahoma, 73101, United States

Location

Local Site # 840045

Myrtle Beach, South Carolina, 29572, United States

Location

Local Site # 840013

Garland, Texas, 75044, United States

Location

Local Site # 8400039

Lubbock, Texas, 79424, United States

Location

Local Site # 840033

McAllen, Texas, 78503, United States

Location

Local Site # 840007

San Marcos, Texas, 78666, United States

Location

Local Site # 840016

Southlake, Texas, 76092, United States

Location

Local Site # 840028

Tyler, Texas, 75701, United States

Location

Local Site # 100002

Rousse, Bulgaria

Location

Local Site # 100005

Rousse, Bulgaria

Location

Local Site # 203002

Hradec Králové, Czechia

Location

Local Site # 203001

Slaný, Czechia

Location

Local Site # 203004

Ústí nad Labem, Czechia

Location

Local Site # 250004

Caen, France

Location

Local Site # 250001

Nantes, France

Location

Local Site # 250003

Vandœuvre-lès-Nancy, France

Location

Local Site # 268001

Tbilisi, Georgia

Location

Local Site # 268002

Tbilisi, Georgia

Location

Local Site # 268003

Tbilisi, Georgia

Location

Local Site # 268004

Tbilisi, Georgia

Location

Local Site # 268005

Tbilisi, Georgia

Location

Local Site # 268006

Tbilisi, Georgia

Location

Local Site # 276005

Berlin, Germany

Location

Local Site # 276008

Brandenburg an der Havel, Germany

Location

Local Site # 276007

Duisburg, Germany

Location

Local Site # 276009

Halle, Germany

Location

Local Site # 276003

Nordhausen, Germany

Location

Local Site # 348004

Békéscsaba, Hungary

Location

Local Site # 348001

Budapest, Hungary

Location

Local Site # 348003

Budapest, Hungary

Location

Local Site # 348002

Székesfehérvár, Hungary

Location

Local Site # 356001

Ahmedabad, India

Location

Local Site # 356003

Jaipur, India

Location

Local Site # 356005

Sūrat, India

Location

Local Site # 380009

Milan, Italy

Location

Local Site # 380001

Negrar, Italy

Location

Local Site # 380004

Pavia, Italy

Location

Local Site # 380008

Rome, Italy

Location

Local Site # 380002

San Giovanni Rotondo, Italy

Location

Local Site # 440002

Panevezys, Lithuania

Location

Local Site # 440001

Vilnius, Lithuania

Location

Local Site # 616010

Bydgoszcz, Poland

Location

Local Site # 616012

Jelenia Góra, Poland

Location

Local Site # 616001

Lodz, Poland

Location

Local Site # 616017

Lodz, Poland

Location

Local Site # 616015

Lublin, Poland

Location

Local Site # 616004

Oświęcim, Poland

Location

Local Site # 616011

Piotrkow Trybunalski, Poland

Location

Local Site # 616008

Poznan, Poland

Location

Local Site # 616014

Rzeszów, Poland

Location

Local Site # 616007

Sosnowiec, Poland

Location

Local Site # 616003

Warsaw, Poland

Location

Local Site # 616006

Warsaw, Poland

Location

Local Site # 616002

Wroclaw, Poland

Location

Local Site # 616009

Wroclaw, Poland

Location

Local Site # 616013

Wroclaw, Poland

Location

Local Site # 688002

Belgrade, Serbia

Location

Local Site # 688003

Belgrade, Serbia

Location

Local Site # 688004

Belgrade, Serbia

Location

Local Site # 688001

Zrenjanin, Serbia

Location

Local Site # 703001

Košice, Slovakia

Location

Local Site # 703003

Prešov, Slovakia

Location

Local Site # 703002

Šahy, Slovakia

Location

Local Site # 410003

Daegu, South Korea

Location

Local Site # 410002

Seoul, South Korea

Location

Local Site # 410004

Wŏnju, South Korea

Location

Related Publications (1)

• Sands BE, Panaccione R, D'Haens G, Schreiber S, Jairath V, DuVall A, Kierkus J, Walczak M, Naik S, Gilder K, Lindstrom B, Ogilvie K, Sandborn WJ, Vermeire S, Rubin DT, Peyrin-Biroulet L, Danese S. Tamuzimod in patients with moderately-to-severely active ulcerative colitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 induction trial. Lancet Gastroenterol Hepatol. 2025 Mar;10(3):210-221. doi: 10.1016/S2468-1253(24)00386-8. Epub 2025 Jan 7.

  PMID: 39793589 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Clinical Trial Contact
• Organization: Oppilan Pharma Ltd

clinicaltrials@ventyxbio.com

+1(888)-411-5176

Study Officials

• Snehal Naik, PhD

  Ventyx Biosciences, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: November 30, 2021
• Primary Completion: August 30, 2023
• Study Completion: March 13, 2025
• Last Updated: April 30, 2026
• Results First Posted: November 13, 2024

Record last verified: 2026-04

Locations

DE (5); IN (3); CZ (3); US (19); FR (3); IT (5); LI (2); GE (6); SE (4); SL (3); PL (15); KR (3); BU (2); HU (4)