Colitis, UlcerativePhase 2NCT05156125
VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
A Phase 2 study testing VTX002 in people with Colitis, Ulcerative, run by Oppilan Pharma Ltd at 77 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- VTX002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 77 sitesin 14 countries
- Study dates
- 30 Nov 2021to 13 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with UC ≥ 3 months prior to Screening.
- Active UC confirmed by endoscopy
Who cannot join
- 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
Trial locations and contacts
77 sites in 14 countries.
77 sites in 14 countries
United States19 sites
Local Site # 840018
Atlanta, Georgia, 30342
Local Site # 840043
Dayton, Ohio, 45415
Local Site # 840030
Garden Grove, California, 92845
Local Site # 840013
Garland, Texas, 75044
Local Site # 840049
Kissimmee, Florida, 34744
Local Site # 840026
Lancaster, California, 93534
Local Site # 8400039
Lubbock, Texas, 79424
Local Site # 840033
McAllen, Texas, 78503
Local Site # 840006
Miami, Florida, 33165
Local Site # 840045
Myrtle Beach, South Carolina, 29572
Local Site # 840046
New Albany, Indiana, 47150
Local Site # 840010
Oklahoma City, Oklahoma, 73101
Local Site # 840040
San Diego, California, 92123
Local Site # 840007
San Marcos, Texas, 78666
Local Site # 840042
Shreveport, Louisiana, 71105
Local Site # 840016
Southlake, Texas, 76092
Local Site # 840028
Tyler, Texas, 75701
Local Site # 840001
Ventura, California, 93003
Local Site # 840044
Ypsilanti, Michigan, 48197
Poland15 sites
Local Site # 616010
Bydgoszcz
Local Site # 616012
Jelenia Góra
Local Site # 616001
Lodz
Local Site # 616017
Lodz
Local Site # 616015
Lublin
Local Site # 616004
Oświęcim
Local Site # 616011
Piotrkow Trybunalski
Local Site # 616008
Poznan
Local Site # 616014
Rzeszów
Local Site # 616007
Sosnowiec
Local Site # 616003
Warsaw
Local Site # 616006
Warsaw
Local Site # 616002
Wroclaw
Local Site # 616009
Wroclaw
Local Site # 616013
Wroclaw
Georgia6 sites
Local Site # 268001
Tbilisi
Local Site # 268002
Tbilisi
Local Site # 268003
Tbilisi
Local Site # 268004
Tbilisi
Local Site # 268005
Tbilisi
Local Site # 268006
Tbilisi
Germany5 sites
Local Site # 276005
Berlin
Local Site # 276008
Brandenburg an der Havel
Local Site # 276007
Duisburg
Local Site # 276009
Halle
Local Site # 276003
Nordhausen
Italy5 sites
Local Site # 380009
Milan
Local Site # 380001
Negrar
Local Site # 380004
Pavia
Local Site # 380008
Rome
Local Site # 380002
San Giovanni Rotondo
Hungary4 sites
Local Site # 348004
Békéscsaba
Local Site # 348001
Budapest
Local Site # 348003
Budapest
Local Site # 348002
Székesfehérvár
Serbia4 sites
Local Site # 688002
Belgrade
Local Site # 688003
Belgrade
Local Site # 688004
Belgrade
Local Site # 688001
Zrenjanin
Czechia3 sites
Local Site # 203002
Hradec Králové
Local Site # 203001
Slaný
Local Site # 203004
Ústí nad Labem
France3 sites
Local Site # 250004
Caen
Local Site # 250001
Nantes
Local Site # 250003
Vandœuvre-lès-Nancy
India3 sites
Local Site # 356001
Ahmedabad
Local Site # 356003
Jaipur
Local Site # 356005
Sūrat
Slovakia3 sites
Local Site # 703001
Košice
Local Site # 703003
Prešov
Local Site # 703002
Šahy
South Korea3 sites
Local Site # 410003
Daegu
Local Site # 410002
Seoul
Local Site # 410004
Wŏnju
About this study
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
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.
Read the 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
- Conditions
- Colitis, Ulcerative
- Being tested
- VTX002, Placebo
- Keywords
- S1P; sphingosine 1 phosphate receptor;, Ventyx; Oppilan;, moderate or severe ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VTX002Drug
Also called OPL-002
Dose A tablet administered orally once daily
VTX002Drug
Also called OPL-002
Dose B Tablet administered orally once daily
PlaceboDrug
Placebo Tablet for VTX002 administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| VTX002 Dose A | Experimental | VTX002 Dose A tablet administered orally once daily Receives: Drug: VTX002 |
| VTX002 Dose B | Experimental | VTX002 Dose B tablet administered orally once daily Receives: Drug: VTX002 |
| Placebo | Placebo comparator | Placebo tablet administered orally once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 of Induction treatment period to Week 13
Secondary outcomes (5)
Endoscopic Improvement at 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).
Measured: Day 1 of Induction Treatment Period to Week 13
Symptomatic Remission at 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.
Measured: Day 1 of Induction Treatment Period to Week 13
Histologic Remission at 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.
Measured: Day 1 of Induction Treatment Period to Week 13
Endoscopic Improvement-Histologic Remission at 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.
Measured: Day 1 of Induction Treatment Period to Week 13
PK of VTX002
Plasma concentrations of VTX002 in samples obtained predose at Weeks 1, 4, 8, and 13 in the Induction Treatment Period
Measured: Weeks 1, 4, 8, and 13 of the Induction Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start30 Nov 2021
- Primary completion30 Aug 2023
- Study completion13 Mar 2025
Why it stopped: The Induction and Long-Term Extension Periods were completed and analyzed as planned. The Sponsor decided to terminate clinical conduct in the Open-Label Extension Period. The decision to terminate the study was not due to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oppilan Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Snehal Naik, PhD, Study director, Ventyx Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156125
- Sponsor's protocol ID
- VTX002-201
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2021
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39793589
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05156125
- Acronym / sponsor ID
- VTX002-201
- Conditions
- Colitis, Ulcerative
- Keywords
- S1P; sphingosine 1 phosphate receptor;, Ventyx; Oppilan;, moderate or severe ulcerative colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Induction and Long-Term Extension Periods were completed and analyzed as planned. The Sponsor decided to terminate clinical conduct in the Open-Label Extension Period. The decision to terminate the study was not due to safety concerns.
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Oppilan Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Posted 13 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VTX002 Dose A | Experimental | Drug: VTX002VTX002 Dose A tablet administered orally once daily |
| VTX002 Dose B | Experimental | Drug: VTX002VTX002 Dose B tablet administered orally once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet administered orally once daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with UC ≥ 3 months prior to Screening.
- Active UC confirmed by endoscopy
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VTX002Also: OPL-002Dose A tablet administered orally once daily | Drug | VTX002 Dose A |
| VTX002Also: OPL-002Dose B Tablet administered orally once daily | Drug | VTX002 Dose B |
| PlaceboPlacebo Tablet for VTX002 administered orally once daily | Drug | Placebo |
Primary outcome
Clinical Remission at 13 Weeks
Time frame: 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.
5 secondary outcomes
Endoscopic Improvement at Week 13
Time frame: Day 1 of Induction Treatment Period to Week 13
Symptomatic Remission at Week 13
Time frame: Day 1 of Induction Treatment Period to Week 13
Histologic Remission at Week 13
Time frame: Day 1 of Induction Treatment Period to Week 13
Endoscopic Improvement-Histologic Remission at Week 13
Time frame: Day 1 of Induction Treatment Period to Week 13
PK of VTX002
Time frame: Weeks 1, 4, 8, and 13 of the Induction Treatment Period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39793589Sands 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Snehal Naik, PhD study director
Ventyx Biosciences, Inc
77 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VTX002 in people with Colitis, Ulcerative, run by Oppilan Pharma Ltd at 77 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Poland, Georgia, Germany, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Remission at 13 Weeks (time frame: Day 1 of Induction treatment period to Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05156125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.