VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
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| ClinicalTrials.gov Identifier: NCT05156125 |
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Recruitment Status :
Active, not recruiting
First Posted : December 14, 2021
Last Update Posted : September 29, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colitis, Ulcerative | Drug: VTX002 Drug: Placebo | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 213 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | 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. |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | November 30, 2021 |
| Actual Primary Completion Date : | August 30, 2023 |
| Estimated Study Completion Date : | August 31, 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: VTX002 Dose A
VTX002 Dose A tablet administered orally once daily
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Drug: VTX002
Dose A tablet administered orally once daily
Other Name: OPL-002 |
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Experimental: VTX002 Dose B
VTX002 Dose B tablet administered orally once daily
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Drug: VTX002
Dose B Tablet administered orally once daily
Other Name: OPL-002 |
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Placebo Comparator: Placebo
Placebo tablet administered orally once daily
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Drug: Placebo
Placebo Tablet for VTX002 administered orally once daily |
- Clinical remission at 13 weeks [ Time Frame: Day 1 of Induction treatment period to week 13 ]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)
- Endoscopic improvement at Week 13 [ Time Frame: Day 1 of Induction Treatment Period to week 13 ]The proportion of subjects with endoscopic improvement at Week 13 ES ≤ 1 (excluding friability)
- Symptomatic remission at Week 13 [ Time Frame: Day 1 of Induction Treatment Period to week 13 ]The proportion of subjects with symptomatic remission at Week 13 as defined as SF subscore = 0 or 1 and RB subscore = 0
- Histologic remission at Week 13 [ Time Frame: Day 1 of Induction Treatment Period to 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
- Endoscopic improvement-histologic remission at Week 13 [ Time Frame: Day 1 of Induction Treatment Period to 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05156125
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| Study Director: | Chohee Yun, MD | Ventyx Biosciences, Inc |
| Responsible Party: | Oppilan Pharma Ltd |
| ClinicalTrials.gov Identifier: | NCT05156125 |
| Other Study ID Numbers: |
VTX002-201 |
| First Posted: | December 14, 2021 Key Record Dates |
| Last Update Posted: | September 29, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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S1P; sphingosine 1 phosphate receptor; Ventyx; Oppilan; moderate or severe ulcerative colitis |
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Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |