Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2025-12-17 @ 6:28 AM
Study NCT ID:
NCT05688852
Status:
None
Last Update Posted:
2025-07-03 00:00:00
First Post:
2023-01-05 00:00:00
Brief Title:
VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease
Sponsor:
Ventyx Biosciences Inc
Organization:
Ventyx Biosciences, Inc
Study Overview
Official Title:
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Participants With Moderately to Severely Active Crohn's Disease
Status:
None
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Harmony-CD
Brief Summary:
This is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of VTX958 in participants with moderately to severely active Crohn's Disease. Approximately 93 eligible patients will be randomized, and randomization will be stratified by prior use of biologics for the treatment of CD (yes/no).
The study consists of a 30-day Screening Period, a 12-week double-blind Induction Treatment Period, a 40-week double-blind Maintenance Treatment Period, an Open-Label Extension (OLE) of up to 144 weeks, and a 30-day safety Follow-Up Period. The maximum duration of treatment will be 36 months, including the Induction, Maintenance, and OLE Periods. For all participants, a Follow-Up visit will be performed at 30 days after the last dose of study drug.
Objectives Primary Objectives
\* Evaluate the efficacy of VTX958 in achieving reduction in Crohn's Disease Activity Index (CDAI) score at the end of the Induction Period
Secondary Objectives
* Evaluate the efficacy of VTX958 in inducing clinical and symptomatic response and remission at the end of the Induction Period
* Evaluate the efficacy of VTX958 in inducing endoscopic response and clinical remission at the end of the Induction Period
The study consists of a 30-day Screening Period, a 12-week double-blind Induction Treatment Period, a 40-week double-blind Maintenance Treatment Period, an Open-Label Extension (OLE) of up to 144 weeks, and a 30-day safety Follow-Up Period. The maximum duration of treatment will be 36 months, including the Induction, Maintenance, and OLE Periods. For all participants, a Follow-Up visit will be performed at 30 days after the last dose of study drug.
Objectives Primary Objectives
\* Evaluate the efficacy of VTX958 in achieving reduction in Crohn's Disease Activity Index (CDAI) score at the end of the Induction Period
Secondary Objectives
* Evaluate the efficacy of VTX958 in inducing clinical and symptomatic response and remission at the end of the Induction Period
* Evaluate the efficacy of VTX958 in inducing endoscopic response and clinical remission at the end of the Induction Period
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled parallel group study to evaluate the efficacy and safety of VTX958 in participants with moderately to severely active Crohns Disease Approximately 132 eligible patients will be randomized and randomization will be stratified by prior use of biologics for the treatment of CD yesno
The study consists of a 30-day Screening Period a 12-week double-blind Induction Treatment Period a 40-week double-blind Maintenance Treatment Period an Open-Label Extension OLE of up to 144 weeks and a 30-day safety Follow-Up Period The maximum duration of treatment will be 36 months including the Induction Maintenance and OLE Periods For all participants a Follow-Up visit will be performed at 30 days after the last dose of study drug
Objectives Primary Objectives
Evaluate the efficacy of VTX958 in achieving reduction in Crohns Disease Activity Index CDAI score and endoscopic response at the end of the Induction Period
Secondary Objectives
Evaluate the efficacy of VTX958 in inducing clinical and symptomatic response and remission at the end of the Induction Period
Evaluate the efficacy of VTX958 in inducing endoscopic response and clinical remission at the end of the Induction Period
The study consists of a 30-day Screening Period a 12-week double-blind Induction Treatment Period a 40-week double-blind Maintenance Treatment Period an Open-Label Extension OLE of up to 144 weeks and a 30-day safety Follow-Up Period The maximum duration of treatment will be 36 months including the Induction Maintenance and OLE Periods For all participants a Follow-Up visit will be performed at 30 days after the last dose of study drug
Objectives Primary Objectives
Evaluate the efficacy of VTX958 in achieving reduction in Crohns Disease Activity Index CDAI score and endoscopic response at the end of the Induction Period
Secondary Objectives
Evaluate the efficacy of VTX958 in inducing clinical and symptomatic response and remission at the end of the Induction Period
Evaluate the efficacy of VTX958 in inducing endoscopic response and clinical remission at the end of the Induction Period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None