VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease

Phase 2

Active, not recruiting

• Conditions: Crohn Disease
• Interventions: Drug: VTX958; Drug: VTX958 Placebo

• Registration Number: NCT05688852
• Lead Sponsor: Ventyx Biosciences, Inc

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.

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 Crohn's Disease. Approximately 132 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 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 Timeline

• Study Start: 2022-12-22
• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-18
• Primary Completion: 2024-06-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1. Men or women, 18 to 75 years of age, inclusive, at the time of consent
2. Capable of giving signed informed consent
3. Documented diagnosis of CD ≥ 3 months prior to Day 1. The diagnosis of CD must be confirmed by clinical, endoscopic, and histologic evidence.
4. Moderately to severely active CD

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Exclusion Criteria

1. Current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis
2. Presence of a stoma or ileoanal pouch
3. Presence of currently known complications of CD such as symptomatic bowel stricture(s) and >2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, left and sigmoid colon, and rectum, fulminant colitis, toxic megacolon or any other manifestation that may require surgery or hospitalization
4. Known diagnosis of short gut or bowel syndrome
5. Previous exposure to VTX958 or any other TYK2 inhibitor (eg, deucravacitinib) in any study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VTX958 Dose A	VTX958	-
VTX958 Dose B	VTX958	-
VTX958 Placebo	VTX958 Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in mean Crohn's disease Activity Index (CDAI) score from baseline to week 12	During screening to week 12	Change in Mean CDAI (Crohn's disease Activity Index). CDAI is a weighted index comprising eight Crohn's Disease (CD)-related clinical and laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600.
The proportion of participants achieving endoscopic response at Week 12	During screening to week 12	SES-CD is an endoscopic grading system is used to assess CD disease activity. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mean simple endoscopic score in Crohn's disease SES-CD at Week 12	During screening to week 12	Change from baseline in mean simple endoscopic score in Crohn's disease SED-CD at 12 weeks. The SES-CD is an endoscopic grading system is used to assess CD disease activity. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum.
Proportion of participants achieving clinical remission at Week 12	During screening to week 12	Clinical remission is defined as a CDAI score \< 150. CDAI is a weighted index comprising eight Crohn's Disease (CD)-related clinical and laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600.
Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12	During screening to week 12	The proportion of participants achieving PRO2 remission at week 12. PRO2 remission is defined is an unweighted CDAI component of daily AP score ≤ 1 and unweighted CDAI component of daily average stool frequency (SF) score ≤ 3
Proportion of participants achieving clinical response at Week 12	During screening to week 12	Proportion of participants achieving clinical response at Week 12. A clinical response is defined as ≥ 100 points reduction from baseline in CDAI score or CDAI score \< 150. CDAI is a weighted index comprising eight Crohn's Disease (CD)-related clinical and laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600.
Proportion of participants achieving both endoscopic response (outcome- measure # 2) and clinical remission (outcome measure # 4) at Week 12	During screening to week 12	Proportion of participants achieving both endoscopic response (as described in outcome measure 2) and clinical remission (as described in outcome measure 4) at Week 12.

Trial Locations

Locations (105)

Local Site # 840105; 🇺🇸 Garden Grove, California, United States

Local Site # 840109; 🇺🇸 Lancaster, California, United States

Local Site # 840124; 🇺🇸 Kissimmee, Florida, United States

Local Site # 840104; 🇺🇸 Miami, Florida, United States

Local Site # 840108; 🇺🇸 Orlando, Florida, United States

Local Site # 840125; 🇺🇸 Orlando, Florida, United States

Local Site # 840112; 🇺🇸 Atlanta, Georgia, United States

Local Site # 840115; 🇺🇸 Glenview, Illinois, United States

Local Site # 840107; 🇺🇸 Gurnee, Illinois, United States

Local Site # 840119; 🇺🇸 New Albany, Indiana, United States

Local Site # 840127; 🇺🇸 Louisville, Kentucky, United States

Local Site # 840113; 🇺🇸 Shreveport, Louisiana, United States

Local Site # 840117; 🇺🇸 Chevy Chase, Maryland, United States

Local Site # 840118; 🇺🇸 Rockville, Maryland, United States

Local Site # 840116; 🇺🇸 Liberty, Missouri, United States

Local Site # 840121; 🇺🇸 Winston-Salem, North Carolina, United States

Local Site # 840122; 🇺🇸 Columbus, Ohio, United States

Local Site # 840106; 🇺🇸 Oklahoma City, Oklahoma, United States

Local Site # 840123; 🇺🇸 Myrtle Beach, South Carolina, United States

Local Site # 840111; 🇺🇸 Garland, Texas, United States

Local Site # 840103; 🇺🇸 Katy, Texas, United States

Local Site # 840110; 🇺🇸 Lubbock, Texas, United States

Local Site # 840114; 🇺🇸 Lubbock, Texas, United States

Local Site # 840102; 🇺🇸 Southlake, Texas, United States

Local Site # 840101; 🇺🇸 Tyler, Texas, United States

Local Site # 840126; 🇺🇸 West Jordan, Utah, United States

Local Site # 036106; 🇦🇺 Concord, Australia

Local Site # 036103; 🇦🇺 Melbourne, Australia

Local Site # 036104; 🇦🇺 Melbourne, Australia

Local Site # 036101; 🇦🇺 Melbourne, Australia

Local Site # 036102; 🇦🇺 Parkville, Australia

Local Site # 036105; 🇦🇺 Perth, Australia

Local Site # 076102; 🇧🇷 Taguatinga, Distrito Federal, Brazil

Local Site # 076104; 🇧🇷 Porto Alegre, Rio Grande do Su, Brazil

Local Site # 076106; 🇧🇷 Curitiba, Brazil

Local Site # 076107; 🇧🇷 Curitiba, Brazil

Local Site # 076101; 🇧🇷 Santo André, Brazil

Local Site # 076103; 🇧🇷 São Paulo, Brazil

Local Site # 076105; 🇧🇷 São Paulo, Brazil

Local Site # 100102; 🇧🇬 Ruse, Bulgaria

Local Site # 100103; 🇧🇬 Sofia, Bulgaria

Local Site # 100101; 🇧🇬 Sofia, Bulgaria

Local Site # 124103; 🇨🇦 Oakville, Ontario, Canada

Local Site # 124104; 🇨🇦 Oshawa, Ontario, Canada

Local Site # 124101; 🇨🇦 Toronto, Ontario, Canada

Local Site # 124102; 🇨🇦 Woodbridge, Ontario, Canada

Local Site # 203106; 🇨🇿 Brno, Czechia

Local Site # 203102; 🇨🇿 Brno, Czechia

Local Site # 203105; 🇨🇿 Hradec Králové, Czechia

Local Site # 203104; 🇨🇿 Ostrava, Czechia

Local Site # 203101; 🇨🇿 Slaný, Czechia

Local Site # 203103; 🇨🇿 Ústí Nad Labem, Czechia

Local Site # 268105; 🇬🇪 Tbilisi, Georgia

Local Site # 268103; 🇬🇪 Tbilisi, Georgia

Local Site # 268101; 🇬🇪 Tbilisi, Georgia

Local Site # 276102; 🇩🇪 Tuebingen, Baden-Wuerttemberg, Germany

Local Site # 276105; 🇩🇪 Ulm, Baden-Wuerttemberg, Germany

Local Site # 276106; 🇩🇪 Duisburg, North Rhine-Westphalia, Germany

Local Site # 276109; 🇩🇪 Berlin, Germany

Local Site # 276104; 🇩🇪 Berlin, Germany

Local Site # 276108; 🇩🇪 Hessen, Germany

Local Site # 276107; 🇩🇪 Kiel, Germany

Local Site # 348101; 🇭🇺 Budapest, Hungary

Local Site # 348102; 🇭🇺 Békéscsaba, Hungary

Local Site # 348106; 🇭🇺 Gyöngyös, Hungary

Local Site #348104; 🇭🇺 Szeged, Hungary

Local Site # 348103; 🇭🇺 Szekszárd, Hungary

Local Site # 348105; 🇭🇺 Tatabánya, Hungary

Local Site # 376108; 🇮🇱 Haifa, Israel

Local Site # 376103; 🇮🇱 Ashkelon, Israel

Local Site # 376105; 🇮🇱 Jerusalem, Israel

Local Site # 376107; 🇮🇱 Jerusalem, Israel

Local Site # 376101; 🇮🇱 Petah tikva, Israel

Local Site # 376102; 🇮🇱 Reẖovot, Israel

Local Site # 380104; 🇮🇹 Milan, Lombardy, Italy

Local Site # 380105; 🇮🇹 Negrar, Verona, Italy

Local Site # 380101; 🇮🇹 Bari, Italy

Local Site # 380107; 🇮🇹 Milan, Italy

Local Site # 380109; 🇮🇹 Rome, Italy

Local Site # 380106; 🇮🇹 Turin, Italy

Local Site # 440101; 🇱🇹 Vilnius, Lithuania

Local Site # 498101; 🇲🇩 Chisinau, Moldova, Republic of

Local Site # 498102; 🇲🇩 Chisinau, Moldova, Republic of

Local Site # 616116; 🇵🇱 Bydgoszcz, Poland

Local Site #616113; 🇵🇱 Knurów, Poland

Local Site # 616112; 🇵🇱 Kraków, Poland

Local Site # 616117; 🇵🇱 Lublin, Poland

Local Site # 616109; 🇵🇱 Nowy Targ, Poland

Local Site # 616107; 🇵🇱 Oświęcim, Poland

Local Site # 616115; 🇵🇱 Poznan, Poland

Local Site # 616104; 🇵🇱 Rzeszów, Poland

Local Site # 616118; 🇵🇱 Staszów, Poland

Local Site # 616106; 🇵🇱 Szczecin, Poland

Local Site # 616102; 🇵🇱 Warsaw, Poland

Local Site # 616114; 🇵🇱 Wrocław, Poland

Local Site # 616103; 🇵🇱 Wrocław, Poland

Local Site # 616108; 🇵🇱 Wrocław, Poland

Local Site # 616110; 🇵🇱 Łódź, Poland

Local Site # 616105; 🇵🇱 Łódź, Poland

Local Site # 616101; 🇵🇱 Łódź, Poland

Local Site # 703103; 🇸🇰 Bratislava, Slovakia

Locla Site # 703101; 🇸🇰 Košice, Slovakia

Local Site # 703106; 🇸🇰 Martin, Slovakia

Local Site # 703104; 🇸🇰 Prešov, Slovakia

Local Site # 703102; 🇸🇰 Šahy, Slovakia