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

Crohn Disease Clinical Trial

— Harmony-CD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05688852
• Other study ID #: VTX958-202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 22, 2022
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Ventyx Biosciences, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: May 2027
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• VTX958
Dose A VTX958
• VTX958
Dose B VTX958
• VTX958 Placebo
Placebo

Locations

Country	Name	City	State
Australia	Local Site # 036106	Concord
Australia	Local Site # 036101	Melbourne
Australia	Local Site # 036103	Melbourne
Australia	Local Site # 036104	Melbourne
Australia	Local Site # 036102	Parkville
Australia	Local Site # 036105	Perth
Brazil	Local Site # 076106	Curitiba
Brazil	Local Site # 076107	Curitiba
Brazil	Local Site # 076104	Porto Alegre	Rio Grande Do Su
Brazil	Local Site # 076101	Santo André
Brazil	Local Site # 076103	São Paulo
Brazil	Local Site # 076105	São Paulo
Brazil	Local Site # 076102	Taguatinga	Distrito Federal
Bulgaria	Local Site # 100102	Ruse
Bulgaria	Local Site # 100101	Sofia
Bulgaria	Local Site # 100103	Sofia
Canada	Local Site # 124103	Oakville	Ontario
Canada	Local Site # 124104	Oshawa	Ontario
Canada	Local Site # 124101	Toronto	Ontario
Canada	Local Site # 124102	Woodbridge	Ontario
Czechia	Local Site # 203102	Brno
Czechia	Local Site # 203106	Brno
Czechia	Local Site # 203105	Hradec Králové
Czechia	Local Site # 203104	Ostrava
Czechia	Local Site # 203101	Slaný
Czechia	Local Site # 203103	Ústí Nad Labem
Georgia	Local Site # 268101	Tbilisi
Georgia	Local Site # 268103	Tbilisi
Georgia	Local Site # 268105	Tbilisi
Germany	Local Site # 276104	Berlin
Germany	Local Site # 276109	Berlin
Germany	Local Site # 276106	Duisburg	North Rhine-Westphalia
Germany	Local Site # 276108	Hessen
Germany	Local Site # 276107	Kiel
Germany	Local Site # 276102	Tuebingen	Baden-Wuerttemberg
Germany	Local Site # 276105	Ulm	Baden-Wuerttemberg
Hungary	Local Site # 348102	Békéscsaba
Hungary	Local Site # 348101	Budapest
Hungary	Local Site # 348106	Gyöngyös
Hungary	Local Site #348104	Szeged
Hungary	Local Site # 348103	Szekszárd
Hungary	Local Site # 348105	Tatabánya
Israel	Local Site # 376103	Ashkelon
Israel	Local Site # 376108	Haifa
Israel	Local Site # 376105	Jerusalem
Israel	Local Site # 376107	Jerusalem
Israel	Local Site # 376101	Petah tikva
Israel	Local Site # 376102	Re?ovot
Italy	Local Site # 380101	Bari
Italy	Local Site # 380104	Milan	Lombardy
Italy	Local Site # 380107	Milan
Italy	Local Site # 380105	Negrar	Verona
Italy	Local Site # 380109	Rome
Italy	Local Site # 380106	Turin
Lithuania	Local Site # 440101	Vilnius
Moldova, Republic of	Local Site # 498101	Chisinau
Moldova, Republic of	Local Site # 498102	Chisinau
Poland	Local Site # 616116	Bydgoszcz
Poland	Local Site #616113	Knurów
Poland	Local Site # 616112	Kraków
Poland	Local Site # 616101	Lódz
Poland	Local Site # 616105	Lódz
Poland	Local Site # 616110	Lódz
Poland	Local Site # 616117	Lublin
Poland	Local Site # 616109	Nowy Targ
Poland	Local Site # 616107	Oswiecim
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 # 616103	Wroclaw
Poland	Local Site # 616108	Wroclaw
Poland	Local Site # 616114	Wroclaw
Slovakia	Local Site # 703102	Šahy
Slovakia	Local Site # 703103	Bratislava
Slovakia	Locla Site # 703101	Košice
Slovakia	Local Site # 703106	Martin
Slovakia	Local Site # 703104	Prešov
United States	Local Site # 840112	Atlanta	Georgia
United States	Local Site # 840117	Chevy Chase	Maryland
United States	Local Site # 840122	Columbus	Ohio
United States	Local Site # 840105	Garden Grove	California
United States	Local Site # 840111	Garland	Texas
United States	Local Site # 840115	Glenview	Illinois
United States	Local Site # 840107	Gurnee	Illinois
United States	Local Site # 840103	Katy	Texas
United States	Local Site # 840124	Kissimmee	Florida
United States	Local Site # 840109	Lancaster	California
United States	Local Site # 840116	Liberty	Missouri
United States	Local Site # 840127	Louisville	Kentucky
United States	Local Site # 840110	Lubbock	Texas
United States	Local Site # 840114	Lubbock	Texas
United States	Local Site # 840104	Miami	Florida
United States	Local Site # 840123	Myrtle Beach	South Carolina
United States	Local Site # 840119	New Albany	Indiana
United States	Local Site # 840106	Oklahoma City	Oklahoma
United States	Local Site # 840108	Orlando	Florida
United States	Local Site # 840125	Orlando	Florida
United States	Local Site # 840118	Rockville	Maryland
United States	Local Site # 840113	Shreveport	Louisiana
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 # 840121	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ventyx Biosciences, Inc

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Bulgaria,  Canada,  Czechia,  Georgia,  Germany,  Hungary,  Israel,  Italy,  Lithuania,  Moldova, Republic of,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean Crohn's disease Activity Index (CDAI) score from baseline 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.	During screening to week 12
Primary	The proportion of participants achieving endoscopic response at 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.	During screening to week 12
Secondary	Change from baseline in mean simple endoscopic score in Crohn's disease SES-CD at 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.	During screening to week 12
Secondary	Proportion of participants achieving clinical remission at 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.	During screening to week 12
Secondary	Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at 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	During screening to week 12
Secondary	Proportion of participants achieving clinical response at 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.	During screening to week 12
Secondary	Proportion of participants achieving both endoscopic response (outcome- measure # 2) and clinical remission (outcome measure # 4) at 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.	During screening to week 12