Clinical trial NCT05688852: VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn Disease
Keywords: VTX958
Harmony
Crohn's disease
TYK2
Lead sponsor: Ventyx Biosciences, Inc
Sponsor class: INDUSTRY
First posted: 2023-01-18
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in mean Crohn's disease Activity Index (CDAI) score from baseline to week 12
timeFrame: During screening to week 12
measure: The proportion of participants achieving endoscopic response at Week 12
timeFrame: During screening to week 12
Secondary outcomes:
measure: Change from baseline in mean simple endoscopic score in Crohn's disease SES-CD at Week 12
timeFrame: During screening to week 12
measure: Proportion of participants achieving clinical remission at Week 12
timeFrame: During screening to week 12
measure: Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12
timeFrame: During screening to week 12
measure: Proportion of participants achieving clinical response at Week 12
timeFrame: During screening to week 12
measure: Proportion of participants achieving both endoscopic response (outcome- measure # 2) and clinical remission (outcome measure # 4) at Week 12
timeFrame: During screening to week 12
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Local Site # 840105
state: California
city: Lancaster
country: United States
facility: Local Site # 840109
state: California
city: Kissimmee
country: United States
facility: Local Site # 840124
state: Florida
city: Miami
country: United States
facility: Local Site # 840104
state: Florida
city: Orlando
country: United States
facility: Local Site # 840108
state: Florida
city: Orlando
country: United States
facility: Local Site # 840125
state: Florida
city: Atlanta
country: United States
facility: Local Site # 840112
state: Georgia
city: Glenview
country: United States
facility: Local Site # 840115
state: Illinois
city: Gurnee
country: United States
facility: Local Site # 840107
state: Illinois
city: New Albany
country: United States
facility: Local Site # 840119
state: Indiana
city: Louisville
country: United States
facility: Local Site # 840127
state: Kentucky
city: Shreveport
country: United States
facility: Local Site # 840113
state: Louisiana
city: Chevy Chase
country: United States
facility: Local Site # 840117
state: Maryland
city: Rockville
country: United States
facility: Local Site # 840118
state: Maryland
city: Liberty
country: United States
facility: Local Site # 840116
state: Missouri
city: Winston-Salem
country: United States
facility: Local Site # 840121
state: North Carolina
city: Columbus
country: United States
facility: Local Site # 840122
state: Ohio
city: Oklahoma City
country: United States
facility: Local Site # 840106
state: Oklahoma
city: Myrtle Beach
country: United States
facility: Local Site # 840123
state: South Carolina
city: Garland
country: United States
facility: Local Site # 840111
state: Texas
city: Katy
country: United States
facility: Local Site # 840103
state: Texas
city: Lubbock
country: United States
facility: Local Site # 840110
state: Texas
city: Lubbock
country: United States
facility: Local Site # 840114
state: Texas
city: Southlake
country: United States
facility: Local Site # 840102
state: Texas
city: Tyler
country: United States
facility: Local Site # 840101
state: Texas
city: West Jordan
country: United States
facility: Local Site # 840126
state: Utah
city: Concord
country: Australia
facility: Local Site # 036106
city: Melbourne
country: Australia
facility: Local Site # 036103
city: Melbourne
country: Australia
facility: Local Site # 036104
city: Melbourne
country: Australia
facility: Local Site # 036101
city: Parkville
country: Australia
facility: Local Site # 036102
city: Perth
country: Australia
facility: Local Site # 036105
city: Taguatinga
country: Brazil
facility: Local Site # 076102
state: Distrito Federal
city: Porto Alegre
country: Brazil
facility: Local Site # 076104
state: Rio Grande do Su
city: Curitiba
country: Brazil
facility: Local Site # 076106
city: Curitiba
country: Brazil
facility: Local Site # 076107
city: Santo André
country: Brazil
facility: Local Site # 076101
city: São Paulo
country: Brazil
facility: Local Site # 076103
city: São Paulo
country: Brazil
facility: Local Site # 076105
city: Ruse
country: Bulgaria
facility: Local Site # 100102
city: Sofia
country: Bulgaria
facility: Local Site # 100103
city: Sofia
country: Bulgaria
facility: Local Site # 100101
city: Oakville
country: Canada
facility: Local Site # 124103
state: Ontario
city: Oshawa
country: Canada
facility: Local Site # 124104
state: Ontario
city: Toronto
country: Canada
facility: Local Site # 124101
state: Ontario
city: Woodbridge
country: Canada
facility: Local Site # 124102
state: Ontario
city: Brno
country: Czechia
facility: Local Site # 203106
city: Brno
country: Czechia
facility: Local Site # 203102
city: Hradec Králové
country: Czechia
facility: Local Site # 203105
city: Ostrava
country: Czechia
facility: Local Site # 203104
city: Slaný
country: Czechia
facility: Local Site # 203101
city: Ústí Nad Labem
country: Czechia
facility: Local Site # 203103
city: Tbilisi
country: Georgia
facility: Local Site # 268105
city: Tbilisi
country: Georgia
facility: Local Site # 268103
city: Tbilisi
country: Georgia
facility: Local Site # 268101
city: Tuebingen
country: Germany
facility: Local Site # 276102
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Local Site # 276105
state: Baden-Wuerttemberg
city: Duisburg
country: Germany
facility: Local Site # 276106
state: North Rhine-Westphalia
city: Berlin
country: Germany
facility: Local Site # 276109
city: Berlin
country: Germany
facility: Local Site # 276104
city: Hessen
country: Germany
facility: Local Site # 276108
city: Kiel
country: Germany
facility: Local Site # 276107
city: Budapest
country: Hungary
facility: Local Site # 348101
city: Békéscsaba
country: Hungary
facility: Local Site # 348102
city: Gyöngyös
country: Hungary
facility: Local Site # 348106
city: Szeged
country: Hungary
facility: Local Site #348104
city: Szekszárd
country: Hungary
facility: Local Site # 348103
city: Tatabánya
country: Hungary
facility: Local Site # 348105
city: Ashkelon
country: Israel
facility: Local Site # 376103
city: Haifa
country: Israel
facility: Local Site # 376108
city: Jerusalem
country: Israel
facility: Local Site # 376105
city: Jerusalem
country: Israel
facility: Local Site # 376107
city: Petah tikva
country: Israel
facility: Local Site # 376101
city: Reẖovot
country: Israel
facility: Local Site # 376102
city: Milan
country: Italy
facility: Local Site # 380104
state: Lombardy
city: Negrar
country: Italy
facility: Local Site # 380105
state: Verona
city: Bari
country: Italy
facility: Local Site # 380101
city: Milan
country: Italy
facility: Local Site # 380107
city: Rome
country: Italy
facility: Local Site # 380109
city: Turin
country: Italy
facility: Local Site # 380106
city: Vilnius
country: Lithuania
facility: Local Site # 440101
city: Chisinau
country: Moldova, Republic of
facility: Local Site # 498101
city: Chisinau
country: Moldova, Republic of
facility: Local Site # 498102
city: Bydgoszcz
country: Poland
facility: Local Site # 616116
city: Knurów
country: Poland
facility: Local Site #616113
city: Kraków
country: Poland
facility: Local Site # 616112
city: Lublin
country: Poland
facility: Local Site # 616117
city: Nowy Targ
country: Poland
facility: Local Site # 616109
city: Oświęcim
country: Poland
facility: Local Site # 616107
city: Poznan
country: Poland
facility: Local Site # 616115
city: Rzeszów
country: Poland
facility: Local Site # 616104
city: Staszów
country: Poland
facility: Local Site # 616118
city: Szczecin
country: Poland
facility: Local Site # 616106
city: Warsaw
country: Poland
facility: Local Site # 616102
city: Wrocław
country: Poland
facility: Local Site # 616114
city: Wrocław
country: Poland
facility: Local Site # 616103
city: Wrocław
country: Poland
facility: Local Site # 616108
city: Łódź
country: Poland
facility: Local Site # 616110
city: Łódź
country: Poland
facility: Local Site # 616105
city: Łódź
country: Poland
facility: Local Site # 616101
city: Bratislava
country: Slovakia
facility: Local Site # 703103
city: Košice
country: Slovakia
facility: Locla Site # 703101
city: Martin
country: Slovakia
facility: Local Site # 703106
city: Prešov
country: Slovakia
facility: Local Site # 703104
city: Šahy
country: Slovakia
facility: Local Site # 703102
Study officials:
References: