Clinical Trials Register

Summary
EudraCT Number:	2022-003365-38
Sponsor's Protocol Code Number:	VTX958-202
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2023-01-30
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2022-003365-38

A.3

Full title of the trial

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

Studio di fase II, multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare l’efficacia e la sicurezza di VTX958 in soggetti affetti da Morbo di Crohn da moderatamente a gravemente attivo

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

VTX958 per il trattamento del Morbo di Crohn da moderatamente a gravemente attivo

A.3.2

Name or abbreviated title of the trial where available

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

VTX958 per il trattamento del Morbo di Crohn da moderatamente a gravemente attivo

A.4.1

Sponsor's protocol code number

VTX958-202

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Ventyx Biosciences, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Ventyx Biosciences, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Ventyx Biosciences, Inc.
B.5.2	Functional name of contact point	Ventyx Clinical Trial Contact
B.5.3	Address:
B.5.3.1	Street Address	662 Encinitas Blvd, Suite 250
B.5.3.2	Town/ city	Encinitas, California
B.5.3.3	Post code	92024
B.5.3.4	Country	United States
B.5.4	Telephone number	+13126598373
B.5.6	E-mail	ClinicalTrials@ventyxbio.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	VTX958
D.3.2	Product code	[VTX958]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	2641636-52-2
D.3.9.2	Current sponsor code	VTX958
D.3.9.3	Other descriptive name	VTX958
D.3.9.4	EV Substance Code	SUB295145
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	VTX958
D.3.2	Product code	[VTX958]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	2641636-52-2
D.3.9.2	Current sponsor code	VTX958
D.3.9.3	Other descriptive name	VTX958
D.3.9.4	EV Substance Code	SUB295145
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	125
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Moderately to severely active Crohn's disease

Morbo di Crohn da moderatamente a gravemente attivo

E.1.1.1

Medical condition in easily understood language

Crohn's disease

Morbo di Crohn

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10011401
E.1.2	Term	Crohn's disease
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the efficacy of VTX958 in achieving reduction in CDAI score and endoscopic response at the end of the Induction Period

Valutare l’efficacia di VTX958 nella riduzione del punteggio CDAI e della risposta endoscopica alla fine del periodo di induzione.

E.2.2

Secondary objectives of the trial

• Evaluate the efficacy of VTX958 in inducing clinical and symptomatic response andremission at the end of the Induction Period
• Evaluate the efficacy of VTX958 in inducing endoscopic response and clinical remissionat the end of the Induction Period

• Valutare l’efficacia di VTX958 nell’induzione della risposta clinica e sintomatica e della remissione alla fine del periodo di induzione
• Valutare l’efficacia di VTX958 nell’induzione della risposta endoscopica e della remissione clinica alla fine del periodo di induzione

E.2.3

Trial contains a sub-study

E.3

Principal 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 > or = 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.

1. Soggetti di sesso maschile o femminile, di età compresa tra 18 e 75 anni, estremi inclusi, al momento del consenso.
2. Soggetti in grado di firmare un consenso informato.
3. Diagnosi di CD > o = 3 mesi prima del Giorno 1. La diagnosi di CD deve essere confermata da evidenze cliniche, endoscopiche e istologiche.
4. CD attivo da moderato a grave.

E.4

Principal 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 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.

1. Diagnosi attuale di colite ulcerosa, colite indeterminata, colite microscopica, colite ischemica o colite infettiva.
2. Presenza di uno stoma o una tasca (pouch) ileo-anale.
3. Presenza di attuali complicanze note del CD quali colite fulminante, megacolon tossico o qualsiasi altra manifestazione che potrebbe richiedere un intervento chirurgico o ricovero.
4. Diagnosi nota di intestino corto o sindrome intestinale.
5. Esposizione precedente a VTX958 o a qualsiasi altro inibitore della TYK2 (ad esempio, deucravacitinib) in qualsiasi studio.

E.5 End points

E.5.1

Primary end point(s)

• Change from baseline in mean Crohn's disease activity index (CDAI) score at Week 12
• Proportion of participants achieving endoscopic response at Week 12

• Variazione media rispetto al basale del punteggio CDAI alla Settimana 12
• Proporzione di pazienti con risposta endoscopica alla Settimana 12

E.5.1.1

Timepoint(s) of evaluation of this end point

At Week 12

Alla Settimana 12

E.5.2

Secondary end point(s)

• Change from baseline in mean simple endoscopic score in Crohn's disease (SES-CD) at Week 12
• Proportion of participants achieving clinical remission at Week 12
• Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12
• Proportion of participants achieving clinical response at Week 12
• Proportion of participants achieving endoscopic response and clinical remission (in the same participant) at Week 12

• Variazione media rispetto al basale del punteggio SES-CD alla Settimana 12
• Proporzione di partecipanti con remissione clinica alla Settimana 12
• Proporzione di partecipanti con remissione dell’esito riferito dal paziente di tipo 2 (PRO2) sul punteggio CDAI alla Settimana 12
• Proporzione di partecipanti con risposta clinica alla Settimana 12
• Proporzione di partecipanti con risposta endoscopica e remissione clinica (dello stesso partecipante) alla Settimana 12

E.5.2.1

Timepoint(s) of evaluation of this end point

At Week 12

Alla Settimana 12

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Brazil

Canada

India

Israel

United States

France

Lithuania

Poland

Bulgaria

Spain

Czechia

Germany

Italy

Belgium

Georgia

Hungary

Moldova, Republic of

Slovakia

Serbia

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

122

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

132

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Nessuno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2023-05-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-02-27

P. End of Trial
P.	End of Trial Status	Ongoing

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