Clinical Trials Register

Summary
EudraCT Number:	2022-002389-33
Sponsor's Protocol Code Number:	CNTO1959CRD3007
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2022-12-22
Trial results	View 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

France - ANSM

A.2

EudraCT number

2022-002389-33

A.3

Full title of the trial

A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants with Crohn’s Disease After Surgical Resection

Étude Randomisée, En Double Aveugle, Contrôlée Contre Placebo, Évaluant La Sécurité Et L’efficacité Du Guselkumab Pour Le Traitement De Participants Atteints De La Maladie De Crohn Après Résection Chirurgicale

A.3.1

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

Prevention of Recurrence post Operatively with Guselkumab Relative to Endoscopy and Symptoms

Prévention de la récidive postopératoire avec le guselkumab par rapport à l'endoscopie et aux symptômes

A.3.2

Name or abbreviated title of the trial where available

PROGRESS

A.4.1

Sponsor's protocol code number

CNTO1959CRD3007

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	Janssen-Cilag International NV
B.1.3.4	Country	Belgium
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	Janssen Research & Development
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	Parexel International
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	70 Sir John Rogerson's Quay
B.5.3.2	Town/ city	Dublin
B.5.3.3	Post code	2
B.5.3.4	Country	Ireland
B.5.6	E-mail	clinicaltrial.enquiries@parexel.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	Guselkumab
D.3.2	Product code	CNTO1959
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Guselkumab
D.3.9.2	Current sponsor code	CNTO1959
D.3.9.3	Other descriptive name	Guselkumab
D.3.9.4	EV Substance Code	SUB179789
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal antibody
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	Guselkumab
D.3.2	Product code	CNTO1959
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Guselkumab
D.3.9.2	Current sponsor code	CNTO1959
D.3.9.3	Other descriptive name	Guselkumab
D.3.9.4	EV Substance Code	SUB179789
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal antibody

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	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Crohn’s Disease After Surgical Resection

Maladie de Crohn après résection chirurgicale

E.1.1.1

Medical condition in easily understood language

Inflammatory bowel disease (IBD)

Maladie inflammatoire de l'intestin (MII)

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

To evaluate the efficacy of guselkumab treatment versus placebo in preventing endoscopic recurrence of CD in participants after surgery

Évaluer l’efficacité du traitement par guselkumab par rapport au placebo dans la prévention de la récidive endoscopique de la MC chez les participants après la chirurgie

E.2.2

Secondary objectives of the trial

- To evaluate clinical remission without disease recurrence in participants treated with guselkumab versus placebo after surgery
- To evaluate disease recurrence in participants treated with guselkumab versus placebo after surgery
- To evaluate symptoms such as stool frequency and abdominal pain scores in guselkumab versus placebo after surgery
- To evaluate the safety of guselkumab in participants with CD in the postoperative period
- The evaluate the efficacy of guselkumab in limiting steroid use and preventing clinical recurrence of patients in clinical remission

- Évaluer la rémission clinique sans récidive de la maladie chez les participants traités par guselkumab par rapport au placebo après la chirurgie
- Évaluer la récidive de la maladie chez les participants traités par guselkumab par rapport au placebo après la chirurgie
- Évaluer les symptômes tels que la fréquence des selles et les scores de douleur abdominale sous guselkumab par rapport au placebo après la chirurgie
- Évaluer la sécurité du guselkumab chez des participants atteints de MC pendant la période post-opératoire
- Évaluer l’efficacité du guselkumab sur la limitation de l’utilisation des corticoïdes et la prévention de la récidive clinique chez les patients en rémission clinique

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Participants ≥18 (or the legal age of consent in the jurisdiction in which the study is taking place).
2. Have a documented diagnosis of CD confirmed by endoscopic, histologic, and/or radiologic studies prior to resection or by tissue obtained at resection.
3. Have undergone an ileocolonic surgical resection (ie, an intestinal resection with an ileocolonic anastomosis) for CD with the following criteria:
- Have no known active CD anywhere in the gastrointestinal (GI) tract, including the findings at surgery,
- Be able to undergo randomization no later than 49 days after surgery, and at least 10 days after surgery (or 8 days after resumption of bowel activity, eg, in case of postoperative ileus),
- Ileocolonic resection was not for the purpose of removing known dysplasia,
- If ileocolonic resection occurs > 10 years since the diagnosis of CD and only fibrostenotic stricturing is present, then length of stricture must be > 10 cm
4. Have a baseline CDAI < 200.

Please refer to protocol for the complete list of inclusion criteria.

1. Âge ≥ 18 ans (ou l’âge légal de consentement dans la juridiction du pays dans lequel se déroule l’étude).
2. Diagnostic documenté de MC confirmé par des examens endoscopiques, histologiques et/ou radiologiques avant la résection ou d’après le tissu issu de la résection chirurgicale.
3. Antécédents de résection iléocolique chirurgicale (c’est-à-dire résection intestinale avec une anastomose iléocolique) pour une MC avec les critères suivants :
- Pas de MC active connue dans le système gastro-intestinal (GI), y compris les observations effectuées au moment de la chirurgie,
- Capacité à être randomisé(e) au maximum 49 jours après la chirurgie et au moins 10 jours après la chirurgie (ou 8 jours après la reprise de l’activité intestinale, par exemple en cas d’iléus post-opératoire),
- Résection iléocolique non effectuée à des fins d’ablation d’une dysplasie connue,
- Si la résection iléocolique a lieu > 10 ans après le diagnostic de MC et que seule une atteinte fibrosténotique est présente, la longueur de la sténose doit être > 10 cm,
4. Score CDAI initial < 200.

Veuillez vous référer au protocole pour la liste complète des critères d'inclusion.

E.4

Principal exclusion criteria

1. Has complications of CD, such as symptomatic strictures or stenoses, short bowel syndrome, a draining (ie, functioning) stoma or ostomy, or any other manifestation, that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab.
2. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery.
3. Have had any active perianal disease within 3 months of screening (except skin tags) or have had any draining fistula within 3 months of screening unless the fistula was removed at the index surgery.
4. Had, in association with their most recent intra-abdominal surgery, postoperative complications such as, but not limited to, postoperative intraabdominal abscess, wound dehiscence, anastomotic leak, the need for a second operation, or have evidence of macroscopically active CD which was not resected at the time of surgery or had active CD in regions beyond the site of surgery in the GI tract within 1 year of the time of enrolment.

7. Has or has had any other clinically significant infection (eg, hepatitis, sepsis, pneumonia, or pyelonephritis, enteric infection), within 8 weeks before the first dose of study intervention. Treated and resolved infections, not considered clinically significant at the discretion of the investigator need not be exclusionary (ie, acute upper respiratory tract infection, uncomplicated urinary tract infection, and clinically resolved infections related to the participant’s Crohn’s-related surgical resection).

Please refer to protocol for the complete list of exclusion criteria.

1. Présence de complications de la MC, telles que des sténoses, un syndrome du grêle court, une stomie drainante (c’est-à-dire fonctionnant), ou toute autre manifestation susceptible de nécessiter une intervention chirurgicale, d’empêcher l’utilisation du score CDAI pour évaluer la réponse au traitement, ou de possiblement interférer sur la capacité à évaluer l’effet du traitement par guselkumab.
2. Présence ou suspicion d’abcès. Les abcès cutanés ou péri-anaux récents ne constituent pas un critère de non-inclusion s’ils sont drainés et traités de manière appropriée au moins 3 semaines avant l’inclusion, ou 8 semaines avant l’inclusion pour les abcès intra-abdominaux, à condition qu’il n’y a pas de nécessité prévisible d’une intervention chirurgicale ultérieure.
3. Antécédents d’atteinte péri-anale active dans les 3 mois précédant la sélection (sauf balises cutanées [« skin tags »]) ou antécédents de fistules drainantes dans les 3 mois précédant la sélection sauf si la fistule a été supprimée lors de l’intervention chirurgicale initiale.
4. Antécédents, en association avec l’intervention chirurgicale intra-abdominale la plus récente, de complications post-opératoires telles que notamment : abcès intra-abdominal post-opératoire, déhiscence de plaie, fuite anastomotique, besoin d’une deuxième intervention chirurgicale, ou signe de MC macroscopiquement active n’ayant pas été réséquée au moment de la chirurgie ou antécédents de MC active dans des régions au-delà du site de l’intervention chirurgicale dans le tube digestif, dans l’année précédant le moment du recrutement.

7. Présence ou antécédents de toute autre infection cliniquement significative (par exemple, hépatite, septicémie, pneumonie ou pyélonéphrite, infection entérique) dans les 8 semaines avant la première dose de l’intervention à l’étude. Les infections traitées et résolues, non considérées comme cliniquement significatives à la discrétion de l’investigateur n’ont pas besoin d’être considérées comme des critères de non-inclusion (c’est-à-dire, infection aiguë des voies respiratoires supérieures, infection urinaire sans complications et infections cliniquement résolues liées à la résection chirurgicale liée à la maladie de Crohn du participant).

Veuillez vous référer au protocole pour la liste complète des critères d'exclusion.

E.5 End points

E.5.1

Primary end point(s)

Endoscopic Recurrence as defined by a modified Rutgeerts score of i2a or greater

Récidive endoscopique telle que définie par un score de Rutgeerts modifié ≥ i2a

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 48

Semaine 48

E.5.2

Secondary end point(s)

- Clinical remission without disease recurrence at Week 48
- Time-to-disease recurrence at the main study database lock
- Abdominal pain free at Week 48
- Time-to-recurrence of symptoms
- Frequency and type of AEs and serious adverse events
- Steroid free clinical remission at Week 48

- Rémission clinique sans récidive de la maladie à la Semaine 48
- Délai avant la récidive de la maladie lors du verrouillage de la base de données de l’étude principale
- Absence de douleur abdominale à la Semaine 48
- Délai avant la récidive des symptômes
- Fréquence et type d’événements indésirables (EI) et d’événements indésirables graves (EIG)
- Rémission clinique sans corticoïdes à la Semaine 48

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 48 or as otherwise noted

Semaine 48 ou comme indiqué

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

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

Canada

Korea, Republic of

United States

Austria

France

Poland

Netherlands

Spain

Czechia

Germany

Italy

Belgium

Hungary

United Kingdom

Serbia

E.8.7

Trial has a data monitoring committee

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:

300

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

219

F.4.2.2

In the whole clinical trial

370

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)

Patients who end their participation in the trial will return to their primary physician to determine standard of care

Les patients qui mettent fin à leur participation à l'essai retourneront voir leur médecin traitant pour déterminer la norme de soins

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

2023-04-07

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	Completed
P.	Date of the global end of the trial	2023-10-10

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IMP with orphan designation in the indication
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