Clinical Trials Register

Summary
EudraCT Number:	2021-005528-39
Sponsor's Protocol Code Number:	78934804UCO2001
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2022-10-24
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

France - ANSM

A.2

EudraCT number

2021-005528-39

A.3

Full title of the trial

A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

Étude multicentrique de phase 2b, randomisée, en double aveugle, contrôlée contre traitement actif et placebo, à groupes parallèles, évaluant l’efficacité et la sécurité de l’association de guselkumab et de golimumab en traitement d’induction et d’entretien chez des participants atteints de rectocolite hémorragique modérément à sévèrement active

A.3.1

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

Efficacy and Safety of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis

Efficacité et sécurité du traitement d’association par guselkumab et golimumab chez des participants atteints de rectocolite hémorragique modérément à sévèrement active

A.3.2

Name or abbreviated title of the trial where available

DUET-UC

A.4.1

Sponsor's protocol code number

78934804UCO2001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT05242484

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 LLC
B.5.2	Functional name of contact point	Clinical Trials 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	JNJ-78934804
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Golimumab
D.3.9.1	CAS number	476181-74-5
D.3.9.2	Current sponsor code	CNTO148
D.3.9.3	Other descriptive name	Golimumab
D.3.9.4	EV Substance Code	SUB25638
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	50
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	Combination of the monoclonal antibodies Guselkumab and Golimumab
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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 in pre-filled syringe
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: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Simponi
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Biologics B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Golimumab
D.3.2	Product code	CNTO148
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
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	Golimumab
D.3.9.1	CAS number	476181-74-5
D.3.9.2	Current sponsor code	CNTO148
D.3.9.3	Other descriptive name	Golimumab
D.3.9.4	EV Substance Code	SUB25638
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 in vial
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

Moderately to Severely Active Ulcerative Colitis

Rectocolite hémorragique modérément à sévèrement active

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	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10045365
E.1.2	Term	Ulcerative colitis
E.1.2	System Organ Class	100000004856

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 JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone)

Évaluer l’efficacité du JNJ-78934804 à la Semaine 48 par rapport à chaque monothérapie (guselkumab seul et golimumab seul)

E.2.2

Secondary objectives of the trial

1 To evaluate the efficacy of JNJ-78934804 compared with each monotherapy across a range of outcome measures
2 To evaluate the efficacy of JNJ-78934804 at Week 24 compared with placebo
3 To evaluate the safety of JNJ-78934804 compared with each monotherapy and placebo
4 To evaluate the pharmacokinetics (PK) and immunogenicity of JNJ-78934804 compared with each monotherapy

1 Évaluer l’efficacité du JNJ-78934804 par rapport à chaque monothérapie sur différents critères d’évaluation
2 Évaluer l’efficacité du JNJ-78934804 à la Semaine 24 par rapport au placebo
3 Évaluer la sécurité du JNJ-78934804 par rapport à chaque monothérapie et au placebo
4 Évaluer la pharmacocinétique (PK) et l’immunogénicité du JNJ-78934804 par rapport à chaque monothérapie

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
•Moderately to severely active UC as assessed by the modified mayo score
•Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
•If female and of childbearing potential, must meet the contraception and reproduction requirements

For an overview of all the inclusion criteria please refer to protocol section 5.1

• Diagnostic documenté de RCH depuis au moins 3 mois avant la sélection
• RCH modérément à sévèrement active, définie par le score Mayo modifié
• Avoir déjà présenté une réponse inadéquate, une perte de réponse ou une intolérance à au moins un médicament biologique ou un nouvel agent oral ayant une activité semblable à celle d'un médicament biologique (" biologic-like ").

• Si une femme et en âge de procréer doit satisfaire aux exigences en matière de contraception et de reproduction.

Pour un aperçu de tous les critères d'inclusion, veuillez vous référer à la section 5.2 du protocole

E.4

Principal exclusion criteria

•Has severe extensive colitis as defined in the protocol
•Extent of inflammatory disease limited to the rectum
•Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease (CD)
•Has a history of, or ongoing, chronic or recurrent infectious disease
•Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)

For an overview of all the exclusion criteria please refer to protocol section 5.2

•Présente une colite extensive sévère telle que définie dans le protocole
•Étendue de la maladie inflammatoire limitée au rectum
•Diagnostic de colite indéterminée, colite microscopique, colite ischémique ou MC.

•Antécédents ou présence de maladies infectieuses chroniques ou récidivantes

•Présence d’un cancer ou antécédents de cancer dans les ≤ 5 ans avant la sélection (exception : cancer cutané non mélanomateux traité de manière appropriée, sans signe de récidive de la maladie pendant 12 mois avant la première dose de l’intervention à l’étude )

Pour un aperçu de tous les critères d’exclusion, veuillez vous référer à la section 5.2 du protocole

E.5 End points

E.5.1

Primary end point(s)

Clinical remission at Week 48

Rémission clinique à la Semaine 48

E.5.1.1

Timepoint(s) of evaluation of this end point

At Week 48

à la Semaine 48

E.5.2

Secondary end point(s)

1 Combination of histological remission and endoscopic improvement
2 Clinical remission of JNJ-78934804 at Week 24 compared with placebo
3 Frequency and type of AEs, serious adverse events (SAEs)
4 Serum concentrations of guselkumab and golimumab over time
5 Incidence and titers of antibodies to guselkumab and golimumab
6 Incidence of neutralizing antibodies to guselkumab and golimumab

1 Association d’une rémission histologique et d’une amélioration endoscopique à la Semaine 48
2 Clinical remission of JNJ-78934804 at Week 24 compared with placebo

3 Fréquence et type d’événements indésirables (EI) et d’événements indésirables graves (EIG)

4 Concentrations sériques de guselkumab et golimumab dans le temps

5 Incidence et titre des anticorps anti-guselkumab et des anticorps anti- golimumab

6 Incidence des anticorps neutralisants contre le guselkumab et le golimumab

E.5.2.1

Timepoint(s) of evaluation of this end point

1 - At Week 48
2 - At Week 24

1- à la Semaine 48
2- à la Semaine 24

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

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

Yes

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Guselkumab and Golimumab (Monotherapy)

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

210

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

Argentina

Australia

Brazil

Canada

Chile

India

Israel

Japan

Jordan

Korea, Republic of

Mexico

New Zealand

Taiwan

United States

Austria

Estonia

Finland

France

Lithuania

Poland

Sweden

Bulgaria

Netherlands

Spain

Switzerland

Czechia

Germany

Greece

Italy

Belgium

Bosnia and Herzegovina

Croatia

Denmark

Hungary

Ireland

Norway

Portugal

Russian Federation

Slovakia

Slovenia

Turkey

Ukraine

United Kingdom

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

The end of study is considered as the last scheduled study assessment shown in the SoA ( Schedule of activities) for the last participant or if a decision has been made by the sponsor not to pursue an indication in UC and appropriate follow-up has been completed.

La fin de l'étude est considérée comme la dernière évaluation d'étude prévue indiquée dans le CoA (Calendrier des activités) pour le dernier participant ou si une décision a été prise par le promoteur de ne pas poursuivre une indication dans la CU et un suivi approprié a été effectué .

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

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:

550

F.1.3

Elderly (>=65 years)

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

118

F.4.2.2

In the whole clinical trial

550

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)

Participants who complete treatment and who are eligible for continued access program (post- study access or other open-label extension study under a different/separate protocol), all others participants will return to their normal treatment.

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

2023-02-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-11-14

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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