Clinical Trials Register

Summary
EudraCT Number:	2020-002701-26
Sponsor's Protocol Code Number:	64304500CRD2002
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-04-07
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-002701-26

A.3

Full title of the trial

A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy with Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants with Active Crohn's Disease

Uno studio clinico di Fase 2a, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, multicentrico, di fattibilità (Proof-of-Concept), volto a valutare la sicurezza e l’efficacia di JNJ-64304500 come terapia aggiuntiva alla terapia biologica standard di cura con anti-fattore di necrosi tumorale alfa o anti-interleuchina 12/23 in partecipanti rispondenti non remittenti con malattia di Crohn attiva

A.3.1

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

A clinical study to evaluate the safety and effectiveness of JNJ-64304500 as an add-on therapy to standard of care biologic therapy with anti-tumor necrosis factor alpha or anti-interleukin 12/23 in responder not remitter participants with active Crohn's Disease

Uno studio clinico per valutare la sicurezza e l'efficacia di JNJ-64304500 come terapia aggiuntiva alla terapia biologica standard di cura con fattore di necrosi antitumorale alfa o anti-interleuchina 12/23 in partecipanti responder non remitter con malattia di Crohn attiva

A.3.2

Name or abbreviated title of the trial where available

DUET

A.4.1

Sponsor's protocol code number

64304500CRD2002

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, LLC
B.4.2	Country	United States
B.4.1	Name of organisation providing support	Janssen-Cilag S.p.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen-Cilag International NV
B.5.2	Functional name of contact point	Clinical Registry group
B.5.3	Address:
B.5.3.1	Street Address	Archimedesweg 29
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 CM
B.5.3.4	Country	Netherlands
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.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-64304500
D.3.2	Product code	[JNJ-64304500]
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	JNJ-64304500
D.3.9.2	Current sponsor code	JNJ-64304500
D.3.9.3	Other descriptive name	sezione * D.3.6.2.1 - valore: 400mg alla settimana 0, in seguito 200mg ogni due settimane
D.3.9.4	EV Substance Code	SUB181366
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	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	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	anticorpo monoclonale

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

Active Crohn's Disease

Malattia di Crohn attiva

E.1.1.1

Medical condition in easily understood language

Active Crohn's Disease

Malattia di Crohn attiva

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

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

1. To evaluate safety and tolerability at Week 12
2. To evaluate efficacy at Week 12 (change in Crohn's Disease Activity Index [CDAI] score from baseline)

1. Valutare sicurezza e tollerabilità alla settimana 12;
2. Valutare l'efficacia alla settimana 12 (variazione del punteggio dell'indice di attività della malattia di Crohn [CDAI] dal basale)

E.2.2

Secondary objectives of the trial

1. To evaluate clinical response/remission at Week 12
2. To evaluate pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD)/biomarkers at Week 12

1. Valutare la risposta / remissione clinica alla settimana 12;
2. Valutare farmacocinetica (PK), immunogenicità e farmacodinamica (PD) / biomarcatori alla settimana 12

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Each potential participant must satisfy all of the following criteria to be enrolled in the study:
1. male or female, 18 to 65 years old (inclusive).
2. have confirmed clinical diagnosis of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration.
3. initiated SOC biologic therapy
- Adalimumab (including HUMIRA or an equivalent biosimilar which could include: HULIO, HYRIMOZ, IMRALDI, or AMGEVITA) at maintenance dose of 40 mg SC q2w
or
- Ustekinumab at maintenance dose of 90 mg SC q8w
4. have healthcare provider documentation of suboptimal response to SOC biologic therapy with no documented deterioration or clinical remission during current treatment.
5. do not have clinically relevant immunogenicity to participant's current SOC biologic therapy at screening.

Please refer to protocol for all inclusion criteria.

Ogni potenziale partecipante deve soddisfare tutti i seguenti criteri per essere arruolato nello studio.
1. sesso maschile o femminile da 18 a 65 anni di età (compresi).
2. Aver ricevuto una diagnosi clinica confermata di malattia di Crohn o di malattia di Crohn fistolizzante da almeno 3 mesi.
3. Aver iniziato la terapia biologica SOC
- Adalimumab (incluso HUMIRA o un biosimilare equivalente che potrebbe includere: HULIO, HYRIMOZ, IMRALDI o AMGEVITA) alla dose di mantenimento di 40 mg SC q2w
o
- Ustekinumab alla dose di mantenimento di 90 mg SC q8w
4. Dispone della documentazione dell'operatore sanitario della risposta non ottimale alla terapia biologica SOC senza deterioramento documentato o remissione clinica durante il trattamento in corso.
5. Non Avere immunogenicità clinicamente rilevante rispetto alla terapia biologica SOC attuale del partecipante allo screening.

Fare riferimento al Protocolo per un elenco completo dei criteri di inclusione.

E.4

Principal exclusion criteria

Any potential participant who meets any of the following criteria will be excluded from participating in the study:
1. has complications of Crohn's disease that could confound the effect of treatment.
2. currently has or is suspected to have abscess
3. has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline
4. has a draining, stoma or ostomy.
5. has had a central line within 12 weeks before first dose

Please refer to protocol for all the exclusion criteria.

Ogni potenziale partecipante che soddisfi uno dei seguenti criteri sarà escluso dalla partecipazione allo studio:
1. Presenza di complicanze della malattia di Crohn che potrebbe confondere la capacità di valutare l’effetto del trattamento con JNJ-64304500.
2. Avere o si sospetta abbia un ascesso.
3. Aver avuto un qualsiasi tipo di resezione intestinale entro 6 mesi o qualsiasi altro intervento chirurgico intra-addominale nei 3 mesi precedenti al basale.
4. Avere uno stoma o una stomia drenante (ovvero, funzionante).
5. Aver inserito un catetere centrale nelle 12 settimane precedenti la prima dose.

Fare riferimento al Protocolo per un elenco completo dei criteri di esclusione.

E.5 End points

E.5.1

Primary end point(s)

1. Descriptive analyses of adverse events (AEs), clinical laboratory tests, and vital signs at Week 12 and applicable visits from Week 0 through Week 26
2. Change from baseline in the CDAI score at Week 12.

1. Analisi descrittive degli eventi avversi (EA), dei test clinici di laboratorio e dei segni vitali alla Settimana 12 e alle visite pertinenti dalla Settimana 0 alla Settimana 26;
2. Variazione rispetto al basale del punteggio CDAI alla Settimana 12.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Throughout the study
2. Week 12

1. Durante lo studio
2. alla Settimana 12

E.5.2

Secondary end point(s)

1. Analyses of the following at Week 12:
- Proportion of participants achieving a clinical response.
- Proportion of participants achieving a clinical remission.
- Change in the simple endoscopic score for Crohn's disease (SES-CD) from baseline.
- Proportion of participants achieving an endoscopic response
- Proportion of participants achieving an endoscopic remission
- Change in abdominal pain (AP) from baseline at all postbaseline visits
- Proportion of participants achieving a Patient-Reported Outcome (PRO)-2 remission
2. Analyses of the following at all applicable visits from Week 0 through Week 26:
- Serum concentrations of investigational drug
- Incidence and titers of antibodies to investigational drug.
- Incidence of neutralizing antibodies to investigational drug.
- Change in PD biomarker levels.

1. Analisi dei seguenti alla Settimana 12:
• percentuale di partecipanti che ottengono una risposta clinica
• Percentuale di partecipanti che ottengono una remissione clinica
• Variazione del punteggio endoscopico semplificato per la malattia di Crohn (SES-CD) rispetto al basale.
• Percentuale di partecipanti che ottengono una risposta endoscopica
• Percentuale di partecipanti che ottengono una remissione endoscopica
• Variazione del dolore addominale (Abdominal Pain, AP) dal basale a tutte le visite
• Percentuale di partecipanti che ottengono una remissione degli esiti riferiti dal paziente (PRO)-2
2. Analisi dei seguenti in tutte le visite pertinenti dalla Settimana 0 fino alla Settimana 26:
• Concentrazioni sieriche del farmaco sperimentale
• Incidenza e titoli degli anticorpi anti-JNJ-64304500.
• Incidenza di anticorpi neutralizzanti anti-JNJ-64304500.
• Variazione dei livelli dei biomarcatori PD

E.5.2.1

Timepoint(s) of evaluation of this end point

1. at Week 12
2. Week 0 through Week 26

1. Alla settimana 12
2. Dalla settimana 0 alla settimana 26

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

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, biomarker evaluations, tolerability and medical resource utilization

Immunogenicità, valutazioni di biomarcatori, tollerabilità e utilizzo delle risorse mediche

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

Canada

Japan

United States

France

Germany

Italy

Spain

Sweden

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

Ultima Vista dell'Ultimo soggetto in Studio (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:

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

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

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

2020-12-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-12

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
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