Clinical Trials Register

Summary
EudraCT Number:	2020-000622-26
Sponsor's Protocol Code Number:	CNTO1959GCA2001
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:	2021-05-24
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-000622-26

A.3

Full title of the trial

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants with New-Onset or Relapsing Giant Cell Arteritis

Studio di fattibilità di Fase 2, multicentrico, randomizzato, controllato con placebo, in doppio cieco, volto a valutare guselkumab per il trattamento dei partecipanti con arterite a cellule giganti di nuova insorgenza o recidivante

A.3.1

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

A Proof-of-Concept Study of Guselkumab in the Treatment of Subjects with New-Onset or Relapsing Giant Cell Arteritis

Uno studio proof-of-concept volto a valutare guselkumab per il trattamento dei partecipanti con arterite a cellule giganti di nuova insorgenza o recidivante

A.3.2

Name or abbreviated title of the trial where available

THEIA

A.4.1

Sponsor's protocol code number

CNTO1959GCA2001

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 Pharmaceutica N.V.
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen Biologics B.V.
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.5.4	Telephone number	0031715242166
B.5.5	Fax number	0031715242110
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	Guselkumab
D.3.2	Product code	[CNTO1959]
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GUSELKUMAB
D.3.9.1	CAS number	1350289-85-8
D.3.9.2	Current sponsor code	CNTO1959
D.3.9.3	Other descriptive name	* D.3.6.2.1 - valore :Every 4 weeks dosing of 400 mg
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	10
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	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	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.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.2.1.2	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	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.3.9.1	CAS number	1350289-85-8
D.3.9.2	Current sponsor code	CNTO1959
D.3.9.3	Other descriptive name	* D.3.6.2.1 - valore : Every 4 weeks dosing of 200 mg * D.3.6.2.1 - valore:Every 4 week dosing from week 12 to week 48
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	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 infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
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

Giant Cell Arteritis

Artrite a cellule giganti

E.1.1.1

Medical condition in easily understood language

Giant Cell Arteritis

Artrite a cellule giganti

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	PT
E.1.2	Classification code	10018250
E.1.2	Term	Giant cell arteritis
E.1.2	System Organ Class	10047065 - Vascular 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 compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA)

Valutare l’efficacia di guselkumab rispetto al placebo, in combinazione con un regime di riduzione graduale di glucocorticoidi (GC) della durata di 26 settimane, in partecipanti adulti con arterite a cellule giganti (Giant Cell Arteritis, GCA) di nuova insorgenza o recidivante

E.2.2

Secondary objectives of the trial

- To evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week GC taper regimen, in adult participants with new-onset or relapsing GCA as measured by alternative definitions of GC free remission, GC-sparing effects, and prevention of disease flares.
- To evaluate the safety of guselkumab, in combination with a 26-week GC taper regimen, in adult participants with new-onset or relapsing GCA.
- To evaluate the PK and immunogenicity of guselkumab, in combination with a 26-week GC taper regimen, in adult participants with new-onset or relapsing GCA.

• Valutare l’efficacia di guselkumab rispetto al placebo, in combinazione con un regime di riduzione graduale di GC della durata di 26 settimane, in partecipanti adulti con GCA di nuova insorgenza o recidivante, misurata mediante definizioni alternative di remissione libera da GC, effetti di risparmio di GC e prevenzione delle riacutizzazioni della malattia.
• Valutare la sicurezza di guselkumab, in combinazione con un regime di riduzione graduale di GC della durata di 26 settimane, in partecipanti adulti con GCA di nuova insorgenza o recidivante.
• Valutare la farmacocinetica (Pharmacokinetics, PK) e l’immunogenicità di guselkumab, in combinazione con un con un regime di riduzione graduale di GC della durata di 26 settimane, in partecipanti adulti con GCA di nuova insorgenza o recidivante.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female (according to their reproductive organs and functions assigned by chromosomal complement)
2. At least 50 years of age, inclusive
3. Diagnosis of GCA according to the revised American College of Rheumatology criteria
4. Temporal artery biopsy revealing features of GCA OR, Evidence of cranial GCA by doppler-ultrasound, cranial Magnetic Resonance Imaging or Magnetic Resonance Angiography
5. Have new onset or relapsing GCA
6. Have active GCA within 6 weeks of first study intervention

Please see section 5.1 in the protocol for all inclusion criteria.

1. sesso maschile o femminile (in base agli organi riproduttivi e alle funzioni assegnate dal complemento cromosomico)
2. età pari o superiore a 50 anni
3. diagnosi di GCA in base ai criteri revisionati dell’American College of Rheumatology
4. Biopsia dell’arteria temporale che rivela le caratteristiche della GCA OPPURE, evidenza di GCA cranica rilevata mediante eco-doppler, risonanza magnetica per immagini o angiografia a risonanza magnetica del cranio o altra modalità di diagnostica per immagini in accordo con lo sponsor.
5. Presentano GCA di nuova insorgenza o recidivante
6.Nuova insorgenza: diagnosi di GCA entro 6 settimane dal primo trattamento dello studio

si prega di far riferimento alla sezione 5.1 del protocollo per tutti i criteri di inclusione

E.4

Principal exclusion criteria

1. Has any known severe or uncontrolled GCA complications
2. Has any rheumatic disease other than GCA such as Takayasu's Arteritis, granulomatosis with polyangiitis (Wegener's), RA, PMR, systemic lupus erythematosus that could interfere with assessment of GCA
3. Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
4. Has or has had any major ischemic event, within 12 weeks of first study intervention
5. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of indetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly

Please see section 5.2 in the protocol for all exclusion criteria.

1. Presenta complicanze gravi o non controllate della GCA
2. È affetto/a da una malattia reumatica diversa da GCA come l’arterite di Takayasu, la granulomatosi con poliangioite (di Wegener), l’artrite reumatoide (AR), la polimialgia reumatica (PMR), il lupus eritematoso sistemico che potrebbe interferire con la valutazione della GCA
3. Presenta diagnosi o segni o sintomi attuali di gravi disturbi progressivi o non controllati cardiaci, renali, vascolari, polmonari, gastrointestinali, endocrini, neurologici, ematologici, reumatologici, psichiatrici o metabolici
4. Ha o ha avuto un evento ischemico maggiore, entro 12 settimane dal primo trattamento dello studio
5. Presenta un’anamnesi di malattia linfoproliferativa, incluso il linfoma; un’anamnesi di gammopatia monoclonale di significatività indeterminata; o segni e sintomi suggestivi di possibile malattia linfoproliferativa, come linfoadenopatia o splenomegalia

si prega di far riferimento alla sezione 5.2 del protocollo per tutti i criteri di inclusione

E.5 End points

E.5.1

Primary end point(s)

The proportion of participants achieving GC-free remission

percentuale di partecipanti che raggiungono la remissione libera da GC

E.5.1.1

Timepoint(s) of evaluation of this end point

48 weeks

48 settimane

E.5.2

Secondary end point(s)

The proportion of participants achieving GC-free remission from Week 28 by visit through Week 52; The proportion of participants achieving GC-free remission and normalization of ESR and/or CRP at Week 28 and by visit through Week 52; Number/proportion of participants with treatment emergent adverse events (TEAEs) through Week 60; Mean (standard deviation [SD]) serum concentrations of guselkumab through Week 52 in participants receiving active study intervention.; Number/proportion of participants with antibodies to guselkumab in participants receiving active study intervention.

La percentuale di partecipanti che raggiungono la remissione libera da GC dalla settimana 28 tramite visita fino alla settimana 52; La percentuale di partecipanti che hanno raggiunto la remissione libera da GC e la normalizzazione della ESR e / o della CRP alla settimana 28 e per visita fino alla settimana 52; Numero / proporzione di partecipanti con eventi avversi emergenti dal trattamento (TEAE) fino alla settimana 60; Concentrazioni sieriche medie (deviazione standard [SD]) di guselkumab fino alla settimana 52 nei partecipanti che hanno ricevuto l'intervento attivo dello studio.; Numero / proporzione di partecipanti con anticorpi anti-guselkumabb nei partecipanti che hanno ricevuto un intervento attivo nello studio.

E.5.2.1

Timepoint(s) of evaluation of this end point

through Week 52; through Week 52; through Week 60; through Week 52; through Week 52

fino alla settimana 52; fino alla settimana 52; fino alla settimana 60; fino alla settimana 52; fino alla settimana 52

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

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

United States

Belgium

France

Germany

Italy

Poland

Spain

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:

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

F.3.3.1

Women of childbearing potential not using contraception

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)

Participants should return to their primary physician to determine standard of care. Participants who complete the study and are in glucocorticoid (GC)-free remission may have the option to participate in a long-term extension (LTE) study.

I partecipanti dovrebbero tornare dal proprio medico di base per determinare lo standard di cura. I partecipanti che completano lo studio e sono in remissione senza glucocorticoidi (GC) possono avere la possibilità di partecipare a uno studio di estensione a lungo termine (LTE).

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

2020-12-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-11-11

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

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