Clinical Trials Register

Summary
EudraCT Number:	2021-000510-42
Sponsor's Protocol Code Number:	80202135ARA2001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-07-09
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

Spain - AEMPS

A.2

EudraCT number

2021-000510-42

A.3

Full title of the trial

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with Active Rheumatoid Arthritis Despite Standard Therapy.

Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo y de prueba de concepto, para evaluar la eficacia y la seguridad de nipocalimab administrado por vía intravenosa en pacientes con artritis reumatoide activa a pesar del tratamiento estándar.

A.3.1

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

A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab
in Participants with Active Rheumatoid Arthritis.

Estudio de prueba de concepto para evaluar la eficacia y la seguridad de nipocalimab en pacientes con artritis reumatoide activa

A.3.2

Name or abbreviated title of the trial where available

IRIS

A.4.1

Sponsor's protocol code number

80202135ARA2001

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 and Development, LLC
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	Janssen-Cilag, S.A
B.5.2	Functional name of contact point	Global Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Paseo de las Doce Estrellas, 5-7
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28042
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34672603548
B.5.6	E-mail	calvare@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	Nipocalimab
D.3.2	Product code	JNJ-80202135
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	Nipocalimab
D.3.9.1	CAS number	2211985-36-1
D.3.9.2	Current sponsor code	JNJ-80202135
D.3.9.3	Other descriptive name	M281
D.3.9.4	EV Substance Code	SUB195356
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	30
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	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	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	Solution for injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Rheumatoid Arthritis (RA)

Artritis Reumatoide (AR)

E.1.1.1

Medical condition in easily understood language

Rheumatoid Arthritis (RA)

Artritis Reumatoide (AR)

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	23.1
E.1.2	Level	PT
E.1.2	Classification code	10039073
E.1.2	Term	Rheumatoid arthritis
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue 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 nipocalimab vs placebo in participants with moderate to severe active RA.

Evaluar la eficacia de nipocalimab frente a placebo en pacientes con Artritis Reumatoide (AR) activa de moderada a grave

E.2.2

Secondary objectives of the trial

1. To evaluate the safety and tolerability of nipocalimab vs placebo in participants with moderate to severe active RA.
2. To evaluate the PK and immunogenicity of IV nipocalimab in participants with moderate to severe active RA.

1. Evaluar la seguridad y tolerabilidad de nipocalimab frente a placebo en pacientes con AR activa de moderada a grave.
2. Evaluar la farmacocinética y la inmunogenicidad de nipocalimab i.v. en pacientes con AR activa de moderada a grave.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or Female, 18 to 75 years of age (inclusive) at the time of consent.
2. Diagnosis of RA and meeting the 2010 ACR / European League Against Rheumatism (EULAR) Criteria for RA for at least 3 months before screening.
3. Has moderate to severe active RA as defined by persistent disease activity with at least 6 swollen and 6 tender joints out of the 66/68-swollen and tender joint count at the time of screening and at baseline.
4. Is positive for ACPA and/or RF at screening.
5. Screening C-reactive protein (CRP) ≥0.3 mg/dL by the central laboratory.

1. Hombre o mujer, entre 18 y 75 años de edad (inclusive) en el momento del consentimiento.
2. Tener un diagnóstico de Artritis Reumatoide (AR) y cumplir los criterios de la ACR/Liga Europea contra el Reumatismo (EULAR) de 2010 para la AR durante al menos 3 meses antes de la selección.
3.Tener AR activa de moderada a grave, definida por la actividad persistente de la enfermedad con 6 articulaciones inflamadas y 6 dolorosas a la palpación como mínimo del recuento de 66/68 articulaciones inflamadas y dolorosas a la palpación en el momento de la selección y en la visita basal.
4. Resultado positivo para ACPA o FR en la selección.
5. Proteína C reactiva (PCR) ≥0,3 mg/dl en la selección según el laboratorio central.
Por favor, refiérase a la sección 5.1 del protocolo para consultar todos
los criterios de inclusión

E.4

Principal exclusion criteria

1. Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her RA or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant.
2. Currently has a malignancy or has a history of malignancy within 3 years before screening (with the exception of localized basal cell carcinoma and/or squamous cell carcinoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks before the first administration of study intervention or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first administration of study intervention).
3. Is (anatomically or functionally) asplenic.
4. Has experienced myocardial infarction (MI), unstable ischemic heart disease, or stroke within 12 weeks of screening.
5. Has other known inflammatory diseases that might confound the evaluations of benefit from nipocalimab therapy, including but not limited to ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, Lyme disease.
6. Is currently taking IgG Fc-related protein therapeutics.

1. Tener confirmación o sospecha de un síndrome de inmunodeficiencia clínico no relacionado con el tratamiento de la AR o tener antecedentes familiares de inmunodeficiencia congénita o hereditaria, a menos que se confirme su ausencia en el paciente.
2. Tener actualmente una neoplasia maligna o antecedentes de tumores malignos en los 3 años anteriores a la selección (a excepción de un carcinoma basocelular y/o carcinoma de piel de células escamosas localizado que se haya tratado adecuadamente sin signos de reaparición durante al menos 12 semanas antes de la primera administración del tratamiento del estudio o un carcinoma de cuello uterino localizado que se haya tratado sin signos de reaparición durante al menos los 3 meses anteriores a la primera administración del tratamiento del estudio).
3. Ser (anatómica o funcionalmente) asplénico.
4. Haber sufrido un infarto de miocardio (IM), una cardiopatía isquémica inestable o un accidente cerebrovascular en las 12 semanas anteriores a la selección.
5. Tener otras enfermedades inflamatorias conocidas que podrían dificultar la interpretación de las evaluaciones de los beneficios del tratamiento con nipocalimab, que incluyen, entre otras, espondilitis anquilosante, artritis psoriásica, lupus eritematoso sistémico o enfermedad de Lyme.
6. Estar tomando actualmente terapias de proteínas relacionadas con Fc de IgG
Por favor, refiérase a la sección 5.2 del protocolo para consultar todos los criterios de exclusión

E.5 End points

E.5.1

Primary end point(s)

• Change from baseline in DAS28-CRP.

• Cambio respecto al valor basal en la DAS28-PCR

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

Semana 12

E.5.2

Secondary end point(s)

1. Proportion of participants who achieve ACR20, ACR50, ACR70, and ACR90 responses.
2. Proportion of participants achieving DAS28-CRP remission.
3. Proportion of participants achieving DAS28-CRP LDA.
4. Change from baseline in HAQ-DI score.
5. Proportion of participants with treatment-emergent AE.
6. Proportion of participants with treatment-emergent SAEs.
7. Serum nipocalimab concentrations over time.
8. Incidence and titers of antibodies to nipocalimab in participants receiving active study intervention.

1. Proporción de pacientes que logran respuestas ACR20, ACR50, ACR70 y ACR90.
2. Proporción de pacientes que logran una remisión de la DAS28-PCR.
3. Proporción de pacientes que logran una LDA en la DAS28-PCR.
4. Cambio respecto al valor basal en la puntuación del HAQ-DI.
5. Proporción de pacientes con Acontecimientos Adversos (AA) derivados del tratamiento.
6. Proporción de pacientes con Acontecimientos Adversos Graves (AAG) derivados del tratamiento.
7. Concentraciones séricas de nipocalimab a lo largo del tiempo.
8. Incidencia y valores de anticuerpos contra nipocalimab en pacientes que reciben el tratamiento activo del estudio.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Week 12
2. Week 12
3. Week 12
4. Week 12
5. Throughout the study
6. Throughout the study
7. W0, W2, W4, W8, W12, W18
8. W0, W2, W4, W8, W12, W18

1. Semana 12
2. Semana 12
3. Semana 12
4. Semana 12
5. A lo largo del estudio
6. A lo largo del estudio
7. S0, S2, S4, S8, S12, S18
8. S0, S2, S4, S8, S12, S18

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

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

United States

Germany

Poland

Spain

United Kingdom

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

Última visita del último paciente

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

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

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

Ninguno

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

2021-09-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-28

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

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