Clinical Trials Register

Summary
EudraCT Number:	2016-001224-63
Sponsor's Protocol Code Number:	CNTO1959PSA3002
National Competent Authority:	Lithuania - SMCA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-06-19
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

Lithuania - SMCA

A.2

EudraCT number

2016-001224-63

A.3

Full title of the trial

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects with Active Psoriatic Arthritis

A.3.1

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

A Phase 3 Study of Guselkumab in Subjects with Active Psoriatic Arthritis

A.3.2

Name or abbreviated title of the trial where available

Discover 2

A.4.1

Sponsor's protocol code number

CNTO1959PSA3002

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 N.V.
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.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	+31 71 5242166
B.5.5	Fax number	+31 71 5242110
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 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 milligram(s)
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 pre-filled syringe
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 Psoriatic Arthritis

E.1.1.1

Medical condition in easily understood language

Active Psoriatic Arthritis

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10037160
E.1.2	Term	Psoriatic arthritis
E.1.2	System Organ Class	100000004859

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 in subjects with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

E.2.2

Secondary objectives of the trial

- Efficacy in improving psoriatic skin lesions
- Improvement in physical function
- Inhibition of progression of structural damage
- Efficacy in improving general and disease specific health-related quality of life and patient-reported health outcomes
- Safety
- Pharmacokinetics, pharmacodynamics, and immunogenicity

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Be a man or a woman at least 18 years of age
2. Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet ClASsification criteria for Psoriatic ARthritis (CASPAR) at screening
3. Have active PsA as defined by:
a. At least 5 swollen joints and at least 5 tender joints at screening and at baseline
-AND-
b. CRP ≥0.6 mg/dL at screening from the central laboratory.
4. Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
5. Have active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis.
6. Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.
- Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance.
- Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance.
- NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance.
7. If currently using non-biologic DMARDs , subjects should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before first administration of study agent and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using MTX, SSZ, or HCQ, must not have received for at least 4 weeks before first administration of study agent. If currently not using LEF, must not have received for at least 12 weeks before first administration of study agent.
a. If using MTX, the route of administration and dose must be stable and the dose must be ≤25 mg/week.
b. If receiving SSZ, the dose must be ≤ 3g/day.
c. If receiving HCQ, the dose must be ≤400 mg/day.
d. If receiving LEF, the dose must be ≤20 mg/day.
8. If currently using NSAIDs or other analgesics for PsA, subjects must be on a stable dose for at least 2 weeks before first administration of study agent. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks before first administration of study agent.
9. If currently using oral corticosteroids for PsA, subjects must be on a stable dose equivalent to ≤10 mg of prednisone/day for at least 2 weeks before first administration of study agent. If currently not using oral corticosteroids, the subject must not have received oral corticosteroids within 2 weeks before first administration of study agent.

For additional inclusion criteria please refer to protocol section 4.1.

E.4

Principal exclusion criteria

1. Has other inflammatory diseases that might confound the evaluations or benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis , systemic lupus erythematosus, or Lyme disease.
2. Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab (AIN457), anti-TNFα agents (such as adalimumab, etanercept, infliximab, golimumab SC or intravenous [IV], certolizumab pegol, or their respective biosimilars), tildrakizumab (MK3222), ixekizumab (LY2439821), brodalumab (AMG827), risankizumab (BI-655066), or other investigative biologic treatment for PsA or psoriasis.
3. Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor.
4. Has received any systemic immunosuppressants within 4 weeks of the first administration of study agent.
5. Is currently receiving 2 or more non-biologic DMARDs specified in Table 4.
6. Has received non-biologic DMARDs (other than MTX, SSZ, HCQ, LEF) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent.
7. Has received apremilast within 4 weeks prior to the first administration of study agent.
8. Has received phototherapy or any systemic medications/treatments that could affect psoriasis evaluations (including, but not limited to, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, fumaric acid derivatives, with the exception of those in Table 4) within 4 weeks of the first administration of study agent.
9. Has used topical medications/treatments that could affect psoriasis evaluations within 2 weeks of the first administration of any study agent.
10. Has received epidural, intra-articular, intramuscular, or IV corticosteroids, including adrenocorticotropic hormone during the 4 weeks before first administration of study agent.
13. Has unstable suicidal ideation or suicidal behavior in the last 6 months, that may be defined as an eC-SSRS rating at screening of
 - Ideation level 4: Some intent to act (“4”), no plan; OR
 - Ideation level 5: Specific plan and intent (“5”), OR
 - Any of the following suicidal behaviors:
– actual suicide attempts
– interrupted attempts
– aborted attempts
– preparatory actions
AND is confirmed to be at risk by the investigator based on an evaluation by a mental health professional. The final decision on excluding a subject will be made at the judgment of the investigator.
35. Is seropositive for antibodies to hepatitis C virus (HCV) at screening, unless the subject had 2 negative HCV ribonucleic acid (RNA) test results at least 6 months apart prior to screening and have a third negative HCV RNA test result at screening.

For additional exclusion criteria please refer to protocol section 4.2.

E.5 End points

E.5.1

Primary end point(s)

The proportion of subjects who achieve an American College of Rheumatology (ACR) 20 response at Week 24.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

E.5.2

Secondary end point(s)

1. Change from baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) score at Week 24.
2. Proportion of subjects who achieve an ACR 50 response at Week 24.
3. Proportion of subjects with a psoriasis response of an Investigator’s Global Assessment (IGA) (ie, an IGA psoriasis score of 0 [cleared] or 1 [minimal] AND ≥2-grade reduction from baseline) at Week 24 among the subjects with ≥3% body surface area (BSA) psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
4. Proportion of subjects who achieve an ACR 20 response at Week 16.
5. Change from baseline in modified van der Heijde-Sharp (vdH-S) score at Week 24.
6. Proportion of subjects with resolution of enthesitis at Week 24 among the subjects with enthesitis at
baseline.
7. Proportion of subjects with resolution of dactylitis at Week 24 among the subjects with dactylitis at baseline.
8. Change from baseline in enthesitis score (based on Leeds Enthesitis Index [LEI]) at Week 24 among the subjects with enthesitis at baseline.
9. Change from baseline in dactylitis score at Week 24 among the subjects with dactylitis at baseline.
10. Change from baseline in 36-item Short Form Health Survey Physical Component Summary (SF-36 PCS) at Week 24.
11. Change from baseline in Disease Activity Score 28 (DAS28) C-reactive protein (CRP) at Week 24.
12. Change from baseline in SF-36 Mental Component Summary (MCS) at Week 24.
13. Proportion of subjects who achieve an ACR 50 response at Week 16.
14. Proportion of subjects who achieve an ACR 70 response at Week 24.

For additional secondary endpoints please refer to the protocol.

E.5.2.1

Timepoint(s) of evaluation of this end point

1 - 3, 5 - 12, 14: Week 24
4, 13: Week 16

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)

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

E.8.1.6

Cross over

Yes

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

126

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

Bulgaria

Czech Republic

Estonia

Germany

Greece

Latvia

Lithuania

Malaysia

Poland

Portugal

Romania

Russian Federation

South Africa

Spain

Taiwan

Ukraine

United States

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

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:

547

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

137

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

650

F.4.2.2

In the whole clinical trial

684

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)

There are no plans for additional treatment or care after the subject ends (or has ended) participation in the trial.

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

2017-08-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-07-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-11-10

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