Clinical Trials Register

Summary
EudraCT Number:	2018-003206-58
Sponsor's Protocol Code Number:	CNTO1959PSO3013
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-04-25
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

Germany - PEI

A.2

EudraCT number

2018-003206-58

A.3

Full title of the trial

A Phase 3b, Multicenter, Interventional, Randomized, Placebo controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis

A.3.1

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

A Clinical Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar Psoriasis

A.3.2

Name or abbreviated title of the trial where available

G-PLUS

A.4.1

Sponsor's protocol code number

CNTO1959PSO3013

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 Pharmaceutica NV
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	+31715242166
B.5.5	Fax number	+31715242110
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	Yes
D.2.1.1.1	Trade name	TREMFYA®
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Cilag International NV
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 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.3.9.1	CAS number	1350289-85-8
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	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	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

Palmoplantar non-Pustular Psoriasis

E.1.1.1

Medical condition in easily understood language

Psoriasis

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10037153
E.1.2	Term	Psoriasis
E.1.2	System Organ Class	10040785 - Skin and subcutaneous 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 guselkumab for the treatment of palmoplantar psoriasis

E.2.2

Secondary objectives of the trial

1) To evaluate the efficacy of guselkumab in improving general plaque psoriasis in participants with palmoplantar psoriasis
2) To evaluate the efficacy of guselkumab in improving clinician assessments and disease related patient-reported quality-of-life measures in participants with palmoplantar psoriasis.
3) To evaluate the efficacy, patient-reported quality-of-life assessments and other scores in the placebo-crossover group at different time points.
4) To evaluate the maintained efficacy of guselkumab for the treatment of palmoplantar psoriasis.
5) To evaluate the efficacy of guselkumab in improving work productivity and limitations in participants with palmoplantar psoriasis
6) To evaluate safety of guselkumab in participants with palmoplantar psoriasis.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Participant population-related inclusion criteria
1. Male or female ≥18 years of age.
2. Criterion changed per Amendment 1:
2.1 Should have aall the following:
- A confirmed diagnosis of moderate-to-severe palmoplantar-non pustular psoriasis with PASI score ≥3 and <10, with both palms and soles affected, withpalm and/or sole involvement and at least 1one plaque outside ofat a body site other than the palms or soles (any size), typically confirmingand soles for at least 6 months, to confirm a diagnosis of chronic psoriasis.
- PASI score ≥3 and <10 at screening and at baseline.
- ppIGA score ≥3 at screening and at baseline.
3. Should be eligible to receive biological treatments; only participants who are naive to biological treatments can be included.
4. Willing to participate in the study.
Reproduction-related inclusion criteria
5.Criterion changed per Amendment 1:
5.1 Before the first administration of guselkumab, a woman must be either:
• Not of childbearing potential
• Of childbearing potential and practicing a highly effective method of contraception
User-dependent methods of contraception: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal; progestogenonly hormone contraception associated with inhibition of ovulation: oral and injectable.
• Agree to remain on a highly effective method throughout the study and for at least 12 weeks after the last dose of study intervention.
6. Criterion changed per Amendment 1:
6.1. A woman of childbearing potential must have a negative serum β- human chorionic gonadotropin (β-hCG) test at screening and a negative urine pregnancy test at screening and at Week 0.
7. A woman must agree not to donate eggs for the purposes of assisted reproduction from the first administration of study intervention through at least 12 weeks after receiving the last administration of guselkumab.
8. A man who is sexually active with a woman of childbearing potential and who has not had a vasectomy must agree to use a barrier method of birth control, during the study and for at least 12 weeks after receiving the last administration of study intervention. All men must also agree to not donate sperm during the study and for at least 12 weeks after receiving the last administration of study intervention.
9. Is considered eligible according to the following TB screening criteria:
a-c no updates compared to previous protocol
d.Within 2 months before the first administration of study agent, has a negative QuantiFERON-TB test result, or has a newly identified positive QuantiFERON TB test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated before the first administration of study agent. Within 2 months before the first administration of study agent, a negative tuberculin skin test (Appendix 2: Tuberculin Skin Testing), or a newly identified positive tuberculin skin test in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated before the first administration of study agent, is additionally required if the QuantiFERON-TB test is not approved/registered in that country or the tuberculin skin test is mandated by local health authorities. A tuberculin skin test is recommended but not required for study centers in Ukraine if tuberculin is not available.
Infectious disease-related inclusion criteria
10. Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention.
11. Agree not to receive a BCG vaccination during the study, and within 12 months after the last administration of study intervention.
12. Criterion changed per Amendment 1:
12.1 Have screening laboratory test results within the following parameters:
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase levels must be ≤12.50 times the upper limit of normal range for the central laboratory conducting the test.
17 Criterion added per Amendment 1:
Compliant with the completion requirements for the PROs used in the study.
For a complete overview of the inclusion criteria, please refer page number 26 to 29 of the protocol.

E.4

Principal exclusion criteria

Medical history-related exclusion criteria
1. Criterion changed per Amendment 1:
1.1 Currently has palmoplantar pustulosis, pustular psoriasis, or any other forms other than or nontype 1 plaque-type psoriasis (eg, erythrodermic, guttate), or hyperkeratotic eczema. Any presence of pustules will not be allowed.
2. Has psoriasis with >10% BSA (criterion deleted per Amendment 1)
3. Has current drug-induced psoriasis.
4. Has had major surgery within 8 weeks before screening, or will not have fully recovered from such surgery, or has such surgery planned during the time the participant is expected to participate in the study.
5. Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
6. Criterion changed per Amendment 1:
6.1 Is pregnant, nursing, or planning a pregnancy within while enrolled in this study, and for at least 12 weeks following after the last administration of study drug intervention. Concomitant or previous medical therapies-related exclusion criteria
7.Criterion changed per Amendment 1:
7.1 Has used topical anti-psoriatic medications/treatments that could affect efficacy evaluations (including, but not limited to, corticosteroids, vitamin D3 derivatives, tacrolimus, andsalicylic acid, urea, antibiotics) or any agents with anti-psoriatic effects) that could affect efficacy evaluations within 2 weeks of the planned first administration of study drug intervention.
8. Has received prior treatment with biological agents for palmoplantarnon-pustular psoriasis.
9. Has had prior exposure, known and reported intolerance to guselkumab or excipients, or ineligible to treatment with biological agents.
10. Criterion changed per Amendment 1:
10.1 Has previously received MTX within 2 weeks, or any Disease-
Modifying Anti Rheumatic Drugs (DMARDs) other than MTX within 4
weeks, including cyclosporin, fumarates and psoralen UVA (PUVA)within 4 weeks of the planned first administration of the study intervention.
11.1 Has received phototherapy or any systemic medications/treatments that could affect efficacy evaluations (including, but not limited to, apremilast, systemic immunosuppressive drugs, cytotoxic drugs, oral or injectable corticosteroids, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, fumaric acid derivatives, herbal treatments, or traditional Taiwanese, Korean, or Chinese medicines) within 4 weeks of the planned first administration of study intervention.
14. Has received, or is expected to receive, any live virus or bacteria vaccination within 3 months before the first administration of study drugintervention.
17. Has a transplanted organ (with exception of a corneal transplant >3 months before the first administration of study drugintervention).
21. Has a chest radiograph within 3 months before the first administration of study drug intervention that shows an abnormality suggestive of a malignancy or current active infection, including TB
26. Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug intervention administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug intervention administration).
32. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocolspecified assessments (Criterion deleted per Amendment 1.)
34. Is an employee of the sSponsor.
35. A potential participant with the following features will be excluded from participating in the study protocol:
• During the 6 weeks prior to baseline, have had ANY of (a) confirmed SARS-CoV-2 (COVID-19) infection (test positive), OR (b) suspected SARS-CoV-2 infection, OR (c) close contact with a person with known or suspected SARS-CoV-2 infection

For a complete overview of the exclusion criteria, refer page number 30 to 33 of the protocol

E.5 End points

E.5.1

Primary end point(s)

Proportion of ppPASI75 responders in the guselkumab group versus the placebo group at Week 16

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 16

E.5.2

Secondary end point(s)

1. Change from baseline in BSA PASI and absolute PASI scores, and percentage change in PASI scores (PASI 75, 90 and 100) in the guselkumab group versus the placebo group at Week 16
2. Change from baseline in PASI BSA and absolute PASI and BSA scores, and percentage change in PASI scores (PASI 75, 90 and 100) in the guselkumab group at Weeks 24 and 48
3. Change from baseline in ppQLI, DLQI, EQ-5D-5L and ppIGA scores in the guselkumab group versus the placebo group at Week 16
4. Change from baseline in f-PGA scores in the guselkumab group versus the placebo group at Week 16
5. Change from baseline in ppQLI, DLQI, EQ-5D-5L and ppIGA scores in the guselkumab group at Weeks 24 and 48
6. Change from baseline in f-PGA scores in the guselkumab group at Weeks 24 and 48

E.5.2.1

Timepoint(s) of evaluation of this end point

1,3,4,7: Week 16
2,5,6,8,9,10,11: Week 24 and 48
12: Throughout the study

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

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

Biomarker analysis and Tolerability

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

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

105

F.4.2.2

In the whole clinical trial

105

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

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

2019-05-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-11-30

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