Clinical Trials Register

Summary
EudraCT Number:	2020-006115-19
Sponsor's Protocol Code Number:	SB17-3001
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-04-02
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2020-006115-19

A.3

Full title of the trial

A Phase III, Randomised, Double-blind, Multicentre Clinical Study to
Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and
Immunogenicity of SB17 (proposed ustekinumab biosimilar) Compared to
Stelara® in Subjects with Moderate to Severe Plaque Psoriasis

A.3.1

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

SB17 versus to Stelara® in Subjects with Moderate to Severe Plaque Psoriasis

A.4.1

Sponsor's protocol code number

SB17-3001

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	Samsung Bioepis Co., Ltd
B.1.3.4	Country	Korea, Republic of
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	Samsung Bioepis Co., Ltd
B.4.2	Country	Korea, Republic of
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Samsung Bioepis Co., Ltd
B.5.2	Functional name of contact point	Information Desk
B.5.3	Address:
B.5.3.1	Street Address	76, Songdogyoyuk-ro, Yeonsu-gu,
B.5.3.2	Town/ city	Incheon
B.5.3.3	Post code	21987
B.5.3.4	Country	Korea, Republic of
B.5.4	Telephone number	+82 32 728 0114
B.5.5	Fax number	+82 32 728 3321
B.5.6	E-mail	bioepisinfo@samsung.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	SB17 (proposed ustekinumab biosimilar)
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	Ustekinumab
D.3.9.1	CAS number	815610-63-0
D.3.9.3	Other descriptive name	Ustekinumab
D.3.9.4	EV Substance Code	SUB27761
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	90
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Stelara®
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.3.4	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	Ustekinumab
D.3.9.1	CAS number	815610-63-0
D.3.9.3	Other descriptive name	Ustekinumab
D.3.9.4	EV Substance Code	SUB27761
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	90
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Moderate to severe plaque psoriasis

E.1.1.1

Medical condition in easily understood language

Moderate to severe plaque psoriasis

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10071117
E.1.2	Term	Plaque psoriasis
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Demonstrate the equivalence of SB17 to Stelara®, in terms of the percent change from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 in subjects with moderate to severe plaque psoriasis

E.2.2

Secondary objectives of the trial

• To evaluate the efficacy of SB17 compared to Stelara®
₋ Percent change from baseline in PASI other than Week 12
₋ Physician’s Global Assessment (PGA)
₋ PASI50, PASI75, and PASI90 response rate
₋ Change from baseline in Dermatology Life Quality Index (DLQI)
• To evaluate safety and tolerability of SB17 compared to Stelara®
• To evaluate the pharmacokinetics (PK) of SB17 compared to Stelara® in subjects participating in PK evaluation
• To evaluate the immunogenicity of SB17 compared to Stelara®
• To evaluate safety and immunogenicity in subjects who transitioned to SB17 and who maintained Stelara® at Week 28 for the transition period

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Pharmacokinetic Assessment: PK will be performed in approximately 140 subjects (70 subjects per treatment group in initial randomisation at Week 0 [Day 1]) participating in PK evaluation. Only subjects who consent to the PK blood sampling will be enrolled in PK sub-study.

E.3

Principal inclusion criteria

1.Aged 18 years or older at Screening.
2.Have plaque psoriasis diagnosed at least 6 months prior to Screening, with or without psoriatic arthritis.
3.Have plaque psoriasis at Screening and Randomisation with the involvement and severity defined as the following:
a.Total affected body surface area (BSA) ≥ 10%.
b.PASI score of ≥ 12.
c.PGA score of ≥ 3 (moderate).
4.Considered to be a candidate for phototherapy or systemic therapy for psoriasis at Screening.
5.Be less than 95 kg of body weight at Screening and at Randomisation.
6.Adequate haematological function at Screening defined as the following by central lab:
a.White blood cell count ≥ 3.5 × 10^3 cells/μL (≥ 3.5 × 10^9 cells/L).
b.Neutrophil count ≥ 1.5 × 10^3 cells/μL (≥ 1.5 × 10^9 cells/L).
c.Haemoglobin ≥ 10 g/dL.
d.Platelet count ≥ 125,000/mm^3 (≥ 125 × 10^9/L).
7.Adequate renal and hepatic function at Screening defined as the following by central lab:
a.Serum creatinine < 1.5 × upper limit of normal (ULN).
b.Serum alanine transaminase (ALT) and aspartate transaminase (AST) < 2 × ULN.
8.Non-childbearing potential female, OR childbearing potential female subjects or male subjects with their partners who agree to use at least two forms of appropriate contraception method from Screening until 15 weeks after the last dose of IP.

E.4

Principal exclusion criteria

1.Have nonplaque forms of psoriasis, including erythrodermic, pustular, guttate, or drug-induced psoriasis at Screening.
2.Have other skin disease than psoriasis that:
a.Requires topical or systemic corticosteroid or other immunosuppressive therapy at Screening.
b.May confound the efficacy evaluation per Investigator discretion at Screening.
3.Have used biologics such as;
a.Any tumour necrosis factor (TNF) inhibitors within the previous 6 months prior to Randomisation.
b.Any interleukin (IL)-12 or IL-23 inhibitor biologics, IL-17 inhibitor, rituximab, or integrin inhibitor biologics at any time prior to Randomisation.
c.Other biologics within the longer of either 5 half-lives or 3 months prior to Randomisation.
4.Known allergic reactions or hypersensitivity to ustekinumab or to any ingredients of Stelara® or SB17 at Screening.
5.History of a systemic allergic reaction or hypersensitivity to prior biologic therapies at Screening.
6.History of life-threatening or corticosteroid-dependent asthma
7.History of exfoliative dermatitis, Reversible Posterior Leukoencephalopathy Syndrome (RPLS), facial palsy, allergic alveolitis, or non-infectious pneumonia including interstitial pneumonia, cryptogenic organizing pneumonia, or eosinophilic pneumonia, etc. at Screening.
8.Have received phototherapy or conventional systemic therapy for psoriasis within 4 weeks prior to Randomisation.
9.Have received topical therapy for psoriasis within 2 weeks prior to Randomisation.
10.Have received any disease-modifying anti-rheumatic drugs (DMARDs), any systemic immunosuppressants or any other injectable or enema corticosteroids, within 4 weeks prior to Randomisation (except for leflunomide: within 12 weeks from Randomisation).
11.Have received non-biologic IP from another study within 5 half-lives of that product prior to Randomisation or use of an investigational device at Randomisation.
12.Women who are pregnant or nursing at Screening, or men and women planning pregnancy during the study period and until 15 weeks after the last dose of IP.
13.Have received a live or live attenuated viral vaccine or a live bacterial vaccine (except Bacille Calmette-Guerin [BCG] vaccination) within 4 weeks prior to Randomisation or plan to do so within 15 weeks after the last dose of IP. For BCG vaccination, subjects who have received BCG within 12 months prior to Randomisation or plan to do so within 12 months after the last dose of IP.
14.Have active or latent tuberculosis (TB) at Screening, by known history or any of the following:
15.History of ongoing infection or a positive test of hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) infection, or any history of primary immunodeficiency at Screening.
16.History of sepsis, chronic or recurrent infection, conditions that require regular antibiotic prophylaxis, opportunistic, granulomatous, or invasive fungal infection at Screening.
17.History of other bacterial, fungal, viral, parasitic, or helminthic infection requiring oral antimicrobial within 2 weeks prior to Randomisation or a serious infection within 8 weeks prior to Randomisation. Other mild infections should be resolved before Randomisation.
18.History of lymphoproliferative disease or leukaemia at Screening.
19.History of malignancy within the last 5 years prior to Screening.
20.History of myocardial infarction, New York Heart Association (NYHA) III/IV congestive heart failure, or stroke within 12 months prior to Randomisation.
21.Have uncontrolled hypertension at Screening.
22.Have uncontrolled diabetes mellitus at Screening.
23.History of organ transplantation at Screening.
24.Evidence of alcohol or substance abuse within the last 12 months prior to Screening.
25.History of a major surgery in the opinion of the Investigator within 12 weeks prior to Randomisation or have a plan to do so during the study period.
26.History of uncontrolled psychiatric disorders or risk of suicide at Screening
27.Have other major organ dysfunction or failure such as liver cirrhosis, dialysis-dependent renal failure, any cardiopulmonary disease with functional disability of NYHA III/IV equivalent, aplastic anaemia or any other transfusion-dependent/stimulating factor dependent haematological disorders, or dementia at Screening.
28.Considered to be at risk of progressive weight gain or widely fluctuating body weight, in the opinion of the Investigator, at Screening.
29.History of COVID-19 as:
a.History of asymptomatic, mild or moderate COVID-19 within 8 weeks prior to Randomisation.
b.Any history of severe or critical COVID-19, or hospitalisation due to COVID-19 at Randomisation.
c.Any history of COVID-19 complications or sequalae including lung fibrosis, thromboembolism, cardiac, gastrointestinal, neuropsychiatric, ‘long COVID’, or dermatologic manifestations, etc. at Randomisation.

E.5 End points

E.5.1

Primary end point(s)

Percent change from baseline in PASI at Week 12

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

E.5.2

Secondary end point(s)

The secondary efficacy endpoints are:
• PGA at Week 2, 4, 8, 12, 16, 20, 24, 28, 40, and 52
• PASI50, PASI75, and PASI90 response rate at Week 2, 4, 8, 12, 16, 20, 24, 28, 40, and 52
• Percent change from baseline in PASI at Week 2, 4, 8, 16, 20, 24, 28, 40, and 52
• Change from baseline in DLQI at Week 4, 12, 16, 28, 40, and 52
The safety endpoints are:
• Incidence of adverse events (AEs)
• Incidence of serious AEs (SAEs)
• Changes in vital signs and clinical laboratory parameters
The PK endpoints are:
• Serum ustekinumab concentration at Week 0, 2, 4, 8, 12, 16, and 28
The immunogenicity endpoints are:
• Incidence of anti-drug antibodies (ADAs) at Week 0, 4, 8, 12, 16, 28, 40, and 52
• Incidence of neutralising antibodies (NAbs) at Week 0, 4, 8, 12, 16, 28, 40, and 52

E.5.2.1

Timepoint(s) of evaluation of this end point

As described in E.5.2

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability and Immunogenicity

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Transition period at Week 28 for subjects PASI50 response

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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.8.5

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

Korea, Republic of

Ukraine

Estonia

Hungary

Latvia

Lithuania

Poland

Czechia

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:

441

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

225

F.4.2

For a multinational trial

F.4.2.1

In the EEA

330

F.4.2.2

In the whole clinical trial

464

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. After study completion, subjects will discuss with their physician to switch to the most appropriate psoriasis treatment.

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

2021-06-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-30

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-12-08

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