Clinical Trials Register

Summary
EudraCT Number:	2013-000747-11
Sponsor's Protocol Code Number:	GP17-301
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:	2013-12-11
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2013-000747-11

A.3

Full title of the trial

A randomized, double-blind, multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar adalimumab (GP2017) and Humira® in patients with moderate to severe chronic plaque-type psoriasis

A.3.1

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

A randomized, double-blind, multicenter study to show similar efficacy and compare safety and immunogenicity of a biosimilar adalimumab (GP2017) and Humira® in patients with moderate to severe chronic plaque-type psioriasis

A.3.2

Name or abbreviated title of the trial where available

ADACCESS

A.4.1

Sponsor's protocol code number

GP17-301

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	Hexal AG
B.1.3.4	Country	Germany
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	Hexal AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Pharma AG
B.5.2	Functional name of contact point	Marion Bastiaansen
B.5.3	Address:
B.5.3.1	Street Address	Postfach
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4002
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	41616966058
B.5.5	Fax number	41613245888
B.5.6	E-mail	marion.bastiaansen@novartis.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	Adalimumab
D.3.2	Product code	GP2017
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	ADALIMUMAB
D.3.9.1	CAS number	331731-18-1
D.3.9.2	Current sponsor code	GP2017
D.3.9.4	EV Substance Code	SUB20016
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	50
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	Humira
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Ltd.
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	Humira
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	ADALIMUMAB
D.3.9.1	CAS number	331731-18-1
D.3.9.4	EV Substance Code	SUB20016
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	50
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 chronic plaque-type psoriasis

E.1.1.1

Medical condition in easily understood language

Moderate to severe 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	14.1
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 demonstrate equivalent efficacy of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI75 response rate at Week 16

E.2.2

Secondary objectives of the trial

Key secondary objectives:
•For treatment period 1: To compare PASI50, PASI75, PASI90 and PASI100 response rates of patients treated with GP2017 and Humira®
•For treatment period 2: to compare efficacy, safety and immunogenicity of pooled data from patients undergoing repeated switches (Groups 1b and 2b) with those from patients constantly treated with GP2017 (Group 1a) and Humira® (Group 2a)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Patients must be able to understand and communicate with the investigator and comply with the requirements of the study (including administration of s.c. injections) and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
2.Men or women of at least 18 years of age at time of screening
3.Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization
4.Moderate to severe psoriasis as defined at randomization by:
•PASI score of 12 or greater and,
•IGA score of 3 or greater (based on a scale of 0 - 4) and,
•Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater
5.Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.
6.Patient with the following laboratory values obtained during Screening :
a)hemoglobin ≥ 10g/dL
b)white blood count (WBC) ≥3,500/µl/);
c)platelet count ≥ 125,000/µl
d)neutrophils ≥ 2000/µl
e)AST, ALT and AP ≤ 2.5 xULN; .
f)serum creatinine level <176.8 μmol/L (2.0 mg/dL)
g)Negative test for serologic or virologic markers for active or latent Hepatitis B (HBV) and/or Hepatitis C (HCV) infections

E.4

Principal exclusion criteria

1.Forms of psoriasis other than chronic plaque-type
2.Ongoing use of prohibited psoriasis treatments
3.Previous exposure to adalimumab
4.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (cut-off as defined by central laboratory)
5.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
6. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment of adalimumab
7.Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy
8.Pre-existing or recent-onset of central of peripheral nervous system demyelinating disorders according to investigator’s discretion and taking into account a neurological assessment; patients who are considered to have an increased risk of developing a demyelinating disease
9.Significant cardiovascular problems, including but not limited to the following: uncontrolled hypertension (≥ 160 systolic/95 diastolic mm Hg), congestive heart failure with known decreased left ventricular ejection fraction
10.Bi-directional chest X-ray, chest high resolution computerized tomography (HR-CT) scan or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process obtained within 12 weeks prior to randomization, and evaluated by a qualified physician. If subjects do not have an image available at the time of screening, a bi-directional chest X-ray must be done prior to randomization after it is fairly certain the patient meets the other inclusion/exclusion criteria in order to minimize unnecessary exposure to X-ray radiation for patients. If presence of latent tuberculosis (TB) is detected by imaging, then TB treatment must have been initiated and maintained according to local country guidelines prior to randomization
11.History of an ongoing, chronic or recurrent infectious disease, or evidence of TB infection as defined by a positive QuantiFERON®-TB Gold test (QFT) at screening. Patients with a positive or indeterminate QFT test may participate in the study if full tuberculosis work up (according to local practice/guidelines) completed within 12 weeks establishes conclusively that the patient has no evidence of active TB. If presence of latent TB is established, then TB treatment must have been initiated and maintained according to local country guidelines prior to randomization
12.Active systemic infections during the last two weeks (exception: common cold) prior to randomization and any infections that reoccur on a regular basis; patients with a history or evidence of opportunistic infections
13.Past medical history record of infection with human immunodeficiency virus (HIV)
14.History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months before screening, and except for carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)
15.Current severe progressive or uncontrolled disease which in the judgment of the clinical investigator renders the patient unsuitable for the study

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy variable is the PASI 75 response rate (proportion of subjects showing at least a 75% improvement PASI at Week 16 in Treatment Period 1)

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 16 of Treatment Period 1

E.5.2

Secondary end point(s)

Treatment Period 1:
•PASI 50, 75, 90 and 100 response rates at Weeks 1, 3, 5, 7, 9, 11, 13, 15, 16, and 17
•Percentage change from baseline in PASI scores at Weeks 1, 3, 5, 7, 9, 11, 13, 15, 16, and 17
•IGA, i.e. proportion of patients achieving clear (0) or almost clear (1) disease state (scale of 0 – 4) at Weeks 1, 3, 5, 7, 9, 11, 13, 15, 16, and 17
•Change from baseline in IGA at Weeks 1, 3, 5, 7, 9, 11, 13, 15, 16, and 17
•Patient's health-related quality of life (HRQoL) as assessed with regard to relative changes in the DLQI, EQ-5DTM-5L and HAQ-DI© (PsA patients only) from baseline to Week 11 and 16; proportion of patients achieving a DLQI of 0 or 1 from baseline in Week 11 and 16.
Treatment Period 2:
•PASI 50, 75, 90 and 100 response rates at Weeks 23, 29, and 35
•Percentage change from Week 17 in PASI scores at Weeks 23, 29, and 35
•IGA, i.e. proportion of patients achieving clear (0) or almost clear (1) disease state (scale of 0 – 4) at Weeks 23, 29, and 35
•Change from Week 17 in IGA at Weeks 23, 29, and 35
•HRQoL as assessed with regard to changes in the DLQI and EQ-5DTM -5L and HAQ-DI© (only in patients with a medical history of PsA) from Week 17 to Weeks 23, 29, and 35; proportion of patients achieving a DLQI of 0 or 1 in Weeks 23, 29 and 35.

E.5.2.1

Timepoint(s) of evaluation of this end point

Multiple time points, main timepoints being week 17 and week 35

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

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

Yes

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)

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.8.4.1

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

Bulgaria

France

Germany

India

Japan

Lithuania

Poland

Romania

Russian Federation

Slovakia

Spain

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

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:

324

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

300

F.4.2.2

In the whole clinical trial

360

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)

The investigator must provide follow-up medical care for all patients who are prematurely withdrawn from the study, or must refer them for appropriate ongoing care according to local guidelines and daily practice, respectively. Patients completing the trial per protocol will be discontinued from the trial and will continue under the supervision of their treating physician per clinical treatment guidelines.

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

2014-03-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-12-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-02-25

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials