Clinical Trials Register

Summary
EudraCT Number:	2018-001377-24
Sponsor's Protocol Code Number:	182RA18009
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-10-14
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

Czechia - SUKL

A.2

EudraCT number

2018-001377-24

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects with Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

Randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení fáze 2a s paralelními skupinami, hodnotící účinnost, bezpečnost, farmakokinetické a biomarkerové profily přípravku CKD 506 podávaného dospělým pacientům se středně těžkou až těžkou revmatoidní artritidou a s nedostatečnou odpovědí na methotrexát

A.3.1

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

Not available.

A.4.1

Sponsor's protocol code number

182RA18009

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	Chong Kun Dang Pharmaceutical Corporation (CKD)
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	Chong Kun Dang Pharmaceutical Corporation (CKD)
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	Chong Kun Dang Pharmaceutical Corporation (CKD)
B.5.2	Functional name of contact point	Clinical Trials information
B.5.3	Address:
B.5.3.1	Street Address	8, Chungjeong-ro, Seodaemun-gu
B.5.3.2	Town/ city	Seoul
B.5.3.3	Post code	03742
B.5.3.4	Country	Korea, Republic of
B.5.4	Telephone number	+82 2 2194 0494
B.5.5	Fax number	+82 2 2194 0467
B.5.6	E-mail	yujeong@ckdpharm.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.3.2	Product code	CKD-506
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not yet assigned
D.3.9.1	CAS number	1637242-36-4
D.3.9.2	Current sponsor code	CKD-506
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	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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	Tablet
D.8.4	Route of administration of the placebo	Oral 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)

E.1.1.1

Medical condition in easily understood language

Rheumatoid arthritis

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	21.0
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 effects of CKD-506 on signs and symptoms of RA in subjects with moderate-to-severe RA who are inadequate responders to methotrexate.

E.2.2

Secondary objectives of the trial

1) To evaluate the effects of CKD-506 on physical function
2) To evaluate the effects of CKD-506 on quality of life
3) To evaluate the safety and tolerability of CKD-506

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects are eligible to be included in the study only if all of the
following criteria apply:
1. Adult male or female aged between 18 and 65 years
2. Diagnosis of RA for at least 6 months prior to Screening, currently
meet the 2010 American College of Rheumatology (ACR)/European
League Against Rheumatism (EULAR) criteria for RA, and are ACR
functional class I-III.
3. Have active RA defined as meeting all criteria below:
a. ≥ 5 swollen joints (from a 66 swollen joint count [SJC]) and ≥ 5
tender joints (from a 68 tender joint count [TJC]) at Screening and
Baseline, AND
b. 28 joint count Disease Activity Score based on C-reactive protein
(DAS28[CRP]) > 3.2 at Screening, AND
c. Serum C-reactive protein (CRP) ≥ upper limit of normal (ULN) at
Screening.
4. Ongoing treatment with a stable dose of MTX as described below:
a. Use of oral or injectable MTX on a continuous basis for at least 12
weeks prior to Baseline and on a stable dose and route of administration
between 15 mg and 25 mg/weekly for at least 8 weeks prior to Baseline
and planned during the study.
b. Subjects should be on an adequate and stable dose of folic acid for at
least 4 weeks prior to first administration of study treatment and
planned during the study.
5. Women of childbearing potential must use a medically acceptable
means of birth control and agree to continue its use during the study and
for at least 12 weeks after the last dose of study treatment.
6. Women of childbearing potential must have a negative serum
pregnancy test at Screening and urine pregnancy test at Baseline
7. Sexually active men, if not surgically sterile, must agree to use a
medically acceptable form of contraception during the study and
continue its use for at least 12 weeks after the last dose of study
treatment.
8. Able and willing to sign the informed consent as approved by the
Institutional Review Boards (IRB)/Independent Ethics Committees
(IEC).

E.4

Principal exclusion criteria

1. Treatments for RA as follows: Alkylating agents at any time; JAK
inhibitors at any time; Intravenous gamma globulin or plasmapheresis
within 6 months prior to Baseline; Antimalarial or tetracycline therapy,
use within 4 weeks prior to Baseline; Leflunomide use within 12 weeks
prior to Baseline or in the case of cholestyramine washout, use within 4
weeks prior to Baseline; cyclosporine, other calcineurin inhibitors, gold
therapy, sulfasalazine, mycophenolate, azathioprine, or other
immunosuppressant drugs or conventional DMARDs within 8 weeks prior
to Baseline; use of any currently licensed biologics with DMARD
properties at any time.
2. Use of oral steroids at a dose >10 mg/day of prednisone or
prednisone equivalent or at a dose that has not been stable for at least 4
weeks prior to Screening.
3. Receipt of an intra-articular or other injectable corticosteroid within 4
weeks prior to Screening.
4. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) which have not
been at a stable dose or route of administration for at least 2 weeks
prior to Baseline and planned during the study.
5. History of malignancy within the past 5 years prior to Screening.
6. History of or current myelo- or lymphoproliferative disorder.
7. History of demyelinating disease or current signs and symptoms
suggestive of demyelinating disease, or immediate family history of
demyelinating disease.
8. History of organ transplant.
9. History of tuberculosis (TB) infection.
10. Positive serology for human immunodeficiency virus 1 or 2, hepatitis
B virus or hepatitis C virus.
11. History of invasive or opportunistic infection or immunodeficiency
syndrome.
12. Currently active infection or history of infection within the last 2
weeks of Screening or Baseline, treatment with injectable antibiotics in
the 2 weeks prior to Screening or Baseline, treatment with any
antivirals/antifungals in the 4 weeks prior to Screening or Baseline,
history of herpes zoster or hospitalization for infection in the 6 months
prior to Screening, history of recurrent infections prior to Screening,
infected joint prosthesis at any time, with the prosthesis still in situ.
13. Administration of a live or attenuated vaccine within 4 weeks prior to
Baseline 23. Participation in any investigational drug/device clinical
study within 30 days or 5 half-lives prior to Screening, whichever is
longer.
14. Lactating within 12 weeks prior to Baseline.
15. The results of the following laboratory tests performed at the central
laboratory at Screening meet any of the criteria listed below:
Hemoglobin <10g/dL ; White blood cells <3.0×103cells/mm3;
Neutrophils <1.5×103cells/mm3; Lymphocytes <0.5×103 cells/mm3 ;
Platelets <125×103cells/mm3; Alanine aminotransferase (ALT) or
aspartate aminotransferase (AST) ≥2.0×ULN; Total bilirubin ≥2.0×ULN;
Creatinine ≥1.5×ULN.
16. Have symptoms or signs of an uncontrolled medical condition other
than RA within 12 weeks prior to Screening; this includes a blood
pressure of ≥160mmHg systolic or ≥ 100mmHg diastolic at Screening or
Baseline upon repeat testing.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in DAS28(CRP)

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12.

E.5.2

Secondary end point(s)

Efficacy:
1) ACR20 response rate at week 2,4,8 and 12
2) Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8
3) ACR50 response rate at week 2,4,8 and 12
4) ACR70 response rate at week 2,4,8 and 12
5) Change from baseline in ACRn at week 2, 4, 8 and 12
6) Change from Baseline in the Functional Assessment of Chronic Illness
Therapy-Fatigue Scale (FACIT-F) at Weeks 4 and 12
7) Change from Baseline in the duration of morning stiffness at Weeks 2,
4, 8, and 12
8) Change from Baseline in the Short Form-36 item Health Survey (SF-
36) at Weeks 4 and 12
9) Change from Baseline in the Simplified Disease Activity Index (SDAI)
at Weeks 2, 4, 8, and 12
10) Change from Baseline in the Clinical Disease Activity Index (CDAI) at
Weeks 2, 4, 8, and 12
11) The proportion of subjects achieving Low Disease Activity (LDA) at
week 2,4,8 and 12
12) The proportion of subjects achieving Clinical Remission at week
2,4,8 and 12
13) Change from baseline in HAQ-DI qt week 2,4,8 and 12
Safety and Tolerability:
The number of subjects with adverse events, abnormal lab tests, vital
sign and ECG.

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary end points will be evaluated at Weeks 2, 4, 8, and 12.

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)

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

Czech Republic

Georgia

Poland

Russian Federation

Ukraine

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

Last visit of the last subject (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:

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

120

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 Sponsor will not provide any additional care to subjects after they leave the study because such care should not differ from what is normally expected for subjects with RA.

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

2018-10-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-09-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-10-29

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