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A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CKD-506
Placebo
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • Have active RA

  • Ongoing treatment with a stable dose of MTX as described below:

    1. 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.
    2. 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.
  • 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.
  • Women of childbearing potential must have a negative serum pregnancy test at Screening and urine pregnancy test at Baseline
  • 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.

Exclusion Criteria:

  • Treatments for RA as follows: JAK inhibitors at any time; use of any currently licensed biologics with DMARD properties at any time.
  • 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.
  • 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.
  • History of tuberculosis (TB) infection.
  • Positive serology for human immunodeficiency virus 1 or 2, hepatitis B virus or hepatitis C virus.
  • Currently active infection or history of infection within the last 2 weeks of Screening or Baseline

Sites / Locations

  • 182RA18009 Stie# CZ06
  • 182RA18009 Stie# CZ03
  • 182RA18009 Stie# CZ02
  • 182RA18009 Stie# CZ05
  • 182RA18009 Stie# CZ07
  • 182RA18009 Stie# CZ08
  • 182RA18009 Stie# CZ09
  • 182RA18009 Stie# CZ01
  • 182RA18009 Stie# UA03
  • 182RA18009 Stie# GE01
  • 182RA18009 Stie# GE02
  • 182RA18009 Stie# GE03
  • 182RA18009 Stie# PL04
  • 182RA18009 Site# PL01
  • 182RA18009 Stie# PL03
  • 182RA18009 Stie# PL02
  • 182RA18009 Stie# PL06
  • 182RA18009 Stie# PL08
  • 182RA18009 Stie# PL05
  • 182RA18009 Stie# PL10
  • 182RA18009 Stie# PL09
  • 182RA18009 Stie# PL07
  • 182RA18009 Stie# RF05
  • 182RA18009 Stie# RF10
  • 182RA18009 Stie# RF09
  • 182RA18009 Stie# RF03
  • 182RA18009 Stie# RF08
  • 182RA18009 Stie# RF02
  • 182RA18009 Stie# RF07
  • 182RA18009 Stie# RF06
  • 182RA18009 Stie# UA10
  • 182RA18009 Stie# UA09
  • 182RA18009 Stie# UA01
  • 182RA18009 Stie# UA04
  • 182RA18009 Stie# UA07
  • 182RA18009 Stie# UA11
  • 182RA18009 Stie# UA05
  • 182RA18009 Stie# UA06

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

CKD-506 Dose A

CKD-506 Dose B

CKD-506 Dose C

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in DAS28(CRP) at week 12

Secondary Outcome Measures

Response to treatment based on the American College of Rheumatology 20% response criteria (ACR20) at Weeks 2, 4, 8, and 12
Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8
Response to treatment based on the ACR50 criteria at Weeks 2, 4, 8, and 12
Response to treatment based on the ACR70 criteria at Weeks 2, 4, 8, and 12
Change from Baseline in ACRn at Weeks 2, 4, 8, and 12
Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Weeks 4 and 12
Change from Baseline in the duration of morning stiffness (in minutes and in severity as measured with a visual analog scale [VAS]) at Weeks 2, 4, 8, and 12
Morning stiffness severity was determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. Participants rated the severity of morning stiffness on awakening over the past 7 days on a scale from 0 (No morning stiffness) to 10 (Worst possible morning stiffness).
Change from Baseline in the Short Form-36 item Health Survey (SF-36) at Weeks 4 and 12
The Short Form-36 item Health Survey (SF-36) consists of eight scaled scores; physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. which are the weighted sums of the questions in their section. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Change from Baseline in the Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, and 12
Change from Baseline in the Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, and 12
Response to treatment based on the achievement of Low Disease Activity (LDA) status based on each of the following definitions at Weeks 2, 4, 8,and 12: DAS28(CRP) ≤ 3.2, SDAI ≤ 11.0, CDAI ≤ 10.0 at Weeks 2, 4, 8, and 12
Response to treatment based on the achievement of remission based on each of the following definitions at Weeks 2, 4, 8, and 12: DAS28(CRP) < 2.6, Boolean parameters, SDAI ≤ 3.3, CDAI ≤ 2.8 at Weeks 2, 4, 8, and 12
Improvement of physical ability defined as change from Baseline in HAQ-DI ≥ 0.22 at Weeks 2, 4, 8, and 12

Full Information

First Posted
December 17, 2019
Last Updated
December 26, 2019
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04204603
Brief Title
A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The primary objective of this study is 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
CKD-506 Dose A
Arm Type
Experimental
Arm Title
CKD-506 Dose B
Arm Type
Experimental
Arm Title
CKD-506 Dose C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CKD-506
Intervention Description
Tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets for oral administration
Primary Outcome Measure Information:
Title
Change from baseline in DAS28(CRP) at week 12
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Response to treatment based on the American College of Rheumatology 20% response criteria (ACR20) at Weeks 2, 4, 8, and 12
Time Frame
At weeks 2, 4, 8 and 12
Title
Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8
Time Frame
Baseline and up to week 8
Title
Response to treatment based on the ACR50 criteria at Weeks 2, 4, 8, and 12
Time Frame
At weeks 2, 4, 8 and 12
Title
Response to treatment based on the ACR70 criteria at Weeks 2, 4, 8, and 12
Time Frame
At weeks 2, 4, 8 and 12
Title
Change from Baseline in ACRn at Weeks 2, 4, 8, and 12
Time Frame
Baseline and up to week 12
Title
Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Weeks 4 and 12
Time Frame
Baseline and weeks 4, 12
Title
Change from Baseline in the duration of morning stiffness (in minutes and in severity as measured with a visual analog scale [VAS]) at Weeks 2, 4, 8, and 12
Description
Morning stiffness severity was determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. Participants rated the severity of morning stiffness on awakening over the past 7 days on a scale from 0 (No morning stiffness) to 10 (Worst possible morning stiffness).
Time Frame
Baseline and up to week 12
Title
Change from Baseline in the Short Form-36 item Health Survey (SF-36) at Weeks 4 and 12
Description
The Short Form-36 item Health Survey (SF-36) consists of eight scaled scores; physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. which are the weighted sums of the questions in their section. Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Time Frame
Baseline and weeks 4, 12
Title
Change from Baseline in the Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, and 12
Time Frame
Baseline and up to week 12
Title
Change from Baseline in the Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, and 12
Time Frame
Baseline and up to week 12
Title
Response to treatment based on the achievement of Low Disease Activity (LDA) status based on each of the following definitions at Weeks 2, 4, 8,and 12: DAS28(CRP) ≤ 3.2, SDAI ≤ 11.0, CDAI ≤ 10.0 at Weeks 2, 4, 8, and 12
Time Frame
At weeks 2, 4, 8 and 12
Title
Response to treatment based on the achievement of remission based on each of the following definitions at Weeks 2, 4, 8, and 12: DAS28(CRP) < 2.6, Boolean parameters, SDAI ≤ 3.3, CDAI ≤ 2.8 at Weeks 2, 4, 8, and 12
Time Frame
At weeks 2, 4, 8 and 12
Title
Improvement of physical ability defined as change from Baseline in HAQ-DI ≥ 0.22 at Weeks 2, 4, 8, and 12
Time Frame
Baseline and up to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Have active RA Ongoing treatment with a stable dose of MTX as described below: 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. 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. 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. Women of childbearing potential must have a negative serum pregnancy test at Screening and urine pregnancy test at Baseline 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. Exclusion Criteria: Treatments for RA as follows: JAK inhibitors at any time; use of any currently licensed biologics with DMARD properties at any time. 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. 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. History of tuberculosis (TB) infection. Positive serology for human immunodeficiency virus 1 or 2, hepatitis B virus or hepatitis C virus. Currently active infection or history of infection within the last 2 weeks of Screening or Baseline
Facility Information:
Facility Name
182RA18009 Stie# CZ06
City
Broumov
Country
Czechia
Facility Name
182RA18009 Stie# CZ03
City
Olomouc
Country
Czechia
Facility Name
182RA18009 Stie# CZ02
City
Praha
Country
Czechia
Facility Name
182RA18009 Stie# CZ05
City
Praha
Country
Czechia
Facility Name
182RA18009 Stie# CZ07
City
Praha
Country
Czechia
Facility Name
182RA18009 Stie# CZ08
City
Praha
Country
Czechia
Facility Name
182RA18009 Stie# CZ09
City
Praha
Country
Czechia
Facility Name
182RA18009 Stie# CZ01
City
Uherské Hradiště
Country
Czechia
Facility Name
182RA18009 Stie# UA03
City
Lviv
Country
Georgia
Facility Name
182RA18009 Stie# GE01
City
Tbilisi
Country
Georgia
Facility Name
182RA18009 Stie# GE02
City
Tbilisi
Country
Georgia
Facility Name
182RA18009 Stie# GE03
City
Tbilisi
Country
Georgia
Facility Name
182RA18009 Stie# PL04
City
Bydgoszcz
Country
Poland
Facility Name
182RA18009 Site# PL01
City
Elbląg
Country
Poland
Facility Name
182RA18009 Stie# PL03
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
182RA18009 Stie# PL02
City
Katowice
Country
Poland
Facility Name
182RA18009 Stie# PL06
City
Poznań
Country
Poland
Facility Name
182RA18009 Stie# PL08
City
Poznań
Country
Poland
Facility Name
182RA18009 Stie# PL05
City
Skierniewice
Country
Poland
Facility Name
182RA18009 Stie# PL10
City
Toruń
Country
Poland
Facility Name
182RA18009 Stie# PL09
City
Warszawa
Country
Poland
Facility Name
182RA18009 Stie# PL07
City
Łódź
Country
Poland
Facility Name
182RA18009 Stie# RF05
City
Moscow
Country
Russian Federation
Facility Name
182RA18009 Stie# RF10
City
Moscow
Country
Russian Federation
Facility Name
182RA18009 Stie# RF09
City
Perm
Country
Russian Federation
Facility Name
182RA18009 Stie# RF03
City
Saint Petersburg
Country
Russian Federation
Facility Name
182RA18009 Stie# RF08
City
Saint Petersburg
Country
Russian Federation
Facility Name
182RA18009 Stie# RF02
City
Togliatti
Country
Russian Federation
Facility Name
182RA18009 Stie# RF07
City
Tver
Country
Russian Federation
Facility Name
182RA18009 Stie# RF06
City
Vladimir
Country
Russian Federation
Facility Name
182RA18009 Stie# UA10
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
182RA18009 Stie# UA09
City
Kharkiv
Country
Ukraine
Facility Name
182RA18009 Stie# UA01
City
Kyiv
Country
Ukraine
Facility Name
182RA18009 Stie# UA04
City
Kyiv
Country
Ukraine
Facility Name
182RA18009 Stie# UA07
City
Kyiv
Country
Ukraine
Facility Name
182RA18009 Stie# UA11
City
Kyiv
Country
Ukraine
Facility Name
182RA18009 Stie# UA05
City
Vinnytsia
Country
Ukraine
Facility Name
182RA18009 Stie# UA06
City
Vinnytsia
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

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