Rheumatoid ArthritisPhase 2NCT04204603
A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate
A Phase 2 study testing CKD-506 in people with Rheumatoid Arthritis, run by Chong Kun Dang Pharmaceutical at 38 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- CKD-506
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 38 sitesin 5 countries
- Study dates
- 30 Nov 2018to 29 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
38 sites in 5 countries.
38 sites in 5 countries
Poland10 sites
182RA18009 Stie# PL04
Bydgoszcz
182RA18009 Site# PL01
Elblag
182RA18009 Stie# PL03
Grodzisk Mazowiecki
182RA18009 Stie# PL02
Katowice
182RA18009 Stie# PL07
Lodz
182RA18009 Stie# PL06
Poznan
182RA18009 Stie# PL08
Poznan
182RA18009 Stie# PL05
Skierniewice
182RA18009 Stie# PL10
Torun
182RA18009 Stie# PL09
Warsaw
Czechia8 sites
182RA18009 Stie# CZ06
Broumov
182RA18009 Stie# CZ03
Olomouc
182RA18009 Stie# CZ02
Prague
182RA18009 Stie# CZ05
Prague
182RA18009 Stie# CZ07
Prague
182RA18009 Stie# CZ08
Prague
182RA18009 Stie# CZ09
Prague
182RA18009 Stie# CZ01
Uherské Hradiště
Russia8 sites
182RA18009 Stie# RF05
Moscow
182RA18009 Stie# RF10
Moscow
182RA18009 Stie# RF09
Perm
182RA18009 Stie# RF03
Saint Petersburg
182RA18009 Stie# RF08
Saint Petersburg
182RA18009 Stie# RF02
Tolyatti
182RA18009 Stie# RF07
Tver'
182RA18009 Stie# RF06
Vladimir
Ukraine8 sites
182RA18009 Stie# UA10
Ivano-Frankivsk
182RA18009 Stie# UA09
Kharkiv
182RA18009 Stie# UA01
Kyiv
182RA18009 Stie# UA04
Kyiv
182RA18009 Stie# UA07
Kyiv
182RA18009 Stie# UA11
Kyiv
182RA18009 Stie# UA05
Vinnytsia
182RA18009 Stie# UA06
Vinnytsia
Georgia4 sites
182RA18009 Stie# UA03
Lviv
182RA18009 Stie# GE01
Tbilisi
182RA18009 Stie# GE02
Tbilisi
182RA18009 Stie# GE03
Tbilisi
About this study
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
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- CKD-506, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-506Drug
Tablets for oral administration
PlaceboDrug
Tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| CKD-506 Dose A | Experimental | Not described Receives: Drug: CKD-506 |
| CKD-506 Dose B | Experimental | Not described Receives: Drug: CKD-506 |
| CKD-506 Dose C | Experimental | Not described Receives: Drug: CKD-506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in DAS28(CRP) at week 12
Measured: Baseline and week 12
Secondary outcomes (13)
Response to treatment based on the American College of Rheumatology 20% response criteria (ACR20) at Weeks 2, 4, 8, and 12
Measured: At weeks 2, 4, 8 and 12
Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8
Measured: Baseline and up to week 8
Response to treatment based on the ACR50 criteria at Weeks 2, 4, 8, and 12
Measured: At weeks 2, 4, 8 and 12
Response to treatment based on the ACR70 criteria at Weeks 2, 4, 8, and 12
Measured: At weeks 2, 4, 8 and 12
Change from Baseline in ACRn at Weeks 2, 4, 8, and 12
Measured: Baseline and up to week 12
Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Weeks 4 and 12
Measured: Baseline and weeks 4, 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).
Measured: Baseline and up to week 12
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.
Measured: Baseline and weeks 4, 12
Change from Baseline in the Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, and 12
Measured: Baseline and up to week 12
Change from Baseline in the Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, and 12
Measured: Baseline and up to week 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
Measured: 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
Measured: 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
Measured: Baseline and up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start30 Nov 2018
- Primary completion30 Sep 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204603
- Sponsor's protocol ID
- 182RA18009
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04204603
- Acronym / sponsor ID
- 182RA18009
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| CKD-506 Dose A | Experimental | Drug: CKD-506 |
| CKD-506 Dose B | Experimental | Drug: CKD-506 |
| CKD-506 Dose C | Experimental | Drug: CKD-506 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD-506Tablets for oral administration | Drug | CKD-506 Dose A, CKD-506 Dose B, CKD-506 Dose C |
| PlaceboTablets for oral administration | Drug | Placebo |
Primary outcome
Change from baseline in DAS28(CRP) at week 12
Time frame: Baseline and week 12
13 secondary outcomes
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
Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8
Time frame: Baseline and up to week 8
Response to treatment based on the ACR50 criteria at Weeks 2, 4, 8, and 12
Time frame: At weeks 2, 4, 8 and 12
Response to treatment based on the ACR70 criteria at Weeks 2, 4, 8, and 12
Time frame: At weeks 2, 4, 8 and 12
Change from Baseline in ACRn at Weeks 2, 4, 8, and 12
Time frame: Baseline and up to week 12
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
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
Time frame: Baseline and up to week 12
Change from Baseline in the Short Form-36 item Health Survey (SF-36) at Weeks 4 and 12
Time frame: Baseline and weeks 4, 12
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CKD-506 in people with Rheumatoid Arthritis, run by Chong Kun Dang Pharmaceutical at 38 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Poland, Czechia, Russia, Ukraine, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in DAS28(CRP) at week 12 (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.