Clinical trial NCT04204603: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-12-19
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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

Primary outcomes:
measure: Change from baseline in DAS28(CRP) at week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Response to treatment based on the American College of Rheumatology 20% response criteria (ACR20) at Weeks 2, 4, 8, and 12
timeFrame: At weeks 2, 4, 8 and 12
measure: Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8
timeFrame: Baseline and up to week 8
measure: Response to treatment based on the ACR50 criteria at Weeks 2, 4, 8, and 12
timeFrame: At weeks 2, 4, 8 and 12
measure: Response to treatment based on the ACR70 criteria at Weeks 2, 4, 8, and 12
timeFrame: At weeks 2, 4, 8 and 12
measure: Change from Baseline in ACRn at Weeks 2, 4, 8, and 12
timeFrame: Baseline and up to week 12
measure: Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Weeks 4 and 12
timeFrame: Baseline and weeks 4, 12
measure: 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
timeFrame: Baseline and up to week 12
measure: Change from Baseline in the Short Form-36 item Health Survey (SF-36) at Weeks 4 and 12
timeFrame: Baseline and weeks 4, 12
measure: Change from Baseline in the Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, and 12
timeFrame: Baseline and up to week 12
measure: Change from Baseline in the Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, and 12
timeFrame: Baseline and up to week 12
measure: 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
timeFrame: At weeks 2, 4, 8 and 12
measure: 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
timeFrame: At weeks 2, 4, 8 and 12
measure: Improvement of physical ability defined as change from Baseline in HAQ-DI ≥ 0.22 at Weeks 2, 4, 8, and 12
timeFrame: Baseline and up to week 12
Other outcomes:
Locations:
city: Broumov
country: Czechia
facility: 182RA18009 Stie# CZ06
city: Olomouc
country: Czechia
facility: 182RA18009 Stie# CZ03
city: Praha
country: Czechia
facility: 182RA18009 Stie# CZ02
city: Praha
country: Czechia
facility: 182RA18009 Stie# CZ05
city: Praha
country: Czechia
facility: 182RA18009 Stie# CZ07
city: Praha
country: Czechia
facility: 182RA18009 Stie# CZ08
city: Praha
country: Czechia
facility: 182RA18009 Stie# CZ09
city: Uherské Hradiště
country: Czechia
facility: 182RA18009 Stie# CZ01
city: Lviv
country: Georgia
facility: 182RA18009 Stie# UA03
city: Tbilisi
country: Georgia
facility: 182RA18009 Stie# GE01
city: Tbilisi
country: Georgia
facility: 182RA18009 Stie# GE02
city: Tbilisi
country: Georgia
facility: 182RA18009 Stie# GE03
city: Bydgoszcz
country: Poland
facility: 182RA18009 Stie# PL04
city: Elbląg
country: Poland
facility: 182RA18009 Site# PL01
city: Grodzisk Mazowiecki
country: Poland
facility: 182RA18009 Stie# PL03
city: Katowice
country: Poland
facility: 182RA18009 Stie# PL02
city: Poznań
country: Poland
facility: 182RA18009 Stie# PL06
city: Poznań
country: Poland
facility: 182RA18009 Stie# PL08
city: Skierniewice
country: Poland
facility: 182RA18009 Stie# PL05
city: Toruń
country: Poland
facility: 182RA18009 Stie# PL10
city: Warszawa
country: Poland
facility: 182RA18009 Stie# PL09
city: Łódź
country: Poland
facility: 182RA18009 Stie# PL07
city: Moscow
country: Russian Federation
facility: 182RA18009 Stie# RF05
city: Moscow
country: Russian Federation
facility: 182RA18009 Stie# RF10
city: Perm
country: Russian Federation
facility: 182RA18009 Stie# RF09
city: Saint Petersburg
country: Russian Federation
facility: 182RA18009 Stie# RF03
city: Saint Petersburg
country: Russian Federation
facility: 182RA18009 Stie# RF08
city: Togliatti
country: Russian Federation
facility: 182RA18009 Stie# RF02
city: Tver
country: Russian Federation
facility: 182RA18009 Stie# RF07
city: Vladimir
country: Russian Federation
facility: 182RA18009 Stie# RF06
city: Ivano-Frankivs'k
country: Ukraine
facility: 182RA18009 Stie# UA10
city: Kharkiv
country: Ukraine
facility: 182RA18009 Stie# UA09
city: Kyiv
country: Ukraine
facility: 182RA18009 Stie# UA01
city: Kyiv
country: Ukraine
facility: 182RA18009 Stie# UA04
city: Kyiv
country: Ukraine
facility: 182RA18009 Stie# UA07
city: Kyiv
country: Ukraine
facility: 182RA18009 Stie# UA11
city: Vinnytsia
country: Ukraine
facility: 182RA18009 Stie# UA05
city: Vinnytsia
country: Ukraine
facility: 182RA18009 Stie# UA06
Study officials:
References: