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

NCT ID: NCT04204603

Last Updated: 2019-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2019-10-29

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets for oral administration

CKD-506 Dose A

Group Type: EXPERIMENTAL

CKD-506

Intervention Type: DRUG

Tablets for oral administration

CKD-506 Dose B

Group Type: EXPERIMENTAL

CKD-506

Intervention Type: DRUG

Tablets for oral administration

CKD-506 Dose C

Group Type: EXPERIMENTAL

CKD-506

Intervention Type: DRUG

Tablets for oral administration

Interventions

CKD-506

Tablets for oral administration

Intervention Type: DRUG

Placebo

Tablets for oral administration

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

182RA18009 Stie# CZ06

Broumov, , Czechia

182RA18009 Stie# CZ03

Olomouc, , Czechia

182RA18009 Stie# CZ02

Prague, , Czechia

182RA18009 Stie# CZ05

Prague, , Czechia

182RA18009 Stie# CZ07

Prague, , Czechia

182RA18009 Stie# CZ08

Prague, , Czechia

182RA18009 Stie# CZ09

Prague, , Czechia

182RA18009 Stie# CZ01

Uherské Hradiště, , Czechia

182RA18009 Stie# UA03

Lviv, , Georgia

182RA18009 Stie# GE01

Tbilisi, , Georgia

182RA18009 Stie# GE02

Tbilisi, , Georgia

182RA18009 Stie# GE03

Tbilisi, , Georgia

182RA18009 Stie# PL04

Bydgoszcz, , Poland

182RA18009 Site# PL01

Elblag, , Poland

182RA18009 Stie# PL03

Grodzisk Mazowiecki, , Poland

182RA18009 Stie# PL02

Katowice, , Poland

182RA18009 Stie# PL07

Lodz, , Poland

182RA18009 Stie# PL06

Poznan, , Poland

182RA18009 Stie# PL08

Poznan, , Poland

182RA18009 Stie# PL05

Skierniewice, , Poland

182RA18009 Stie# PL10

Torun, , Poland

182RA18009 Stie# PL09

Warsaw, , Poland

182RA18009 Stie# RF05

Moscow, , Russia

182RA18009 Stie# RF10

Moscow, , Russia

182RA18009 Stie# RF09

Perm, , Russia

182RA18009 Stie# RF03

Saint Petersburg, , Russia

182RA18009 Stie# RF08

Saint Petersburg, , Russia

182RA18009 Stie# RF02

Tolyatti, , Russia

182RA18009 Stie# RF07

Tver', , Russia

182RA18009 Stie# RF06

Vladimir, , Russia

182RA18009 Stie# UA10

Ivano-Frankivsk, , Ukraine

182RA18009 Stie# UA09

Kharkiv, , Ukraine

182RA18009 Stie# UA01

Kyiv, , Ukraine

182RA18009 Stie# UA04

Kyiv, , Ukraine

182RA18009 Stie# UA07

Kyiv, , Ukraine

182RA18009 Stie# UA11

Kyiv, , Ukraine

182RA18009 Stie# UA05

Vinnytsia, , Ukraine

182RA18009 Stie# UA06

Vinnytsia, , Ukraine

Countries

Czechia; Georgia; Poland; Russia; Ukraine

Other Identifiers

182RA18009

Identifier Type: -

Identifier Source: org_study_id