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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04204603
• Other study ID #: 182RA18009
• Status: Completed
• Phase: Phase 2
• Start date: November 30, 2018
• Est. completion date: October 29, 2019

Study information

• Verified date: December 2019
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 29, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• CKD-506
Tablets for oral administration
• Placebo
Tablets for oral administration

Locations

Country	Name	City	State
Czechia	182RA18009 Stie# CZ06	Broumov
Czechia	182RA18009 Stie# CZ03	Olomouc
Czechia	182RA18009 Stie# CZ02	Praha
Czechia	182RA18009 Stie# CZ05	Praha
Czechia	182RA18009 Stie# CZ07	Praha
Czechia	182RA18009 Stie# CZ08	Praha
Czechia	182RA18009 Stie# CZ09	Praha
Czechia	182RA18009 Stie# CZ01	Uherské Hradište
Georgia	182RA18009 Stie# UA03	Lviv
Georgia	182RA18009 Stie# GE01	Tbilisi
Georgia	182RA18009 Stie# GE02	Tbilisi
Georgia	182RA18009 Stie# GE03	Tbilisi
Poland	182RA18009 Stie# PL04	Bydgoszcz
Poland	182RA18009 Site# PL01	Elblag
Poland	182RA18009 Stie# PL03	Grodzisk Mazowiecki
Poland	182RA18009 Stie# PL02	Katowice
Poland	182RA18009 Stie# PL07	Lódz
Poland	182RA18009 Stie# PL06	Poznan
Poland	182RA18009 Stie# PL08	Poznan
Poland	182RA18009 Stie# PL05	Skierniewice
Poland	182RA18009 Stie# PL10	Torun
Poland	182RA18009 Stie# PL09	Warszawa
Russian Federation	182RA18009 Stie# RF05	Moscow
Russian Federation	182RA18009 Stie# RF10	Moscow
Russian Federation	182RA18009 Stie# RF09	Perm
Russian Federation	182RA18009 Stie# RF03	Saint Petersburg
Russian Federation	182RA18009 Stie# RF08	Saint Petersburg
Russian Federation	182RA18009 Stie# RF02	Togliatti
Russian Federation	182RA18009 Stie# RF07	Tver
Russian Federation	182RA18009 Stie# RF06	Vladimir
Ukraine	182RA18009 Stie# UA10	Ivano-Frankivs'k
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

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Countries where clinical trial is conducted

Czechia,  Georgia,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in DAS28(CRP) at week 12		Baseline and week 12
Secondary	Response to treatment based on the American College of Rheumatology 20% response criteria (ACR20) at Weeks 2, 4, 8, and 12		At weeks 2, 4, 8 and 12
Secondary	Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8		Baseline and up to week 8
Secondary	Response to treatment based on the ACR50 criteria at Weeks 2, 4, 8, and 12		At weeks 2, 4, 8 and 12
Secondary	Response to treatment based on the ACR70 criteria at Weeks 2, 4, 8, and 12		At weeks 2, 4, 8 and 12
Secondary	Change from Baseline in ACRn at Weeks 2, 4, 8, and 12		Baseline and up to week 12
Secondary	Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Weeks 4 and 12		Baseline and weeks 4, 12
Secondary	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).	Baseline and up to week 12
Secondary	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.	Baseline and weeks 4, 12
Secondary	Change from Baseline in the Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, and 12		Baseline and up to week 12
Secondary	Change from Baseline in the Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, and 12		Baseline and up to week 12
Secondary	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		At weeks 2, 4, 8 and 12
Secondary	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		At weeks 2, 4, 8 and 12
Secondary	Improvement of physical ability defined as change from Baseline in HAQ-DI = 0.22 at Weeks 2, 4, 8, and 12		Baseline and up to week 12