NCT04204603

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach
5 countries

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
Last Updated

December 30, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

December 17, 2019

Last Update Submit

December 26, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in DAS28(CRP) at week 12

    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

    At weeks 2, 4, 8 and 12

  • Change from Baseline in DAS28(CRP) at Weeks 2, 4, and 8

    Baseline and up to week 8

  • Response to treatment based on the ACR50 criteria at Weeks 2, 4, 8, and 12

    At weeks 2, 4, 8 and 12

  • Response to treatment based on the ACR70 criteria at Weeks 2, 4, 8, and 12

    At weeks 2, 4, 8 and 12

  • Change from Baseline in ACRn at Weeks 2, 4, 8, and 12

    Baseline and up to week 12

  • +8 more secondary outcomes

Study Arms (4)

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

Interventions

CKD-506DRUG

Tablets for oral administration

CKD-506 Dose ACKD-506 Dose BCKD-506 Dose C
PlaceboDRUG

Tablets for oral administration

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

182RA18009 Stie# CZ06

Broumov, Czechia

Location

182RA18009 Stie# CZ03

Olomouc, Czechia

Location

182RA18009 Stie# CZ02

Prague, Czechia

Location

182RA18009 Stie# CZ05

Prague, Czechia

Location

182RA18009 Stie# CZ07

Prague, Czechia

Location

182RA18009 Stie# CZ08

Prague, Czechia

Location

182RA18009 Stie# CZ09

Prague, Czechia

Location

182RA18009 Stie# CZ01

Uherské Hradiště, Czechia

Location

182RA18009 Stie# UA03

Lviv, Georgia

Location

182RA18009 Stie# GE01

Tbilisi, Georgia

Location

182RA18009 Stie# GE02

Tbilisi, Georgia

Location

182RA18009 Stie# GE03

Tbilisi, Georgia

Location

182RA18009 Stie# PL04

Bydgoszcz, Poland

Location

182RA18009 Site# PL01

Elblag, Poland

Location

182RA18009 Stie# PL03

Grodzisk Mazowiecki, Poland

Location

182RA18009 Stie# PL02

Katowice, Poland

Location

182RA18009 Stie# PL07

Lodz, Poland

Location

182RA18009 Stie# PL06

Poznan, Poland

Location

182RA18009 Stie# PL08

Poznan, Poland

Location

182RA18009 Stie# PL05

Skierniewice, Poland

Location

182RA18009 Stie# PL10

Torun, Poland

Location

182RA18009 Stie# PL09

Warsaw, Poland

Location

182RA18009 Stie# RF05

Moscow, Russia

Location

182RA18009 Stie# RF10

Moscow, Russia

Location

182RA18009 Stie# RF09

Perm, Russia

Location

182RA18009 Stie# RF03

Saint Petersburg, Russia

Location

182RA18009 Stie# RF08

Saint Petersburg, Russia

Location

182RA18009 Stie# RF02

Tolyatti, Russia

Location

182RA18009 Stie# RF07

Tver', Russia

Location

182RA18009 Stie# RF06

Vladimir, Russia

Location

182RA18009 Stie# UA10

Ivano-Frankivsk, Ukraine

Location

182RA18009 Stie# UA09

Kharkiv, Ukraine

Location

182RA18009 Stie# UA01

Kyiv, Ukraine

Location

182RA18009 Stie# UA04

Kyiv, Ukraine

Location

182RA18009 Stie# UA07

Kyiv, Ukraine

Location

182RA18009 Stie# UA11

Kyiv, Ukraine

Location

182RA18009 Stie# UA05

Vinnytsia, Ukraine

Location

182RA18009 Stie# UA06

Vinnytsia, Ukraine

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

CKD-506

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 19, 2019

Study Start

November 30, 2018

Primary Completion

September 30, 2019

Study Completion

October 29, 2019

Last Updated

December 30, 2019

Record last verified: 2019-12

Locations

CZ(8)RU(8)PL(10)GE(4)UA(8)