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Completed

NCT Number: 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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

182RA18009 Stie# CZ06, Broumov, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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

Treatment and study plan

CKD-506

Drug

Tablets for oral administration

Placebo

Drug

Tablets for oral administration

Primary outcomes

  1. Change from baseline in DAS28(CRP) at week 12

    Time frame: Baseline and week 12

Secondary outcomes

  1. 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

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

    Time frame: Baseline and up to week 8

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

    Time frame: At weeks 2, 4, 8 and 12

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

    Time frame: At weeks 2, 4, 8 and 12

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

    Time frame: Baseline and up to week 12

  6. 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

  7. 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

    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).

  8. 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

    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.

  9. 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

  10. 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

  11. 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

  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

  13. 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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2019
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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