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

Chong Kun Dang

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: CKD-506; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04204603

182RA18009

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

CKD-506 Dose A

Experimental group

Treatment:

Drug: CKD-506

CKD-506 Dose B

Experimental group

Treatment:

Drug: CKD-506

CKD-506 Dose C

Experimental group

Treatment:

Drug: CKD-506