Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis

A Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GCK in Rheumatoid Arthritis Patients

This is a phase Ib study to investigate the safety, pharmacokinetics and preliminary efficacy of ginsenoside compound K (GCK) tablets in patients with rheumatoid arthritis. This study is to be run in China involving 10-12 sites. It will enroll approximately 240 patients to ensure 128 randomized with active rheumatoid arthritis. The treatment period is 12 weeks and total study duration per patient is approximately 14 weeks.

Study Overview

• Status: Unknown
• Conditions: Early Rheumatoid Arthritis
• Intervention / Treatment: Drug: GCK 100 mg + Placebo 200 mg; Drug: GCK 200 mg + Placebo 100 mg; Drug: GCK 300 mg; Drug: Placebo 300mg

Detailed Description

In this double-blind, placebo-controlled, phase Ib study, 128 patients with active RA are planned to be enrolled and randomly assigned 1:1:1:1 to receive placebo, or different doses of GCK tablet (100/200/300 mg). This study will evaluate the safety, pharmacokinetics and preliminary efficacy of GCK tablets in patients with rheumatoid arthritis

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jianwei Liao, Master; Phone Number: +8657688827869; Email: jwliao@hisunpharm.com
• Study Contact Backup: Name: Dong Xiao, PhD; Phone Number: +8657688827869; Email: xiaodong@hisunpharm.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100010
      • Recruiting
      • Department of rheumatology
      • Contact: Yin Su, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients have active RA as confirmed by the following criteria:

  1. ≥ 4 swollen joints and ≥ 4 tender joints at screening and baseline using the DAS28 joint count.
  2. ESR ≥ 28 mm/hour, or CRP ≥ 1.5 times ULN.
• Patients on non-prohibited medications must receive stable dose for at least 2 weeks prior to study drug administration and maintain an unchanged regimen during the study.
• Patients who are able and wish to sign the informed consent and comply with the requirements of the study protocol.

Exclusion Criteria:

• Patients have prior exposure to any csDMARDs or bDMARDs.
• Patients have received corticosteroids, or Chinese medicine preparations such as tripterygium wilfordii, total glucosides of paeony for RA treatment.
• Patients with fibromyalgia
• Patients diagnosed with any systemic inflammatory disease other than RA, including but not limited to juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout, and siccasyndrome.
• Diagnosis of Felty Syndrome.
• Any major surgery has been performed within 8 weeks prior to the study, or will be performed during the study, from which investigators believe posing an unacceptable risk to the patient.
• Patient with cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders or any other serious and/or unstable disease or medical history, or serious infection, and the investigators believe that these diseases or history may pose risks in the case of taking research drugs, or may interfere with the analysis of data.
• Patients who are unable to carry on normal activity or to do active work or unable to take care of themselves.
• Patients with history of malignant tumors and lymphoproliferative diseases.
• Patients with active HBV or HCV or history of HIV infection.
• Active TB diagnosed during screening or with a history of active TB that has not been appropriately treated.
• Patients who are currently pregnant or breastfeeding.
• Female patients of childbearing potential or male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and 28 days after last administration.
• Patient who participated in any investigational drug study within three months.

Specific laboratory abnormality including:

1. AST or ALT > 1.5 times ULN
2. Total bilirubin > 1.5 times ULN
3. Hemoglobin ≤ 85 g/L
4. White blood cells count ≤ 3.5×109/L
5. Absolute neutrophil count < 1.5×109/L
6. Lymphocyte Count < 0.75×109/L
7. Platelet count < 90×109/L

8. Creatinine > ULN

   • Any other situation, in the opinion of the investigator, characterizes the subject as not being a good candidate for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GCK 100 mg group; GCK 100 mg+ Placebo 200 mg GCK tablet 100 mg + Placebo tablet 100 mgX2 tablets, once daily for 12 weeks (oral)	Drug: GCK 100 mg + Placebo 200 mg; GCK 100 mg + Placebo 200 mg, oral, 12 weeks; Other Names: GCK
Experimental: GCK 200 mg group; GCK 200 mg + Placebo 100 mg GCK tablet 100 mg X 2 tablets+ Placebo tablet 100 mg once daily for 12 weeks (oral)	Drug: GCK 200 mg + Placebo 100 mg; GCK 200 mg + Placebo 100 mg, oral, 12 weeks; Other Names: GCK
Experimental: GCK 300 mg group; GCK tablet 300 mg GCK tablet 100 mgX3 tablets once daily for 12 weeks (oral)	Drug: GCK 300 mg; GCK 300 mg, oral, 12 weeks; Other Names: GCK
Placebo Comparator: Placebo of GCK group; Placebo 300 mg Placebo tablet 100 mgX3 tablets, once daily for 12 weeks (oral)	Drug: Placebo 300mg; Placebo 300mg, oral, 12 weeks; Other Names: Placebo of GCK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects reaching (the American College of Rheumatology response criteria 20 (ACR 20)	ACR 20 would be examined	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in DAS 28-CRP	DAS 28-CRP would be assessed	Week 4/8/12
Proportion of subjects reaching ACR 20	ACR 20 would be assessed	Week 4/8
Proportion of subjects reaching ACR 50 and 70	ACR 50 and 70 would be assessed	Time Frame: Week 4/8/12
Change from baseline in ESR and CRP	ESR and CRP would assessed	Time Frame: Week 4/8/12

Collaborators and Investigators

• Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Yin Su, PhD, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2017
• Primary Completion (Anticipated): July 11, 2019
• Study Completion (Anticipated): December 11, 2019

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 25, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 25, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Ginsenoside compound K tablet; Phase Ib study
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: HISUN-GCK-Ib-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No