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

NCT03755258 | Unknown Phase 1

• 1 other identifier: HISUN-GCK-Ib-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Rheumatoid Arthritis

Keywords

Ginsenoside compound K tablet; Rheumatoid Arthritis; Phase Ib study

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects reaching (the American College of Rheumatology response criteria 20 (ACR 20)

  ACR 20 would be examined

  Week 12

Secondary Outcomes (4)

• Change from baseline in DAS 28-CRP

  Week 4/8/12

• Proportion of subjects reaching ACR 20

  Week 4/8

• Proportion of subjects reaching ACR 50 and 70

  Time Frame: Week 4/8/12

• Change from baseline in ESR and CRP

  Time Frame: Week 4/8/12

Study Arms (4)

GCK 100 mg group

EXPERIMENTAL

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 200 mg group

EXPERIMENTAL

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 300 mg group

EXPERIMENTAL

GCK tablet 300 mg GCK tablet 100 mgX3 tablets once daily for 12 weeks (oral)

Drug: GCK 300 mg

Placebo of GCK group

PLACEBO COMPARATOR

Placebo 300 mg Placebo tablet 100 mgX3 tablets, once daily for 12 weeks (oral)

Drug: Placebo 300mg

Interventions

GCK 100 mg + Placebo 200 mg DRUG

GCK 100 mg + Placebo 200 mg, oral, 12 weeks

Also known as: GCK

GCK 100 mg group

GCK 200 mg + Placebo 100 mg DRUG

GCK 200 mg + Placebo 100 mg, oral, 12 weeks

Also known as: GCK

GCK 200 mg group

GCK 300 mg DRUG

GCK 300 mg, oral, 12 weeks

Also known as: GCK

GCK 300 mg group

Placebo 300mg DRUG

Placebo 300mg, oral, 12 weeks

Also known as: Placebo of GCK

Placebo of GCK group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients have active RA as confirmed by the following criteria:
• ≥ 4 swollen joints and ≥ 4 tender joints at screening and baseline using the DAS28 joint count.
• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Zhejiang Hisun Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Department of Rheumatology

Beijing, Beijing Municipality, 100010, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Glucokinase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Yin Su, PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianwei Liao, Master

CONTACT

+8657688827869; jwliao@hisunpharm.com

Dong Xiao, PhD

CONTACT

+8657688827869; xiaodong@hisunpharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple Ascending Dose, Multiple Groups, Multiple Centers

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 27, 2018
• Study Start: March 16, 2017
• Primary Completion: July 11, 2019
• Study Completion: December 11, 2019
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

CN (1)