Early Rheumatoid ArthritisPhase 1NCT03755258
Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis
A Phase 1 study testing GCK 300 mg in people with Early Rheumatoid Arthritis, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Early Rheumatoid Arthritis
- What is being tested?
- GCK 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2017to 11 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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:
- AST or ALT > 1.5 times ULN
- Total bilirubin > 1.5 times ULN
- Hemoglobin ≤ 85 g/L
- White blood cells count ≤ 3.5×109/L
- Absolute neutrophil count < 1.5×109/L
- Lymphocyte Count < 0.75×109/L
- Platelet count < 90×109/L
- Creatinine > ULN
- Any other situation, in the opinion of the investigator, characterizes the subject as not being a good candidate for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Rheumatology
Beijing, Beijing Municipality, 100010
Yin Su, PhD
About this study
Official title: 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.
Read the 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
- Conditions
- Early Rheumatoid Arthritis
- Being tested
- GCK 100 mg + Placebo 200 mg, GCK 200 mg + Placebo 100 mg, GCK 300 mg, Placebo 300mg
- Keywords
- Ginsenoside compound K tablet, Rheumatoid Arthritis, Phase Ib study
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCK 100 mg + Placebo 200 mgDrug
Also called GCK
GCK 100 mg + Placebo 200 mg, oral, 12 weeks
GCK 200 mg + Placebo 100 mgDrug
Also called GCK
GCK 200 mg + Placebo 100 mg, oral, 12 weeks
GCK 300 mgDrug
Also called GCK
GCK 300 mg, oral, 12 weeks
Placebo 300mgDrug
Also called Placebo of GCK
Placebo 300mg, oral, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Drug: GCK 300 mg |
| Placebo of GCK group | Placebo comparator | Placebo 300 mg Placebo tablet 100 mgX3 tablets, once daily for 12 weeks (oral) Receives: Drug: Placebo 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects reaching (the American College of Rheumatology response criteria 20 (ACR 20)
ACR 20 would be examined
Measured: Week 12
Secondary outcomes (4)
Change from baseline in DAS 28-CRP
DAS 28-CRP would be assessed
Measured: Week 4/8/12
Proportion of subjects reaching ACR 20
ACR 20 would be assessed
Measured: Week 4/8
Proportion of subjects reaching ACR 50 and 70
ACR 50 and 70 would be assessed
Measured: Time Frame: Week 4/8/12
Change from baseline in ESR and CRP
ESR and CRP would assessed
Measured: Time Frame: Week 4/8/12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start16 Mar 2017
- Primary completion11 Jul 2019 (estimated)
- Study completion11 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multiple Ascending Dose, Multiple Groups, Multiple Centers
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yin Su, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755258
- Sponsor's protocol ID
- HISUN-GCK-Ib-01
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GCK in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT03755258
- Acronym / sponsor ID
- HISUN-GCK-Ib-01
- Conditions
- Early Rheumatoid Arthritis
- Keywords
- Ginsenoside compound K tablet, Rheumatoid Arthritis, Phase Ib study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 11 Jul 2019 (estimated)
- Study completion
- 11 Dec 2019 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Multiple Ascending Dose, Multiple Groups, Multiple Centers
| Arm | Type | Receives |
|---|---|---|
| GCK 100 mg group | Experimental | Drug: GCK 100 mg + Placebo 200 mgGCK 100 mg+ Placebo 200 mg GCK tablet 100 mg + Placebo tablet 100 mgX2 tablets, once daily for 12 weeks (oral) |
| GCK 200 mg group | Experimental | Drug: GCK 200 mg + Placebo 100 mgGCK 200 mg + Placebo 100 mg GCK tablet 100 mg X 2 tablets+ Placebo tablet 100 mg once daily for 12 weeks (oral) |
| GCK 300 mg group | Experimental | Drug: GCK 300 mgGCK tablet 300 mg GCK tablet 100 mgX3 tablets once daily for 12 weeks (oral) |
| Placebo of GCK group | Placebo comparator | Drug: Placebo 300mgPlacebo 300 mg Placebo tablet 100 mgX3 tablets, once daily for 12 weeks (oral) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients have active RA as confirmed by the following criteria:
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GCK 100 mg + Placebo 200 mgAlso: GCKGCK 100 mg + Placebo 200 mg, oral, 12 weeks | Drug | GCK 100 mg group |
| GCK 200 mg + Placebo 100 mgAlso: GCKGCK 200 mg + Placebo 100 mg, oral, 12 weeks | Drug | GCK 200 mg group |
| GCK 300 mgAlso: GCKGCK 300 mg, oral, 12 weeks | Drug | GCK 300 mg group |
| Placebo 300mgAlso: Placebo of GCKPlacebo 300mg, oral, 12 weeks | Drug | Placebo of GCK group |
Primary outcome
Proportion of subjects reaching (the American College of Rheumatology response criteria 20 (ACR 20)
Time frame: Week 12
ACR 20 would be examined
4 secondary outcomes
Change from baseline in DAS 28-CRP
Time frame: Week 4/8/12
Proportion of subjects reaching ACR 20
Time frame: Week 4/8
Proportion of subjects reaching ACR 50 and 70
Time frame: Time Frame: Week 4/8/12
Change from baseline in ESR and CRP
Time frame: Time Frame: Week 4/8/12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yin Su, PhD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GCK 300 mg in people with Early Rheumatoid Arthritis, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianwei Liao, Master (+8657688827869, jwliao@hisunpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects reaching (the American College of Rheumatology response criteria 20 (ACR 20) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.