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Rheumatoid ArthritisPhase 2NCT04638426

Phase 2a Clinical Trial of HL237 for Rheumatoid Arthritis

A Phase 2 study testing HL237 tablet in people with Rheumatoid Arthritis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this clinical trial is to determine the optimal dose of HL237 tablets in rheumatoid arthritis patients by comparing the efficacy and safety of the three dose groups of HL237 tablets and the control group. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
HL237 tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
196 participants
Where
1 siteSouth Korea
Study dates
10 Sep 2020to Aug 2021
Phase
Phase 2
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or Female, 19 years ≤ age ≤ 80 years
  • In the case of women of childbearing age, those who have a negative pregnancy test before randomization
  • Patients who agree to use a medically accepted method of contraception during the clinical trial
  • Patients corresponding to ACR functional class Ⅰ,Ⅱ,Ⅲ
  • Patients with active rheumatoid arthritis with DAS28-ESR > 3.2 in the evaluation of DAS28-ESR identified at the screening
  • Patients who were diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria at least 3 months prior to the screening, and showed insufficient response or refractory to treatment with one or more DMARDs.
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  • Among the subjects who have previously been continuously administering the following rheumatoid arthritis drugs without stopping, those who have used them according to the conditions before randomization and can maintain the current administration regimen and dose during the clinical trial.
  • cDMARDs : Patients who received the same cDMARDs for 12 weeks or more continuously and did not change the dosage and administration of the cDMARDs for 4 weeks or more until the 2nd visit(ex. methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, bucillamine etc.)
  • Prednisolone : Patients who received corticosteroids with a daily dose of 10mg or less of oral prednisolone equivalent continuously, and did not change the dosage and administration for more than 2 weeks until the 2nd visit.
  • Tramadol or NSAIDs : Patients who did not change the dosage and administration for more than 2 weeks consecutively until the 2nd visit
  • Patients who have completed the wash-out period as follows until the 2nd visit including the screening period (each period refers to the case where it continues consecutively, and these drugs are contraindicated from the screening).
  • bDMARDs abatacept, adalimumab, certolizumab pegol, golimumab : 10 weeks or more anakinra : 10 days or more etanercept : 3 weeks or more infliximab : 8 weeks or more tocilizumab : 5 weeks or more rituximab : 6 months or more
  • JAK inhibitors tofacitinib, baricitinib : 2 weeks or more
  • immunosuppressants tacrolimus, cyclosporin, azathioprine, cyclophosphamide mizoribine etc : 4 weeks or more
  • tramadol, analgesics and anti-inflammatory analgesic other than NSAIDs : 4 days or more
  • Volunteer, be willing and able to provide written informed consent for the trial
  • Patients who can read and understand written instructions

Who cannot join

  • Patients corresponding to ACR functional class Ⅳ
  • Patients with acquired immune deficiency syndrome or autoimmune diseases other than rheumatoid arthritis
  • Severe heart failure, congestive heart failure (NYHA II～IV), ischemic heart disease, peripheral artery disease and/or cerebrovascular disease
  • Patients with a history of gastrointestinal bleeding or perforation due to treatment of nonsteroidal anti-inflammatory drugs
  • Patients with bleeding or a current history of blood coagulation disorder
  • Patients suffering from infectious disease (including tuberculosis, shingles, etc.) at the time of screening or undergoing treatment with the medical history
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  • Patients with a history of malignant tumors within 5 years prior to screening
  • Patients with peptic ulcer confirmed by endoscopy or radiographic examination within 6 months prior to screening
  • Patients with a history of gastric or duodenal perforation or obstruction, patients with a history of gastrointestinal surgery (except appendicitis), and patients with a history of upper or lower gastrointestinal bleeding (excluding simple hemorrhoids) within the past year
  • Patients with symptoms or signs of pyloric obstruction
  • Patients diagnosed with malabsorption within 12 weeks prior to the screening
  • Patients with hypersensitive reaction or history of clinically significant hypersensitive reaction to investigational product or its excipients
  • Patients with aspirin asthma (asthma attacks caused by nonsteroidal anti-inflammatory drugs) or a history of the same
  • Patients with inflammatory bowel disease such as crohn's disease or ulcerative colitis
  • Pregnant or breast-feeding
  • Patients administered intraarticular, intramuscular, intravenous corticosteroids within 4 weeks priro to the screening.
  • Patients with significant psychiatric disorders or taking antidepressants, anticonvulsants, or sedatives
  • Patients with substance or alcohol abuse or dependence
  • Patients who participate in other clinical trials within 12 weeks prior to the screening and administer investigational drugs or apply clinical trial medical devices
  • Patients expected to inevitably administer contraindicated drugs during the clinical trial
  • Patients with severe renal dysfuntion(seurum creatinine is 2.0 times higher than the upper limit of normal (based on the institution))
  • Patients with severe liver dysfuntion(ALT, AST or total bilirubin is 2.0 times higher than the upper limit of normal (based on the institution))
  • Patients that the investigator deems unsuitable for participation in the clinical trial

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • The Catholic University of Korea Seoul ST.MARY'S Hospital

    Seoul

Other trials in South Korea

About this study

Official title: For 12 Weeks, the Multi Center, Randomized, Double Blinded, Placebo Controlled, Parallel, Dose-finding Clinical Study for the Therapeutic Exploration of Safety and Efficacy Assessment of HL237 Tablet in Patients With Rheumatoid Arthritis (Phase IIa)

The purpose of this clinical trial is to determine the optimal dose of HL237 tablets in rheumatoid arthritis patients by comparing the efficacy and safety of the three dose groups of HL237 tablets and the control group.

Being tested
HL237 tablet, Placebo of HL237 tablet
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HL237 tabletDrug

    Treatment A : HL237 100mg, twice a day, Treatment B : HL237 200mg, twice a day, Treatment C : HL237 400mg, twice a day

  • Placebo of HL237 tabletDrug

    Placebo of HL237, twice a day

Study groups in NCT04638426
Study groupRoleWhat they receive
Treatment AExperimentalHL237 tab. 200mg/day
Receives: Drug: HL237 tablet
Treatment BExperimentalHL237 tab. 400mg/day
Receives: Drug: HL237 tablet
Treatment CExperimentalHL237 tab. 800mg/day
Receives: Drug: HL237 tablet
PlaceboPlacebo comparatorPlacebo of HL237 tab.
Receives: Drug: Placebo of HL237 tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ACR20(american college of rheumatology 20) response rate

    ACR20(american college of rheumatology 20) response rate at 12 weeks after administering investigational products

    Measured: at 12 weeks after administering investigational products

Secondary outcomes (14)

  1. ACR20(american college of rheumatology 20) response rate

    ACR20(american college of rheumatology 20) response rate at 4, 8 weeks after administering investigational products

    Measured: at 4, 8 weeks after administering investigational products

  2. DAS28-ESR(Disease Activity Score 28- erythrocyte sedimentation rate) score

    Change of DAS28-ESR(Disease Activity Score 28- erythrocyte sedimentation rate) score

    Measured: at 4, 8, 12 weeks after administering investigational products

  3. DAS28-CRP(Disease Activity Score 28-C-reactive protein) score

    Change of DAS28-CRP(Disease Activity Score 28-C-reactive protein) score Change of DAS28-ESR(Disease Activity Score 28- erythrocyte sedimentation rate) score

    Measured: at 4, 8, 12 weeks after administering investigational products

  4. Tender joint count

    Change of Tender joint count

    Measured: at 4, 8, 12 weeks after administering investigational products

  5. Swollen joint count

    Change of Swollen joint count

    Measured: at 4, 8, 12 weeks after administering investigational products

  6. Investigator's composite assessment of disease activity

    Change of Investigator's composite assessment of disease activity (100 mm visual analog scale (0: not active at all, 100: most severely active))

    Measured: at 4, 8, 12 weeks after administering investigational products

  7. Subject's composite assessment of disease activity

    Change of Subject's composite assessment of disease activity (100 mm visual analog scale (0: not active at all, 100: most severely active))

    Measured: at 4, 8, 12 weeks after administering investigational products

  8. Subject's assessment of pain (visual analog scale)

    Change of Subject's assessment of pain (100 mm visual analog scale(0: no pain, 100: severe pain))

    Measured: at 4, 8, 12 weeks after administering investigational products

  9. Subject's assessment of physical function (Korean health assessment questionnaire)

    Change of Subject's assessment of physical function (Korean health assessment

    Measured: at 4, 8, 12 weeks after administering investigational products

  10. Erythrocyte Sedimentation Rate (ESR)

    Change of Erythrocyte Sedimentation Rate (ESR)

    Measured: at 4, 8, 12 weeks after administering investigational products

  11. C-Reactive Protein (CRP)

    Change of C-Reactive Protein (CRP)

    Measured: at 4, 8, 12 weeks after administering investigational products

  12. morning stiffness duration

    Change of morning stiffness duration

    Measured: at 4, 8, 12 weeks after administering investigational products

  13. The average number of times of use the remedy per day

    Change of The average number of times of use the remedy per day

    Measured: at 4, 8, 12 weeks after administering investigational products

  14. The percentage of subjects who use the remedy

    Change of the percentage of subjects who use the remedy

    Measured: at 4, 8, 12 weeks after administering investigational products

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2020
  2. Study start10 Sep 2020
  3. Primary completionMay 2021 (estimated)
  4. Study completionAug 2021 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04638426
Sponsor's protocol ID
HL237-201
Status last verified
Nov 2020
First submitted
13 Nov 2020
Last updated
20 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HL237 tablet in people with Rheumatoid Arthritis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.

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 17 inclusion and 23 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 20 Nov 2020. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACR20(american college of rheumatology 20) response rate (time frame: at 12 weeks after administering investigational products). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04638426.

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 20 Nov 2020.

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