Phase 2a Clinical Trial of HL237 for Rheumatoid Arthritis

NCT04638426 | Unknown Phase 2

• 1 other identifier: HL237-201
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• ACR20(american college of rheumatology 20) response rate

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

  at 12 weeks after administering investigational products

Secondary Outcomes (14)

• ACR20(american college of rheumatology 20) response rate

  at 4, 8 weeks after administering investigational products

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

  at 4, 8, 12 weeks after administering investigational products

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

  at 4, 8, 12 weeks after administering investigational products

• Tender joint count

  at 4, 8, 12 weeks after administering investigational products

• Swollen joint count

  at 4, 8, 12 weeks after administering investigational products

Study Arms (4)

Treatment A

EXPERIMENTAL

HL237 tab. 200mg/day

Drug: HL237 tablet

Treatment B

EXPERIMENTAL

HL237 tab. 400mg/day

Drug: HL237 tablet

Treatment C

EXPERIMENTAL

HL237 tab. 800mg/day

Drug: HL237 tablet

Placebo

PLACEBO COMPARATOR

Placebo of HL237 tab.

Drug: Placebo of HL237 tablet

Interventions

HL237 tablet DRUG

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

Treatment A; Treatment B; Treatment C

Placebo of HL237 tablet DRUG

Placebo of HL237, twice a day

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 20, 2020
• Study Start: September 10, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

KR (1)