IA-14069 for Rheumatoid Arthritis

Overseen By Youjin Jang, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ILAb Co., Ltd.

Must be taking: MTX

Must not be taking: Biologic DMARDs, Targeted DMARDs

Disqualifiers: Pregnancy, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new medication, IA-14069, in healthy people and RA patients on Methotrexate. It aims to see if IA-14069 is safe, how it is processed by the body, and if it helps with RA symptoms.

Will I have to stop taking my current medications?

The trial requires that RA patients continue taking a stable dose of methotrexate (MTX) throughout the study. However, you must stop using other prescription or nonprescription drugs, including vitamins and supplements, at least 7 days before starting the study, unless the investigator approves them.

What makes the drug IA-14069 unique for treating rheumatoid arthritis?

The drug IA-14069 is unique because it is being investigated as a potentially more effective and less toxic option compared to existing treatments, which often have intolerable side effects or insufficient efficacy for some patients. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for healthy adults and those with active rheumatoid arthritis (RA) on stable methotrexate doses. Participants must be non-smokers, not pregnant or breastfeeding, willing to avoid alcohol and caffeine before visits, and use contraception if of childbearing potential. They should have no significant health issues as per the study's criteria.

Inclusion Criteria

I am a male or female, regardless of my ability to have children.

I weigh at least 50 kg.

I agree to use contraception and not donate sperm.

Exclusion Criteria

I am pregnant, breastfeeding, or planning to become pregnant.

Tobacco or nicotine product use within specified timeframe

Positive drug and alcohol screen at screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending oral doses of IA-14069 or placebo for 10 to 28 days, with methotrexate administered on specific days

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

Treatment Details

Interventions

• IA-14069

Trial Overview The MAD Study of IA-14069 tests a new drug's safety, how it's processed by the body, and its effects in healthy subjects and RA patients taking methotrexate. It involves multiple oral doses of IA-14069 compared to placebo to see if there are any benefits for RA treatment.

Participant Groups

Group I: IA-14069 MAD RA patients Experimental Treatment 3 Interventions

Patients will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 28 days. Patients will be on a stable dose of methotrexate throughout the study period.

Group II: IA-14069 MAD Experimental Treatment 2 Interventions

Subjects will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 10 days.

Group III: IA-14069 DDI Experimental Treatment 3 Interventions

Subjects will be administrated multiple oral doses of IA-14069 at three ascending dose levels or matching placebo for 10 days. On day 11, subjects will be adminiatrated oral dose of IA-14069 or matching placebo with methotrexate. On day 21, subjects will be administrated methotrexate alone.

Who Is Running the Clinical Trial?

ILAb Co., Ltd.

Lead Sponsor

Trials

2

Recruited

120+

Findings from Research

Current treatments for rheumatoid arthritis, including analgesics and immunomodulators, often have limited efficacy or cause significant side effects, leading to a need for safer alternatives.

The article reviews several new pharmaceutical agents under investigation, such as zileuton and tenidap for inflammation, and leflunomide and mycophenolic acid for immunosuppression, which may offer better outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigational agents for rheumatoid arthritis. Merkel, PA., Letourneau, EN., Polisson, RP.[2007]

Rheumatoid arthritis affects 0.5-1.0% of adults in industrialized countries, with significant risk factors including genetic predisposition and smoking, leading to serious health issues like joint damage and decreased quality of life.

Disease-modifying antirheumatic drugs (DMARDs), particularly methotrexate, are the primary treatment for rheumatoid arthritis, effectively reducing inflammation and improving function, while biological agents are reserved for cases where DMARDs are ineffective or cause adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rheumatoid arthritis. Scott, DL., Wolfe, F., Huizinga, TW.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Investigational agents for rheumatoid arthritis. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Nomenclature for the Phases of the Development of Rheumatoid Arthritis. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Disease Characteristics and Rheumatoid Arthritis Development in Patients with Early Undifferentiated Arthritis: A 2-year Followup Study. [2018]

4. France pubmed.ncbi.nlm.nih.gov

[Classification criteria for rheumatoid arthritis]. [2012]

5. England pubmed.ncbi.nlm.nih.gov

Rheumatoid arthritis. [2022]