What is the mechanism of action of this treatment?

Common treatments for Rheumatoid Arthritis (RA) include Disease-Modifying Antirheumatic Drugs (DMARDs) like Methotrexate (MTX) and biologic agents such as TNF inhibitors. MTX works by inhibiting dihydrofolate reductase, reducing inflammation and slowing disease progression. Biologic agents target specific immune components, like TNF, to reduce inflammation and prevent joint damage. These mechanisms are crucial for RA patients as they help in selecting effective treatments, improving quality of life, and reducing long-term joint damage.

What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis (RA) include Methotrexate (MTX), which can cause liver toxicity, interstitial lung disease, and bone marrow suppression. Nonsteroidal anti-inflammatory drugs (NSAIDs) may lead to gastrointestinal, renal, and cardiovascular issues. Glucocorticoids can result in weight gain, osteoporosis, and increased infection risk. Newer treatments like Tofacitinib and Baricitinib, which are Janus kinase (JAK) inhibitors, have side effects such as increased risk of infections, elevated liver enzymes, and lipid abnormalities.

What prior FDA approvals exist?

The FDA has approved several biologics and small molecule inhibitors for the treatment of Rheumatoid Arthritis. Notable biologics include infliximab, etanercept, adalimumab, and rituximab, which target specific cytokines or immune cells involved in the inflammatory process. Small molecule inhibitors like methotrexate, tofacitinib, and baricitinib have also been approved, targeting intracellular signaling pathways to reduce inflammation and disease progression. These treatments have shown efficacy in managing RA symptoms and slowing disease progression.

What other types of research exist?

Promising novel alternatives to IA-14069 for Rheumatoid Arthritis patients in 2024 include JAK inhibitors such as baricitinib, decernotinib, filgotinib, and peficitinib. Other potential options are biologics like abatacept and guselkumab, which have shown efficacy in patients who have not responded to other treatments.

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Unknown

IA-14069 for Rheumatoid Arthritis

Phase 1

Recruiting

Research Sponsored by ILAb Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 35

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse reactions related to the drug IA-14069. This can include typical medication-related symptoms such as digestive discomforts, allergic reactions or changes in blood pressure or heart rate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 35

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 35

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 35 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidnece and severity of adverse events

Secondary study objectives

AUC

CL/F

Cmax

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: IA-14069 MAD RA patientsExperimental Treatment3 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 MADExperimental Treatment2 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 DDIExperimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methotrexate

2019

Completed Phase 4

~4400

IA-14069

2021

Completed Phase 1

~40

Placebo

1995

Completed Phase 3

~2670

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Rheumatoid Arthritis (RA) include Disease-Modifying Antirheumatic Drugs (DMARDs) like Methotrexate (MTX) and biologic agents such as TNF inhibitors. MTX works by inhibiting dihydrofolate reductase, reducing inflammation and slowing disease progression. Biologic agents target specific immune components, like TNF, to reduce inflammation and prevent joint damage. These mechanisms are crucial for RA patients as they help in selecting effective treatments, improving quality of life, and reducing long-term joint damage.

[Mechanism of action of gold compounds].Current evidence for a strategic approach to the management of rheumatoid arthritis with disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis.