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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medication, IA-14069, to determine its safety and effectiveness for people with rheumatoid arthritis (RA). It targets those managing RA with a stable dose of methotrexate, a common treatment for this condition. The study examines how the drug functions in the body and its potential benefits in reducing RA symptoms. Participants may qualify if they have active RA with at least 6 swollen and 6 tender joints while on methotrexate. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that IA-14069 is likely to be safe for humans?

Research shows that IA-14069 is a new medication under testing to assess its safety and tolerability. Early results suggest it blocks certain proteins that cause inflammation, potentially helping treat rheumatoid arthritis (RA) and other inflammatory diseases.

As this is an early-stage study, the main goal is to understand the body's reaction to the drug and identify any side effects. Similar early studies typically test treatments on small groups to gather safety information. While IA-14069 appears promising, more research is needed to fully understand its safety. Participants might experience some side effects, but the research team closely monitors these. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about IA-14069 for rheumatoid arthritis because it offers a potentially novel approach compared to standard treatments like methotrexate, NSAIDs, or biologics. IA-14069 is administered orally, which is often more convenient than injections required by some current therapies. Additionally, the treatment involves multiple ascending doses, suggesting that it may be tailored to individual patient needs, potentially leading to more personalized care. This flexibility and ease of administration could provide a significant advantage in managing rheumatoid arthritis.

What evidence suggests that IA-14069 might be an effective treatment for rheumatoid arthritis?

Research shows that IA-14069 is a promising new treatment for rheumatoid arthritis (RA). It blocks a protein in the body that causes inflammation. Early studies suggest that IA-14069 may reduce inflammation in RA patients, potentially leading to less pain and swelling in the joints. In this trial, participants will receive multiple oral doses of IA-14069 at three ascending dose levels or a matching placebo. Although more research is needed to confirm its effectiveness, the initial results are encouraging. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

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THU0047 IA-14069, A NOVEL SMALL-MOLECULE ...

Conclusion: The data indicate that IA-14069 can be a novel and potential TNF-α inhibitor for the treatment of RA and other inflammatory diseases.

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MAD Study of IA-14069 | Clinical Research Trial Listing ...

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending oral doses of IA- ...

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withpower.com

withpower.com/trial/phase-1-arthritis-8-2022-20c84

IA-14069 for Rheumatoid Arthritis

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 ...

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ard.bmj.com

ard.bmj.com/content/annrheumdis/78/Suppl_2/291.1.full.pdf

Scientific Abstracts Thursday, 13 June 2019 291

Conclusion: The data indicate that IA-14069 can be a novel and poten- tial TNF-a inhibitor for the treatment of RA and other inflammatory.

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IA-14069 - Drug Targets, Indications, Patents

Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ...

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The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending oral doses of IA-14069 in healthy ...

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IA-14069 | Endogenous Metabolite

IA-14069 is a TNF-alpha inhibitor that exhibits anti-inflammatory properties while also influencing the production of pro-inflammatory cytokines, ...