IA-14069 for Rheumatoid Arthritis
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.12345Why 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.13467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple ascending oral doses of IA-14069 or placebo for 10 to 28 days, with methotrexate administered on specific days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IA-14069
Find a Clinic Near You
Who Is Running the Clinical Trial?
ILAb Co., Ltd.
Lead Sponsor