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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
Weight: ≥ 50 kg at screening
Males must agree to use adequate contraception and not donate sperm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 35
Awards & highlights

Study Summary

This trial is testing a new RA drug to see if it is safe and effective.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 50 kg.
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I agree to use contraception and not donate sperm.
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I am not pregnant or breastfeeding.
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I will avoid alcohol, caffeine, and certain foods before each clinic visit.
Select...
I have active rheumatoid arthritis and have been treated with methotrexate.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidnece and severity of adverse events
Secondary outcome measures
AUC
CL/F
Cmax
+3 more
Other outcome measures
Change from baseline in concentration of Tumor necrosis factor in blood
Disease

Side effects data

From 2015 Phase 3 trial • 139 Patients • NCT02001987
14%
Rheumatoid arthritis
12%
Bronchitis
9%
Nasopharyngitis
9%
Rhinitis
7%
Asthenia
7%
Alanine aminotransferase increased
7%
Headache
6%
Back pain
6%
Ear infection
6%
Urinary tract infection
6%
Neutropenia
6%
Arthralgia
6%
Diarrhoea
5%
Injection site erythema
4%
Insomnia
4%
Pruritus
4%
Abdominal pain
4%
Nausea
4%
Transaminases increased
4%
Hypertension
4%
Hepatocellular injury
3%
Psoriasis
2%
Neck pain
1%
Deep vein thrombosis
1%
Cervical dysplasia
1%
Dyspepsia
1%
Gastric volvulus
1%
Intestinal ischaemia
1%
Vomiting
1%
Pulmonary embolism
1%
Hypertensive crisis
1%
Iron deficiency anaemia
1%
Myocardial infarction
1%
Cataract
1%
Angioedema
1%
Disseminated tuberculosis
1%
Septic shock
1%
Fall
1%
Nephrolithiasis
1%
Lung disorder
1%
Gastric ulcer
1%
Meningitis tuberculous
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ - All Participants
TCZ COMBO - All Participants
TCZ MONO - All Participants

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
Placebo
1995
Completed Phase 3
~2670
Methotrexate
2013
Completed Phase 4
~3800
IA-14069
2021
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ILAb Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

IA-14069 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05533372 — Phase 1
Rheumatoid Arthritis Research Study Groups: IA-14069 MAD, IA-14069 MAD RA patients, IA-14069 DDI
Rheumatoid Arthritis Clinical Trial 2023: IA-14069 Highlights & Side Effects. Trial Name: NCT05533372 — Phase 1
IA-14069 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05533372 — Phase 1
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT05533372 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to join this medical experiment?

"This medical experiment is looking for 75 individuals with rheumatoid arthritis aged 18 to 70. The prerequisites are as follows: Gender (male or female, including non-childbearing and postmenopausal); Age Range (18 - 55 years old for healthy contributors in Part 1 and 18 - 70 years old for RA patients in Part 2 at screening); BMI (18 - 32 kg/m2 inclusive for healthy participants in part one and 18 – 40 kg/m2 inclusive for RA patients in part two at screening); Weight (>= 50kg inclusive at screening); Status (healthy subjects desired for part one, Rheumatoid Ar"

Answered by AI

Are elderly participants being admitted for this research project?

"This clinical trial is only open to participants between the ages of 18 and 70. However, there are 101 studies available for people under age 18 and 699 trials suitable for individuals aged 65 or above."

Answered by AI

Are any additional participants in the clinical trial being recruited currently?

"According to the clinicaltrials.gov listing, this healthcare trial is actively recruiting eligible candidates. The initial post was made on October 10th 2022 and it was last revised November 4th 2022."

Answered by AI

What is the aggregate sum of participants joining this experiment?

"Confirmed. Per the information accessed via clinicaltrials.gov, this medical trial is still seeking participants to join in on their experiment. It was initially posted 10/10/2022 and subsequently updated 11/4/2022, with a goal of enrolling 75 individuals from one site."

Answered by AI

Can IA-14069 be consumed with a minimal risk of adverse effects?

"Limited data exists to support safety and efficacy of IA-14069, so it receives a score 1 on our team's evaluation scale."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Kansas
What site did they apply to?
ICON plc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’ve been in trials before and like to help advance medical research.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long does the trial last?
PatientReceived no prior treatments
~17 spots leftby Sep 2024