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IA-14069 for Rheumatoid Arthritis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rheumatoid Arthritis+1 MoreIA-14069 - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Rheumatoid Arthritis
  • Healthy Subjects

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Methotrexate
1
Cohort 1
1
Methotrexate

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: up to Day 35

up to Day 28
AUC
CL/F
Change from baseline in concentration of Tumor necrosis factor in blood
Disease
Cmax
Tmax
VD/F
t1/2el
up to Day 35
Incidnece and severity of adverse events

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Methotrexate
1
Cohort 1
2
Methotrexate

Side Effects for

TCZ COMBO - All Participants
11%Rheumatoid arthritis
11%Rhinitis
9%Bronchitis
9%Asthenia
8%Arthralgia
8%Alanine aminotransferase increased
8%Headache
8%Nasopharyngitis
7%Neutropenia
6%Diarrhoea
5%Hepatocellular injury
5%Transaminases increased
5%Insomnia
5%Back pain
5%Abdominal pain
4%Urinary tract infection
3%Ear infection
3%Injection site erythema
3%Pruritus
2%Hypertension
2%Nausea
1%Intestinal ischaemia
1%Cataract
1%Septic shock
1%Cervical dysplasia
1%Gastric volvulus
1%Angioedema
1%Disseminated tuberculosis
1%Deep vein thrombosis
1%Pulmonary embolism
1%Gastric ulcer
1%Meningitis tuberculous
1%Iron deficiency anaemia
1%Hypertensive crisis
1%Fall
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT02001987) in the TCZ COMBO - All Participants ARM group. Side effects include: Rheumatoid arthritis with 11%, Rhinitis with 11%, Bronchitis with 9%, Asthenia with 9%, Arthralgia with 8%.

Trial Design

3 Treatment Groups

IA-14069 MAD
1 of 3
IA-14069 MAD RA patients
1 of 3
IA-14069 DDI
1 of 3

Experimental Treatment

75 Total Participants · 3 Treatment Groups

Primary Treatment: IA-14069 · Has Placebo Group · Phase 1

IA-14069 MADExperimental Group · 2 Interventions: Placebo, IA-14069 · Intervention Types: Drug, Drug
IA-14069 MAD RA patientsExperimental Group · 3 Interventions: Methotrexate, Placebo, IA-14069 · Intervention Types: Drug, Drug, Drug
IA-14069 DDIExperimental Group · 3 Interventions: Methotrexate, Placebo, IA-14069 · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
2013
Completed Phase 4
~3710
Placebo
1995
Completed Phase 3
~2670
IA-14069
2021
Completed Phase 1
~40

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to day 35

Who is running the clinical trial?

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

Eligibility Criteria

Age 18 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 to 55 years, inclusive, for healthy subjects in Part 1 and 18 to 70 years, inclusive, for RA patients in Part 2, at screening.
You are female and not of childbearing potential.
Female subjects/patients of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception from at least 4 weeks prior to administration of the study drug until 90 days after the last dosing of study drug.
References

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