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AP1189 + Methotrexate for Rheumatoid Arthritis

Phase 2
Recruiting
Research Sponsored by SynAct Pharma Aps
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be naïve to any Disease-modifying anti-rheumatic drugs (DMARDs)
Participants with at least 6/68 tender and 6/66 swollen joints at Screening Visit and Baseline
Must not have
Rheumatic autoimmune disease other than RA, i.e. systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to RA
Current inflammatory joint disease other than RA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12

Summary

This trial is testing a new drug called AP1189 in combination with methotrexate for people with early rheumatoid arthritis. Participants will be given different doses of AP1189 for 12

Who is the study for?
This trial is for people who have just been diagnosed with early rheumatoid arthritis and haven't taken any disease-modifying anti-rheumatic drugs (DMARDs) yet. They should be experiencing active inflammation but can't join if they've had certain other treatments or health conditions that the study details exclude.
What is being tested?
The trial is testing different doses of a new pill, AP1189, to see how well it works and how safe it is when given alongside methotrexate, a common medication for rheumatoid arthritis. Participants will randomly receive either 40 mg, 70 mg, or 100 mg of AP1189 or a placebo without knowing which one they're getting.
What are the potential side effects?
Possible side effects of AP1189 are not specified here but could include typical drug reactions such as stomach issues, headaches, dizziness, or allergic reactions. Methotrexate may cause nausea, fatigue, mouth sores and increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not taken any DMARDs for my condition.
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I have at least 6 tender and 6 swollen joints.
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My arthritis is very active, with high scores on specific health tests.
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I am using two forms of birth control or will remain abstinent during and for 90 days after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an autoimmune disease like lupus, but not RA.
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I have an inflammatory joint condition that is not rheumatoid arthritis.
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I do not have severe or worsening conditions affecting my kidneys, liver, blood, stomach, hormones, lungs, heart, or nervous system.
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My kidney function is reduced, with a creatinine clearance below 45 mL/min.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Disease Activity Score 28 (DAS28)-C-Reactive Protein (CRP) score

Trial Design

4Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
12 weeks daily treatment of oral AP1189 matching placebo as add-on to Methotrexate (MTX)
Group II: AP1189 70 mgExperimental Treatment1 Intervention
12 weeks daily treatment of oral AP1189 70 mg as add-on to Methotrexate (MTX)
Group III: AP1189 40 mgExperimental Treatment1 Intervention
12 weeks daily treatment of oral AP1189 40 mg as add-on to Methotrexate (MTX)
Group IV: AP1189 100 mgExperimental Treatment1 Intervention
12 weeks daily treatment of oral AP1189 100 mg as add-on to Methotrexate (MTX)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AP1189, 100 mg
2022
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

NBCD A/SIndustry Sponsor
9 Previous Clinical Trials
1,605 Total Patients Enrolled
2 Trials studying Rheumatoid Arthritis
252 Patients Enrolled for Rheumatoid Arthritis
SynAct Pharma ApsLead Sponsor
4 Previous Clinical Trials
380 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
357 Patients Enrolled for Rheumatoid Arthritis
~160 spots leftby Dec 2025
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