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FX201 for Osteoarthritis

Phase 1

Waitlist Available

Research Sponsored by Flexion Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate pain in the index joint

Male or female 30 to 80 years of age, inclusive, on the day of enrollment (Day 1)

Must not have

Anticipated major surgery during the study period

ECG abnormality at Screening or Baseline judged clinically significant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 1, day 2, week 1, week 2, week 3, week 4

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new drug, FX201, for treating painful osteoarthritis of the index knee. The trial will have a Single Ascending Dose (SAD) Phase, where a small number of patients will be given gradually increasing doses of the drug to test safety. The trial will also have an Expansion Phase, where a larger number of patients will be given the drug to further test safety and effectiveness.

Who is the study for?

This trial is for men and women aged 30-80 with painful knee osteoarthritis (K-L Grade 2, 3 or 4), a BMI ≤40 kg/m², who have tried at least two conservative therapies or one therapy plus an injection treatment without success. Participants must be willing to use effective contraception.

What is being tested?

The study tests FX201, a new drug given as a single injection in the knee. The first part involves escalating doses in small groups monitored for safety. The second part expands patient numbers at each dose level after safety review.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions at the injection site, general discomfort, and other risks typically associated with intra-articular injections which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience moderate pain in one of my joints.

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I am between 30 and 80 years old.

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I have been diagnosed with knee osteoarthritis and have X-ray evidence.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I expect to have major surgery during the study.

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My heart's electrical activity is unusual and considered significant by a doctor.

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I haven't had any joint injections in the last 6 months or longer.

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I have had or currently have an infection in my knee.

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I have a type of arthritis linked to inflammation or bowel disease.

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I haven't taken IV antibiotics or antivirals in the last 4 weeks or oral ones in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 1, day 2, week 1, week 2, week 3, week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 1, day 2, week 1, week 2, week 3, week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 1, day 2, week 1, week 2, week 3, week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure: Incidence of treatment emergent adverse events after a single intra-articular (IA) injection of FX201 (safety and tolerability)

Secondary study objectives

Measure: Characterization of the systemic biodistribution of FX201 as seen through the percentage of patients positive for FX201 at Baseline, Day 1, Day 2, Week 1, Week 2, Week 3, and Week 4