FX201 for Osteoarthritis

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Flexion Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This two-part study will be conducted in male and female patients, 30 - 80 years of age with painful OA of the index knee with Kellgren-Lawrence (K-L) Grade 2, 3 or 4. Part 1 - Single Ascending Dose (SAD) Phase: Up to three ascending doses of FX201 will be tested in cohorts of 5-8 patients. Each patient will only receive one injection of FX201. An independent Data Monitoring Committee (DMC) will review safety and guide the conduct of the study. Part 2 - Expansion Phase: Up to an additional 35 patients will be enrolled at each dose level reviewed by the DMC. Each patient will only receive one injection of FX201.

Research Team

Cecilia Barese, MD

Principal Investigator

Pacira Pharmaceuticals, Inc

Eligibility Criteria

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.

Inclusion Criteria

Written consent to participate in the study

I have tried at least two treatments for my knee arthritis without success.

I experience moderate pain in one of my joints.

See 4 more

Exclusion Criteria

I expect to have major surgery during the study.

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

You have used any experimental medication, biologic, or medical device within the past 3 months.

See 12 more

Treatment Details

Interventions

FX201 (Other)

Trial OverviewThe 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.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Mid Dose FX201Experimental Treatment1 Intervention

Single mid dose FX201 injection

Group II: Low Dose FX201Experimental Treatment1 Intervention

Single low dose FX201 injection

Group III: High Dose FX201Experimental Treatment1 Intervention

Single high dose FX201 injection