NCT04065074

Brief Summary

This is a multi-center, single-arm, open-label study of FX006 in patients with hip OA. A maximum number of approximately 30 patients may be enrolled in this protocol. All enrolled patients will receive a single intra-articular (IA) injection of FX006.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 1, 2020

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

August 12, 2019

Results QC Date

October 10, 2020

Last Update Submit

January 22, 2024

Conditions

Osteoarthritis, Hip

Keywords

OsteoarthritisHipIntra-articularInjection

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Successful Study Drug Administrations

    Successful study drug administration, defined as Injector reporting complete study drug administration.

    Day 1

Study Arms (1)

FX006 32 mg

EXPERIMENTAL

Single intra-articular (IA) injection of FX006 32 mg

Drug: FX006 32 mg

Interventions

FX006 32 mgDRUG

Extended-release 32 mg FX006 IA injection

FX006 32 mg

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
  • Patients 40 to 80 years of age, inclusive, on the day of consent
  • Body Mass Index (BMI) ≤ 40 kg/m\^2
  • Has a documented clinical diagnosis of unilateral or bilateral hip OA for at least six months
  • Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by local read of X-ray obtained during Screening or ≤ 6 months of Screening visit
  • Has clinically significant pain in the index hip

You may not qualify if:

  • Has a history of hypersensitivity to triamcinolone acetonide, PLGA or lidocaine
  • Is receiving anticoagulants (including warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparin, ritonavir or cobicistat)
  • Has had any previous surgery on the index hip
  • Presence of surgical hardware or other foreign body in the index hip
  • Has a history of infection of the index hip
  • Has a diagnosis of other disorders in the index hip that can cause pain
  • Has received any intra-articular injection in the index hip of corticosteroids, investigational (including FX006) or marketed (including Zilretta®) within the 3 months prior to Screening
  • Has had trauma to the index hip in the past 3 months requiring immobilization
  • Has a history or evidence of active or latent systemic fungal or mycobacterial infection (including tuberculosis), or of ocular herpes simplex
  • Has, at screening, or any time prior to day of scheduled injection (Day 1), clinical suspicion of local or systemic infection, including any infection in the index leg.
  • Has a history of or active significant concomitant illness (known or suspected)
  • Any bacterial or viral infection requiring parental antibiotics within 4 weeks of Day 1 or oral antibiotics within 2 weeks of Day 1
  • Is a woman who is pregnant, nursing, lactating, or plans to become pregnant during the study
  • Is a man who plans to conceive during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

Biosolutions Clinical Research Center

La Mesa, California, 91942, United States

Location

Dream Team Clinical Research

Pomona, California, 91767, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis

Interventions

FX006

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Limitations and Caveats

Only 16 of the planned 30 patients were enrolled in this trial as the procedure for intra-articular injection of FX006 in patients with hip OA did not reduce the incidence of incomplete study drug administrations.

Results Point of Contact

Title
David Golod, Vice President, Clinical Operations
Organization
Flexion Therapeutics, Inc.
dgolod@flexiontherapeutics.com
(781) 305-7572

Study Officials

  • Scott Kelley

    Pacira Pharmaceuticals, Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 22, 2019

Study Start

July 30, 2019

Primary Completion

October 11, 2019

Study Completion

December 30, 2019

Last Updated

January 24, 2024

Results First Posted

December 1, 2020

Record last verified: 2024-01

Locations

US(5)