NCT04885972

Brief Summary

This study evaluates the efficacy and safety of a single IA injection of various RTX doses, Zilretta or placebo for the treatment of pain due to moderate to severe osteoarthritis knee pain..

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

6 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 10, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

May 10, 2021

Last Update Submit

January 12, 2023

Conditions

Osteoarthritis, KneeKnee OsteoarthritisKnee Pain Chronic

Keywords

osteoarthritisknee painknee

Outcome Measures

Primary Outcomes (1)

  • Change in Worst Average Daily Pain at Week 26

    Change from baseline through Week 26 in the weekly mean of Worst Average Daily Pain in the previous 24 hours with walking (WADP) using the Numerical Rating Scale of pain intensity, 0-10 scale (NRS)

    Baseline to Week 26

Secondary Outcomes (4)

  • Duration of response

    Baseline through end of study at Week 52

  • Change in Worst Average Daily Pain at Week 12

    Baseline to Week 12

  • Change in quality of life

    Baseline to Week 26

  • Change in WOMAC score

    Baseline to Week 12

Study Arms (3)

Resiniferatoxin

EXPERIMENTAL

7.5 mcg, 10 mcg, 12.5 mcg, 15 mcg, or 20 mcg in 5 mL injected once intra-articularly

Drug: Resiniferatoxin

Zilretta

ACTIVE COMPARATOR

32 mg in 5 mL injected once intra-articularly

Drug: Zilretta

Placebo

PLACEBO COMPARATOR

5 mL injected once intra-articularly

Drug: Placebo

Interventions

ResiniferatoxinDRUG

Resiniferatoxin is a compound purified from natural sources.

Also known as: RTX
Resiniferatoxin
ZilrettaDRUG

Zilretta is an extended-release corticosteroid approved to manage osteoarthritis knee pain.

Also known as: triamcinolone acetonide
Zilretta
PlaceboDRUG

Vehicle solution

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \< 50 kg/m
  • Have moderate-to-severe pain in the index knee due to osteoarthritis (OA) as assessed by the investigator, based on American College of Rheumatology criteria
  • Have had OA pain duration in the index knee ≥ 6 months prior to Screening
  • Reports worst daily average pain with walking of ≥ 4 on the 0 to 10 NRS for pain intensity during the week prior to Screening
  • Have a knee x-ray or MRI scan with KL grade ≥ 2 in the index knee based upon radiographic images obtained within 3 months prior to Screening (image must be available for review)
  • Have had treatment failure with at least two prior analgesic agents (at least one NSAID) defined as discontinuation due to side effects or inadequate response to treatment
  • Willing to abstain from other IA injections or knee surgery for at least 6 months after study treatment unless elects early discontinuation from the study
  • Able to comply with the study procedures and give informed consent
  • If on any analgesic medications, have been taking a stable dose for at least one month prior to screening with no increase in dose leading up to study treatment. Note that if the subject is on "as needed" or PRN analgesic medications, these may be continued during the study
  • Willing to follow contraception guidelines

You may not qualify if:

  • Have a history of a hemorrhagic event that is CTCAEv5 Grade 2 or higher within the 6 months prior to screening
  • Have evidence of or history of a serious coagulopathy or hemostasis problem at Screening or Baseline
  • Have had an IA injection in the index knee within one month prior to screening (3 months if prior IA injection with Zilretta)
  • Have undergone arthroscopic or open surgery or replacement surgery to the index knee within 6 months of screening
  • Have surgical hardware or other foreign bodies within the index knee joint
  • Have current instability/misalignment in the index knee post repair
  • Have a sensory peripheral neuropathy that is CTCAEv5 Grade 2 or higher involving the index leg at Screening
  • Have significant pain in other joints or body locations that make it difficult to assess pain in the index knee
  • If on opioid analgesics to treat knee OA, have an upper limit of 30 mg/day as converted to an oral morphine equivalent dose
  • Have a history of substance abuse
  • Have an allergy or hypersensitivity to capsaicin, chili peppers, lidocaine or resiniferatoxin
  • Pregnant at Screening or planning on becoming pregnant or currently breastfeeding
  • Have had a non-study related minor surgical procedure ≤ 3 days or major surgical procedure ≤ 14 days prior to Screening and must be sufficiently recovered and stable prior to study treatment
  • Have any medical condition or medical comorbidities that, in the Investigator's opinion, could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Horizon Clinical Research

La Mesa, California, 91942, United States

Location

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Affinity Health

Oak Brook, Illinois, 60523, United States

Location

Advance Pain

Edgewood, Kentucky, 41017, United States

Location

HD Research LLC

Bellaire, Texas, 77401, United States

Location

HD Research LLC

Carrollton, Texas, 75006, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

resiniferatoxinTriamcinoloneTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Mike Royal, MD

    Sorrento Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 13, 2021

Study Start

November 15, 2021

Primary Completion

September 1, 2023

Study Completion

November 1, 2023

Last Updated

January 17, 2023

Record last verified: 2023-01

Locations

US(6)