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Osteoarthritis, KneePhase 2NCT04885972

Study to Evaluate Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis

A Phase 2 study testing Resiniferatoxin and Zilretta in people with Osteoarthritis, Knee and Knee Osteoarthritis, run by Sorrento Therapeutics, Inc. at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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.. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Resiniferatoxin and Zilretta
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
6 sitesUnited States
Study dates
15 Nov 2021to Nov 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • HD Research LLC

    Bellaire, Texas, 77401

  • HD Research LLC

    Carrollton, Texas, 75006

  • Advance Pain

    Edgewood, Kentucky, 41017

  • Horizon Clinical Research

    La Mesa, California, 91942

  • Affinity Health

    Oak Brook, Illinois, 60523

  • Lotus Clinical Research

    Pasadena, California, 91105

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Active and Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of Intra-articular Resiniferatoxin to Treat Moderate to Severe Pain From Knee Osteoarthritis

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..

Read the detailed description

This study is a multi-center, Phase 2, randomized, dose ranging, assessor-blinded, active and placebo-controlled, parallel-group prospective study evaluating 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.

A planned 112 subjects will be randomized to one of 7 groups (n=16 each) with each subject receiving one IA injection in the index knee joint (the knee primarily affected by pain if bilateral).

Being tested
Resiniferatoxin, Zilretta, Placebo
Keywords
osteoarthritis, knee pain, knee
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ResiniferatoxinDrug

    Also called RTX

    Resiniferatoxin is a compound purified from natural sources.

  • ZilrettaDrug

    Also called triamcinolone acetonide

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

  • PlaceboDrug

    Vehicle solution

Study groups in NCT04885972
Study groupRoleWhat they receive
ResiniferatoxinExperimental7.5 mcg, 10 mcg, 12.5 mcg, 15 mcg, or 20 mcg in 5 mL injected once intra-articularly
Receives: Drug: Resiniferatoxin
ZilrettaActive comparator32 mg in 5 mL injected once intra-articularly
Receives: Drug: Zilretta
PlaceboPlacebo comparator5 mL injected once intra-articularly
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline to Week 26

Secondary outcomes (4)

  1. Duration of response

    Time to return to within 10% of baseline pain score with walking based on the weekly mean WADP scores using the NRS (0-10)

    Measured: Baseline through end of study at Week 52

  2. Change in Worst Average Daily Pain at Week 12

    Change from baseline through Week 12 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).

    Measured: Baseline to Week 12

  3. Change in quality of life

    Change from baseline to Week 26 in the Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subscale

    Measured: Baseline to Week 26

  4. Change in WOMAC score

    Change from baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score (WOMAC-TW12) and subscale scores

    Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2021
  2. Study start15 Nov 2021
  3. Primary completionSep 2023 (estimated)
  4. Study completionNov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04885972
Sponsor's protocol ID
RTX-OAK-201
Status last verified
Jan 2023
First submitted
10 May 2021
Last updated
17 Jan 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Resiniferatoxin and Zilretta in people with Osteoarthritis, Knee and Knee Osteoarthritis, run by Sorrento Therapeutics, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Worst Average Daily Pain at Week 26 (time frame: Baseline to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04885972.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.

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