AzTrials
AzTrials

Knee OsteoarthritisPhase 2NCT05025787

A Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects With Knee Osteoarthritis Pain.

A Phase 2 study testing CNTX-6970 in people with Knee Osteoarthritis, run by Maurizio Fava, MD at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the safety and efficacy of CNTX-6970 for the treatment of pain related to OA of the knee compared to placebo. CNTX-6970 is being developed as a new treatment for chronic pain, including painful osteoarthritis of the knee. Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
CNTX-6970
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
16 sitesUnited States
Study dates
25 Oct 2021to 11 Jun 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

A subject will be eligible for study participation if they meet all of the following criteria:

  1. Individuals between 40 and 90 years of age (inclusive) at the time of the Screening Visit.
  2. Willing to use a mobile smart device during the study period. Individuals who do not have access to a mobile device will be provided with one for the duration of the study and trained in its use.
  3. Can understand the nature of the study and protocol requirements and is willing to comply with study drug administration requirements and discontinue prohibited concomitant medications.
  4. Radiography of both knees with a posterior-anterior, fixed-flexion view taken during the Screening visit. The Index knee must show evidence of chronic OA with a K-L Grading Scale of 1, 2, 3, or 4. Such evidence will be provided by a central reading of the radiography of both knees from an expert radiologist of the CCC of EPPIC-Net.
  5. Moderate to severe pain in the Index knee associated with OA and stable for a minimum of 6 months prior to Screening in the opinion of the investigator.
  6. Confirmation of OA of the index knee: American College of Rheumatology (ACR) diagnostic criteria.
  7. Subjects must have failed 2 or more prior therapies. Failure is deemed to be inadequate relief in the opinion of the investigator.
  8. Body mass index (BMI) of ≤ 40 kg/m2.
  9. Willing to refrain from illicit drug use during the study, and to have illicit drug testing at screening and at later time points.

A subject will be excluded from the study if they meet any of the following criteria:

  1. Any form of joint replacement surgery, open surgery, or arthroscopic surgery of the index knee/knee joint with 12 months of Screening.
  2. Any painful condition(s) of the index knee due to disease other than OA. For example, periarticular or referred pain involving the index knee, or from joint disease other than OA associated with the index knee.
  3. Other chronic pain anywhere in the lower extremities (e.g. hips, legs, feet) that is equal or greater in intensity or impairment than index knee pain or that requires the use of analgesic medications. This includes radicular low back pain with radiation to the knee.
  4. Documented history of neuropathic arthropathy in the knee.
  5. Significant instability (e.g., cruciate ligament tear or rupture or previous repair) within the past 5 years or current misalignment (>10 degrees varus or valgus) of the index knee.
  6. Plans to have surgery, invasive procedures, or intra-articular (IA) injections of the index knee or procedure or surgery otherwise contraindicated for study participation while in the study.
  7. Concomitant Medications for Pain - i. Continuous use of one of the following medications prescribed for pain: tramadol, gabapentin, duloxetine, pregabalin, milnacipran, or tricyclic antidepressants that is:
  8. chronic for at least 12 weeks; and
  9. at a stable dose for at least 4 weeks before Screening ii. Intermittent use of opioids that is: <!-- -->
  10. ongoing for at least 4 weeks before Screening;
  11. at a frequency no more than 4 days/week; and
  12. not be taken within 24 hours of a study visit iii. As needed use of acetaminophen iv. Continuous use of medical marijuana (or equivalent) that is chronic for at least 12 weeks and at a stable dose for 4 weeks v. Topical creams (includes CBD topicals)
  13. Continuous use allowed if chronic and stable for at least 12 weeks
  14. Intermittent use allowed if at a frequency of no more than 4 days/week
  15. Concomitant Medications for Non-Pain Indications That May Impact Pain - i. Continuous use of medication for non-pain indications that are known to potentially impact pain, e.g. duloxetine for depression, that is at a stable dose for at least 12 weeks prior to Screening. ii. Low-dose aspirin for the purposes of heart disease prophylaxis
  16. Corticosteroid injection in the index knee within 30 days of Screening or during study participation (unless the injectable is a long-acting agent such as triamcinolone acetonide extended-release injectable suspension (Zilretta) in which case the injection cannot be within 90 days of screening).
  17. Received IA viscosupplementation (e.g., Synvisc®, Hyalgan®) within 90 days of Screening.
  18. Use of an investigational medication within 30 days of Screening, or 5 pharmacokinetic or pharmacodynamic half-lives (whichever is longer) or scheduled to receive such an agent while participating in the current study.
  19. Current therapy with any immunosuppressive therapy, including corticosteroids (>5 mg/day of prednisone).

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • UTsouthwestern Medical Center

    Dallas, Texas, 75390

  • University of Florida

    Gainesville, Florida, 32611

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

  • University of California San Diego

    La Jolla, California, 92037

  • University of Wisconsin- Madison

    Madison, Wisconsin, 53715-1218

  • M&M Clinical Trials

    Miami, Florida, 33185

  • New York University Langone Health

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19146

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15206

  • University of Rochester

    Rochester, New York, 14618

  • University of California- Davis

    Sacramento, California, 95817

  • University of Washington

    Seattle, Washington, 98195

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: EN20-01: A 24 Week Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects With Moderate to Severe Knee Osteoarthritis Pain.

The primary objective of this study is to evaluate the safety and efficacy of CNTX-6970 for the treatment of pain related to OA of the knee compared to placebo. CNTX-6970 is being developed as a new treatment for chronic pain, including painful osteoarthritis of the knee.

Read the detailed description

The study will employ a randomized, allocation-concealed, multicenter, placebo-controlled, multi-period crossover design (Schmid et al, 2018). This multi-period crossover randomized, controlled trial allows comparability and assessment of efficacy through repeated exposures within each subject to the active treatment and a control (placebo) in randomized sequence. Such multi-period crossover designs are ideal for treatments with rapid onset of action and short half-life such as the asset under study here. We have strived to minimize the complexity of this powerful design by using only 2 blocks with 2 periods each. The modest additional complexity of the proposed multi-period crossover design, compared to a parallel-groups design, is justified by the marked improvement in efficiency. The gains in efficiency afforded by the multi-period crossover design allow a substantial reduction in sample size without sacrificing statistical power.

The trial will compare an active treatment vs. placebo. Each block will consist of two treatment periods with each period lasting 6 weeks. Treatment assignments (active drug versus placebo) will be randomized for each patient to the two periods within each block. The period length of 6 weeks was chosen based on several considerations: (i) Most efficacious analgesic drugs demonstrate separation from placebo by 6 weeks; (ii) The decision to move CNTX-6970 forward to Phase 3 will require a clinically meaningful separation from placebo by 6 weeks; (iii) In this Phase 2 study, implementing a treatment block longer than 6 weeks would make the overall design more challenging and burdensome by extending the duration of overall testing beyond 6 months; (iv).

In this study, the placebo will consist of inactive tablets identical to the active treatment tablets. Treatment assignments (active drug versus placebo) will be randomized for each patient to the two treatment periods within each block.

Being tested
CNTX-6970, Placebo
Medical subject headings
Osteoarthritis, Knee

What participants receive

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

  • CNTX-6970Drug

    CNTX-6970, a novel potent antagonist of CCR2 with lesser effects on CCR5, is being developed as a new treatment for chronic pain, including painful osteoarthritis of the knee.

  • PlaceboDrug

    Also called Matching Placebo

    BID

Study groups in NCT05025787
Study groupRoleWhat they receive
300mg BID CNTX-6970, Then PlaceboExperimentalParticipants initially received 300 mg BID of CNTX-6970 for 6 weeks (Block 1, Period 1). Following this, they were administered matching placebo BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received 300 mg BID of CNTX-6970 again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received a matching placebo for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.
Receives: Drug: CNTX-6970; Drug: Placebo
Placebo, then 300 mg BID CNTX-6970Placebo comparatorParticipants initially received placebo BID for 6 weeks (Block 1, Period 1). Following this, they were administered 300 mg CNTX-9670 BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received placebo BID again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received a 300 mg CNTX-6970 BID for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.
Receives: Drug: CNTX-6970; Drug: Placebo

What is being measured

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

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)

    The primary outcome measure used to assess efficacy will be patient-reported knee pain using the WOMAC Part A (Bellamy, et al., 1988).We will use the numerical rating scale version of the WOMAC, with the subject assessing each of 5 questions using an 11-point (0 to 10) scale; the total score is the sum of the individual item scores (range 0-50). A higher WOMAC score represents worse symptom severity.

    Measured: 24 Weeks

  2. Treatment Emergent Adverse Events (TEAEs)

    The primary safety endpoint is the incidence of treatment emergent adverse events (TEAEs), reported between the administration of study drug on Day 1 and the completion of the study at week 24 or early termination.

    Measured: 24 Weeks

Secondary outcomes (9)

  1. Numeric Rating Scale (NRS)

    Daily Knee Pain Intensity on a 0-10 Numeric Rating Scale (NRS). Pain intensity is reported by patients with chronic pain as one of the most important targets of treatment, and daily pain intensity ratings are a recommended core outcome measure for clinical trials of treatments for chronic pain. Daily ratings are preferable to ratings of recalled pain over longer time periods such as a week, as daily ratings minimize the influence of recall biases (Dworkin et al., 2005). Participants provide one-daily reports (at the end of the day) of their average knee pain intensity on a 0-10 pain intensity NRS over the course of a week, and those daily ratings are averaged to compute a mean knee pain intensity score. Participants will record their Daily Pain Intensity Numeric Rating Scale (NRS) 0-10 each day for one week prior to each clinic visit using NEForm. Lower NRS values correspond to less pain.

    Measured: 24 Weeks

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-C)

    WOMAC-C (Function subscale) (Bellamy et al, 1988). The WOMAC-physical function subscale contains 17 items assessing daily functioning, each using an 11-point (0 to 10) numerical rating scale. The total index score (0-170) is the sum of the items. A higher WOMAC function score represents worse functioning and less ability to engage in daily activities.

    Measured: 24 Weeks

  3. Hospital Anxiety and Depression Scale (HADS) - Anxiety

    The HADS is a 14-item self-report questionnaire designed to assess symptoms of anxiety and depression in those with medical illness (Norton et al, 2013). This scale has 14 items, 7 related to anxiety and 7 to depression, rated on 4 points (0 to 3) in domains of intensity or frequency. Scoring is done separately for depression and for anxiety and each domain is interpreted as normal for scores of 0-7, borderline abnormal (borderline case) for scores of 8-10 and abnormal (case) for scores of 11-21. This scale is used to assess depression and anxiety in addition to HEAL/EPPIC-Net core data elements (CDEs) because of its higher sensitivity to change especially in patients with medical illnesses.

    Measured: 24 Weeks

  4. Patient Global Impression of Change (PGIC)

    The PGIC is a single-item measure of patient-reported improvement that is widely used as a general outcome measure in studies of chronic pain patients, including OA patients (Salaff et al, 2004). It is often used as an index of treatment-associated change, and patient-reported improvements in the form of PGIC scores correlate robustly with significant improvement in pain intensity, pain interference with activities of daily living, mood, and quality of life (Perrot and Lanteri-Minet, 2019).

    The PCIC was collected at baseline and week 24. PGIC is scored from 0-6, where lower values correspond to better outcomes (e.g., 0 = very much improved, whereas 6 is very much worse).

    Measured: 24 Weeks

  5. Serum Levels of Cytokines and Chemokines

    Assessed at baseline and at the end of each treatment period (weeks 6, 12, 18, and 24).Serum levels are measured in Picograms per millilitre (pg/mL). Analyses were performed for Aim 5 to assess the efficacy of CNTX-6970 (300mg BID) in comparison to placebo in biomarkers from (b) serum and synovial fluid levels of chemokines and cytokines; and (c) Synovial monocyte chemoattractant protein-1/CCR-2 receptor binding inhibition in blood and synovial fluid.

    The following 9 biomarkers had sufficient data based on either the ability to fit models A and/or B and at least 50% of the values were above the minimum detectable threshold:

    Alpha.2.Macroglobulin..A2Macro, Immunoglobulin.A..IgA, Macrophage.Inflammatory.Protein.1.beta..MIP.1.beta, Monocyte.Chemotactic.Protein.1..MCP.1, Serum.Amyloid.P.Component..SAP,

    Measured: 24 Weeks

  6. MCP-1/CCR-2

    Monocyte chemoattractant serum protein-1(MCP-1)/CCR-2 receptor binding inhibition by CNTX-6970. This will be assessed at baseline and at the end of each treatment period (weeks 6, 12, 18 and 24).

    The data is measured in pg per mL, the data in analyzed in the natural log of pg per mL, with higher numbers indicating more binding inhibition.

    Measured: 24 Weeks

  7. Hospital Anxiety and Depression Scale (HADS) - Depression

    The HADS is a 14-item self-report questionnaire designed to assess symptoms of anxiety and depression in those with medical illness (Norton et al, 2013). This scale has 14 items, 7 related to anxiety and 7 to depression, rated on 4 points (0 to 3) in domains of intensity or frequency. Scoring is done separately for depression and for anxiety and each domain is interpreted as normal for scores of 0-7, borderline abnormal (borderline case) for scores of 8-10 and abnormal (case) for scores of 11-21. This scale is used to assess depression and anxiety in addition to HEAL/EPPIC-Net core data elements (CDEs) because of its higher sensitivity to change especially in patients with medical illnesses.

    Measured: 24 Weeks

  8. PROMIS - 6A

    PROMIS Sleep Disturbance Scale 6A (Yu et al, 2011). Sleep disruption has a bi-directional relationship with chronic pain and is an important secondary outcome to measure in pain trials (Edwards et al, 2016). The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance short form is a convenient 6-item scale that correlates strongly with the longer forms. It shows greater measurement precision for assessing sleep disturbance than other commonly-used (and much longer) questionnaires such as the Pittsburgh Sleep Quality Index and the Epworth Sleepiness Scale; its brevity and convenience are a major advantage for both research and clinical settings (Yu et al, 2011). 60 is the most commonly used threshold for clinically significant sleep. The PROMIS Sleep Disturbance Scale is expressed as a T-score, with a population mean of 50 and SD of 10. A higher T-score indicates better physical functioning. Possible T scores in this distribution range from 31.7 to 76.1.

    Measured: 24 Weeks

  9. Staircase-evoked Pain Assessment

    This procedure consists of stepping fully up and down onto an 8in (20.32cm) high platform with both feet a total of 24 times. The lead leg is alternated between each up/down cycle. Subjects are instructed to use their normal gait for completing this task and are encouraged to complete the task despite increasing pain, without stopping if possible. The procedure is timed, and current knee pain intensity on a 0-10 Numeric Rating Scale (NRS) is assessed immediately before and following the procedure while the subject is in a seated, resting position. Lower values correspond to less pain.

    The NRS from the post-step was analyzed.

    Measured: 24 Weeks

Timeline

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

  1. First posted27 Aug 2021
  2. Study start25 Oct 2021
  3. Primary completion11 Jun 2024
  4. Study completion11 Jun 2024

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
Crossover
Model description
The study will employ a randomized, allocation-concealed, multicenter, placebo-controlled, multi-period crossover design.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05025787
Sponsor's protocol ID
2021p002273 (EN20-01)
Status last verified
Nov 2025
First submitted
16 Aug 2021
Last updated
26 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The EPPIC-Net DCC's NYU Center for Biospecimen Research and Development (CBRD) will store and manage biological samples (biosamples) collected in this clinical trial. The samples will be used for the present study and also for potential future research as permitted by the study-specific informed consent form. Biosamples stored for this study may include, but are not limited to: whole blood, plasma, stool, synovial fluid, and/or derivatives of these specimens. The samples will be stored only for the period defined in the informed consent form, which may be indefinite. Biospecimens may be shared in accordance with the protocol-defined data and sample sharing plan and the informed consent form. Biosamples will be documented in LabVantage, a secure network linking biospecimens to corresponding clinical and pathological data. LabVantage does not include any identifying personal health information (PHI). The CBRD and LabVantage meet all General Lab Protocol (GLP) and FDA guidelines.

Publications

  • Arnold SE, Betensky RA. Multicrossover Randomized Controlled Trial Designs in Alzheimer Disease. Ann Neurol. 2018 Aug;84(2):168-175. doi: 10.1002/ana.25280. Epub 2018 Aug 29.

    PubMed 30014506

  • Arroll B, Goodyear-Smith F, Crengle S, Gunn J, Kerse N, Fishman T, Falloon K, Hatcher S. Validation of PHQ-2 and PHQ-9 to screen for major depression in the primary care population. Ann Fam Med. 2010 Jul-Aug;8(4):348-53. doi: 10.1370/afm.1139.

    PubMed 20644190

  • Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

    PubMed 3068365

  • Bhangoo S, Ren D, Miller RJ, Henry KJ, Lineswala J, Hamdouchi C, Li B, Monahan PE, Chan DM, Ripsch MS, White FA. Delayed functional expression of neuronal chemokine receptors following focal nerve demyelination in the rat: a mechanism for the development of chronic sensitization of peripheral nociceptors. Mol Pain. 2007 Dec 12;3:38. doi: 10.1186/1744-8069-3-38.

    PubMed 18076762

  • Boakye M, Harkema S, Ellaway PH, Skelly AC. Quantitative testing in spinal cord injury: overview of reliability and predictive validity. J Neurosurg Spine. 2012 Sep;17(1 Suppl):141-50. doi: 10.3171/2012.5.AOSPINE1296.

    PubMed 22985380

  • Bruehl S, Liu X, Burns JW, Chont M, Jamison RN. Associations between daily chronic pain intensity, daily anger expression, and trait anger expressiveness: an ecological momentary assessment study. Pain. 2012 Dec;153(12):2352-2358. doi: 10.1016/j.pain.2012.08.001. Epub 2012 Aug 30.

    PubMed 22940462

  • Buckner JD, Crosby RD, Silgado J, Wonderlich SA, Schmidt NB. Immediate antecedents of marijuana use: an analysis from ecological momentary assessment. J Behav Ther Exp Psychiatry. 2012 Mar;43(1):647-55. doi: 10.1016/j.jbtep.2011.09.010. Epub 2011 Sep 14.

    PubMed 21946296

  • Chen X, Chen P. A comparison of four methods for the analysis of N-of-1 trials. PLoS One. 2014 Feb 4;9(2):e87752. doi: 10.1371/journal.pone.0087752. eCollection 2014.

    PubMed 24503561

  • Centrexion Investigator's Brochure for CNTX-6970. Version 2, 21 February 2019.

  • Ciarleglio A, Petkova E, Ogden T, Tarpey T. Constructing treatment decision rules based on scalar and functional predictors when moderators of treatment effect are unknown. J R Stat Soc Ser C Appl Stat. 2018 Nov;67(5):1331-1356. doi: 10.1111/rssc.12278. Epub 2018 Apr 16.

    PubMed 30546161

  • Dunton GF. Ecological Momentary Assessment in Physical Activity Research. Exerc Sport Sci Rev. 2017 Jan;45(1):48-54. doi: 10.1249/JES.0000000000000092.

    PubMed 27741022

  • Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.

    PubMed 15621359

  • Edwards RR, Dworkin RH, Turk DC, Angst MS, Dionne R, Freeman R, Hansson P, Haroutounian S, Arendt-Nielsen L, Attal N, Baron R, Brell J, Bujanover S, Burke LB, Carr D, Chappell AS, Cowan P, Etropolski M, Fillingim RB, Gewandter JS, Katz NP, Kopecky EA, Markman JD, Nomikos G, Porter L, Rappaport BA, Rice ASC, Scavone JM, Scholz J, Simon LS, Smith SM, Tobias J, Tockarshewsky T, Veasley C, Versavel M, Wasan AD, Wen W, Yarnitsky D. Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations. Pain. 2016 Sep;157(9):1851-1871. doi: 10.1097/j.pain.0000000000000602.

    PubMed 27152687

  • Evans K, Romero H, Katz N. Qualitative evaluation and responsiveness of the staircase-evoked pain procedure (STEPP) in two clinical trials of treatments for knee osteoarthritis (OA). https://www.oarsijournal.com/article/S1063-4584(20)30302-2/abstract DOI:https://doi.org/10.1016/j.joca.2020.02.235.

  • Farrar JT, Troxel AB, Haynes K, Gilron I, Kerns RD, Katz NP, Rappaport BA, Rowbotham MC, Tierney AM, Turk DC, Dworkin RH. Effect of variability in the 7-day baseline pain diary on the assay sensitivity of neuropathic pain randomized clinical trials: an ACTTION study. Pain. 2014 Aug;155(8):1622-1631. doi: 10.1016/j.pain.2014.05.009. Epub 2014 May 14.

    PubMed 24831421

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CNTX-6970 in people with Knee Osteoarthritis, run by Maurizio Fava, MD at 16 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?

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: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

Yes. Results are posted in the registry (first posted 26 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A) (time frame: 24 Weeks). The study lists 2 primary outcomes in all. 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 NCT05025787, which also lists 64 linked publications.

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 26 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in