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

NCT05025787 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2021p002273 (EN20-01)
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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.

  24 Weeks

• 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.

  24 Weeks

Secondary Outcomes (9)

• Numeric Rating Scale (NRS)

  24 Weeks

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

  24 Weeks

• Hospital Anxiety and Depression Scale (HADS) - Anxiety

  24 Weeks

• Patient Global Impression of Change (PGIC)

  24 Weeks

• Serum Levels of Cytokines and Chemokines

  24 Weeks

Study Arms (2)

300mg BID CNTX-6970, Then Placebo

EXPERIMENTAL

Participants 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.

Drug: CNTX-6970; Drug: Placebo

Placebo, then 300 mg BID CNTX-6970

PLACEBO COMPARATOR

Participants 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.

Drug: CNTX-6970; Drug: Placebo

Interventions

CNTX-6970 DRUG

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.

300mg BID CNTX-6970, Then Placebo; Placebo, then 300 mg BID CNTX-6970

Placebo DRUG

BID

Also known as: Matching Placebo

300mg BID CNTX-6970, Then Placebo; Placebo, then 300 mg BID CNTX-6970

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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. a. 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: 1. chronic for at least 12 weeks; and 2. at a stable dose for at least 4 weeks before Screening ii. Intermittent use of opioids that is: <!-- --> 1. ongoing for at least 4 weeks before Screening; 2. at a frequency no more than 4 days/week; and 3. 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) 1. Continuous use allowed if chronic and stable for at least 12 weeks 2. Intermittent use allowed if at a frequency of no more than 4 days/week b. 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 7. 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). 8. Received IA viscosupplementation (e.g., Synvisc®, Hyalgan®) within 90 days of Screening. 10\. 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. 11\. Current therapy with any immunosuppressive therapy, including corticosteroids (\>5 mg/day of prednisone).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Maurizio Fava, MD: lead

Study Sites (16)

University of California San Diego

La Jolla, California, 92037, United States

Location

University of California- Davis

Sacramento, California, 95817, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

M&M Clinical Trials

Miami, Florida, 33185, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

New York University Langone Health

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Rochester

Rochester, New York, 14618, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

UTsouthwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Wisconsin- Madison

Madison, Wisconsin, 53715-1218, United States

Location

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• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

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• Zucker DR, Schmid CH, McIntosh MW, D'Agostino RB, Selker HP, Lau J. Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment. J Clin Epidemiol. 1997 Apr;50(4):401-10. doi: 10.1016/s0895-4356(96)00429-5.

  PMID: 9179098 BACKGROUND

• Edwards RR, Tarpey T, Ashburn M, Baer C, Campbell A, Dworkin RH, Gaspard G, Flynn M, Hade E, Jain N, Judge H, Kamp C, Li Y, Meropol S, Petkova E, Philip A, Przkora R, Rathmell JP, Robinson-Papp J, Samuels J, Sehgal N, Sienty J, Stacey B, Wallace M, Wasan AD, Wise B, Yu C, Fava M, Troxel AB. A double-blind, placebo-controlled, multi-crossover trial of treatment with a chemokine antagonist for knee osteoarthritis pain. Pain. 2026 Jan 6. doi: 10.1097/j.pain.0000000000003904. Online ahead of print.

  PMID: 41468282 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Allison Campbell
• Organization: MGH

acampbell17@mgh.harvard.edu

617-595-8372

Study Officials

• Maurizio Fava, MD

  Massachusetts General Hosptial

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of the randomization assignment from trial subjects, staff from the Clinical Sites, CCC, and DCC will be ensured through the use of the IXRS.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychiatrist in Chief

Model Details: The study will employ a randomized, allocation-concealed, multicenter, placebo-controlled, multi-period crossover design.

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 27, 2021
• Study Start: October 25, 2021
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

US (16)