A Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects With Knee Osteoarthritis Pain.
NCT ID: NCT05025787
Last Updated: 2025-11-26
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
55 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-10-25
Study Completion Date
2024-06-11
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Knee Osteoarthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
The study will employ a randomized, allocation-concealed, multicenter, placebo-controlled, multi-period crossover design.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
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.
Study Groups
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300mg BID CNTX-6970, Then Placebo
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.
Group Type
EXPERIMENTAL
CNTX-6970
Intervention Type
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.
Placebo
Intervention Type
DRUG
BID
Placebo, then 300 mg BID CNTX-6970
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.
Group Type
PLACEBO_COMPARATOR
CNTX-6970
Intervention Type
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.
Placebo
Intervention Type
DRUG
BID
Interventions
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CNTX-6970
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.
Intervention Type
DRUG
Placebo
BID
Intervention Type
DRUG
Other Intervention Names
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Matching Placebo
Eligibility Criteria
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Inclusion 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:
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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).
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).
Minimum Eligible Age
40 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Maurizio Fava, MD
OTHER
Sponsor Role
lead
Responsible Party
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Maurizio Fava, MD
Psychiatrist in Chief
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Maurizio Fava, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hosptial
Locations
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University of California San Diego
La Jolla, California, United States
Site Status
University of California- Davis
Sacramento, California, United States
Site Status
University of Florida
Gainesville, Florida, United States
Site Status
M&M Clinical Trials
Miami, Florida, United States
Site Status
Massachusetts General Hospital
Boston, Massachusetts, United States
Site Status
Healthcare Research Network
Hazelwood, Missouri, United States
Site Status
New York University Langone Health
New York, New York, United States
Site Status
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Site Status
University of Rochester
Rochester, New York, United States
Site Status
Montefiore Medical Center
The Bronx, New York, United States
Site Status
Center for Clinical Research
Winston-Salem, North Carolina, United States
Site Status
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Site Status
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Site Status
UTsouthwestern Medical Center
Dallas, Texas, United States
Site Status
University of Washington
Seattle, Washington, United States
Site Status
University of Wisconsin- Madison
Madison, Wisconsin, United States
Site Status
Countries
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United States
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021p002273 (EN20-01)
Identifier Type: -
Identifier Source: org_study_id
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