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    Clinical Trial Results:
    An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX-4975-05 Intra-articular Injection in Subjects with Chronic, Moderate-to-Severe Osteoarthritis Knee Pain

    Summary
    EudraCT number
    		 2018-003094-10
    Trial protocol
    		 GB   DE   ES  
    Global end of trial date
    17 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jan 2021
    First version publication date
    27 Jan 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CNTX-4975i-OA-303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03661996
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centrexion Therapeutics Corp
    Sponsor organisation address
    200 State Street, 6th Floor, Boston , United States,
    Public contact
    Kimberley Guedes, Centrexion Therapeutics Corp, +1 6178376920, kguedes@centrexion.com
    Scientific contact
    Kimberley Guedes, Centrexion Therapeutics Corp, +1 6178376920, kguedes@centrexion.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    17 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to determine the optimal procedures for administering CNTX-4975-05 as a single IA injection into knee(s) with OA, balancing comfort and ease of use of methods of cooling and administration.
    Protection of trial subjects
    Ethics Committee Approval
    Background therapy
    		 Subjects were able to enroll into the study with a single analgesic of their choice for their OA knee pain. (prescription or OTC).
    Evidence for comparator
    		 This was an open-label study. No comparators were used in this trial.
    Actual start date of recruitment
    28 Sep 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 74
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Germany: 97
    Country: Number of subjects enrolled
    United States: 668
    Worldwide total number of subjects
    848
    EEA total number of subjects
    180
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    458
    From 65 to 84 years
    384
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruitment period for Germany, Spain and United Kingdom: 31 January 2019 to 17 October 2019 Screening Period was up to 15 days

    Pre-assignment
    Screening details
    		 Number of subjects Screened by Country: • United Kingdom = 16 • Spain = 93 • Germany = 106 • United States = 1189 • Total Screened = 1404

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    open label study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Breg Cooling solution
    Arm description
    		 Joint cooling was provided by a cooling wrap with an ice water pump system (Breg Cooler). Cooling was applied 15 minutes prior to IA injection of 15 mL 2% lidocaine (without epinephrine) into the knee. Cooling was resumed for a further 30-minutes prior to the IA injection of CNTX-4975-05 using a separate syringe and needle. Controlled cooling could then be reapplied for 30-90 minutes post-injection.
    Arm type
    		 control group

    Investigational medicinal product name
    Capsaicin 1mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    1mg CNTX-4975-05 on day 1

    Arm title
    		 Gel Pack Cooling
    Arm description
    		 Joint cooling was provided by a Gel pack applied for 40 -minutes prior to injection of 2% lidocaine (without epinephrine) into the knee. Cooling was resumed for a further 10-minutes prior to the IA injection of CNTX-4975-05 using a separate syringe and needle. Controlled cooling could then be reapplied for 10-90 minutes post-injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capsaicin 1mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    1mg CNTX-4975-05 on day 1

    Arm title
    		 Shortened Gel Pack Cooling
    Arm description
    		 Joint cooling was provided by a Gel pack applied for 30 -minutes prior to injection of 2% lidocaine (without epinephrine) into the knee. Cooling was resumed for a further 5-minutes prior to the IA injection of CNTX-4975-05 using a separate syringe and needle. Controlled cooling could then be reapplied for up to 90 minutes post-injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capsaicin 1mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    1mg CNTX-4975-05 on day 1

    Arm title
    		 Single Needle Injection, Gel Pack Cooling, 2% Lidocaine
    Arm description
    		 Joint cooling was provided by a Gel pack applied for 45 minutes prior to injection of 2% lidocaine (without epinephrine) into the knee. An IA injection of CNTX-4975-05 using the same needle followed immediately after the 2% lidocaine injection. Controlled cooling could then be reapplied for up to 90 minutes post-injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capsaicin 1mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    1mg CNTX-4975-05 on day 1

    Arm title
    		 Single Needle Injection, Gel Pack Cooling, 1% Lidocaine
    Arm description
    		 Joint cooling was provided by a Gel pack applied for 45 -minutes prior to injection of 1% lidocaine (without epinephrine) into the knee. An IA injection of CNTX-4975-05 using the same needle followed immediately after the 1% lidocaine injection. Gel pack cooling could then be reapplied for up to 90 minutes post-injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capsaicin 1mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    1mg CNTX-4975-05 on day 1

    Number of subjects in period 1
    		Breg Cooling solution Gel Pack Cooling Shortened Gel Pack Cooling Single Needle Injection, Gel Pack Cooling, 2% Lidocaine Single Needle Injection, Gel Pack Cooling, 1% Lidocaine
    Started
    162
    179
    175
    160
    172
    Completed
    150
    172
    170
    150
    159
    Not completed
    12
    7
    5
    10
    13
         Consent withdrawn by subject
    3
    5
    1
    7
    6
         Physician decision
    1
    1
    1
    -
    -
         Adverse event, non-fatal
    -
    -
    1
    1
    -
         study terminated by sponsor
    2
    -
    -
    -
    -
         Lost to follow-up
    5
    1
    2
    2
    6
         not specified
    1
    -
    -
    -
    -
         Protocol deviation
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 848 848
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 458 458
        From 65-84 years
    		 384 384
        85 years and over
    		 6 6
    Gender categorical
    Units: Subjects
        Female
    		 508 508
        Male
    		 340 340

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Breg Cooling solution
    Reporting group description
    		 Joint cooling was provided by a cooling wrap with an ice water pump system (Breg Cooler). Cooling was applied 15 minutes prior to IA injection of 15 mL 2% lidocaine (without epinephrine) into the knee. Cooling was resumed for a further 30-minutes prior to the IA injection of CNTX-4975-05 using a separate syringe and needle. Controlled cooling could then be reapplied for 30-90 minutes post-injection.

    Reporting group title
    Gel Pack Cooling
    Reporting group description
    		 Joint cooling was provided by a Gel pack applied for 40 -minutes prior to injection of 2% lidocaine (without epinephrine) into the knee. Cooling was resumed for a further 10-minutes prior to the IA injection of CNTX-4975-05 using a separate syringe and needle. Controlled cooling could then be reapplied for 10-90 minutes post-injection.

    Reporting group title
    Shortened Gel Pack Cooling
    Reporting group description
    		 Joint cooling was provided by a Gel pack applied for 30 -minutes prior to injection of 2% lidocaine (without epinephrine) into the knee. Cooling was resumed for a further 5-minutes prior to the IA injection of CNTX-4975-05 using a separate syringe and needle. Controlled cooling could then be reapplied for up to 90 minutes post-injection.

    Reporting group title
    Single Needle Injection, Gel Pack Cooling, 2% Lidocaine
    Reporting group description
    		 Joint cooling was provided by a Gel pack applied for 45 minutes prior to injection of 2% lidocaine (without epinephrine) into the knee. An IA injection of CNTX-4975-05 using the same needle followed immediately after the 2% lidocaine injection. Controlled cooling could then be reapplied for up to 90 minutes post-injection.

    Reporting group title
    Single Needle Injection, Gel Pack Cooling, 1% Lidocaine
    Reporting group description
    		 Joint cooling was provided by a Gel pack applied for 45 -minutes prior to injection of 1% lidocaine (without epinephrine) into the knee. An IA injection of CNTX-4975-05 using the same needle followed immediately after the 1% lidocaine injection. Gel pack cooling could then be reapplied for up to 90 minutes post-injection.

    Primary: assessment of the CNTX-4975-05 joint treatment regimens, with the Breg Cooling Control Group as the control, using a combination of 3 assessments of the index knee.

    		 Close Top of page
    End point title
    		 assessment of the CNTX-4975-05 joint treatment regimens, with the Breg Cooling Control Group as the control, using a combination of 3 assessments of the index knee. [1]
    End point description
    The primary efficacy endpoint was a composite measure assessing pain after injection and subject and investigator satisfaction with the treatment regimen. Secondary measures included: 1. Assessment of the composite measure in the non-index knee. 2. OMERACT-OARSI Responders at Week 8
    End point type
    Primary
    End point timeframe
    Day 3, week 4, week 8
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary analysis, performed on the ITT population, compared each experimental treatment regimen with the Breg Cooling Control Group calculated from the following3measures:1)pain 30 minutes after CNTX-4975-05 injection (using the following 5-point scale: 0 [none],1 [mild],2 [moderate],3 [moderately severe],and4[severe]),2)SS with the treatment regimen;and3)IS with the treatment regimen,all assessed on the index knee. Allsecondary efficacyendpoints were summarized using descriptive statistics
    End point values
    		 Breg Cooling solution Gel Pack Cooling Shortened Gel Pack Cooling Single Needle Injection, Gel Pack Cooling, 2% Lidocaine Single Needle Injection, Gel Pack Cooling, 1% Lidocaine
    Number of subjects analysed
    162
    179
    175
    160
    172
    Units: pain measurement scale
        number (not applicable)
    150
    172
    170
    150
    159
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During clinical trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Treatment emergent AEs were reported in 22% of subjects; < 1% of the subjects experienced TEAEs that were serious. The TEAEs occurring in > 2% of subjects were procedural pain (2.9%), arthralgia (2.2%), and nausea (2.1%), with no meaningful differences between treatment groups.
    Serious adverse events
    		 overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 848 (0.71%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    6 / 848 (0.71%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Hypersensitivity
    Additional description: Due to the temporal relationship between IA injection and SAE, the Investigator considered this event of hypersensitivity to be "possibly related" to study drug.
         subjects affected / exposed
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 848 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 848 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Aug 2019
    This amendment was to update the protocol and IB with a reported serious adverse event. The amendment was to inform investigators that acute allergic/hypersensitivity reactions are an identified risk following CNTX-4975 treatment. investigators should ensure subjects are observed for 30 minutes post-IA injection to ensure appropriate management should an allergic reaction occur. A new section was included in the protocol to highlight the hypersensitivity reaction as an adverse event of special interest. The reference safety information section was updated in the IB

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    08 May 2019
    The trial was briefly paused (08 May-13 June 2019) following the single event of acute allergic reaction (hypersensitivity) to allow for a clinical evaluation of the risk, to inform the study sites and the ethics committees of the event, and to allow for clinical sites to add additional safety equipment per the FDA.
    13 Jun 2019

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    none
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