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    Clinical Trial Results:
    A Randomized, Crossover Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients with Nephropathic Cystinosis

    Summary
    EudraCT number
    		 2009-017882-42
    Trial protocol
    		 FR   NL  
    Global end of trial date
    03 Jun 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 May 2017
    First version publication date
    20 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RP103-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01000961
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Horizon Pharma USA, Inc.
    Sponsor organisation address
    150 S. Saunders Road, Lake Forest, Illinois, United States, 60045
    Public contact
    Evelyn Olson, BS, Horizon Pharma USA, Inc., clinicaltrials@horizonpharma.com
    Scientific contact
    Evelyn Olson, BS, Horizon Pharma USA, Inc., clinicaltrials@horizonpharma.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Jun 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. RP103 is a formulation of cysteamine bitartrate that is being studied to see if it may be able to be given less frequently, once every 12 hours, and have similar results to four times a day Cystagon®.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. The study was conducted in accordance with legal and regulatory requirements including Guidance for Good Clinical Practice (International Conference on Harmonization [ICH] 1996), and the Declaration of Helsinki (World Medical Association 2008). Only subjects who met the inclusion criteria and none of the exclusion criteria were enrolled to this study. Written informed consent was to be obtained from the subject’s legally acceptable representative and assent by the minor subject, as applicable, before screening or baseline assessments. Instructions were given to the subject's legally acceptable representative in case of emergency or other questions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jun 2010
    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
    United States: 26
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Netherlands: 4
    Worldwide total number of subjects
    44
    EEA total number of subjects
    18
    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)
    24
    Adolescents (12-17 years)
    16
    Adults (18-64 years)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants randomized to each per sequence Arm are expected to remain in the same Arm throughout all intervention periods.

    Pre-assignment period milestones
    Number of subjects started
    		 44
    Number of subjects completed
    		 43

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 1
    Period 1
    Period 1 title
    Run-in Period of 2-3 weeks on Cystagon
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cystagon first, then Cystagon, then RP103
    Arm description
    		 Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in first intervention (after Run-in period) and RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in second intervention period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cystagon®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Prior to treatment, eligible subjects underwent a 2 to 3 week Run-in Period of their stable dose of Cystagon® administered every 6 hours.

    Arm title
    		 Cystagon first, then RP103, then Cystagon
    Arm description
    		 RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in first intervention (after Run-in period) and Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in second intervention period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cystagon®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Prior to treatment, eligible subjects underwent a 2 to 3 week Run-in Period of their stable dose of Cystagon® administered every 6 hours.

    Number of subjects in period 1 [1]
    		Cystagon first, then Cystagon, then RP103 Cystagon first, then RP103, then Cystagon
    Started
    21
    22
    Completed
    21
    22
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One subject was withdrawn prior to randomization, and is accounted for in the Pre-assignment Milestones table.
    Period 2
    Period 2 title
    First Intervention (3 weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cystagon first, then Cystagon, then RP103
    Arm description
    		 Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in first intervention (after Run-in period) and RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in second intervention period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cystagon®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    3 weeks (±3 days) treatment with Cystagon® every 6 hours

    Arm title
    		 Cystagon first, then RP103, then Cystagon
    Arm description
    		 RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in first intervention (after Run-in period) and Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in second intervention period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cysteamine bitartrate
    Investigational medicinal product code
    RP103
    Other name
    PROCYSBI®
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    3 weeks (±3 days) of RP103 administered every 12 hours

    Number of subjects in period 2
    		Cystagon first, then Cystagon, then RP103 Cystagon first, then RP103, then Cystagon
    Started
    21
    22
    Completed
    21
    20
    Not completed
    0
    2
         Consent withdrawn by subject
    -
    1
         Infection after pre-planned surgery
    -
    1
    Period 3
    Period 3 title
    Second Intervention (3 weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cystagon first, then Cystagon, then RP103
    Arm description
    		 Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in first intervention (after Run-in period) and RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in second intervention period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cysteamine bitartrate
    Investigational medicinal product code
    RP103
    Other name
    PROCYSBI®
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    3 weeks (±3 days) of RP103 administered every 12 hours

    Arm title
    		 Cystagon first, then RP103, then Cystagon
    Arm description
    		 RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in first intervention (after Run-in period) and Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in second intervention period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cystagon®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    3 weeks (±3 days) treatment with Cystagon® every 6 hours

    Number of subjects in period 3
    		Cystagon first, then Cystagon, then RP103 Cystagon first, then RP103, then Cystagon
    Started
    21
    20
    Completed
    21
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Run-in Period of 2-3 weeks on Cystagon
    Reporting group description
    		 -

    Reporting group values
    		 Run-in Period of 2-3 weeks on Cystagon Total
    Number of subjects
    		 43 43
    Age Categorical
    Units: Participants
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.7 ± 4.19 -
    Gender, Male/Female
    Units: Participants
        Female
    		 19 19
        Male
    		 24 24

    End points

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    End points reporting groups
    Reporting group title
    Cystagon first, then Cystagon, then RP103
    Reporting group description
    		 Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in first intervention (after Run-in period) and RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in second intervention period.

    Reporting group title
    Cystagon first, then RP103, then Cystagon
    Reporting group description
    		 RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in first intervention (after Run-in period) and Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in second intervention period.
    Reporting group title
    Cystagon first, then Cystagon, then RP103
    Reporting group description
    		 Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in first intervention (after Run-in period) and RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in second intervention period.

    Reporting group title
    Cystagon first, then RP103, then Cystagon
    Reporting group description
    		 RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in first intervention (after Run-in period) and Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in second intervention period.
    Reporting group title
    Cystagon first, then Cystagon, then RP103
    Reporting group description
    		 Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in first intervention (after Run-in period) and RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in second intervention period.

    Reporting group title
    Cystagon first, then RP103, then Cystagon
    Reporting group description
    		 RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in first intervention (after Run-in period) and Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in second intervention period.

    Subject analysis set title
    RP103 and Cystagon® crossover
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Per Protocol Population

    Subject analysis set title
    RP103
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Population

    Subject analysis set title
    Cystagon®
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Population

    Primary: The Steady-State White Blood Cell Cystine Levels of RP103 Compared to Cystagon®

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    End point title
    		 The Steady-State White Blood Cell Cystine Levels of RP103 Compared to Cystagon®
    End point description
    End point type
    Primary
    End point timeframe
    4 weeks after the last subject has completed the study
    End point values
    		 RP103 Cystagon®
    Number of subjects analysed
    39
    39
    Units: nmol ½ Cystine / mg protein
        least squares mean (standard error)
    0.5152 ± 0.05555
    0.4367 ± 0.05555
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    16-subject study will have 90% power to reject the null hypothesis of non-inferiority at the 0.025 level of significance with a non-inferiority margin of 0.3. Final analysis was performed at a nominal significance level of 0.02104.
    Comparison groups
    RP103 v Cystagon®
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.0001
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0785
    Confidence interval
         level
    		 95.8%
         sides
    2-sided
         lower limit
    		 0.0107
         upper limit
    		 0.1464
    Notes
    [1] - The non-inferiority endpoint of the clinical trial would be achieved if the upper limit of the 95.8% CI of the difference between RP103 and Cystagon® was less than the a-priori 0.3 non-inferiority margin, which would correspond to an observed p-value less than or equal to 0.02104

    Secondary: Comparison of Cysteamine PK Profiles, Steady State Cmax, Between RP103 and Cystagon®

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    End point title
    		 Comparison of Cysteamine PK Profiles, Steady State Cmax, Between RP103 and Cystagon®
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks after the last subject has completed the study
    End point values
    		 RP103 Cystagon®
    Number of subjects analysed
    37
    39
    Units: Cmax (mg/L)
        least squares mean (standard deviation)
    3.7 ± 1.72
    2.73 ± 1.36
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    RP103 v Cystagon®
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.17
         upper limit
    		 1.67

    Secondary: Comparison of Cysteamine PK profiles, Steady State Tmax, Between RP103 and Cystagon®

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    End point title
    		 Comparison of Cysteamine PK profiles, Steady State Tmax, Between RP103 and Cystagon®
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks after the last subject has completed the study
    End point values
    		 RP103 Cystagon®
    Number of subjects analysed
    37
    39
    Units: Tmax (minute)
        least squares mean (standard deviation)
    187 ± 89
    72 ± 31
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Cystagon® v RP103
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    105
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 90
         upper limit
    		 150

    Secondary: Comparison of Cysteamine PK Profiles, AUC(0-t), Between RP103 and Cystagon®

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    End point title
    		 Comparison of Cysteamine PK Profiles, AUC(0-t), Between RP103 and Cystagon®
    End point description
    End point type
    Secondary
    End point timeframe
    6 hours post dosing for Cystagon®; 12 hours post dosing for RP103.
    End point values
    		 RP103 Cystagon®
    Number of subjects analysed
    37
    39
    Units: AUC(0-t) (min*mg/L)
        least squares mean (standard deviation)
    739 ± 334
    357 ± 150
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Cystagon® v RP103
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.75
         upper limit
    		 2.39

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment periods
    Adverse event reporting additional description
    Safety population AE reporting.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Cystagon®
    Reporting group description
    		 Safety population during treatment periods

    Reporting group title
    RP103
    Reporting group description
    		 Safety Population during treatment periods

    Serious adverse events
    		 Cystagon® RP103
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 41 (2.44%)
    6 / 43 (13.95%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Femur Fracture
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Discomfort
    Additional description: possibly related to study drug
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Knee deformity
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypovolaemia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cystagon® RP103
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 41 (12.20%)
    16 / 43 (37.21%)
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    3 / 41 (7.32%)
    5 / 43 (11.63%)
         occurrences all number
    5
    8
    Nausea
         subjects affected / exposed
    2 / 41 (4.88%)
    5 / 43 (11.63%)
         occurrences all number
    3
    7
    Abdominal Pain
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    4
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Feb 2010
    Per the CSR, the rationale for Amendment 1 (21 February 2010) was to revise aspects of the protocol design to incorporate input from the FDA. The most significant of these was to update and clarify study endpoints and analysis plans, update and finalize sample size estimate, and add collection of PK data to the study design. In addition, the study schedule and procedures were changed to reduce discomfort and impact to the subject and their family. Minor editorial changes were made to clarify statements and instructions and correct typographical and formatting errors in the protocol.
    03 May 2010
    Per the CSR, as was the case for Amendment 1, Amendment 2 (03 May 2010) was intended to incorporate input from the FDA. The most significant revisions included the addition of a Run-in Period and randomized parallel crossover which allowed for Cystagon® dose adjustment. Inclusion and exclusion criteria were modified to establish entry criteria for subjects with low WBC cystine levels, specify subject age and weight restrictions, and provide specific parameters for clinically significant changes in liver and renal function. Study objectives, endpoints, and analysis plans were updated. Minor editorial changes were made to clarify statements and instructions and correct typographical and formatting errors in the protocol.
    22 Jul 2010
    Per the CSR, Amendment 3 (22 July 2010) was intended to incorporate input from the FDA. The most significant revisions included restricting study participation to those subjects with a 3-day average WBC cystine level ≤2 nmol ½ cystine/mg protein during Week 2 of the Run-in Period; adjustment of RP103 PD sampling timepoints to ensure appropriate collection; including stratification of subjects according to baseline WBC cystine levels; eliminating one week from the Run-in Period; and setting the minimum sample size to 30 subjects. Inclusion criteria were modified to include subjects with WBC cystine levels ≤2 nmol ½ cystine/mg protein. Minor editorial changes were made to clarify statements and instructions and correct typographical and formatting errors in the protocol.
    22 Oct 2010
    Per the CSR, Amendment 4 (22 October 2010) was intended primarily to change the starting total daily dose of RP103 from 70% to 80% at the end of the Run-in Period Cystagon® total daily dose and allow a maximum RP103 dose increase to 100% at the end of the Run-in Period Cystagon® total daily dose, with additional information on the background and rationale for the change in RP103 starting dose. Minor editorial changes were made to clarify statements and instructions and correct typographical and formatting errors in the protocol.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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