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    Clinical Trial Results:
    An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

    Summary
    EudraCT number
    2017-003910-16
    Trial protocol
    GB   DE  
    Global end of trial date
    11 Feb 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    06 May 2021
    First version publication date
    06 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CB8025-31731
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03301506
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    CymaBay Therapeutics, Inc.
    Sponsor organisation address
    7575 Gateway Blvd, Suite 110, Newark, United States, 94560
    Public contact
    Mary Standen, CymaBay Therapeutics, Inc., 1 5102938800, mstanden@cymabay.com
    Scientific contact
    Elaine Watkins, CymaBay Therapeutics, Inc., 1 5102938800, ewatkins@cymabay.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
    Final
    Date of interim/final analysis
    14 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of seladelpar. In this long-term (~5 year) interventional study of PBC, subjects who completed a previous study with seladelpar (CB8025-21629, CB8025-31735, or CB8025-21838) were invited to continue treatment. The primary endpoint was safety, and secondary endpoint was efficacy. The End of Treatment Visit for the subjects from the prior PBC study was meant to be coincident with the Day 1 visit of this study. Subjects from prior study participation (CB8025-21629 and CB8025-31735) with a study drug interruption ≤4 weeks prior to Day 1, did not require evaluation for exclusion criteria, and the screening period could be omitted. Subjects with study drug interruption from prior study >4 weeks prior to Day 1 entered the screening period and could not have met any of the exclusion criteria. Subjects participating in CB8025-21838 were to undergo screening period, but none were enrolled into the study .
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and its revisions and the International Conference on Harmonisation (ICH) Harmonized Tripartite Guideline for Good Clinical Practice (GCP). The study was also in compliance with the applicable local regulatory requirements and laws of each country in which the study was conducted, as well as with any applicable guidelines.
    Background therapy
    Standard of care ursodeoxycholic acid (UDCA) was administered in subjects who could tolerate it and seladelpar was administered as an add-on. For subjects with UDCA intolerance, seladelpar was administered as a monotherapy.
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Dec 2017
    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 Kingdom: 17
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    United States: 72
    Worldwide total number of subjects
    106
    EEA total number of subjects
    12
    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)
    72
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at a total of 31 clinical sites in North America (United States and Canada) and Europe (United Kingdom and Germany) between 11 December 2017 to 11 February 2020.

    Pre-assignment
    Screening details
    Total of 106 subjects from parental seladelpar PBC studies were enrolled and analyzed - 104 (CB8025-21629) and 2 (CB8025-31735). All 106 subjects rolled over at approximately Week 52 visit and entered study while on seladelpar dose 2 mg (1), 5 mg (18), 10 mg (87). Subject on 2 mg was included in safety analysis but excluded from efficacy analysis

    Period 1
    Period 1 title
    Seladelpar Total (Initial Dose) (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Seladelpar 2 mg (initial dose)
    Arm description
    One subject received two 1 mg seladelpar capsules orally once daily for the study duration
    Arm type
    Experimental

    Investigational medicinal product name
    Seladelpar
    Investigational medicinal product code
    MBX-8025
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One subject received two 1 mg seladelpar capsules orally once daily for the study duration

    Arm title
    Seladelpar 5 mg (initial dose)
    Arm description
    Subjects received 5 mg seladelpar capsule orally once daily for the study duration
    Arm type
    Experimental

    Investigational medicinal product name
    Seladelpar
    Investigational medicinal product code
    MBX-8025
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 5 mg seladelpar capsule orally once daily for the study duration

    Arm title
    Seladelpar 10 mg (initial dose)
    Arm description
    Subjects received 10 mg seladelpar capsule orally once daily for the study duration
    Arm type
    Experimental

    Investigational medicinal product name
    Seladelpar
    Investigational medicinal product code
    MBX-8025
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 10 mg seladelpar capsule orally once daily for the study duration

    Number of subjects in period 1
    Seladelpar 2 mg (initial dose) Seladelpar 5 mg (initial dose) Seladelpar 10 mg (initial dose)
    Started
    1
    18
    87
    Completed
    0
    0
    0
    Not completed
    1
    18
    87
         Other - Study Closure
    1
    18
    80
         Other - Prohibitive concomitant Medication Use
    -
    -
    1
         Other - Administrative Decision
    -
    -
    1
         Adverse event, non-fatal
    -
    -
    3
         Other - Lack of response withdrawl
    -
    -
    1
         Lost to follow-up
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Seladelpar 2 mg (initial dose)
    Reporting group description
    One subject received two 1 mg seladelpar capsules orally once daily for the study duration

    Reporting group title
    Seladelpar 5 mg (initial dose)
    Reporting group description
    Subjects received 5 mg seladelpar capsule orally once daily for the study duration

    Reporting group title
    Seladelpar 10 mg (initial dose)
    Reporting group description
    Subjects received 10 mg seladelpar capsule orally once daily for the study duration

    Reporting group values
    Seladelpar 2 mg (initial dose) Seladelpar 5 mg (initial dose) Seladelpar 10 mg (initial dose) Total
    Number of subjects
    1 18 87 106
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    1 11 60 72
        >65 years
    0 7 27 34
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    63 ( 0 ) 61.2 ( 8.57 ) 58.1 ( 9.24 ) -
    Gender categorical
    Units: Subjects
        Female
    1 18 81 100
        Male
    0 0 6 6
    Race
    Units: Subjects
        White
    1 18 79 98
        Black or African-American
    0 0 3 3
        Asian
    0 0 2 2
        American Indian or Alaska Native
    0 0 0 0
        Native Hawaiian or other Pacific Islander
    0 0 0 0
        Other
    0 0 2 2
        Multiple (White, Turkish)
    0 0 1 1
    Subject analysis sets

    Subject analysis set title
    Seladelpar Total (initial dose)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received 2 mg, 5 mg, 10 mg seladelpar capsule (s) orally once daily for the study duration

    Subject analysis sets values
    Seladelpar Total (initial dose)
    Number of subjects
    106
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    72
        >65 years
    34
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    58.7 ( 9.13 )
    Gender categorical
    Units: Subjects
        Female
    100
        Male
    6
    Race
    Units: Subjects
        White
    98
        Black or African-American
    3
        Asian
    2
        American Indian or Alaska Native
    0
        Native Hawaiian or other Pacific Islander
    0
        Other
    2
        Multiple (White, Turkish)
    1

    End points

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    End points reporting groups
    Reporting group title
    Seladelpar 2 mg (initial dose)
    Reporting group description
    One subject received two 1 mg seladelpar capsules orally once daily for the study duration

    Reporting group title
    Seladelpar 5 mg (initial dose)
    Reporting group description
    Subjects received 5 mg seladelpar capsule orally once daily for the study duration

    Reporting group title
    Seladelpar 10 mg (initial dose)
    Reporting group description
    Subjects received 10 mg seladelpar capsule orally once daily for the study duration

    Subject analysis set title
    Seladelpar Total (initial dose)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received 2 mg, 5 mg, 10 mg seladelpar capsule (s) orally once daily for the study duration

    Primary: Number of Participants with Adverse Events (AEs)

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    End point title
    Number of Participants with Adverse Events (AEs) [1] [2]
    End point description
    The primary endpoint of the study was safety analysis of Treatment-emergent adverse events (TEAEs) (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0) results. Adverse events were coded by SOC and preferred term using MedDRA 22.0. The severity of AEs was graded from 1 to 5 based on NCI CTCAE, Version 5.0. The safety data were analyzed for seladelpar 5 mg, 10 mg, and the overall population, which included subjects who received seladelpar 2 mg dose.
    End point type
    Primary
    End point timeframe
    Over 21 months
    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: Statistical analysis was descriptive (summary statistics), with no formal statistical testing performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The overall population represented by the Seladelpar Total (initial dose) includes the single subject who received seladelpar 2 mg dose, therefore the 2 mg arm from baseline period is not reported here. Statistical analysis was descriptive (summary statistics), with no formal statistical testing performed.
    End point values
    Seladelpar 5 mg (initial dose) Seladelpar 10 mg (initial dose) Seladelpar Total (initial dose)
    Number of subjects analysed
    18
    87
    106
    Units: Subjects with at least one
        TEAE
    11
    72
    84
        Serious TEAE (S-TEAE)
    0
    14
    14
        Grade 3 or Higher TEAE
    0
    14
    14
        Treatment-related TEAE (T-R-TEAE)
    3
    9
    13
        T-R Serious TEAE
    0
    0
    0
        T-R Grade 3 or Higher TEAE
    0
    1
    1
        TEAE Leading to Treatment Discontinuation
    0
    4
    4
        T-R TEAE Leading to Treatment Discontinuation
    0
    1
    1
        TEAE Leading to Dose Interruption or Adjustment
    1
    7
    9
        TEAE with Fatal Outcome
    0
    1
    1
        T-R TEAE with Fatal Outcome
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study duration
    Adverse event reporting additional description
    Adverse events
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Seladelpar 5 mg (initial Dose)
    Reporting group description
    Subjects received seladelpar 5 mg capsules orally once daily for the study duration

    Reporting group title
    Seladelpar 10 mg (initial dose)
    Reporting group description
    Subjects received seladelpar 10 mg capsules orally once daily for the study duration

    Reporting group title
    Seladelpar Total (initial dose)
    Reporting group description
    Subjects received any seladelpar capsules for the study duration

    Serious adverse events
    Seladelpar 5 mg (initial Dose) Seladelpar 10 mg (initial dose) Seladelpar Total (initial dose)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    14 / 87 (16.09%)
    14 / 106 (13.21%)
         number of deaths (all causes)
    0
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Toxic encephalopathy
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Microcytic anaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Complication associated with device
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 87 (2.30%)
    2 / 106 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Systemic scleroderma
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 87 (1.15%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    Seladelpar 5 mg (initial Dose) Seladelpar 10 mg (initial dose) Seladelpar Total (initial dose)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 18 (61.11%)
    71 / 87 (81.61%)
    83 / 106 (78.30%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 18 (5.56%)
    4 / 87 (4.60%)
    5 / 106 (4.72%)
         occurrences all number
    2
    5
    7
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 18 (11.11%)
    5 / 87 (5.75%)
    7 / 106 (6.60%)
         occurrences all number
    2
    5
    7
    Headache
         subjects affected / exposed
    2 / 18 (11.11%)
    5 / 87 (5.75%)
    7 / 106 (6.60%)
         occurrences all number
    3
    5
    8
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 18 (5.56%)
    9 / 87 (10.34%)
    10 / 106 (9.43%)
         occurrences all number
    1
    10
    11
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 18 (5.56%)
    8 / 87 (9.20%)
    9 / 106 (8.49%)
         occurrences all number
    1
    9
    10
    Abdominal pain
         subjects affected / exposed
    2 / 18 (11.11%)
    4 / 87 (4.60%)
    7 / 106 (6.60%)
         occurrences all number
    2
    4
    7
    Diarrhoea
         subjects affected / exposed
    1 / 18 (5.56%)
    4 / 87 (4.60%)
    6 / 106 (5.66%)
         occurrences all number
    5
    4
    10
    Skin and subcutaneous tissue disorders
    Pruritus generalised
         subjects affected / exposed
    1 / 18 (5.56%)
    9 / 87 (10.34%)
    10 / 106 (9.43%)
         occurrences all number
    1
    9
    10
    Pruritus
         subjects affected / exposed
    0 / 18 (0.00%)
    6 / 87 (6.90%)
    6 / 106 (5.66%)
         occurrences all number
    0
    6
    6
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 18 (0.00%)
    5 / 87 (5.75%)
    5 / 106 (4.72%)
         occurrences all number
    0
    5
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 18 (0.00%)
    7 / 87 (8.05%)
    7 / 106 (6.60%)
         occurrences all number
    0
    7
    7
    Myalgia
         subjects affected / exposed
    2 / 18 (11.11%)
    4 / 87 (4.60%)
    6 / 106 (5.66%)
         occurrences all number
    2
    5
    7
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 18 (5.56%)
    8 / 87 (9.20%)
    9 / 106 (8.49%)
         occurrences all number
    1
    8
    9
    Bronchitis
         subjects affected / exposed
    0 / 18 (0.00%)
    5 / 87 (5.75%)
    5 / 106 (4.72%)
         occurrences all number
    0
    5
    5
    Nasopharyngitis
         subjects affected / exposed
    1 / 18 (5.56%)
    4 / 87 (4.60%)
    5 / 106 (4.72%)
         occurrences all number
    1
    4
    5
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    0 / 18 (0.00%)
    5 / 87 (5.75%)
    5 / 106 (4.72%)
         occurrences all number
    0
    5
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2017
    Protocol amendment (version 1.1) for United Kingdom •Required subjects to have participated in a prior seladelpar study for at least 8 weeks. •Required that, in the Investigator’s opinion, subjects had to have derived a net benefit from participation in a prior PBC study with seladelpar. •Required that female subjects of childbearing potential have a serum pregnancy test performed at every On-Treatment Visit, and between On-Treatment Visits, perform a urine pregnancy test at home monthly (every 30 days).
    04 Jan 2018
    Protocol amendment (version 1.2) for Germany •Required subjects to have participated in a prior seladelpar study for at least 8 weeks. •Required that, in the Investigator’s opinion, subjects had to have derived a net benefit from participation in a prior PBC study with seladelpar. •Required that female subjects of childbearing potential have a serum pregnancy test performed at every On-Treatment Visit.
    16 Jul 2019
    Protocol Amendment 1 (version 2.0) •Enrollment into the study was expanded to allow subjects who completed PBC Studies CB8025-31735 (double-blind placebo-controlled study) and CB8025-21838 (single dose hepatic impairment study in PBC population). •Clinical data from Phase 1 and Phase 2 studies was updated. •The study design was updated to add partial randomization. •A secondary objective was added to collect data to support pruritis that was also assessed in study CB8025-31735 and to support future population PK analysis. •The composite response endpoint of ALP and total bilirubin and normalization of ALP were added to analyze similar data collected in a Phase 3 study. •Secondary measures were added to include PBC clinical events to be collected to evaluate the long-term effect of seladelpar. •Patient-reported outcome (pruritus NRS) was added to evaluate the effect of seladelpar based on similar data collected in Phase 3 study. •PK of seladelpar and its metabolites and exposure-response relationship to seladelpar were added to expand seladelpar PK profile in PBC population. •Exclusion criteria was modified for consistency with study CB8025-31735 and with other clinical studies. •The 1 mg dose was removed based on the data collected in study CB8025-21629. •Clearer instructions were added on how to handle safety issues when dose down-titration occurred. •Study assessments were modified to align with updated study measures and with data collected in Phase 3 study. Month 1 visit was added to evaluate safety of the subjects after initiation of seladelpar (specifically, for placebo subjects from Phase 3 and for subjects from Study CB8025-21838). •A dose adjustment during the first year was added to protect the blinding of the Phase 3 study. Dose adjustment criteria were updated to match the Phase 3 study. •Clarification on the liver, muscle, and pancreatic safety monitoring, and serum creatinine monitoring were added.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    25 Nov 2019
    On 25 November 2019, as a precautionary measure due to unexpected histology observations in an ongoing study in subjects with nonalcoholic steatohepatitis (NASH) study CB8025-21730; study CB8025-31731 was put on-hold, and subject enrollment or treatment with study drug was stopped. At that time, a total of 106 subjects were enrolled -104 subjects from study CB8025-21629 and 2 subjects from study CB8025-31735. No subjects were enrolled from study CB8025-21838. Given the time needed to conduct an investigation, the study was terminated on 20 December 2019. The study design was amended in 2019 to implement changes relevant for subjects rolling over from CB8025-31735 e.g., pruritus data collection, PK collection, liver biopsy collection, dose adjustment at specific timepoints (Month 6 and Month 12). Since, study was discontinued when 2 subjects from CB8025-31735 were enrolled and were in the study for a limited time while still on the study drug (<1 month), none of the changes from protocol amendment of 2019 were implemented. The duration of exposure to seladelpar in this study is from Day 1 to over 21 months and when combined with that of the parental study is up to 33 months (12 months in a parental PBC study).
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study results for primary endpoint (safety) are presented. Study was terminated early, therefore secondary efficacy endpoints are not presented.
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