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    Clinical Trial Results:
    An Open-Label Exploratory Study of UCB5857 in Subjects with Activated Phosphoinositide 3 Kinase (PI3K) Delta Syndrome (APDS)

    Summary
    EudraCT number
    2015-002900-10
    Trial protocol
    IT   DE   ES   FR  
    Global end of trial date
    23 Jan 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Aug 2018
    First version publication date
    05 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    APD001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Celltech, UK Registered Branch of UCB Pharma SA
    Sponsor organisation address
    208 Bath Road, Slough, United Kingdom, SL1 3WE
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.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
    20 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of UCB5857 in subjects with Activated PI3K delta syndrome (APDS).
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored, including a Safety Monitoring Committee review of ongoing safety and efficacy data.
    Background therapy
    Background therapy as permitted in the protocol.
    Evidence for comparator
    Not applicable.
    Actual start date of recruitment
    23 May 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Spain: 2
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    6
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll subjects in May 2016 and concluded in Jan 2018.

    Pre-assignment
    Screening details
    The study included 8 subjects in the Enrollment Set. 1 subject represented a screen failure due to being underweight, leaving 7 subjects that formed the Safety Set (SS) and the Pharmacokinetic Set (PKS).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    UCB5857
    Arm description
    UCB5857 capsules were supplied at doses of 5 mg, 15 mg, and 30 mg, depending on body weight, to allow a flexible dosing regimen by combining the capsule strengths. The study investigational medicinal product (IMP) was administered orally, once per day, in the morning, during a 12-week Treatment Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Seletalisib
    Investigational medicinal product code
    UCB5857
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules of UCB5857 5 mg,15 mg or 30 mg, administered daily, by oral intake for 12 weeks.

    Number of subjects in period 1
    UCB5857
    Started
    7
    Completed
    5
    Not completed
    2
         Adverse event, non-fatal
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    UCB5857
    Reporting group description
    UCB5857 capsules were supplied at doses of 5 mg, 15 mg, and 30 mg, depending on body weight, to allow a flexible dosing regimen by combining the capsule strengths. The study investigational medicinal product (IMP) was administered orally, once per day, in the morning, during a 12-week Treatment Period.

    Reporting group values
    UCB5857 Total
    Number of subjects
    7 7
    Age categorical
    Units: Subjects
        <=18 years
    6 6
        Between 18 and 65 years
    1 1
        >=65 years
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    15.7 ± 4.1 -
    Gender categorical
    Units: Subjects
        Male
    5 5
        Female
    2 2

    End points

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    End points reporting groups
    Reporting group title
    UCB5857
    Reporting group description
    UCB5857 capsules were supplied at doses of 5 mg, 15 mg, and 30 mg, depending on body weight, to allow a flexible dosing regimen by combining the capsule strengths. The study investigational medicinal product (IMP) was administered orally, once per day, in the morning, during a 12-week Treatment Period.

    Subject analysis set title
    UCB5857 (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    At least one dose of UCB5857 capsules was administered orally to all subjects forming the Safety Set (SS), once per day during a 12-week Treatment Period, supplied at doses of 5 mg, 15 mg, and 30 mg, depending on body weight, to allow a flexible dosing regimen by combining the capsule strengths.

    Subject analysis set title
    UCB5857 (PKS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    At least one dose of UCB5857 capsules was administered orally to all subjects forming the Pharmacokinetic Set (PKS), once per day during a 12-week Treatment Period, supplied at doses of 5 mg, 15 mg, and 30 mg, depending on body weight, to allow a flexible dosing regimen by combining the capsule strengths. Subjects had at least 1 measurable plasma concentration available of the UCB5857 investigational medicinal product.

    Primary: The total number of subjects experiencing at least one Treatment Emergent Adverse Event during the study

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    End point title
    The total number of subjects experiencing at least one Treatment Emergent Adverse Event during the study [1]
    End point description
    Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
    End point type
    Primary
    End point timeframe
    Baseline to week 16
    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: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    UCB5857 (SS)
    Number of subjects analysed
    7
    Units: Subjects
        Subjects
    7
    No statistical analyses for this end point

    Primary: The total number of subjects experiencing at least one Serious Adverse Event during the study

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    End point title
    The total number of subjects experiencing at least one Serious Adverse Event during the study [2]
    End point description
    A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.
    End point type
    Primary
    End point timeframe
    Baseline to week 16
    Notes
    [2] - 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: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
    End point values
    UCB5857 (SS)
    Number of subjects analysed
    7
    Units: Subjects
        Subjects
    3
    No statistical analyses for this end point

    Secondary: Plasma Concentration of UCB5857 at Baseline Visit, 15-30 minutes post-dose

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    End point title
    Plasma Concentration of UCB5857 at Baseline Visit, 15-30 minutes post-dose
    End point description
    UCB5857 concentration in plasma was expressed in nanograms per milliliter (ng/mL) as measured by a validated high-performance liquid chromatography method with tandem mass spectrometry (HPLC-MS). Summary statistics (except for n, Min, and Max) were only performed if at least 2/3 of the concentrations were quantified at the respective time-point. *Note: -9999 is a placeholder value that replaced missing or bellow limit of quantification values
    End point type
    Secondary
    End point timeframe
    Baseline Visit, 15-30 minutes post-dose
    End point values
    UCB5857 (PKS)
    Number of subjects analysed
    7
    Units: ng/mL
    median (full range (min-max))
        15-30 minutes
    -9999 (-9999 to 127)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of UCB5857 at Baseline Visit, 2-4 hours post-dose

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    End point title
    Plasma Concentration of UCB5857 at Baseline Visit, 2-4 hours post-dose
    End point description
    UCB5857 concentration in plasma was expressed in nanograms per milliliter (ng/mL) as measured by a validated high-performance liquid chromatography method with tandem mass spectrometry (HPLC-MS). Summary statistics (except for n, Min, and Max) were only performed if at least 2/3 of the concentrations were quantified at the respective time-point.
    End point type
    Secondary
    End point timeframe
    Baseline Visit, 2-4 hours post-dose
    End point values
    UCB5857 (PKS)
    Number of subjects analysed
    7
    Units: ng/mL
    median (full range (min-max))
        2-4 hours
    988 (256 to 1650)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of UCB5857 at Baseline Visit, 24 hours post-dose

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    End point title
    Plasma Concentration of UCB5857 at Baseline Visit, 24 hours post-dose
    End point description
    UCB5857 concentration in plasma was expressed in nanograms per milliliter (ng/mL) as measured by a validated high-performance liquid chromatography method with tandem mass spectrometry (HPLC-MS). Summary statistics (except for n, Min, and Max) were only performed if at least 2/3 of the concentrations were quantified at the respective time-point.
    End point type
    Secondary
    End point timeframe
    Baseline Visit, 24 hours post-dose
    End point values
    UCB5857 (PKS)
    Number of subjects analysed
    7
    Units: ng/mL
    median (full range (min-max))
        24 hours
    271 (75.7 to 735)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of UCB5857 at Week 2, pre-dose

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    End point title
    Plasma Concentration of UCB5857 at Week 2, pre-dose
    End point description
    UCB5857 concentration in plasma was expressed in nanograms per milliliter (ng/mL) as measured by a validated high-performance liquid chromatography method with tandem mass spectrometry (HPLC-MS). Summary statistics (except for n, Min, and Max) were only performed if at least 2/3 of the concentrations were quantified at the respective time-point.
    End point type
    Secondary
    End point timeframe
    Week 2, pre-dose
    End point values
    UCB5857 (PKS)
    Number of subjects analysed
    7
    Units: ng/mL
    median (full range (min-max))
        pre-dose
    435 (128 to 814)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of UCB5857 at Week 2, 2-4 hours post-dose

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    End point title
    Plasma Concentration of UCB5857 at Week 2, 2-4 hours post-dose
    End point description
    UCB5857 concentration in plasma was expressed in nanograms per milliliter (ng/mL) as measured by a validated high-performance liquid chromatography method with tandem mass spectrometry (HPLC-MS). Summary statistics (except for n, Min, and Max) were only performed if at least 2/3 of the concentrations were quantified at the respective time-point.
    End point type
    Secondary
    End point timeframe
    Week 2, 2-4 hours post-dose
    End point values
    UCB5857 (PKS)
    Number of subjects analysed
    7
    Units: ng/mL
    median (full range (min-max))
        2-4 hours
    1170 (781 to 1500)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of UCB5857 at Week 6, pre-dose

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    End point title
    Plasma Concentration of UCB5857 at Week 6, pre-dose
    End point description
    UCB5857 concentration in plasma was expressed in nanograms per milliliter (ng/mL) as measured by a validated high-performance liquid chromatography method with tandem mass spectrometry (HPLC-MS). Summary statistics (except for n, Min, and Max) were only performed if at least 2/3 of the concentrations were quantified at the respective time-point.
    End point type
    Secondary
    End point timeframe
    Week 6, pre-dose
    End point values
    UCB5857 (PKS)
    Number of subjects analysed
    5
    Units: ng/mL
    median (full range (min-max))
        pre-dose
    532 (307 to 1140)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of UCB5857 at Week 6, 2-4 hours post-dose

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    End point title
    Plasma Concentration of UCB5857 at Week 6, 2-4 hours post-dose
    End point description
    UCB5857 concentration in plasma was expressed in nanograms per milliliter (ng/mL) as measured by a validated high-performance liquid chromatography method with tandem mass spectrometry (HPLC-MS). Summary statistics (except for n, Min, and Max) were only performed if at least 2/3 of the concentrations were quantified at the respective time-point.
    End point type
    Secondary
    End point timeframe
    Week 6, 2-4 hours post-dose
    End point values
    UCB5857 (PKS)
    Number of subjects analysed
    6
    Units: ng/mL
    median (full range (min-max))
        2-4 hours
    1111 (640 to 1910)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of UCB5857 at Week 12, pre-dose

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    End point title
    Plasma Concentration of UCB5857 at Week 12, pre-dose
    End point description
    UCB5857 concentration in plasma was expressed in nanograms per milliliter (ng/mL) as measured by a validated high-performance liquid chromatography method with tandem mass spectrometry (HPLC-MS). Summary statistics (except for n, Min, and Max) were only performed if at least 2/3 of the concentrations were quantified at the respective time-point.
    End point type
    Secondary
    End point timeframe
    Week 12, pre-dose
    End point values
    UCB5857 (PKS)
    Number of subjects analysed
    5
    Units: ng/mL
    median (full range (min-max))
        pre-dose
    345 (309 to 1240)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of UCB5857 at Week 12, 15-30 minutes post-dose

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    End point title
    Plasma Concentration of UCB5857 at Week 12, 15-30 minutes post-dose
    End point description
    UCB5857 concentration in plasma was expressed in nanograms per milliliter (ng/mL) as measured by a validated high-performance liquid chromatography method with tandem mass spectrometry (HPLC-MS). Summary statistics (except for n, Min, and Max) were only performed if at least 2/3 of the concentrations were quantified at the respective time-point.
    End point type
    Secondary
    End point timeframe
    Week 12, 15-30 minutes post-dose
    End point values
    UCB5857 (PKS)
    Number of subjects analysed
    5
    Units: ng/mL
    median (full range (min-max))
        15-30 minutes
    460 (339 to 1200)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of UCB5857 at Week 12, 2-4 hours post-dose

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    End point title
    Plasma Concentration of UCB5857 at Week 12, 2-4 hours post-dose
    End point description
    UCB5857 concentration in plasma was expressed in nanograms per milliliter (ng/mL) as measured by a validated high-performance liquid chromatography method with tandem mass spectrometry (HPLC-MS). Summary statistics (except for n, Min, and Max) were only performed if at least 2/3 of the concentrations were quantified at the respective time-point.
    End point type
    Secondary
    End point timeframe
    Week 12, 2-4 hours post-dose
    End point values
    UCB5857 (PKS)
    Number of subjects analysed
    5
    Units: ng/mL
    median (full range (min-max))
        2-4 hours
    892 (683 to 1740)
    No statistical analyses for this end point

    Secondary: Plasma Concentration of UCB5857 at Week 12, 24 hours post-dose

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    End point title
    Plasma Concentration of UCB5857 at Week 12, 24 hours post-dose
    End point description
    UCB5857 concentration in plasma was expressed in nanograms per milliliter (ng/mL) as measured by a validated high-performance liquid chromatography method with tandem mass spectrometry (HPLC-MS). Summary statistics (except for n, Min, and Max) were only performed if at least 2/3 of the concentrations were quantified at the respective time-point. *Note: 999 is a placeholder value, as mean concentration was not calculated.
    End point type
    Secondary
    End point timeframe
    Week 12, 24 hours post-dose
    End point values
    UCB5857 (PKS)
    Number of subjects analysed
    4
    Units: ng/mL
    median (full range (min-max))
        24 hours
    999 (671 to 2090)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to week 24
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    UCB5857 (SS)
    Reporting group description
    At least one dose of UCB5857 capsules was administered orally to all subjects forming the Safety Set (SS), once per day during a 12-week Treatment Period, supplied at doses of 5 mg, 15 mg, and 30 mg, depending on body weight, to allow a flexible dosing regimen by combining the capsule strengths.

    Serious adverse events
    UCB5857 (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 7 (42.86%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    UCB5857 (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Vessel puncture site haematoma
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Dyspnoea
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Weight increased
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    3
    Aphonia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Splenomegaly
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Ear discomfort
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Gastrointestinal disorders
    Aphthous ulcer
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Stomatitis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Arthritis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Tendon disorder
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    3
    Rhinitis
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Sinusitis
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Abscess
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Ear infection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Increased appetite
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2016
    Protocol Amendment 2 was implemented to prohibit the co-administration of known P-glycoprotein (PGP) inhibitors with UCB5857. Since UCB5857 is likely (although not yet confirmed) to be a substrate of PGP, the possibility exists that UCB5857 might be susceptible to Pharmacokinetic (PK) interactions as a victim drug when co administered with a PGP inhibitor. In addition, subjects were required to remain at the site for 24 hours after their first dose of Investigational Medicinal Product (IMP) at Baseline (Visit 2). Subjects were observed as a safety precaution, and had vital signs and electrocardiogram (ECG) recordings taken, in addition to obtaining 24 hour blood samples for PK and phospho-S6 ribosomal protein (p-S6) measurements.
    05 Apr 2017
    Protocol Amendment 4, provided the following key changes: •Modified the restriction regarding PGP inhibitors and removed the table of PGP inhibitors from the protocol based on newly available nonclinical data •Added procedures for assessment and management of Tuberculosis (TB) in order to comply with the UCB policy applied to all UCB-sponsored studies (excluding noninterventional studies) that include subjects with immunological diseases, who are at increased risk of TB infection either associated with the IMP, underlying disease, concomitant treatments, or other medical or sociological factors •Aligned local versions of the protocol into a single global version •Added guidance on Adverse Events Of Interest (AEOI), management of AEOI, and immediate reporting of Adverse Events (AEs)

    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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