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    Clinical Trial Results:
    A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, and Safety of LNP1955 in Patients with Moderate-to-Severe Plaque Psoriasis

    Summary
    EudraCT number
    		 2016-001531-12
    Trial protocol
    		 HU  
    Global end of trial date
    11 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Mar 2019
    First version publication date
    08 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LRP/LNP1955/2016/003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lupin Limited
    Sponsor organisation address
    46A/47A, Nande, Pune, India, 412115
    Public contact
    Project Director, Lupin Limited, 0091 20 66749068, chiragshah@lupin.com
    Scientific contact
    Project Director, Lupin Limited, 0091 20 66749068, chiragshah@lupin.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
    11 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Oct 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of the study are as follows: • To assess the POE of LNP1955 and find an optimum dose in patients with moderate-to-severe plaque psoriasis
    Protection of trial subjects
    To alleviate the symptoms of Psoriasis, patients were allowed to use topical emollients, moisturizers, and shampoos without anti-psoriatic ingredients during the study period, antihistamines were also allowed as per investigators' discretion. In combination arm, along with methotrexate therapy, folic acid was allowed to be administered to avoid folate deficiency. Based on review of ongoing safety monitoring of this study of LNP1955 conducted in Psoriasis (N=35 patients) in Europe, a significant number of patients reported elevations in AST/ALT; unblinding was done for these patients and it was observed that all patients belonged to active treatment arms, thus indicating an unfavorable risk: benefit ratio. Such a potential risk for liver enzyme elevation is undesirable in a non-life-threatening condition such as psoriasis, which was one of the target indications for LNP1955. In light of this cumulative assessment and keeping patient safety in mind, Sponsor decided to terminate this study of LNP1955 with due conscientiousness towards scientific rigor & commitment towards developing safe and effective research products.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Sep 2016
    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
    Hungary: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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)
    31
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 48 patients were screened for the study out of which 13 patients were screen failures and of these patients 35 were randomized/ enrolled in the main and Add on part of the study. Among those, 27 patients were randomized in Main double blind part and 8 patients on MTX add on part of the study.

    Pre-assignment
    Screening details
    		 Male/female ambulatory patients aged 18 to 75 years diagnosed with moderate to severe chronic stable plaque psoriasis with active disease for at least 6 months, with a PASI score of ≥10 & affected body surface area (BSA) ≥10% and who were candidates for phototherapy, photo-chemotherapy, or systemic therapy for plaque Psoriasis

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LNP1955 40 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    LNP1955
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Enteral use
    Dosage and administration details
    LNP1955 was administered orally two times a day for 12 weeks.

    Arm title
    		 LNP1955 80mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    LNP1955
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Enteral use
    Dosage and administration details
    LNP1955 was administered orally two times a day for 12 weeks.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo of LNP1955
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Enteral use
    Dosage and administration details
    Placebo of LNP1955 was administered orally two times a day for 12 weeks.

    Arm title
    		 LNP1955 40mg +MTX
    Arm description
    		 This arm was an open label MTX add on part.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LNP1955
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Enteral use
    Dosage and administration details
    LNP1955 40mg was administered orally two times a day for 12 weeks.

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    In the non-randomized, open label MTX Add on part of the study, patients received LNP1955 40 mg bid in combination with a fixed weekly dose of 7.5 mg of MTX administered orally in 3 divided doses of 2.5 mg approximately 12 hours apart.

    Number of subjects in period 1
    		LNP1955 40 mg LNP1955 80mg Placebo LNP1955 40mg +MTX
    Started
    10
    9
    8
    8
    Completed
    4
    6
    7
    8
    Not completed
    6
    3
    1
    0
         Physician decision
    2
    -
    -
    -
         Adverse event, non-fatal
    -
    1
    -
    -
         Sponsor decision
    4
    2
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LNP1955 40 mg
    Reporting group description
    		 -

    Reporting group title
    LNP1955 80mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    LNP1955 40mg +MTX
    Reporting group description
    		 This arm was an open label MTX add on part.

    Reporting group values
    		 LNP1955 40 mg LNP1955 80mg Placebo LNP1955 40mg +MTX Total
    Number of subjects
    		 10 9 8 8 35
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.9 ( 14.66 ) 39.8 ( 11.44 ) 45.3 ( 18.20 ) 46.1 ( 12.83 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2 1 1 6
        Male
    		 8 7 7 7 29

    End points

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    End points reporting groups
    Reporting group title
    LNP1955 40 mg
    Reporting group description
    		 -

    Reporting group title
    LNP1955 80mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    LNP1955 40mg +MTX
    Reporting group description
    		 This arm was an open label MTX add on part.

    Subject analysis set title
    LNP1955 40mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population includes patients who are randomized and received at least one dose of IP. Patients will be analyzed based on the treatment they actually received.

    Subject analysis set title
    LNP1955 80mg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population includes patients who are randomized and received at least one dose of IP. Patients will be analyzed based on the treatment they actually received.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population includes patients who are randomized and received at least one dose of IP. Patients will be analyzed based on the treatment they actually received.

    Subject analysis set title
    MTX add on arm
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population includes patients who are randomized and received at least one dose of IP. Patients will be analyzed based on the treatment they actually received.

    Primary: • The proportion of patients achieving at least 75% reduction (PASI 75) from baseline in PASI after 12 weeks of treatment.

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    End point title
    		 • The proportion of patients achieving at least 75% reduction (PASI 75) from baseline in PASI after 12 weeks of treatment. [1]
    End point description
    End point type
    Primary
    End point timeframe
    PASI score was assessed at each visit every 4 weeks until 12 weeks of treatment period.
    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: Based on ongoing safety monitoring of study a significant number of patients reported elevations in AST/ALT in active treatment arms, thus indicating an unfavorable risk: benefit ratio. Such a potential risk for liver enzyme elevation is undesirable. In light of this cumulative assessment and keeping patient safety in mind, Sponsor decided to prematurely terminate the study and hence efficacy analysis (primary and secondary), PK-PD analysis was not performed.
    End point values
    		 LNP1955 40 mg LNP1955 80mg Placebo LNP1955 40mg +MTX
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    Units: NA
    Notes
    [2] - No Efficacy analysis done for this study
    [3] - No Efficacy analysis done for this study
    [4] - No Efficacy analysis done for this study
    [5] - No Efficacy analysis done for this study
    No statistical analyses for this end point

    Secondary: Adevrse event assessment

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    End point title
    		 Adevrse event assessment
    End point description
    End point type
    Secondary
    End point timeframe
    Adverse event assessment is done at each visit until end of 12 weeks of treatment period and at follow up visit at 7 days after the end of treatment
    End point values
    		 LNP1955 40 mg LNP1955 80mg Placebo LNP1955 40mg +MTX LNP1955 40mg LNP1955 80mg Placebo MTX add on arm
    Number of subjects analysed
    10
    9
    8
    8
    10
    9
    8
    8
    Units: NA
    5
    5
    3
    3
    5
    5
    3
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs, regardless of severity, causality and whether or not they occur during the screening and washout period, treatment period of 12 weeks or FU period until 7 days after end of treatment,
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    LNP1955 40 mg
    Reporting group description
    		 -

    Reporting group title
    LNP1955 80mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    LNP1955 40mg +MTX
    Reporting group description
    		 This arm was an open label MTX add on part.

    Serious adverse events
    		 LNP1955 40 mg LNP1955 80mg Placebo LNP1955 40mg +MTX
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Drug use disorder
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 LNP1955 40 mg LNP1955 80mg Placebo LNP1955 40mg +MTX
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 10 (50.00%)
    5 / 9 (55.56%)
    2 / 8 (25.00%)
    3 / 8 (37.50%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin Papilloma
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    0
    1
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Hepatic Enzyme Increased
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Blood Pressure Increased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Electrocardiogram Qt Prolonged
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haematocrit Decreased
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lipids Increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    2
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 9 (22.22%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    2
    0
    0
    faeces soft
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Glossodynia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hepatobiliary disorders
    Hepatic Cyst
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psoriasis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Seborrhea
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal Cyst
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Fungal Infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oral Herpes
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Pyuria
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    1
    Herpes Simplex
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Cholesterosis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Based on ongoing safety monitoring significant number of patients reported elevations in AST/ALT in active treatments arms hence, study was terminated prematurely in view of patient's safety. Efficacy, PK, PD were thus not analyzed for this study.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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