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    Clinical Trial Results:
    A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.

    Summary
    EudraCT number
    		 2016-001532-35
    Trial protocol
    		 HU   BG  
    Global end of trial date
    11 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Mar 2020
    First version publication date
    07 Mar 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    LRP/LNP1955/2016/002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lupin Ltd
    Sponsor organisation address
    46A/47A, Village Nande, Taluka Mulshi, Pune, India, 412115
    Public contact
    Project Director, Lupin Limited , Lupin Limited, +91 2067917368, chiragshah@lupin.com
    Scientific contact
    Project Director, Lupin Limited, Lupin Limited, +91 2067917368, 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 objective is to assess the proof of efficacy of LNP1955 and find an optimum dose in patients with moderate to severe rheumatoid arthritis (RA).
    Protection of trial subjects
    The study was conducted in accordance with the principles of the Declaration of Helsinki including amendments in force up to and including the time the study was conducted. The study was conducted in compliance with the International Conference on Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP) (Committee for Proprietary Medicinal Products (CPMP) guideline CPMP/ICH/135/95), and compliant with the European Union Clinical Trial Directive (EU CTD): Directive 2001/20/EC.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Oct 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
    Poland: 14
    Country: Number of subjects enrolled
    Bulgaria: 25
    Country: Number of subjects enrolled
    Hungary: 19
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    46
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 80 patients were screened for the study out of which 22 were screen failures and 58 were enrolled into the study. Among those, 48 were randomized in the main double-blind part and 10 patients on methotrexate (MTX) add-on part of the study.

    Pre-assignment
    Screening details
    		 A total of 80 patients were screened and 58 were enrolled into the study.

    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
    Blinding implementation details
    The Main part of the study was a randomized, double-blind, comparative, placebo-controlled, parallel-group. The MTX Add-on part was an open-label study. Based on ongoing safety monitoring & laboratory data, considerable number of patients from treated arms were observed to have elevations in Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) of >3 times normal. Therefore, in view of patients’ safety, unblinding of these was done by Sponsor.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Main Part: Placebo
    Arm description
    		 Twice daily (bid) dose of Matching placebo was administered orally.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo was administered twice daily (bid) orally for 12 weeks.

    Arm title
    		 Main Part: LNP1955 (40 mg)
    Arm description
    		 Twice daily (bid) dose of LNP1955 (40 mg) was administered orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LNP1955
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg of LNP 1955 was administered twice daily (bid) orally for 12 weeks.

    Arm title
    		 Main Part: LNP1955 (80 mg)
    Arm description
    		 Twice daily (bid) dose of LNP1955 (80 mg) was administered orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LNP1955
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    80 mg of LNP1955 was administered twice daily (bid) orally for 12 weeks.

    Arm title
    		 MTX Add-on part
    Arm description
    		 Twice daily (bid) dose of LNP1955 (40 mg) was administered orally. and a dose of 7.5 mg of methotrexate was administered orally (in 3 divided doses of 2.5 mg, approximately 12 hours apart) in a week.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LNP1955
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg of LNP 1955 was administered twice daily (bid) orally for 12 weeks.

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    A dose of 2.5 mg of methotrexate was administered orally once in a week for 12 weeks.

    Number of subjects in period 1
    		Main Part: Placebo Main Part: LNP1955 (40 mg) Main Part: LNP1955 (80 mg) MTX Add-on part
    Started
    16
    16
    16
    10
    Completed
    9
    8
    7
    8
    Not completed
    7
    8
    9
    2
         Consent withdrawn by subject
    -
    2
    2
    -
         Physician decision
    -
    -
    2
    1
         Adverse event, non-fatal
    1
    3
    1
    -
         Sponsor decision
    6
    3
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main Part: Placebo
    Reporting group description
    		 Twice daily (bid) dose of Matching placebo was administered orally.

    Reporting group title
    Main Part: LNP1955 (40 mg)
    Reporting group description
    		 Twice daily (bid) dose of LNP1955 (40 mg) was administered orally.

    Reporting group title
    Main Part: LNP1955 (80 mg)
    Reporting group description
    		 Twice daily (bid) dose of LNP1955 (80 mg) was administered orally.

    Reporting group title
    MTX Add-on part
    Reporting group description
    		 Twice daily (bid) dose of LNP1955 (40 mg) was administered orally. and a dose of 7.5 mg of methotrexate was administered orally (in 3 divided doses of 2.5 mg, approximately 12 hours apart) in a week.

    Reporting group values
    		 Main Part: Placebo Main Part: LNP1955 (40 mg) Main Part: LNP1955 (80 mg) MTX Add-on part Total
    Number of subjects
    		 16 16 16 10 58
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 13 11 10 46
        From 65-84 years
    		 4 3 5 0 12
    Gender categorical
    Units: Subjects
        Female
    		 12 12 13 9 46
        Male
    		 4 4 3 1 12

    End points

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    End points reporting groups
    Reporting group title
    Main Part: Placebo
    Reporting group description
    		 Twice daily (bid) dose of Matching placebo was administered orally.

    Reporting group title
    Main Part: LNP1955 (40 mg)
    Reporting group description
    		 Twice daily (bid) dose of LNP1955 (40 mg) was administered orally.

    Reporting group title
    Main Part: LNP1955 (80 mg)
    Reporting group description
    		 Twice daily (bid) dose of LNP1955 (80 mg) was administered orally.

    Reporting group title
    MTX Add-on part
    Reporting group description
    		 Twice daily (bid) dose of LNP1955 (40 mg) was administered orally. and a dose of 7.5 mg of methotrexate was administered orally (in 3 divided doses of 2.5 mg, approximately 12 hours apart) in a week.

    Primary: Proportion of patients achieving an American College of Rheumatology 20% (ACR20) response at Week 12.

    		 Close Top of page
    End point title
    		 Proportion of patients achieving an American College of Rheumatology 20% (ACR20) response at Week 12. [1]
    End point description
    Efficacy & PD was not analyzed, as the study was terminated by the sponsor due to safety reasons
    End point type
    Primary
    End point timeframe
    American College of Rheumatology 20% (ACR20) response at Week 12.
    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, considerable 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
    		 Main Part: Placebo Main Part: LNP1955 (40 mg) Main Part: LNP1955 (80 mg) MTX Add-on part
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    Units: Numbers
    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

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs), vital signs, Physical examination were evaluated up to 12 weeks of treatment and follow-up period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Main Part: Placebo
    Reporting group description
    		 Twice daily (bid) dose of Matching placebo was administered orally.

    Reporting group title
    Main Part: LNP1955 (40 mg)
    Reporting group description
    		 Twice daily (bid) dose of LNP1955 (40 mg) was administered orally.

    Reporting group title
    Main Part: LNP1955 (80 mg)
    Reporting group description
    		 Twice daily (bid) dose of LNP1955 (80 mg) was administered orally.

    Reporting group title
    MTX Add-on part
    Reporting group description
    		 Twice daily (bid) dose of LNP1955 (40 mg) was administered orally. and a dose of 7.5 mg of methotrexate was administered orally (in 3 divided doses of 2.5 mg, approximately 12 hours apart) in a week.

    Serious adverse events
    		 Main Part: Placebo Main Part: LNP1955 (40 mg) Main Part: LNP1955 (80 mg) MTX Add-on part
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    1
    0
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 10 (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
    Septic shock
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Main Part: Placebo Main Part: LNP1955 (40 mg) Main Part: LNP1955 (80 mg) MTX Add-on part
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 16 (31.25%)
    11 / 16 (68.75%)
    9 / 16 (56.25%)
    5 / 10 (50.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 16 (0.00%)
    3 / 16 (18.75%)
    0 / 16 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    4
    0
    0
    Arteriosclerosis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Persistent depressive disorder
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Neutrophil count increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    4 / 16 (25.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    2
    4
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    4 / 16 (25.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    4
    1
    Blood cholesterol increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Monocyte count decreased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Transaminases increased
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Cardiomegaly
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Microcytic anaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Lymphopenia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Eosinophilia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye disorders
    Swelling of eyelid
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    2 / 16 (12.50%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Flatulence
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Chronic gastritis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cholelithiasis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Alopecia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Laryngitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ascariasis
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Septic shock
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1

    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 considerable number of patients reported elevations in AST/ALT in active treatments arms hence, study was terminated prematurely in view of patient's safety.
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    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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