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    Clinical Trial Results:
    A Multicenter, Randomized, Blinded, Parallel Group, Interchangeability Study in Moderate to Severe Chronic Plaque Psoriasis evaluating Pharmacokinetics, Efficacy, Safety, and Immunogenicity Between Subjects Receiving Humira® Pre-filled syringe (40 mg/0.4 mL) Continuously and Subjects Undergoing Repeated Switches Between Humira® Pre-filled Syringe (40 mg/0.4mL) and Hulio Pre-filled Syringe (40 mg/0.8 mL)

    Summary
    EudraCT number
    		 2021-006015-29
    Trial protocol
    		 CZ   EE   BG   PL  
    Global end of trial date
    19 Sep 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Feb 2025
    First version publication date
    20 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ADA-IJZ-3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05637515
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biocon Biologics Limited (Study taken over from Mylan)
    Sponsor organisation address
    Electronic City phase II, , Bangalore, India, 560100
    Public contact
    Dr. Jayanti Panda, Biocon Biologics Limited, Jayanti.Panda@biocon.com
    Scientific contact
    Dr. Sarika S Deodhar, Biocon Biologics Limited, Sarika.Deodhar@biocon.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
    19 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Sep 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate interchangeability of Hulio and Humira by examining adalimumab steady-state PK in a switching arm (following 3 switches between Humira and Hulio) as compared to a non-switching arm (receiving only Humira).
    Protection of trial subjects
    This study was conducted in accordance with the principles of ICH GCP, applicable regulatory requirements and Sponsor/CRO Standard Operating Procedures. The study followed the recommendations of ICH GCP R2 with quality oversight provided by the sponsor to ensure human subject protection and the reliability of trial results. Quality was ensured through the designing, conducting, recording, and reporting of the study. The subjects were enrolled in the trial after the informed consent process
    Background therapy
    		 -
    Evidence for comparator
    		 Humira(R) is approved product in EU and FDA. Hulio is a monoclonal antibody currently approved as a biosimilar to the European Union approved and United States (US)-Licensed Humira. The study is designed to confirm the pharmacokinetic equivalence of alternating between the use of Humira and Hulio and Humira without such alternation or switch, in accordance with the US Food and Drug Administration Guidance for Industry, Considerations in Demonstrating Interchangeability with a Reference product . Based on this, Hulio is investigated against Humira as a comparator.
    Actual start date of recruitment
    05 Dec 2022
    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
    Czechia: 62
    Country: Number of subjects enrolled
    Poland: 212
    Country: Number of subjects enrolled
    Bulgaria: 91
    Country: Number of subjects enrolled
    Estonia: 9
    Worldwide total number of subjects
    374
    EEA total number of subjects
    374
    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)
    332
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 386 subjects were enrolled to Runin period at Week 1, all subjects were treated with Humira for 11 weeks. 374 subjects were randomized into randomized interchangeable treatment period which comprised of 2 groups: Group 1(N=193) continued receiving Humira until Week 26; While subjects in Group 2(N=181),went multiple switches until Week 26

    Pre-assignment
    Screening details
    		 A total of 479 subjects were screened; 93 were screen failures. The reasons for screen failure were, 66 subjects did not meet eligibility criteria, 16 subjects withdrew consent, 5 subjects were withdrawn based on Sponsor’s decision, and 6 subjects due to other reasons

    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
    		 Investigator, Monitor, Assessor, Subject
    Blinding implementation details
    This was a double-blind randomised trial. except for the designated site monitor responsible for unblinded monitoring, everyone in the trial was blinded until after completion of the trial and the final blinded data review.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Humira non-switching treatment arm (Group 1).
    Arm description
    		 Subjects continue to receive Humira (40 mg every other week) until Week 26/Visit 14.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Humira
    Investigational medicinal product code
    Adalimumab
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg in 0.4 mL Subcutaneous injection in pre-filled syringe

    Arm title
    		 Hulio and Humira switching arm (Group 2)
    Arm description
    		 Subjects undergo repeated switches between Humira and Hulio between week 12 to week26. - Hulio (40 mg every other week) at Week 12 and Week14 - Humira (40 mg every other week) at Week 16 and Week18, and - Hulio (40 mg every other week) at Week 20, Week 22,Week 24 and Week26.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hulio
    Investigational medicinal product code
    Adalimumab
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg in 0.8 mL Subcutaneous injection in pre-filled syringe

    Investigational medicinal product name
    Humira
    Investigational medicinal product code
    Adalimumab
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40 mg in 0.4 mL Subcutaneous injection in pre-filled syringe

    Number of subjects in period 1
    		Humira non-switching treatment arm (Group 1). Hulio and Humira switching arm (Group 2)
    Started
    193
    181
    Completed
    176
    164
    Not completed
    17
    17
         Adverse event, serious fatal
    -
    1
         Physician decision
    2
    -
         Adverse event, non-fatal
    1
    1
         Other reasons
    14
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Humira non-switching treatment arm (Group 1).
    Reporting group description
    		 Subjects continue to receive Humira (40 mg every other week) until Week 26/Visit 14.

    Reporting group title
    Hulio and Humira switching arm (Group 2)
    Reporting group description
    		 Subjects undergo repeated switches between Humira and Hulio between week 12 to week26. - Hulio (40 mg every other week) at Week 12 and Week14 - Humira (40 mg every other week) at Week 16 and Week18, and - Hulio (40 mg every other week) at Week 20, Week 22,Week 24 and Week26.

    Reporting group values
    		 Humira non-switching treatment arm (Group 1). Hulio and Humira switching arm (Group 2) Total
    Number of subjects
    		 193 181 374
    Age categorical
    the demographic profile was balanced between the treatment groups with respect to age, gender, race, and ethnic origin.
    Units: Subjects
        Adults (18-64 years)
    		 173 157 330
        From 65-84 years
    		 20 22 42
        <=18 years
    		 0 2 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.4 ( 12.86 ) 45.7 ( 13.40 ) -
    Gender categorical
    Units: Subjects
        Female
    		 61 69 130
        Male
    		 132 112 244
    Subject analysis sets

    Subject analysis set title
    Full Analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis set

    Subject analysis sets values
    		 Full Analysis set
    Number of subjects
    374
    Age categorical
    the demographic profile was balanced between the treatment groups with respect to age, gender, race, and ethnic origin.
    Units: Subjects
        Adults (18-64 years)
    330
        From 65-84 years
    42
        <=18 years
    2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    46.0 ( 13.11) )
    Gender categorical
    Units: Subjects
        Female
    130
        Male
    244

    End points

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    End points reporting groups
    Reporting group title
    Humira non-switching treatment arm (Group 1).
    Reporting group description
    		 Subjects continue to receive Humira (40 mg every other week) until Week 26/Visit 14.

    Reporting group title
    Hulio and Humira switching arm (Group 2)
    Reporting group description
    		 Subjects undergo repeated switches between Humira and Hulio between week 12 to week26. - Hulio (40 mg every other week) at Week 12 and Week14 - Humira (40 mg every other week) at Week 16 and Week18, and - Hulio (40 mg every other week) at Week 20, Week 22,Week 24 and Week26.

    Subject analysis set title
    Full Analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis set

    Primary: Pharmacokinetics-AUC, Cmax, Cmin

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    End point title
    		 Pharmacokinetics-AUC, Cmax, Cmin
    End point description
    End point type
    Primary
    End point timeframe
    Week 26 - 28
    End point values
    		 Humira non-switching treatment arm (Group 1). Hulio and Humira switching arm (Group 2)
    Number of subjects analysed
    166
    159
    Units: ug/mL
        arithmetic mean (standard deviation)
    7.69 ( 4.96 )
    8.46 ( 5.42 )
    Statistical analysis title
    		 Statistical Analysis 1_AUCÏ„, 26-28
    Comparison groups
    Humira non-switching treatment arm (Group 1). v Hulio and Humira switching arm (Group 2)
    Number of subjects included in analysis
    325
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    104.76
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 98.23
         upper limit
    		 111.74
    Statistical analysis title
    		 Statistical Analysis 2_Cmax, 26-28
    Comparison groups
    Humira non-switching treatment arm (Group 1). v Hulio and Humira switching arm (Group 2)
    Number of subjects included in analysis
    325
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    104.23
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 95.85
         upper limit
    		 113.36
    Statistical analysis title
    		 Statistical Analysis Cmin, 26-28
    Comparison groups
    Hulio and Humira switching arm (Group 2) v Humira non-switching treatment arm (Group 1).
    Number of subjects included in analysis
    325
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    107.85
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 99.99
         upper limit
    		 116.37

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Till 30 Weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 -

    Reporting group title
    Group 2
    Reporting group description
    		 -

    Serious adverse events
    		 Group 1 Group 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 193 (1.55%)
    3 / 181 (1.66%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Multiple fractures
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vestibular neuronitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group 1 Group 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 193 (34.20%)
    54 / 181 (29.83%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 193 (2.07%)
    1 / 181 (0.55%)
         occurrences all number
    4
    1
    Phlebitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Intraocular lens implant
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    3 / 193 (1.55%)
    3 / 181 (1.66%)
         occurrences all number
    10
    4
    Injection site pain
         subjects affected / exposed
    4 / 193 (2.07%)
    1 / 181 (0.55%)
         occurrences all number
    6
    1
    Injection site pruritus
         subjects affected / exposed
    2 / 193 (1.04%)
    2 / 181 (1.10%)
         occurrences all number
    6
    4
    Injection site swelling
         subjects affected / exposed
    2 / 193 (1.04%)
    2 / 181 (1.10%)
         occurrences all number
    7
    2
    Injection site hypersensitivity
         subjects affected / exposed
    0 / 193 (0.00%)
    2 / 181 (1.10%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    1 / 193 (0.52%)
    1 / 181 (0.55%)
         occurrences all number
    3
    1
    Administration site erythema
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Administration site swelling
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Injection site bruising
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Panic attack
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 193 (2.59%)
    3 / 181 (1.66%)
         occurrences all number
    5
    4
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 193 (1.55%)
    3 / 181 (1.66%)
         occurrences all number
    3
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 193 (1.55%)
    2 / 181 (1.10%)
         occurrences all number
    4
    2
    Blood glucose increased
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 181 (0.00%)
         occurrences all number
    2
    0
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Monocyte count increased
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    2
    Traumatic fracture
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 193 (3.11%)
    4 / 181 (2.21%)
         occurrences all number
    8
    6
    Sciatica
         subjects affected / exposed
    0 / 193 (0.00%)
    2 / 181 (1.10%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Haematotoxicity
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Normocytic anaemia
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 193 (1.04%)
    2 / 181 (1.10%)
         occurrences all number
    2
    2
    Food poisoning
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Fatty liver alcoholic
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Hepatic steatosis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    3 / 193 (1.55%)
    2 / 181 (1.10%)
         occurrences all number
    3
    2
    Acne
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Dermatitis acneiform
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Palmoplantar pustulosis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Pustular psoriasis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Skin irritation
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 193 (0.52%)
    1 / 181 (0.55%)
         occurrences all number
    1
    1
    Acute kidney injury
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Dysuria
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Leukocyturia
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Proteinuria
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Renal cyst
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Renal failure
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 193 (1.04%)
    3 / 181 (1.66%)
         occurrences all number
    2
    5
    Back pain
         subjects affected / exposed
    1 / 193 (0.52%)
    3 / 181 (1.66%)
         occurrences all number
    1
    5
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 193 (0.00%)
    3 / 181 (1.66%)
         occurrences all number
    0
    3
    Arthropathy
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    11 / 193 (5.70%)
    4 / 181 (2.21%)
         occurrences all number
    11
    4
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 193 (2.07%)
    4 / 181 (2.21%)
         occurrences all number
    4
    4
    Pharyngitis
         subjects affected / exposed
    4 / 193 (2.07%)
    2 / 181 (1.10%)
         occurrences all number
    4
    2
    Rhinitis
         subjects affected / exposed
    3 / 193 (1.55%)
    1 / 181 (0.55%)
         occurrences all number
    3
    1
    Tonsillitis
         subjects affected / exposed
    2 / 193 (1.04%)
    2 / 181 (1.10%)
         occurrences all number
    2
    2
    Urinary tract infection
         subjects affected / exposed
    2 / 193 (1.04%)
    2 / 181 (1.10%)
         occurrences all number
    2
    2
    Influenza
         subjects affected / exposed
    1 / 193 (0.52%)
    2 / 181 (1.10%)
         occurrences all number
    1
    2
    Sinusitis
         subjects affected / exposed
    2 / 193 (1.04%)
    1 / 181 (0.55%)
         occurrences all number
    2
    1
    Oral herpes
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 181 (0.00%)
         occurrences all number
    2
    0
    Pulpitis dental
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 181 (0.00%)
         occurrences all number
    2
    0
    Bacteriuria
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Helicobacter infection
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Lyme disease
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Pseudomonas infection
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 181 (0.55%)
         occurrences all number
    0
    1
    Varicella zoster virus infection
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Skin candida
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Urinary casts
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Hyperlipidaemia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0
    Obesity
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 181 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Aug 2022
    ADA-IJZ-3001 - Protocol v2.0 dated 24 August 2022

    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.
    Not applicable
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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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