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A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis

Sponsor
Bond Avillion 2 Development LP (Industry)
Overall Status
Completed
CT.gov ID
NCT03384745
Collaborator
Avillion LLP (Industry)
313
Enrollment
60
Locations
6
Arms
19.8
Actual Duration (Months)
5.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites in North America and Europe.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
313 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2b Randomized, Double-blind, Placebo Controlled, Multi-center 12-week Study With an Additional 40-week Follow-up Assessment of Efficacy, Safety and Tolerability of M1095 in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Actual Study Start Date :
Jul 31, 2018
Actual Primary Completion Date :
Jun 20, 2019
Actual Study Completion Date :
Mar 26, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: M1095 (Sonelokimab) 30mg

M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

Drug: M1095 (Sonelokimab)
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
Other Names:
  • Sonelokimab

    		•
    Experimental: M1095 (Sonelokimab) 60mg

    M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

    Drug: M1095 (Sonelokimab)
    M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
    Other Names:
  • Sonelokimab

    		•
    Experimental: M1095 (Sonelokimab) 120mg - regimen 1

    M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.

    Drug: M1095 (Sonelokimab)
    M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
    Other Names:
  • Sonelokimab

    		•
    Experimental: M1095 (Sonelokimab) 120mg - regimen 2

    M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.

    Drug: M1095 (Sonelokimab)
    M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
    Other Names:
  • Sonelokimab

    		•
    Placebo Comparator: Placebo / M1095 (Sonelokimab) 120mg

    Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks.

    Drug: M1095 (Sonelokimab)
    M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
    Other Names:
  • Sonelokimab

    • Drug: Placebo
    Placebo contains no active drug.
    Active Comparator: Secukinumab

    Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.

    Drug: Secukinumab
    Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
    Other Names:
  • Cosentyx®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 [Week 12, as compared to Week 0 (baseline)]

      The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.

    Secondary Outcome Measures

    1. Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis) [Week 12, as compared to Week 0 (baseline)]

      PASI 100, i.e. a subject's psoriasis has completely cleared at Week 12, compared to baseline.

    2. Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis) [Week 12, as compared to baseline]

      PASI 90, i.e. a subject's psoriasis has cleared by 90% at Week 12, compared to baseline

    3. Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis) [Week 12, as compared to Week 0 (baseline)]

      PASI 75, i.e. a subject's psoriasis has cleared by 75% at Week 12, compared to baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male and female subjects between 18 and 75 years of age.

    2. Moderate to severe plaque-type psoriasis for at least 6 months.

    3. Subject is a candidate for systemic biologic therapy.

    4. Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline.

    5. Subject is able to comply with the study procedures.

    6. Subject must provide informed consent.

    Exclusion Criteria (Main):

    1. Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed).

    2. Other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. Subjects will be screened for tuberculosis and hepatitis B / hepatitis C.

    3. Laboratory abnormalities at screening, as defined in the study protocol.

    4. Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.

    5. Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.

    6. History of suicidal thoughts within 12 months.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigative Site Birmingham Alabama United States 35205
    2 Investigative Site San Diego California United States 92123
    3 Investigative Site DeLand Florida United States 32720
    4 Investigative Site Sandy Springs Georgia United States 30328
    5 Investigative Site Saint Louis Missouri United States 63117
    6 Investigative Site Albuquerque New Mexico United States 87102
    7 Investigative Site New York New York United States 10029
    8 Investigative Site Bexley Ohio United States 43209
    9 Investigative Site Dallas Texas United States 75246
    10 Investigative Site Houston Texas United States 77004
    11 Investigative Site San Antonio Texas United States 78229
    12 Investigative Site Dupnitsa Bulgaria 2600
    13 Investigative Site Sofia Bulgaria 1431
    14 Investigative Site Varna Bulgaria 9010
    15 Investigative Site Edmonton Alberta Canada T5K 1X3
    16 Investigative Site Surrey British Columbia Canada V3R 6A7
    17 Investigative Site Surrey British Columbia Canada V3V 0C6
    18 Investigative Site Markham Ontario Canada L3P 1X2
    19 Investigative Site North Bay Ontario Canada P1B 3Z7
    20 Investigative Site Oakville Ontario Canada L6J 7W5
    21 Investigative Site Ottawa Ontario Canada K2G 6E2
    22 Investigative Site Richmond Hill Ontario Canada L4B 1A5
    23 Investigative Site Waterloo Ontario Canada N2J 1C4
    24 Investigative Site Windsor Ontario Canada N8W 1E6
    25 Investigative Site Quebec City Quebec Canada G1V 4X7
    26 Investigative Site Brno Czechia 602 00
    27 Investigative Site Nový Jičín Czechia 741 01
    28 Investigative Site Náchod Czechia 547 01
    29 Investigative Site Ostrava Czechia 702 00
    30 Investigative Site Ostrava Czechia 708 52
    31 Investigative Site Pardubice Czechia 530 02
    32 Investigative Site Praha Czechia 130 00
    33 Investigative Site Uherské Hradiště Czechia 686 01
    34 Investigative Site Augsburg Germany 86179
    35 Investigative Site Berlin Germany 10789
    36 Investigative Site Bochum Germany 44793
    37 Investigative Site Darmstadt Germany 64297
    38 Investigative Site Frankfurt/Main Germany 60590
    39 Investigative Site Friedrichshafen Germany 88045
    40 Investigative Site Hamburg Germany 20354
    41 Investigative Site Kiel Germany 24105
    42 Investigative Site Mahlow Germany 15831
    43 Investigative Site Mainz Germany 55131
    44 Investigative Site Osnabrück Germany 49074
    45 Investigative Site Quedlinburg Germany 06484
    46 Investigative Site Schwerin Germany 19055
    47 Investigative Site Budapest Hungary 1085
    48 Investigative Site Budapest Hungary 1135
    49 Investigative Site Kecskemét Hungary 6000
    50 Investigative Site Orosháza Hungary 5900
    51 Investigative Site Szeged Hungary 6720
    52 Investigative Site Szolnok Hungary 5000
    53 Investigative Site Katowice Poland 40-060
    54 Investigative Site Lublin Poland 20-314
    55 Investigative Site Poznań Poland 60-848
    56 Investigative Site Siedlce Poland 08-110
    57 Investigative Site Skierniewice Poland 96-100
    58 Investigative Site Warszawa Poland 02-507
    59 Investigative Site Warszawa Poland 02-777
    60 Investigative Site Warszawa Poland 04-141

    Sponsors and Collaborators

    • Bond Avillion 2 Development LP
    • Avillion LLP

    Investigators

    • Principal Investigator: Dr. Kim Papp, Probity Medical Research Inc

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Bond Avillion 2 Development LP
    ClinicalTrials.gov Identifier:
    NCT03384745
    Other Study ID Numbers:
    • AV002
    First Posted:
    Dec 27, 2017
    Last Update Posted:
    Aug 3, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    Participant Flow

    Recruitment Details Subjects were adults aged 18-75 years with stable, moderate to severe plaque type psoriasis for >6 months prior to randomisation, and who were candidates for systemic biologic therapy.
    Pre-assignment Detail
    Arm/Group Title M1095 30mg M1095 60mg M1095 120mg - Regimen 1 M1095 120mg - Regimen 2 Placebo / M1095 120mg Secukinumab
    Arm/Group Description M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. Subjects with IGA>1 at Week 12 were escalated to receive M1095, 120mg M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. Subjects with IGA>1 at Week 12 were escalated to receive M1095, 120mg M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Placebo: Placebo contains no active drug. Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
    Period Title: Placebo Controlled Induction (W0 - W12)
    STARTED 52 52 53 51 52 53
    COMPLETED 52 51 50 49 49 51
    NOT COMPLETED 0 1 3 2 3 2
    Period Title: Placebo Controlled Induction (W0 - W12)
    STARTED 52 51 50 49 49 51
    COMPLETED 52 51 49 47 47 51
    NOT COMPLETED 0 0 1 2 2 0
    Period Title: Placebo Controlled Induction (W0 - W12)
    STARTED 52 51 49 47 47 51
    COMPLETED 51 48 45 43 46 49
    NOT COMPLETED 1 3 4 4 1 2

    Baseline Characteristics

    Arm/Group Title M1095 30mg M1095 60mg M1095 120mg - Regimen 1 M1095 120mg - Regimen 2 Placebo / M1095 120mg Secukinumab Total
    Arm/Group Description M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Placebo: Placebo contains no active drug. Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A. Total of all reporting groups
    Overall Participants 52 52 53 51 52 53 313
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    48.2
    (13.4)
    46.9
    (12.3)
    44.1
    (13.1)
    43.2
    (13.2)
    45.9
    (12.9)
    47.5
    (13.8)
    46.0
    (13.1)
    Sex: Female, Male (Count of Participants)
    Female
    36
    69.2%
    38
    73.1%
    43
    81.1%
    34
    66.7%
    39
    75%
    38
    71.7%
    228
    72.8%
    Male
    16
    30.8%
    14
    26.9%
    10
    18.9%
    17
    33.3%
    13
    25%
    15
    28.3%
    85
    27.2%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    4
    7.7%
    3
    5.8%
    3
    5.7%
    2
    3.9%
    1
    1.9%
    2
    3.8%
    15
    4.8%
    Not Hispanic or Latino
    48
    92.3%
    49
    94.2%
    50
    94.3%
    49
    96.1%
    51
    98.1%
    51
    96.2%
    298
    95.2%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    1.9%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.3%
    Asian
    2
    3.8%
    1
    1.9%
    8
    15.1%
    2
    3.9%
    6
    11.5%
    3
    5.7%
    22
    7%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    1
    1.9%
    0
    0%
    2
    3.9%
    2
    3.8%
    1
    1.9%
    6
    1.9%
    White
    49
    94.2%
    48
    92.3%
    45
    84.9%
    47
    92.2%
    44
    84.6%
    49
    92.5%
    282
    90.1%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    1.9%
    1
    1.9%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    0.6%
    Region of Enrollment (participants) [Number]
    Canada
    7
    13.5%
    9
    17.3%
    11
    20.8%
    9
    17.6%
    12
    23.1%
    11
    20.8%
    59
    18.8%
    Hungary
    6
    11.5%
    8
    15.4%
    6
    11.3%
    4
    7.8%
    5
    9.6%
    4
    7.5%
    33
    10.5%
    United States
    10
    19.2%
    7
    13.5%
    6
    11.3%
    5
    9.8%
    3
    5.8%
    5
    9.4%
    36
    11.5%
    Czechia
    13
    25%
    14
    26.9%
    13
    24.5%
    8
    15.7%
    16
    30.8%
    16
    30.2%
    80
    25.6%
    Poland
    8
    15.4%
    8
    15.4%
    7
    13.2%
    13
    25.5%
    5
    9.6%
    10
    18.9%
    51
    16.3%
    Bulgaria
    7
    13.5%
    4
    7.7%
    8
    15.1%
    10
    19.6%
    9
    17.3%
    5
    9.4%
    43
    13.7%
    Germany
    1
    1.9%
    2
    3.8%
    2
    3.8%
    2
    3.9%
    2
    3.8%
    2
    3.8%
    11
    3.5%
    Height (cm) (centimetres) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [centimetres]
    173
    (10.4)
    173
    (9.60)
    174
    (9.89)
    173
    (11.2)
    173
    (10.1)
    172
    (9.98)
    173
    (10.2)
    Weight at baseline (kg) (kilograms) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilograms]
    92.0
    (19.0)
    91.5
    (20.6)
    89.0
    (18.3)
    93.0
    (22.6)
    91.3
    (24.1)
    90.3
    (22.4)
    91.2
    (21.1)
    Prior biological use (actual) (Count of Participants)
    Yes
    9
    17.3%
    10
    19.2%
    9
    17%
    7
    13.7%
    8
    15.4%
    7
    13.2%
    50
    16%
    No
    43
    82.7%
    42
    80.8%
    44
    83%
    44
    86.3%
    44
    84.6%
    46
    86.8%
    263
    84%
    Duration of psoriasis (years) (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    20.0
    (13.6)
    19.7
    (12.8)
    15.8
    (12.9)
    18.0
    (11.7)
    16.3
    (12.1)
    20.2
    (13.6)
    18.3
    (12.8)
    Presence of psoriatic arthritis (Count of Participants)
    Yes
    2
    3.8%
    5
    9.6%
    7
    13.2%
    6
    11.8%
    3
    5.8%
    2
    3.8%
    25
    8%
    No
    50
    96.2%
    47
    90.4%
    46
    86.8%
    45
    88.2%
    49
    94.2%
    51
    96.2%
    288
    92%
    Investigator's Global Assessment (IGA) at baseline (Count of Participants)
    3
    38
    73.1%
    37
    71.2%
    39
    73.6%
    40
    78.4%
    41
    78.8%
    38
    71.7%
    233
    74.4%
    4
    14
    26.9%
    15
    28.8%
    14
    26.4%
    11
    21.6%
    11
    21.2%
    15
    28.3%
    80
    25.6%
    Psoriasis Area and Severity Index (PASI) at baseline (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    20.3
    (7.91)
    20.7
    (9.34)
    21.1
    (8.38)
    20.6
    (7.15)
    20.5
    (6.89)
    21.7
    (8.80)
    20.8
    (8.08)
    Percentage of total Body Surface Area (BSA) affected at baseline (% of body surface area affected) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [% of body surface area affected]
    26.0
    (15.7)
    24.8
    (15.6)
    25.3
    (14.8)
    26.4
    (12.8)
    26.2
    (16.7)
    28.1
    (16.1)
    26.1
    (15.2)

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1
    Description The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.
    Time Frame Week 12, as compared to Week 0 (baseline)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title M1095 30mg M1095 60mg M1095 120mg - Normal Load Group M1095 120mg - Augmented Load Group Placebo Secukinumab
    Arm/Group Description M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10 weeks. Placebo: Placebo contains no active drug. Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, and 8 weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
    Measure Participants 52 52 53 51 52 53
    Count of Participants [Participants]
    25
    48.1%
    44
    84.6%
    41
    77.4%
    45
    88.2%
    0
    0%
    41
    77.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection M1095 30mg, Placebo
    Comments Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (<=90; >90kg).
    Type of Statistical Test Superiority
    Comments A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates >88% for study drug and <=7% for placebo.
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Other Statistical Analysis At Week 12, none (0.0% [95% CI 0.0-6.8]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 25 (48.1% [34.0-62.4], p<0.0001) of 52 participants in the M1095 30mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection M1095 60mg, Placebo
    Comments Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (<=90; >90kg).
    Type of Statistical Test Superiority
    Comments A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates >88% for study drug and <=7% for placebo.
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Other Statistical Analysis At Week 12, none (0.0% [95% CI 0.0-6.8]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 44 (84.6% [71.9-93.1], p<0.0001) of 52 participants in the M1095 60mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection M1095 120mg - Normal Load Group, Placebo
    Comments Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (<=90; >90kg).
    Type of Statistical Test Superiority
    Comments A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates >88% for study drug and <=7% for placebo.
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Other Statistical Analysis At Week 12, none (0.0% [95% CI 0.0-6.8]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 41 (77.4% [63.8-87.7], p<0.0001) of 53 participants in the M1095 120mg normal load treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection M1095 120mg - Augmented Load Group, Placebo
    Comments Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (<=90; >90kg).
    Type of Statistical Test Superiority
    Comments A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates >88% for study drug and <=7% for placebo.
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Other Statistical Analysis At Week 12, none (0.0% [95% CI 0.0-6.8]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 45 (88.2% [76.1-95.6], p<0.0001) of 51 participants in the M1095 120mg augmented load treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Secukinumab
    Comments Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (<=90; >90kg).
    Type of Statistical Test Superiority
    Comments A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates >88% for study drug and <=7% for placebo.
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    Other Statistical Analysis At Week 12, none (0.0% [95% CI 0.0-6.8]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 41 (77.4% [63.8-87.7], p<0.0001) of 53 participants in the secukinumab 300mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.
    2. Secondary Outcome
    Title Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)
    Description PASI 100, i.e. a subject's psoriasis has completely cleared at Week 12, compared to baseline.
    Time Frame Week 12, as compared to Week 0 (baseline)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title M1095 30mg M1095 60mg M1095 120mg - Regimen 1 M1095 120mg - Regimen 2 Placebo / M1095 120mg Secukinumab
    Arm/Group Description M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10 weeks. Placebo: Placebo contains no active drug. Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, and 8 weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
    Measure Participants 52 52 53 51 52 53
    Count of Participants [Participants]
    9
    17.3%
    13
    25%
    20
    37.7%
    17
    33.3%
    0
    0%
    15
    28.3%
    3. Secondary Outcome
    Title Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)
    Description PASI 90, i.e. a subject's psoriasis has cleared by 90% at Week 12, compared to baseline
    Time Frame Week 12, as compared to baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title M1095 30mg M1095 60mg M1095 120mg - Regimen 1 M1095 120mg - Regimen 2 Placebo / M1095 120mg Secukinumab
    Arm/Group Description M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10 weeks. Placebo: Placebo contains no active drug. Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, and 8 weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
    Measure Participants 52 52 53 51 52 53
    Count of Participants [Participants]
    19
    36.5%
    34
    65.4%
    37
    69.8%
    39
    76.5%
    0
    0%
    34
    64.2%
    4. Secondary Outcome
    Title Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)
    Description PASI 75, i.e. a subject's psoriasis has cleared by 75% at Week 12, compared to baseline
    Time Frame Week 12, as compared to Week 0 (baseline)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title M1095 30mg M1095 60mg M1095 120mg - Regimen 1 M1095 120mg - Regimen 2 Placebo / M1095 120mg Secukinumab
    Arm/Group Description M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10 weeks. Placebo: Placebo contains no active drug. Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, and 8 weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
    Measure Participants 52 52 53 51 52 53
    Count of Participants [Participants]
    34
    65.4%
    46
    88.5%
    45
    84.9%
    46
    90.2%
    0
    0%
    48
    90.6%

    Adverse Events

    Time Frame Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52).
    Adverse Event Reporting Description Arms/groups for presentation of adverse event reporting were pre-specified in the Statistical Analysis Plan.
    Arm/Group Title Placebo (Week 0 to Week 12) M1095 30mg (Week 0 to Week 12) M1095 60 mg (Week 0 to Week 12) M1095 120mg - Normal Load Group (Week 0 to Week 12) M1095 120mg - Augmented Load Group (Week 0 to Week 12) Secukinumab (Week 0 to Week 12) M1095 - All Participants (Week 0 to Week 12 ) M1095 - All Participants (Week 12 to Week 52) Secukinumab (Week 12 to Week 52)
    Arm/Group Description Placebo given at Weeks 0, 2, 4 and 8. Placebo: Placebo contains no active drug. M1095, 30mg, given at Weeks 0, 2, 4 and 8. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 60mg, given at Weeks 0, 2, 4 and 8. M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Weeks 0, 2, 4 and 8. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. M1095, 120 mg, given at Weeks 0, 2, 4, 6, 8 and 10. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Secukinumab, 300mg, given at Weeks 0, 1, 2, 3, 4 and 8. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A. All participants receiving M1095, 30mg, 60mg, or 120mg from Week 0 to Week 12. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. All participants receiving M1095, 30mg, 60mg, or 120mg from Week 12 to Week 44, including subjects randomised to placebo, who received M1095 120mg from Weeks 12, 14, 16, 20, etc. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Secukinumab, 300mg, given at Weeks 12, 16, 20 and every 4 weeks to week 44) Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
    All Cause Mortality
    Placebo (Week 0 to Week 12) M1095 30mg (Week 0 to Week 12) M1095 60 mg (Week 0 to Week 12) M1095 120mg - Normal Load Group (Week 0 to Week 12) M1095 120mg - Augmented Load Group (Week 0 to Week 12) Secukinumab (Week 0 to Week 12) M1095 - All Participants (Week 0 to Week 12 ) M1095 - All Participants (Week 12 to Week 52) Secukinumab (Week 12 to Week 52)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/52 (0%) 0/52 (0%) 0/52 (0%) 0/53 (0%) 0/51 (0%) 0/53 (0%) 0/208 (0%) 1/251 (0.4%) 0/51 (0%)
    Serious Adverse Events
    Placebo (Week 0 to Week 12) M1095 30mg (Week 0 to Week 12) M1095 60 mg (Week 0 to Week 12) M1095 120mg - Normal Load Group (Week 0 to Week 12) M1095 120mg - Augmented Load Group (Week 0 to Week 12) Secukinumab (Week 0 to Week 12) M1095 - All Participants (Week 0 to Week 12 ) M1095 - All Participants (Week 12 to Week 52) Secukinumab (Week 12 to Week 52)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/52 (1.9%) 2/52 (3.8%) 1/52 (1.9%) 1/53 (1.9%) 1/51 (2%) 0/53 (0%) 5/208 (2.4%) 12/251 (4.8%) 2/51 (3.9%)
    Cardiac disorders
    Arteriosclerosis coronary artery 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 1/251 (0.4%) 1 0/51 (0%) 0
    Atrial fibrillation 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 2/251 (0.8%) 2 0/51 (0%) 0
    Cardiopulmonary failure 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 1/251 (0.4%) 1 0/51 (0%) 0
    Myocardial infarction 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 1/251 (0.4%) 1 0/51 (0%) 0
    Eye disorders
    Optic ischaemic neuropathy 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 1/251 (0.4%) 1 0/51 (0%) 0
    Gastrointestinal disorders
    Salivary gland calculus 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 1/251 (0.4%) 1 0/51 (0%) 0
    Infections and infestations
    Erysipelas 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 1/251 (0.4%) 1 0/51 (0%) 0
    Infectious pleural effusion 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 0/251 (0%) 0 1/51 (2%) 1
    Oesophageal candidiasis 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 0/251 (0%) 0 1/51 (2%) 1
    Oropharyngeal candidiasis 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 1/251 (0.4%) 1 0/51 (0%) 0
    Pneumonia 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 1/51 (2%) 1 0/53 (0%) 0 1/208 (0.5%) 1 0/251 (0%) 0 1/51 (2%) 1
    Pyelonephritis acute 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 1/251 (0.4%) 1 0/51 (0%) 0
    Injury, poisoning and procedural complications
    Forearm fracture 0/52 (0%) 0 0/52 (0%) 0 1/52 (1.9%) 1 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 1/208 (0.5%) 1 0/251 (0%) 0 0/51 (0%) 0
    Upper limb fracture 0/52 (0%) 0 1/52 (1.9%) 1 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 1/208 (0.5%) 1 0/251 (0%) 0 0/51 (0%) 0
    Nervous system disorders
    Neuroglycopenia 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 1/251 (0.4%) 1 0/51 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 1/51 (2%) 1 0/53 (0%) 0 1/208 (0.5%) 1 0/251 (0%) 0 0/51 (0%) 0
    Renal colic 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 1/53 (1.9%) 1 0/51 (0%) 0 0/53 (0%) 0 1/208 (0.5%) 1 0/251 (0%) 0 0/51 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis 0/52 (0%) 0 1/52 (1.9%) 1 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 1/208 (0.5%) 1 0/251 (0%) 0 0/51 (0%) 0
    Skin and subcutaneous tissue disorders
    Psoriasis 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 1/251 (0.4%) 1 0/51 (0%) 0
    Vascular disorders
    Deep vein thrombosis 0/52 (0%) 0 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 1/251 (0.4%) 1 0/51 (0%) 0
    Hypertension 1/52 (1.9%) 1 0/52 (0%) 0 0/52 (0%) 0 0/53 (0%) 0 0/51 (0%) 0 0/53 (0%) 0 0/208 (0%) 0 0/251 (0%) 0 0/51 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo (Week 0 to Week 12) M1095 30mg (Week 0 to Week 12) M1095 60 mg (Week 0 to Week 12) M1095 120mg - Normal Load Group (Week 0 to Week 12) M1095 120mg - Augmented Load Group (Week 0 to Week 12) Secukinumab (Week 0 to Week 12) M1095 - All Participants (Week 0 to Week 12 ) M1095 - All Participants (Week 12 to Week 52) Secukinumab (Week 12 to Week 52)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 11/52 (21.2%) 13/52 (25%) 16/52 (30.8%) 18/53 (34%) 15/51 (29.4%) 14/53 (26.4%) 62/208 (29.8%) 57/251 (22.7%) 16/51 (31.4%)
    Infections and infestations
    Nasopharyngitis 4/52 (7.7%) 4/52 (7.7%) 11/52 (21.2%) 9/53 (17%) 4/51 (7.8%) 6/53 (11.3%) 28/208 (13.5%) 26/251 (10.4%) 7/51 (13.7%)
    Upper respiratory tract infection 1/52 (1.9%) 1/52 (1.9%) 3/52 (5.8%) 3/53 (5.7%) 2/51 (3.9%) 3/53 (5.7%) 9/208 (4.3%) 12/251 (4.8%) 3/51 (5.9%)
    Oral candidiasis 0/52 (0%) 0/52 (0%) 1/52 (1.9%) 2/53 (3.8%) 3/51 (5.9%) 0/53 (0%) 6/208 (2.9%) 13/251 (5.2%) 0/51 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/52 (1.9%) 3/52 (5.8%) 0/52 (0%) 1/53 (1.9%) 2/51 (3.9%) 0/53 (0%) 6/208 (2.9%) 5/251 (2%) 2/51 (3.9%)
    Nervous system disorders
    Headache 1/52 (1.9%) 0/52 (0%) 3/52 (5.8%) 3/53 (5.7%) 1/51 (2%) 3/53 (5.7%) 7/208 (3.4%) 3/251 (1.2%) 1/51 (2%)
    Skin and subcutaneous tissue disorders
    Pruritus 2/52 (3.8%) 3/52 (5.8%) 4/52 (7.7%) 3/53 (5.7%) 4/51 (7.8%) 1/53 (1.9%) 14/208 (6.7%) 6/251 (2.4%) 1/51 (2%)
    Vascular disorders
    Hypertension 2/52 (3.8%) 3/52 (5.8%) 1/52 (1.9%) 0/53 (0%) 2/51 (3.9%) 1/53 (1.9%) 6/208 (2.9%) 5/251 (2%) 2/51 (3.9%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Avillion LLP
    Phone +44 (0)203 764 9530
    Email avillion@avillionllp.com
    Responsible Party:
    Bond Avillion 2 Development LP
    ClinicalTrials.gov Identifier:
    NCT03384745
    Other Study ID Numbers:
    • AV002
    First Posted:
    Dec 27, 2017
    Last Update Posted:
    Aug 3, 2021
    Last Verified:
    Aug 1, 2021