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    Clinical Trial Results:
    A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients with Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet

    Summary
    EudraCT number
    		 2020-000649-16
    Trial protocol
    		 NL   ES  
    Global end of trial date
    30 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Aug 2025
    First version publication date
    13 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PRV-015-002B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04424927
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Provention Bio, Inc.
    Sponsor organisation address
    55 Broad Street, 2nd Floor, Red Bank, New Jersey, United States, 07701
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    07 Nov 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of PRV-015 in attenuating the symptoms of celiac disease in adult participants with nonresponsive celiac disease as measured by the Abdominal Symptoms domain of the celiac disease patient reported outcome (CeD PRO) questionnaire.
    Protection of trial subjects
    Participants were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the participant and considering the local culture. During the course of the trial, participants were provided with individual participant cards indicating the nature of the trial the participant is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Aug 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Spain: 32
    Country: Number of subjects enrolled
    United States: 187
    Worldwide total number of subjects
    226
    EEA total number of subjects
    33
    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)
    215
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 39 centers in 4 countries. A total of 648 participants were screened between 24 August 2020 and 16 January 2024, of which 255 participants were screen failures and 5 participants discontinued before run-in period. Screen failures were mainly due to not meeting eligibility criteria.

    Pre-assignment
    Screening details
    		 A total of 388 participants entered the single-blind placebo run-in period and among them, 9 participants discontinued during run-in or were not dosed, and 27 participants were considered run-in failures. Another 126 participants were considered randomization failures. A total of 226 participants were enrolled and randomized in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo matching with PRV-015 subcutaneous (SC) injection every 2 weeks (q2w) in double-blind treatment period for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo SC injection q2w for 24 weeks.

    Arm title
    		 PRV-015 100 mg
    Arm description
    		 Participants received PRV-015 100 milligram (mg) SC injection q2w in double-blind treatment period for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PRV-015
    Investigational medicinal product code
    Other name
    Ordesekimab, AMG 714
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PRV-015 100 mg SC injection q2w for 24 weeks.

    Arm title
    		 PRV-015 300 mg
    Arm description
    		 Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PRV-015
    Investigational medicinal product code
    Other name
    Ordesekimab, AMG 714
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PRV-015 300 mg SC injection q2w for 24 weeks.

    Arm title
    		 PRV-015 600 mg
    Arm description
    		 Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PRV-015
    Investigational medicinal product code
    Other name
    Ordesekimab, AMG 714
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PRV-015 600 mg SC injection q2w for 24 weeks.

    Number of subjects in period 1
    		Placebo PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg
    Started
    57
    56
    57
    56
    Received treatment
    57
    56
    57
    54
    Completed
    51
    47
    51
    49
    Not completed
    6
    9
    6
    7
         Consent withdrawn by subject
    3
    5
    5
    6
         Unspecified
    1
    3
    1
    -
         Lost to follow-up
    1
    1
    -
    -
         Investigator or Sponsor judgement
    1
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching with PRV-015 subcutaneous (SC) injection every 2 weeks (q2w) in double-blind treatment period for 24 weeks.

    Reporting group title
    PRV-015 100 mg
    Reporting group description
    		 Participants received PRV-015 100 milligram (mg) SC injection q2w in double-blind treatment period for 24 weeks.

    Reporting group title
    PRV-015 300 mg
    Reporting group description
    		 Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.

    Reporting group title
    PRV-015 600 mg
    Reporting group description
    		 Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.

    Reporting group values
    		 Placebo PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg Total
    Number of subjects
    		 57 56 57 56 226
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41.0 ( 14.53 ) 41.9 ( 14.82 ) 39.0 ( 12.25 ) 37.9 ( 12.58 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 53 38 50 45 186
        Male
    		 4 18 7 11 40
    Race
    Units: Subjects
        Black or African American
    		 0 1 0 0 1
        White
    		 57 55 56 53 221
        Not Reported
    		 0 0 0 2 2
        Unknown
    		 0 0 0 1 1
        Multiple
    		 0 0 1 0 1
    CeD PRO Abdominal Symptoms Domain Score
    The CeD PRO questionnaire was captured daily in the electronic (e)Diary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Abdominal Symptoms domain included abdominal cramping, abdominal pain, bloating and gas. Total score for abdominal symptoms domain range from 0 to 40. Higher scores indicated worse outcome.
    Units: Subjects
        Score: <3
    		 13 13 13 13 52
        Score: >=3
    		 44 43 44 43 174
    Stratification Factor Villous Height-to-Crypt Depth Ratio (VH:CD)
    The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Abdominal Symptoms domain included abdominal cramping, abdominal pain, bloating and gas. Total score for abdominal symptoms domain range from 0 to 40. Higher scores indicated worse outcome.
    Units: Subjects
        Score: <2
    		 37 37 37 36 147
        Score: >=2
    		 20 19 20 20 79

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching with PRV-015 subcutaneous (SC) injection every 2 weeks (q2w) in double-blind treatment period for 24 weeks.

    Reporting group title
    PRV-015 100 mg
    Reporting group description
    		 Participants received PRV-015 100 milligram (mg) SC injection q2w in double-blind treatment period for 24 weeks.

    Reporting group title
    PRV-015 300 mg
    Reporting group description
    		 Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.

    Reporting group title
    PRV-015 600 mg
    Reporting group description
    		 Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.

    Primary: Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24

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    End point title
    		 Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Abdominal Symptoms Domain Score Through Week 24
    End point description
    The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Abdominal Symptoms domain included abdominal cramping, abdominal pain, bloating and gas. Total score for abdominal symptoms domain range from 0 to 40. Higher scores indicated worse outcome. Baseline abdominal symptoms domain score was defined as the average of the daily scores for the last week of the placebo run-in period. The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and up to Week 24 are reported.
    End point type
    Primary
    End point timeframe
    Baseline (average of Day -7 to Day -1) up to Week 24
    End point values
    		 Placebo PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg
    Number of subjects analysed
    56
    55
    56
    52
    Units: score on a scale
        least squares mean (confidence interval 95%)
    -1.32 (-1.66 to -0.98)
    -1.28 (-1.62 to -0.94)
    -1.21 (-1.55 to -0.88)
    -1.28 (-1.63 to -0.93)
    Statistical analysis title
    		 Treatment difference in CeD PRO questionnaire 1
    Statistical analysis description
    Estimates/p-value are from a mixed model for repeated measures (MMRM) with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.
    Comparison groups
    Placebo v PRV-015 100 mg
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8543
    Method
    		 MMRM
    Parameter type
    		 Least square (LS) mean difference
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.52
    Statistical analysis title
    		 Treatment difference in CeD PRO questionnaire 2
    Statistical analysis description
    Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.
    Comparison groups
    Placebo v PRV-015 300 mg
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6552
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.59
    Statistical analysis title
    		 Treatment difference in CeD PRO questionnaire 3
    Statistical analysis description
    Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.
    Comparison groups
    Placebo v PRV-015 600 mg
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8705
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 0.53

    Secondary: Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24

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    End point title
    		 Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Diarrhea and Loose Stool Domain Score Through Week 24
    End point description
    The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Diarrhea and loose stool domain included diarrhea and loose stool. Total score for diarrhea and loose stool domain range from 0 to 20. Higher scores indicated worse outcome. Baseline diarrhea and loose stool domain score was defined as the average of the daily scores for the last week of the placebo run-in period. The mITT analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and up to Week 24 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline (average of Day -7 to Day -1) up to Week 24
    End point values
    		 Placebo PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg
    Number of subjects analysed
    56
    55
    56
    52
    Units: score on a scale
        least squares mean (confidence interval 95%)
    -0.77 (-1.15 to -0.40)
    -0.66 (-1.04 to -0.28)
    -1.02 (-1.39 to -0.64)
    -1.07 (-1.46 to -0.68)
    Statistical analysis title
    		 Treatment difference in CeD PRO questionnaire 1
    Statistical analysis description
    Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.
    Comparison groups
    Placebo v PRV-015 100 mg
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6757
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 0.65
    Statistical analysis title
    		 Treatment difference in CeD PRO questionnaire 2
    Statistical analysis description
    Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.
    Comparison groups
    Placebo v PRV-015 300 mg
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3645
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.78
         upper limit
    		 0.29
    Statistical analysis title
    		 Treatment difference in CeD PRO questionnaire 3
    Statistical analysis description
    Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.
    Comparison groups
    Placebo v PRV-015 600 mg
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2791
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.84
         upper limit
    		 0.24

    Secondary: Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through Week 24

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    End point title
    		 Absolute Change From Baseline in Celiac Disease Patient-Reported Outcome Total Gastrointestinal (GI) Score Through Week 24
    End point description
    The CeD PRO questionnaire was captured daily in the eDiary. The questionnaire included 9 items: abdominal cramping, abdominal pain, bloating, gas, diarrhea, loose stool, nausea, headache and tiredness. Participants were asked to rate their symptom severity on an 11-point scale and scores range from 0 (not experiencing the symptom) to 10 (the worst possible symptom experience). Total GI domain included abdominal symptoms domain, diarrhea, loose stool and nausea. Total GI score range from 0 to 70. Higher scores indicated worse outcome. Baseline GI score was defined as the average of the daily scores for the last week of the placebo run-in period. The mITT analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and up to Week 24 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline (average of Day -7 to Day -1) up to Week 24
    End point values
    		 Placebo PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg
    Number of subjects analysed
    56
    55
    56
    52
    Units: score on a scale
        least squares mean (confidence interval 95%)
    -0.89 (-1.15 to -0.63)
    -0.84 (-1.10 to -0.57)
    -0.88 (-1.14 to -0.62)
    -1.05 (-1.32 to -0.78)
    Statistical analysis title
    		 Treatment difference in CeD PRO questionnaire 1
    Statistical analysis description
    Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.
    Comparison groups
    Placebo v PRV-015 100 mg
    Number of subjects included in analysis
    111
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7829
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.32
         upper limit
    		 0.42
    Statistical analysis title
    		 Treatment difference in CeD PRO questionnaire 3
    Statistical analysis description
    Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.
    Comparison groups
    Placebo v PRV-015 600 mg
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4107
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 0.22
    Statistical analysis title
    		 Treatment difference in CeD PRO questionnaire 2
    Statistical analysis description
    Estimates/p-value are from a MMRM with treatment, week, and treatment by week as fixed effects; continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio as covariates, and participant as a random effect.
    Comparison groups
    Placebo v PRV-015 300 mg
    Number of subjects included in analysis
    112
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9503
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.36
         upper limit
    		 0.38

    Secondary: Absolute Change From Baseline in Intraepithelial Lymphocyte (IEL) Density at Week 24

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    End point title
    		 Absolute Change From Baseline in Intraepithelial Lymphocyte (IEL) Density at Week 24
    End point description
    The small intestinal mucosal inflammation was measured by IEL density using immunohistochemistry. Baseline was defined as IEL density from the esophagogastroduodenoscopy biopsy conducted during the run-in period. The mITT analysis set included all randomized participants who received at least 1 dose of double-blind treatment. Only participants with data collected at baseline and Week 24 are reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Day -28 up to Day -1) and Week 24
    End point values
    		 Placebo PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg
    Number of subjects analysed
    51
    49
    51
    48
    Units: cells/100 epithelial cells
        least squares mean (confidence interval 95%)
    -0.39 (-3.82 to 3.03)
    1.54 (-1.99 to 5.07)
    -4.11 (-7.56 to -0.66)
    -4.53 (-8.13 to -0.93)
    Statistical analysis title
    		 Treatment difference in IEL density 1
    Statistical analysis description
    Estimates/p-value are from an analysis of covariance (ANCOVA) model with treatment as a fixed effect. Continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio are included as covariates.
    Comparison groups
    Placebo v PRV-015 100 mg
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4397
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    1.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 6.87
    Statistical analysis title
    		 Treatment difference in IEL density 2
    Statistical analysis description
    Estimates/p-value are from an ANCOVA model with treatment as a fixed effect. Continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio are included as covariates.
    Comparison groups
    Placebo v PRV-015 300 mg
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1337
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -3.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.58
         upper limit
    		 1.15
    Statistical analysis title
    		 Treatment difference in IEL density 3
    Statistical analysis description
    Estimates/p-value are from an ANCOVA model with treatment as a fixed effect. Continuous baseline CeD PRO Abdominal Symptoms domain score and baseline VH:CD ratio are included as covariates.
    Comparison groups
    Placebo v PRV-015 600 mg
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1021
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -4.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.11
         upper limit
    		 0.83

    Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs)

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events of Special Interest (AESIs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs included severe opportunistic infections and hypersensitivity reactions of at least moderate severity. A TEAE was defined as an AE that occurred from the first dose of post-randomization study drug administration through the end of the study. The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
    End point values
    		 Placebo PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg
    Number of subjects analysed
    57
    56
    57
    54
    Units: participants
        Any TEAE
    34
    34
    36
    29
        TEAE leading to study treatment discontinuation
    1
    1
    2
    0
        Treatment-emergent SAE
    1
    0
    0
    1
        Treatment-emergent AESI
    2
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Participants With Potentially Clinically Important Changes in Hematology

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    End point title
    		 Number of Participants With Potentially Clinically Important Changes in Hematology
    End point description
    Blood samples were collected to determine the hematology laboratory important changes. The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Only participants with data collected are reported. CHG= Change from baseline hemoglobin.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
    End point values
    		 Placebo PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg
    Number of subjects analysed
    57
    56
    57
    53
    Units: participants
        Hemoglobin: CHG <=-20
    0
    0
    1
    2
        Neutrophils: <1
    2
    1
    4
    2
    No statistical analyses for this end point

    Secondary: Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry

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    End point title
    		 Number of Participants With Potentially Clinically Important Changes in Clinical Chemistry
    End point description
    Blood samples were collected to determine the clinical chemistry laboratory important changes. The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Only participants with data collected are reported. Here, ULN= Upper limit of normal, mmol/L= millimoles per liter and mcmol/L= micromoles per liter.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
    End point values
    		 Placebo PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg
    Number of subjects analysed
    57
    56
    57
    53
    Units: participants
        Alanine Aminotransferase: >=3x ULN
    1
    4
    1
    2
        Aspartate Aminotransferase: >=3x ULN
    1
    2
    0
    0
        Chloride: >125 mmol/L
    1
    0
    1
    0
        Creatinine: >=132 mcmol/L
    1
    1
    0
    0
        Potassium: >6 mmol/L
    0
    0
    2
    1
        Sodium: <125 mmol/L
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Potentially Clinically Important Changes in Urinalysis

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    End point title
    		 Number of Participants With Potentially Clinically Important Changes in Urinalysis
    End point description
    Urine samples were collected to determine the important changes in urine. The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Here, n= number of participants with data collected for each specific parameter and 99999= no participant was analyzed. Squamous Epithelial Cells= SEC, TNTC= Too numerous to count, LPF= Low power field and HPF= High power field.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
    End point values
    		 Placebo PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg
    Number of subjects analysed
    57
    56
    57
    53
    Units: participants
        Bacteria: Present (n=54,51,55,47)
    54
    51
    55
    47
        Crystals: Present (n=3,4,2,5)
    3
    4
    2
    5
        Erythrocytes (/HPF): Many/TNTC (n=55,56,56,53)
    1
    0
    4
    3
        Glucose: 3+/4+ (n=57,56,57,53)
    1
    2
    1
    0
        Hyaline Casts (/HPF): Few/Moderate/Many(n=8,7,9,7)
    3
    2
    3
    0
        Hyaline Casts (/LPF): Few/Moderate/Many(n=0,2,1,0)
    99999
    1
    1
    99999
        Ketones: 3+ (n=57,56,57,53)
    1
    2
    3
    1
        Leukocyte Esterase: 3+/4+ (n=57,56,57,53)
    19
    12
    16
    15
        Leukocytes (/HPF): Many/TNTC (n=56,56,57,53)
    11
    3
    9
    7
        Nitrite: Positive (n=57,56,57,53)
    2
    1
    2
    1
        SEC (/HPF): Many/TNTC(n=54,54,54,49)
    6
    0
    6
    8
    No statistical analyses for this end point

    Secondary: Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight

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    End point title
    		 Number of Participants With Potentially Clinically Important Changes in Vital Signs and Body Weight
    End point description
    Participant's vital signs and body weight were examined to determine the important changes. Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization. Here, mmHg= millimeters of mercury, DFB= Decrease from baseline and IFB= Increase from baseline.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
    End point values
    		 Placebo PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg
    Number of subjects analysed
    57
    56
    57
    54
    Units: participants
        SBP: <=95 mmHg and DFB >=20 mmHg
    5
    2
    6
    1
        SBP: >=160 mmHg and IFB >=20 mmHg
    2
    1
    0
    1
        DBP: >=110 mmHg and IFB >=10 mmHg
    0
    0
    0
    1
        Heart Rate: <=50 bpm and DFB >=20 bpm
    1
    1
    1
    0
        Heart Rate: >=120 bpm and IFB >=20 bpm
    0
    0
    0
    1
        Body weight: >=5% DFB
    8
    11
    9
    7
        Body weight: >=5% IFB
    9
    8
    13
    5
    No statistical analyses for this end point

    Secondary: Number of Participants With Anti-PRV-015 Antibodies

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    End point title
    		 Number of Participants With Anti-PRV-015 Antibodies [1]
    End point description
    Blood samples were collected to determine the presence of anti-drug antibodies by immunoassay. The Immunogenicity analysis set included participants who were randomized, dosed, and had at least 1 evaluable immunogenicity assessment. Here, n= number of participants with data collected at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Weeks 2, 4, 12, 22, 24 and 28
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants treated with the study drug are analyzed for this endpoint.
    End point values
    		 PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg
    Number of subjects analysed
    53
    56
    53
    Units: participants
        Baseline (n=52,52,50)
    3
    8
    7
        Week 2 (n=53,56,51)
    8
    9
    9
        Week 4 (n=52,51,48)
    5
    6
    5
        Week 12 (n=51,51,53)
    4
    5
    4
        Week 22 (n=49,49,48)
    4
    4
    2
        Week 24 (n=49,51,49)
    4
    3
    2
        Week 28 (n=50,52,48)
    4
    3
    2
    No statistical analyses for this end point

    Secondary: Minimum Serum Concentrations (Cmin) of PRV-015

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    End point title
    		 Minimum Serum Concentrations (Cmin) of PRV-015 [2]
    End point description
    Blood samples were collected at specified timepoints to determine the Cmin. The Pharmacokinetic (PK) analysis set included participants who were randomized, dosed, and had at least 1 post-dose evaluable PK assessment. Here, n= number of participants with data collected at specific time point.
    End point type
    Secondary
    End point timeframe
    Pre-dose on Day 1 and Weeks 2, 4, 8, 12, 16, 20, 22, 24 and 28
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants treated with the study drug are analyzed for this endpoint.
    End point values
    		 PRV-015 100 mg PRV-015 300 mg PRV-015 600 mg
    Number of subjects analysed
    52
    53
    48
    Units: nanogram per milliliter
    geometric mean (geometric coefficient of variation)
        Pre-dose on Day 1 (n=52,51,48)
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        Week 2 (n=46,53,46)
    8778 ( 74.1 )
    27820 ( 39.8 )
    66400 ( 46.1 )
        Week 4 (n=36,43,39)
    15140 ( 42.8 )
    51190 ( 42.1 )
    98420 ( 49.4 )
        Week 8 (n=31,40,33)
    21790 ( 46.4 )
    61990 ( 66.5 )
    142600 ( 43.7 )
        Week 12 (n=28,33,32)
    23630 ( 46.8 )
    73150 ( 56.5 )
    168300 ( 37.9 )
        Week 16 (n=25,27,26)
    22960 ( 46.7 )
    75830 ( 65.1 )
    166700 ( 44.9 )
        Week 20 (n=20,25,21)
    27000 ( 42.5 )
    74110 ( 67.8 )
    186400 ( 51.2 )
        Week 22 (n=20,22,21)
    25410 ( 36.2 )
    73120 ( 64.2 )
    181000 ( 55.6 )
        Week 24 (n=18,18,18)
    26680 ( 40.3 )
    72400 ( 49.6 )
    160500 ( 47.5 )
        Week 28 (n=26,25,27)
    10210 ( 58.0 )
    32810 ( 80.0 )
    69370 ( 78.3 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug administration (Day 1) up to 28 days after the last dose administration, 197 days
    Adverse event reporting additional description
    The Safety analysis set included all participants who received at least 1 dose of the study drug post-randomization.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo matching with PRV-015 SC injection q2w in double-blind treatment period for 24 weeks.

    Reporting group title
    PRV-015 300 mg
    Reporting group description
    		 Participants received PRV-015 300 mg SC injection q2w in double-blind treatment period for 24 weeks.

    Reporting group title
    PRV-015 600 mg
    Reporting group description
    		 Participants received PRV-015 600 mg SC injection q2w in double-blind treatment period for 24 weeks.

    Reporting group title
    PRV-015 100 mg
    Reporting group description
    		 Participants received PRV-015 100 mg SC injection q2w in double-blind treatment period for 24 weeks.

    Serious adverse events
    		 Placebo PRV-015 300 mg PRV-015 600 mg PRV-015 100 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
    0 / 56 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Pelvic Fracture
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
    0 / 54 (0.00%)
    0 / 56 (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
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 57 (0.00%)
    1 / 54 (1.85%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo PRV-015 300 mg PRV-015 600 mg PRV-015 100 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 57 (38.60%)
    22 / 57 (38.60%)
    19 / 54 (35.19%)
    18 / 56 (32.14%)
    Nervous system disorders
    Migraine
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 57 (1.75%)
    1 / 54 (1.85%)
    2 / 56 (3.57%)
         occurrences all number
    4
    1
    1
    2
    Headache
         subjects affected / exposed
    1 / 57 (1.75%)
    5 / 57 (8.77%)
    2 / 54 (3.70%)
    4 / 56 (7.14%)
         occurrences all number
    2
    5
    2
    4
    General disorders and administration site conditions
    Injection Site Bruising
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 57 (3.51%)
    3 / 54 (5.56%)
    0 / 56 (0.00%)
         occurrences all number
    0
    2
    3
    0
    Injection Site Erythema
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 57 (5.26%)
    2 / 54 (3.70%)
    3 / 56 (5.36%)
         occurrences all number
    2
    6
    7
    8
    Injection Site Reaction
         subjects affected / exposed
    1 / 57 (1.75%)
    3 / 57 (5.26%)
    3 / 54 (5.56%)
    3 / 56 (5.36%)
         occurrences all number
    2
    6
    9
    4
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 57 (0.00%)
    4 / 54 (7.41%)
    3 / 56 (5.36%)
         occurrences all number
    3
    0
    4
    3
    Abdominal Distension
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 57 (0.00%)
    2 / 54 (3.70%)
    3 / 56 (5.36%)
         occurrences all number
    1
    0
    2
    4
    Nausea
         subjects affected / exposed
    1 / 57 (1.75%)
    5 / 57 (8.77%)
    3 / 54 (5.56%)
    2 / 56 (3.57%)
         occurrences all number
    1
    5
    3
    2
    Diarrhoea
         subjects affected / exposed
    6 / 57 (10.53%)
    4 / 57 (7.02%)
    4 / 54 (7.41%)
    1 / 56 (1.79%)
         occurrences all number
    7
    6
    4
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 57 (7.02%)
    3 / 57 (5.26%)
    1 / 54 (1.85%)
    0 / 56 (0.00%)
         occurrences all number
    4
    3
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 57 (0.00%)
    2 / 54 (3.70%)
    3 / 56 (5.36%)
         occurrences all number
    2
    0
    2
    3
    Infections and infestations
    Covid-19
         subjects affected / exposed
    3 / 57 (5.26%)
    8 / 57 (14.04%)
    5 / 54 (9.26%)
    5 / 56 (8.93%)
         occurrences all number
    3
    8
    5
    5
    Upper Respiratory Tract Infection
         subjects affected / exposed
    5 / 57 (8.77%)
    4 / 57 (7.02%)
    4 / 54 (7.41%)
    3 / 56 (5.36%)
         occurrences all number
    6
    4
    4
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Mar 2021
    The antibody tests on the Day -14 visit (Visit -2) were removed to avoid any delay for the Day 0 visit and the start of study treatment. All urine samples were collected at each visit. The maximum levels of tissue transglutaminase and deamidated gluten peptide antibodies for inclusion was revised from 1.5 to 2.0 times the cutoff value for positivity. The Data Monitoring Committee member composition was updated. The window for the baseline endoscopy was increased to 12 days prior to Visit 2 to improve scheduling feasibility. Updated to allow the inclusion of participants with less common human leukocyte antigen types associated with celiac disease. Clarified the consenting procedures for participants undergoing rescreening. Corrected to include hemoglobin A1C at visits designated in the Schedule of Activities. Clarified the procedures for SAE reporting.
    24 Mar 2022
    The level of tissue transglutaminase and deamidated gluten peptide antibodies for study inclusion was revised from <2.0 to <3.0 times the cutoff value for positivity. Updated inclusion and exclusion criteria. The planned method for the analysis of delayed TEAEs in participants who discontinued study treatment was removed and deferred to the Statistical Analysis Plan.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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