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    Clinical Trial Results:
    A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307)

    Summary
    EudraCT number
    2017-000617-23
    Trial protocol
    IE   GB   NL   AT   LT   CZ   BE   ES   HU   SK   DE   PT   EE   PL   BG   GR   HR   IT   RO  
    Global end of trial date
    13 Sep 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Mar 2022
    First version publication date
    19 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SHP647-307
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03627091
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Shire
    Sponsor organisation address
    300 Shire Way, Lexington, United States, MA 02421
    Public contact
    Study Director, Shire, ClinicalTransparency@takeda.com
    Scientific contact
    Study Director, Shire, ClinicalTransparency@takeda.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
    13 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Sep 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in subjects with moderate to severe Crohn’s disease (CD).
    Protection of trial subjects
    The study was conducted in accordance with current applicable industry regulations, International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 (1996) and any updates, European Union (EU) Directive 2001/20/EC and its updates, the ethical principles in the Declaration of Helsinki, and local ethical and legal requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Feb 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    57 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 1
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Japan: 1
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Russian Federation: 2
    Country: Number of subjects enrolled
    Slovakia: 5
    Country: Number of subjects enrolled
    South Africa: 2
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Ukraine: 7
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    40
    EEA total number of subjects
    20
    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)
    1
    Adults (18-64 years)
    38
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 33 sites between 06 February 2019 (first participant first visit) and 13 September 2021 (last participant last visit). 278 sites were initiated in this study, but only 33 sites had enrolled participants.

    Pre-assignment
    Screening details
    A total of 40 participants with moderate to severe CD who completed their participation in an induction study (either SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) and fulfilled the efficacy entry criteria of this study were enrolled and received study treatment in this 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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received matched placebo of ontamalimab subcutaneous (SC) injection using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) once every 4 weeks for up to 52 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo matched to ontamalimab, injection, subcutaneously using a prefilled syringe.

    Arm title
    Ontamalimab 25 mg
    Arm description
    Participants received 25 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) once every 4 weeks for up to 52 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Ontamalimab
    Investigational medicinal product code
    SHP647
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received ontamalimab 25 mg, injection, subcutaneously using a prefilled syringe.

    Arm title
    Ontamalimab 75 mg
    Arm description
    Participants received 75 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) once every 4 weeks for up to 52 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Ontamalimab
    Investigational medicinal product code
    SHP647
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received ontamalimab 75 mg, injection, subcutaneously using a prefilled syringe.

    Number of subjects in period 1
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Started
    19
    10
    11
    Completed
    7
    4
    6
    Not completed
    12
    6
    5
         Disease relapse
    7
    5
    1
         Physician decision
    2
    -
    -
         Site terminated by sponsor
    -
    1
    -
         Adverse event, non-fatal
    -
    -
    2
         Unspecified
    1
    -
    -
         Consent withdrawn by subject
    2
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received matched placebo of ontamalimab subcutaneous (SC) injection using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) once every 4 weeks for up to 52 weeks.

    Reporting group title
    Ontamalimab 25 mg
    Reporting group description
    Participants received 25 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) once every 4 weeks for up to 52 weeks.

    Reporting group title
    Ontamalimab 75 mg
    Reporting group description
    Participants received 75 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) once every 4 weeks for up to 52 weeks.

    Reporting group values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg Total
    Number of subjects
    19 10 11 40
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    37.7 ± 14.26 38.4 ± 7.18 45.8 ± 14.85 -
    Gender categorical
    Units: Subjects
        Male
    12 4 6 22
        Female
    7 6 5 18
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 1 0 1
        Asian
    1 0 0 1
        Native Hawaiian or Other Pacific Islander
    0 0 1 1
        Black or African American
    1 0 0 1
        White
    17 8 10 35
        More than one race
    0 0 0 0
        Unknown or Not Reported
    0 1 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0 2 1 3
        Not Hispanic or Latino
    19 8 10 37
        Unknown or Not Reported
    0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received matched placebo of ontamalimab subcutaneous (SC) injection using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) once every 4 weeks for up to 52 weeks.

    Reporting group title
    Ontamalimab 25 mg
    Reporting group description
    Participants received 25 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) once every 4 weeks for up to 52 weeks.

    Reporting group title
    Ontamalimab 75 mg
    Reporting group description
    Participants received 75 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) once every 4 weeks for up to 52 weeks.

    Primary: Number of Participants With Clinical Remission at Week 52

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    End point title
    Number of Participants With Clinical Remission at Week 52 [1]
    End point description
    Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (<=) 3 (based on 11 point numerical rating scale [NRS] ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency <= 2 of type 6/7 (very soft stools/liquid stools) as per the Bristol Stool Form Scale (BSFS) over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or discontinuation before Week 52 were considered failures. Number of participants with clinical remission at Week 52 were reported. Full analysis set (FAS) consisted of all randomized participants who had received at least 1 dose of study treatment.
    End point type
    Primary
    End point timeframe
    At Week 52
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Due to the premature discontinuation of the study only descriptive data was planned to be analyzed for this endpoint.
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    19
    10
    11
    Units: Participants
        Number analyzed
    2
    3
    5
    No statistical analyses for this end point

    Primary: Number of Participants With Enhanced Endoscopic Response at Week 52

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    End point title
    Number of Participants With Enhanced Endoscopic Response at Week 52 [2]
    End point description
    Enhanced endoscopic response was defined as a decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) of at least 50 percent (%) from induction study (either SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29] baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 52 or who discontinued before Week 52 were considered non responders. Number of participants with enhanced endoscopic response at Week 52 were reported. FAS consisted of all randomized participants who had received at least 1 dose of study treatment.
    End point type
    Primary
    End point timeframe
    At Week 52
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Due to the premature discontinuation of the study only descriptive data was planned to be analyzed for this endpoint.
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    19
    10
    11
    Units: Participants
    2
    4
    6
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52

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    End point title
    Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52
    End point description
    Clinical remission was defined as a CDAI score of < 150. CDAI assessed CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, > 451 points: severely active to fulminant disease. Higher score indicating more severity. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with clinical remission as measured by CDAI at Week 52 were reported. FAS consisted of all randomized participants who had received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    19
    10
    11
    Units: Participants
    8
    4
    7
    No statistical analyses for this end point

    Secondary: Number of Participants With Glucocorticoid-free Clinical Remission at Week 52

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    End point title
    Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
    End point description
    Glucocorticoid-free clinical remission was defined as clinical remission by 2-item PRO in addition to not requiring any treatment with glucocorticoids for at least 12 weeks prior to the Week 52 visit. Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain <= 3 (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency <= 2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). FAS consisted of all randomized participants who had received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    19
    10
    11
    Units: Participants
    2
    1
    3
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) e-diary Sub-scores- at Week 52

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    End point title
    Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) e-diary Sub-scores- at Week 52
    End point description
    Clinical remission was defined by CD daily e-diary 2-item PRO subscores of average daily abdominal pain <= 1 (based on the 4 point scale, with scores ranging from 0 [none] to 3 [severe]) over 7 most recent days and average daily stool frequency <= 3 of type 6/7 (very soft stools/liquid stools) as per the BSFS over 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or who discontinued before Week 52 considered failures. Number of participants with clinical remission based on Crohn's Disease (CD) e-diary Sub-scores for abdominal pain was reported. FAS consisted of all randomized participants who had received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    19
    10
    11
    Units: Participants
    2
    3
    7
    No statistical analyses for this end point

    Secondary: Number of Participants With Sustained Clinical Remission at Week 52

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    End point title
    Number of Participants With Sustained Clinical Remission at Week 52
    End point description
    Sustained clinical remission was defined as clinical remission by 2-item PRO at both Week 52 visit and the maintenance baseline in this Study. Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (<=) 3 (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency <= 2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Number of participants with sustained clinical remission at Week 52 were reported. FAS consisted of all randomized participants who had received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    19
    10
    11
    Units: Participants
    2
    1
    2
    No statistical analyses for this end point

    Secondary: Number of Participants With Sustained Enhanced Endoscopic Response at Week 52

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    End point title
    Number of Participants With Sustained Enhanced Endoscopic Response at Week 52
    End point description
    Sustained enhanced endoscopic response was defined as enhanced endoscopic response at both Week 52 visit and the maintenance baseline in this study. Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50 % from induction study (either SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Number of participants with sustained enhanced endoscopic response at Week 52 were reported. FAS consisted of all randomized participants who had received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    19
    10
    11
    Units: Participants
    1
    2
    3
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinical Remission Based on 2-item PRO With Enhanced Endoscopic Response at Week 52

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    End point title
    Number of Participants With Clinical Remission Based on 2-item PRO With Enhanced Endoscopic Response at Week 52
    End point description
    Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain <= 3 (based on 11-point NRS) over the 7 most recent days and average daily stool frequency <= 2 of Type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50% from induction study (SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29] baseline. Participants with missing data at Week 52 or who discontinued before Week 52 were considered non-responders. FAS consisted of all randomized participants who had received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    19
    10
    11
    Units: Participants
    0
    3
    4
    No statistical analyses for this end point

    Secondary: Number of Participants With Complete Endoscopic Healing at Week 52

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    End point title
    Number of Participants With Complete Endoscopic Healing at Week 52
    End point description
    Complete endoscopic healing was defined as SES-CD scale score from 0-2. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with complete endoscopic healing at Week 52 were reported. FAS consisted of all randomized participants who had received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    At Week 52
    End point values
    Placebo Ontamalimab 25 mg Ontamalimab 75 mg
    Number of subjects analysed
    19
    10
    11
    Units: Participants
    0
    3
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study drug administration up to 56 weeks
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received matched placebo of ontamalimab subcutaneous (SC) injection using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) once every 4 weeks for up to 52 weeks.

    Reporting group title
    Ontamalimab 75 mg
    Reporting group description
    Participants received 75 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) once every 4 weeks for up to 52 weeks.

    Reporting group title
    Ontamalimab 25 mg
    Reporting group description
    Participants received 25 mg ontamalimab SC injection, using prefilled syringe on Day 1 Baseline Visit (Week 16 of the SHP647-305 [2017-000575-88] or SHP647-306 [2017-000576-29]) once every 4 weeks for up to 52 weeks.

    Serious adverse events
    Placebo Ontamalimab 75 mg Ontamalimab 25 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileal perforation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Peritonitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Ontamalimab 75 mg Ontamalimab 25 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 19 (47.37%)
    8 / 11 (72.73%)
    5 / 10 (50.00%)
    Vascular disorders
    Capillary fragility
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Anxiety disorder
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Stress
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Prostatic disorder
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Procedural pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Lymphopenia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Thrombocytosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    2
    4
    0
    Paraesthesia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    Anal fissure
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Crohn's disease
         subjects affected / exposed
    3 / 19 (15.79%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    1
    Constipation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Proctalgia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroduodenitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Gastritis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Skin disorder
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Dyshidrotic eczema
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    1
    Fistula
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Back pain
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Oral herpes
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    Corona virus infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Aug 2018
    Protocol Amendment 1: Updated the global fax number. Updated inclusion criterion 3b (ii) to indicate that subjects must have a decrease of at least 100 points in CDAI score from induction study baseline. Updated exclusion criterion 7 to indicate that subjects who developed enterovesical or enterovaginal fistulae during the induction study would be excluded. Updated exclusion criterion 12 to indicate that subjects meeting the few lab criteria would be excluded. Updated exclusion criterion 5 to indicate the exclusion of subjects who do not agree to postpone donation of any organ or tissue. Added statement that subjects who are withdrawn early from the study due to fulfilling the criteria for treatment failure also may be eligible to enter the long-term safety study. Updated key secondary endpoint to include the stipulated window for not requiring any treatment with glucocorticoids. Added describing risks and benefits of treatment. Added pregnancy to the list of reasons subject may be withdrawn from study treatment. Added language to specify that any antidiarrheal opiate drugs must be taken at stable doses for the duration of the study.
    22 Nov 2019
    Protocol Amendment 2: Updated language for reporting of product quality complaints. Added complete endoscopic healing will be measured by centrally read endoscopy. Revised exclusion criterion 4. Added that adverse events of special interest will be summarized by treatment group. Revised to extend window between Visit 14 and Visit 14 to 10 days. Added footnote for unscheduled assessment for calculating CDAI. Revised colonoscopy preparation may be done as colonoscopy procedure. Updated key secondary point. Added criteria of treatment failure as reason of subject withdrawal. Changed term ‘protocol violations’ to ‘protocol deviations. Updated to specify investigator may perform unscheduled CDAI assessment based on subject’s reported symptoms. Changed ‘very soft stools/liquid stools’ to ‘very soft stool/liquid stool frequency’. Updated method for calculating 2-item PRO and SES-CD score. Added ileocolectomy along with partial colectomy. Text updated to calculate CDAI scores.
    17 Sep 2020
    Protocol Amendment 3: Changed safety follow-up period from 16 weeks to 12 weeks. Added note after the implementation of Amendment 3, the participant’s next scheduled visit will be the Week 52/ET visit, which should be conducted no later than 4 weeks from the participant’s last study visit prior to the implementation of SHP647-304 Amendment 4. Updated pharmacokinetic assessments; removed health-related quality of life assessments. Updated footnotes ‘c’ and ‘d’. Added footnote in case of a DTP situation, some procedures will be performed by remote visits via virtual communications and allow clinical laboratory assays to be done by local laboratory in case of issues related to COVID-19. Added footnote to specify that subjects performing home administrations consecutively for 3 months will need to perform liver function testing locally. Added language to clarify the early termination of this study by the sponsor, colonoscopy is optional for subjects who received less than 52 weeks of treatment. Addition of details around DTP program/provision for home administration of investigational product. Removed other secondary objectives and text regarding treatment failures. Added text on allowing continued treatment with ontamalimab for subjects benefiting. Added text on allowing study program to be stopped in case of no clinical efficacy. Updated participant’s maximum study duration.

    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.
    The study was closed early as the sponsor discontinued the ontamalimab clinical trial program in CD for reasons unrelated to safety or efficacy.
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