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    Clinical Trial Results:
    A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study

    Summary
    EudraCT number
    		 2019-000333-39
    Trial protocol
    		 CZ   FR   HU   ES   BE   PL   IT  
    Global end of trial date
    02 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2025
    First version publication date
    18 Apr 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Darvadstrocel-3003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04075825
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    95 Hayden Ave, Lexington, Massachusetts, United States, 02421
    Public contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Scientific contact
    Takeda, Study Director, TrialDisclosures@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
    02 Apr 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trials was to evaluate the long-term safety of a single dose of darvadstrocel in participants with crohn's disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).
    Protection of trial subjects
    Each participant signed an informed consent form (ICF) before participating in the study.
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    05 Nov 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Czechia: 6
    Country: Number of subjects enrolled
    France: 19
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Israel: 17
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Spain: 27
    Country: Number of subjects enrolled
    United States: 55
    Worldwide total number of subjects
    150
    EEA total number of subjects
    78
    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)
    147
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at various investigative sites globally from 05 November 2019 to 02 April 2024.

    Pre-assignment
    Screening details
    		 Participants diagnosed with Complex Perianal Fistula in Crohn’s Disease (CD) who completed the Week 52 visit in the parent study ADMIRE-CD II (Cx601-0303, NCT03279081) were enrolled. Participants remained in the treatment group (placebo or darvadstrocel) to which they were assigned in ADMIRE-CD II study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intralesional use
    Dosage and administration details
    Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

    Arm title
    		 Darvadstrocel
    Arm description
    		 Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Darvadstrocel
    Investigational medicinal product code
    Cx601
    Other name
    Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intralesional use
    Dosage and administration details
    Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

    Number of subjects in period 1
    		Placebo Darvadstrocel
    Started
    74
    76
    Completed
    57
    63
    Not completed
    17
    13
         Consent withdrawn by subject
    6
    8
         Physician decision
    3
    1
         Participation in New Clinical Trial
    1
    1
         Reason Not Specified
    2
    2
         Lost to follow-up
    5
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

    Reporting group title
    Darvadstrocel
    Reporting group description
    		 Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

    Reporting group values
    		 Placebo Darvadstrocel Total
    Number of subjects
    		 74 76
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.9 ( 11.33 ) 40.6 ( 12.04 ) -
    Gender categorical
    Units: Subjects
        Female
    		 28 35 63
        Male
    		 46 41 87
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 1 1
        White
    		 73 68 141
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 1 7 8
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 5 4 9
        Not Hispanic or Latino
    		 65 62 127
        Unknown or Not Reported
    		 4 10 14

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

    Reporting group title
    Darvadstrocel
    Reporting group description
    		 Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

    Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Treatment Emergent Adverse Events (TEAEs) [1]
    End point description
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)
    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: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Placebo Darvadstrocel
    Number of subjects analysed
    74
    76
    Units: participants
    40
    43
    No statistical analyses for this end point

    Primary: Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) [2]
    End point description
    TEAE is defined as: any adverse event emerging/manifesting at or after the initiation of treatment with a study intervention/medicinal product or any existing event that worsens in either intensity/frequency following exposure to the study intervention/medicinal product. Serious adverse event (SAE) is an untoward medical occurrence, significant hazard, contraindication, side effect/precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)
    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: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Placebo Darvadstrocel
    Number of subjects analysed
    74
    76
    Units: participants
    14
    11
    No statistical analyses for this end point

    Primary: Number of Participants With Specific Adverse Events of Special Interest (AESIs)

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    End point title
    		 Number of Participants With Specific Adverse Events of Special Interest (AESIs) [3]
    End point description
    AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that require close monitoring and prompt reporting to the sponsor. Protocol pre-specified AESIs included immunogenicity/allo-immunoreactions, tumorigenicity, ectopic tissue formation and fistula/abscess. In addition, ad hoc AESIs of anaphylactic reaction, hypersensitivity, and malignancy.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)
    Notes
    [3] - 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: Only descriptive analyses was planned for this endpoint.
    End point values
    		 Placebo Darvadstrocel
    Number of subjects analysed
    74
    76
    Units: participants
        Immunogenicity/Allo-immunoreactions
    3
    7
        Tumorgenicity
    1
    3
        Fistula, Abscess
    6
    7
        Ectopic Tissue Formation
    1
    0
        Hypersensitivity
    3
    3
        Anaphylactic Reaction
    0
    0
        Malignancy
    1
    2
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)

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    End point title
    		 Percentage of Participants who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)
    End point description
    Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression. Percentages were rounded off to the nearest second decimal place.
    End point type
    Secondary
    End point timeframe
    At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)
    End point values
    		 Placebo Darvadstrocel
    Number of subjects analysed
    74
    76
    Units: percentage of participants
    number (confidence interval 95%)
        Week 52
    36.49 (25.52 to 47.45)
    50.00 (38.76 to 61.24)
        Week 104
    31.08 (20.54 to 41.63)
    43.42 (32.28 to 54.56)
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)

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    End point title
    		 Percentage of Participants who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)
    End point description
    Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression. Percentages were rounded off to the nearest second decimal place.
    End point type
    Secondary
    End point timeframe
    At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)
    End point values
    		 Placebo Darvadstrocel
    Number of subjects analysed
    74
    76
    Units: percentage of participants
    number (confidence interval 95%)
        Week 52
    40.54 (29.35 to 51.73)
    56.58 (45.44 to 67.72)
        Week 104
    32.43 (21.77 to 43.10)
    47.37 (36.14 to 58.59)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Relapse at Week 156 After Achieving Combined Remission at Week 52 of ADMIRE-CD II

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    End point title
    		 Percentage of Participants With Relapse at Week 156 After Achieving Combined Remission at Week 52 of ADMIRE-CD II
    End point description
    Relapse is defined as participants who were in combined remission at Week 52 of ADMIRE-CD II and who have either reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed or, the development of a perianal fluid collection >2 cm of the treated perianal fistulas confirmed by centrally read magnetic resonance imaging (MRI) assessment. Combined remission at Week 52 was defined as clinically assessed closure of all treated external openings that were draining at baseline of ADMIRE-CD II, despite gentle finger compression, and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central MRI assessment. Percentages were rounded off to the nearest second decimal place.
    End point type
    Secondary
    End point timeframe
    At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)
    End point values
    		 Placebo Darvadstrocel
    Number of subjects analysed
    42
    40
    Units: percentage of participants
        number (confidence interval 95%)
    54.76 (39.71 to 69.81)
    42.50 (27.18 to 57.82)
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieve Combined Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study)

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    End point title
    		 Percentage of Participants who Achieve Combined Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study)
    End point description
    Combined remission of complex perianal fistula(s) is defined as the clinical assessment of closure of all treated external openings that were draining at baseline of ADMIRE-CD II, despite gentle finger compression, and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by centrally read blinded MRI assessment. Percentages were rounded off to the nearest second decimal place.
    End point type
    Secondary
    End point timeframe
    At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)
    End point values
    		 Placebo Darvadstrocel
    Number of subjects analysed
    74
    76
    Units: percentage of participants
        number (confidence interval 95%)
    29.73 (19.32 to 40.14)
    36.84 (26.00 to 47.69)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156

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    End point title
    		 Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156
    End point description
    Percentages were rounded off to the nearest second decimal place.
    End point type
    Secondary
    End point timeframe
    At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)
    End point values
    		 Placebo Darvadstrocel
    Number of subjects analysed
    74
    76
    Units: percentage of participants
        number (confidence interval 95%)
    9.62 (3.20 to 21.03)
    7.02 (1.95 to 17.00)
    No statistical analyses for this end point

    Secondary: Change from Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156

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    End point title
    		 Change from Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156
    End point description
    The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, only ‘discharge’ was used for this outcome measure. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4); a higher score indicates more severe disease.
    End point type
    Secondary
    End point timeframe
    From Baseline of ADMIRE-CD II up to Weeks 52 and 104 of this study (From Baseline up to Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)
    End point values
    		 Placebo Darvadstrocel
    Number of subjects analysed
    59
    67
    Units: score on a scale
    arithmetic mean (standard deviation)
        ADMIRE-CD II Baseline (BL) Score
    1.53 ( 1.072 )
    1.25 ( 0.893 )
        Change from ADMIRE-CD II BL to Week52(this study)
    -0.67 ( 1.178 )
    -0.56 ( 1.218 )
        Change from ADMIRE-CD II BL to Week104(this study)
    -0.67 ( 1.279 )
    -0.50 ( 1.128 )
    No statistical analyses for this end point

    Secondary: Change from Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156

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    End point title
    		 Change from Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156
    End point description
    The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, only ‘pain’ was used for this outcome measure. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4); a higher score indicates more severe disease.
    End point type
    Secondary
    End point timeframe
    From Baseline of ADMIRE-CD II up to Weeks 52 and 104 of this study (From Baseline up to Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)
    End point values
    		 Placebo Darvadstrocel
    Number of subjects analysed
    59
    67
    Units: score on a scale
    arithmetic mean (standard deviation)
        ADMIRE-CD II Baseline (BL) Score
    1.25 ( 1.060 )
    1.06 ( 0.936 )
        Change from ADMIRE-CD II BL to Week52(this study)
    -0.49 ( 1.391 )
    -0.54 ( 1.010 )
        Change from ADMIRE-CD II BL to Week104(this study)
    -0.56 ( 1.271 )
    -0.45 ( 1.060 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II)
    Adverse event reporting additional description
    Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Darvadstrocel
    Reporting group description
    		 Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

    Serious adverse events
    		 Darvadstrocel Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 76 (14.47%)
    14 / 74 (18.92%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Multiple sclerosis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anorectal disorder
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 76 (1.32%)
    2 / 74 (2.70%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 76 (1.32%)
    2 / 74 (2.70%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctalgia
         subjects affected / exposed
    1 / 76 (1.32%)
    2 / 74 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Terminal ileitis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fistula discharge
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    3 / 76 (3.95%)
    2 / 74 (2.70%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    2 / 76 (2.63%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 74 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 74 (1.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Darvadstrocel Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 76 (18.42%)
    11 / 74 (14.86%)
    Investigations
    SARS-CoV-2 test positive
         subjects affected / exposed
    5 / 76 (6.58%)
    3 / 74 (4.05%)
         occurrences all number
    5
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    9 / 76 (11.84%)
    8 / 74 (10.81%)
         occurrences all number
    11
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jan 2022
    The following change was made as per Amendment 01: The legal entity was changed from Millennium Pharmaceuticals, Inc, to Takeda Development Center Americas, Inc.
    17 Nov 2022
    The following changes were made as per Amendment 02: 1. Defined the end of the study. 2. Defined the situations in which a participant was considered a treatment failure. 3. Included the option of remote site visits in sites/countries where allowed by local legislation. 4. Included an interim analysis (IA).

    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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