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    Clinical Trial Results:
    A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

    Summary
    EudraCT number
    		 2019-002105-22
    Trial protocol
    		 FR   ES   IT  
    Global end of trial date
    29 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Sep 2025
    First version publication date
    10 Sep 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BGB-A317-210
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04318080
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BeiGene, Ltd., c/o BeiGene USA, Inc.
    Sponsor organisation address
    311 Pennington-Rocky Hill Rd, Pennington, NJ, United States, 08534
    Public contact
    BeiGene Clinical Support, BeiGene USA, Inc., 1 877-828-5568, clinicaltrials@beigene.com
    Scientific contact
    BeiGene Clinical Support, BeiGene USA, Inc., 1 877-828-5568, clinicaltrials@beigene.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
    29 Aug 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was a Phase 2 trial evaluating the effectiveness and safety of tislelizumab in participants with relapsed or hard-to-treat classical Hodgkin lymphoma (cHL). Participants were grouped by prior treatments. The main outcome was to assess overall response rate (ORR) across both cohorts. Participants continued receiving the study treatment until their disease got worse, side effects became too severe, or they chose to stop for other reasons.
    Protection of trial subjects
    This study was conducted in accordance with sponsor procedures, which comply with the principles of Good Clinical Practice (GCP), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines, the Declaration of Helsinki, and applicable local regulatory requirements. The protocol, any amendments, and informed consent forms were reviewed and approved by the Independent Ethics Committee/Institutional Review Board in conformance with GCP and applicable regulatory requirements. Before a patient was enrolled in the study, he or she was provided with a written informed consent form that complied with GCP. The investigator (or designee) explained to each patient the nature of the study, its purpose, procedures, expected duration, and the benefits and risks involved with study participation. Patients were given the opportunity to ask questions and were informed of their right to withdraw from the study at any time without prejudice. Informed consent was obtained before any screening or study-specific procedures were performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Aug 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    France: 38
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    46
    EEA total number of subjects
    41
    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)
    25
    From 65 to 84 years
    18
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at multiple centers across France, the United States, Belgium, and Australia from August 20, 2020, to August 29, 2024.

    Pre-assignment
    Screening details
    		 Treatment started within 14 days of eligibility confirmation, within the screening window. Treatment continued until disease progression, unacceptable toxicity, or withdrawal. Participants who did not meet eligibility criteria during screening were excluded prior to assignment to treatment groups.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Cohort 1
    Arm description
    		 Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tislelizumab
    Investigational medicinal product code
    BGB-A317
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tislelizumab: 200 miligrams (mg) intravenously every 3 weeks (Q3W)

    Arm title
    		 Cohort 2
    Arm description
    		 Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tislelizumab
    Investigational medicinal product code
    BGB-A317
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tislelizumab: 200 miligrams (mg) intravenously every 3 weeks (Q3W)

    Arm title
    		 Total
    Arm description
    		 Participants received tislelizumab 200 mg intravenously every 3 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tislelizumab
    Investigational medicinal product code
    BGB-A317
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tislelizumab: 200 miligrams (mg) intravenously every 3 weeks (Q3W)

    Number of subjects in period 1
    		Cohort 1 Cohort 2 Total
    Started
    15
    31
    46
    Treated
    14
    31
    45
    Completed
    0
    0
    0
    Not completed
    15
    31
    46
         Consent withdrawn by subject
    1
    -
    1
         Protocol Deviation
    1
    -
    1
         Death
    3
    9
    12
         Study Completed by Sponsor
    10
    22
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.

    Reporting group title
    Cohort 2
    Reporting group description
    		 Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.

    Reporting group title
    Total
    Reporting group description
    		 Participants received tislelizumab 200 mg intravenously every 3 weeks.

    Reporting group values
    		 Cohort 1 Cohort 2 Total Total
    Number of subjects
    		 15 31 46
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.9 ( 15.78 ) 59.6 ( 21.95 ) 54.7 ( 21.37 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 11 15 15
        Male
    		 10 20 30 30
        Not recorded
    		 1 0 1 1
    Patient Status at Time of Enrollment
    Refractory refers to participants whose disease did not respond to their most recent prior therapy (no complete or partial response). Relapse or Progression refers to participants whose disease initially responded to prior therapy but later worsened, progressed, or returned. One participant in Cohort 1 was enrolled but did not receive study drug due to screen failure. This participant is included in the baseline characteristics to meet EudraCT reporting requirements, but was not included in the efficacy or safety analyses.
    Units: Subjects
        Refractory
    		 0 13 13 13
        Relapse or Progression
    		 14 18 32 32
        Unknown
    		 1 0 1 1
    Number of prior lines of therapy for cHL
    One participant in Cohort 1 was enrolled but did not receive study drug due to screen failure. This participant is included in the baseline characteristics to meet EudraCT reporting requirements, but was not included in the efficacy or safety analyses.
    Units: Subjects
        One
    		 0 7 7 7
        Two
    		 9 17 26 26
        Three
    		 4 6 10 10
        Four
    		 1 1 2 2
        Not Collected
    		 1 0 1 1
    Eastern Cooperative Oncology Group Performance Status
    Eastern Cooperative Oncology Group Performance Status is a standard scale used to assess how a partiicpant's disease impacts their daily living abilities. Zero refers to normal activities. One is ambulatory able to carry out work. One participant in Cohort 1 was enrolled but did not receive study drug due to screen failure. This participant is included in the baseline characteristics to meet EudraCT reporting requirements, but was not included in the efficacy or safety analyses.
    Units: Subjects
        Zero
    		 10 18 28 28
        One
    		 4 13 17 17
        Not Collected
    		 1 0 1 1
    Race (customized)
    Units: Subjects
        White
    		 3 5 8 8
        Not collected
    		 12 26 38 38

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.

    Reporting group title
    Cohort 2
    Reporting group description
    		 Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.

    Reporting group title
    Total
    Reporting group description
    		 Participants received tislelizumab 200 mg intravenously every 3 weeks.

    Primary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR)
    End point description
    ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) by Positron Emission Tomography (PET) and Computed Tomography (CT) per the Lugano Classification and as determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT, with no new lesions detected. PR was defined as a significant reduction in metabolic activity or lesion size consistent with partial tumor shrinkage as per Lugano criteria.
    End point type
    Primary
    End point timeframe
    From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.
    End point values
    		 Cohort 1 Cohort 2 Total
    Number of subjects analysed
    14
    31
    45
    Units: Percentage of Participants
        number (confidence interval 95%)
    64.3 (35.1 to 87.2)
    64.5 (45.4 to 80.8)
    64.4 (48.8 to 78.1)
    Statistical analysis title
    		 ORR
    Statistical analysis description
    The primary analysis was conducted on both cohorts combined, A binomial exact test was performed to test the null hypothesis (H0: ORR = 45% based on previous clinical trials) and alternative hypothesis (ORR >45%). If the one-sided p-value was ≤ 0.05, tislelizumab was considered to statistically significantly increase ORR compared to the historical control.
    Comparison groups
    Total v Cohort 2 v Cohort 1
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0044 [2]
    Method
    		 Binomial Exact Test
    Confidence interval
    Notes
    [1] - Analysis tested whether ORR with tislelizumab was superior to a historical ORR of 45% using a one-sided binomial exact test (α = 0.05).
    [2] - One-sided p-value based on a binomial exact test comparing observed ORR to historical rate of 45%.

    Secondary: Complete Response Rate (CRR)

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    End point title
    		 Complete Response Rate (CRR)
    End point description
    CRR was defined as the percentage of participants who achieved a best overall response of complete response (CR) by PET-CT or CT per the Lugano Classification and determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT or CT, with no new lesions detected.
    End point type
    Secondary
    End point timeframe
    From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.
    End point values
    		 Cohort 1 Cohort 2 Total
    Number of subjects analysed
    14
    31
    45
    Units: Percentage of Participants
        number (confidence interval 95%)
    42.9 (17.7 to 71.1)
    25.8 (11.9 to 44.6)
    31.1 (18.2 to 46.6)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR was defined as the time from the date that response criteria (CR or PR) were first met to the date of objectively documented disease progression or death, whichever occurred first. Participants without an event were censored at the data cutoff or end of study, whichever occurred first. Participants who received new anti-lymphoma therapies, including Hematopoietic Stem Cell Transplantation (HSCT), before having an event were censored at the date of therapy initiation. Only participants with confirmed response were included in the analysis. Median DOR was estimated using the Kaplan-Meier method. The responder analysis set only included participants with a confirmed response (CR) or partial response (PR).
    End point type
    Secondary
    End point timeframe
    From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.
    End point values
    		 Cohort 1 Cohort 2 Total
    Number of subjects analysed
    9
    20
    29
    Units: Months
        median (confidence interval 95%)
    12.25 (5.55 to 12.25)
    6.64 (2.79 to 9999)
    12.25 (3.02 to 9999)
    No statistical analyses for this end point

    Secondary: Time to Response (TTR)

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    End point title
    		 Time to Response (TTR)
    End point description
    TRR was defined as the time from the date of the first dose of tislelizumab to the date the response criteria were first met CR or PR per the Lugano Classification, and was analyzed only in participants who achieved an overall response; CR was defined as complete disappearance of disease, PR as ≥50% reduction in tumor burden, and Overall Response Rate (ORR) included participants with either CR or PR. Median TTR was estimated using the Kaplan-Meier method. Safety Analysis Set. Only participants who had achieved an overall response were included in the analysis of time to response.
    End point type
    Secondary
    End point timeframe
    From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months.
    End point values
    		 Cohort 1 Cohort 2 Total
    Number of subjects analysed
    9
    20
    29
    Units: Months
        median (confidence interval 95%)
    2.69 (2.1 to 5.5)
    2.69 (0.3 to 5.6)
    2.69 (0.3 to 5.6)
    No statistical analyses for this end point

    Secondary: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [3]
    End point description
    Adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Treatment-emergent adverse events (TEAEs) were defined as any AE that began or worsened in severity after the first dose of study treatment and up to 90 days following the last dose, regardless of initiation of new anti-lymphoma therapy. The following safety data are reported: Number of participants with any TEAEs: Participants who experienced at least one TEAE of any grade. Number of participants with any Grade ≥3 TEAEs: Participants who experienced at least one TEAE that was Grade 3 or higher in severity. Number of participants with any SAEs: Participants who experienced at least one serious adverse event, regardless of relationship to study treatment, occurring up to 90 days after the last dose.
    End point type
    Secondary
    End point timeframe
    From the date of the first dose of tislelizumab through 90 days after the last dose (maximum duration of tislelizumab exposure was 168 weeks)
    Notes
    [3] - 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: The third arm in the baseline period is labeled as Total to show the totals for efficacy endpoints. It does not pertain to safety analysis and cannot be reported on.
    End point values
    		 Cohort 1 Cohort 2
    Number of subjects analysed
    14
    31
    Units: Participants
        Number of participants with any TEAEs
    12
    30
        Number of participants with any TEAEs with grade >
    4
    12
        Number of participants with any SAEs
    4
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    Cohort 2
    Reporting group description
    		 Cohort 2

    Reporting group title
    Cohort 1
    Reporting group description
    		 Cohort 1

    Serious adverse events
    		 Cohort 2 Cohort 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 31 (29.03%)
    4 / 14 (28.57%)
         number of deaths (all causes)
    9
    3
         number of deaths resulting from adverse events
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cutaneous t-cell lymphoma
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Coeliac disease
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Cohort 2 Cohort 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 31 (96.77%)
    12 / 14 (85.71%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Superior vena cava syndrome
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Vena cava thrombosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Haematoma
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Raynaud's phenomenon
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    9 / 31 (29.03%)
    1 / 14 (7.14%)
         occurrences all number
    16
    2
    Chest pain
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Fatigue
         subjects affected / exposed
    4 / 31 (12.90%)
    2 / 14 (14.29%)
         occurrences all number
    6
    2
    Chills
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    General physical health deterioration
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Injection site haematoma
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 14 (0.00%)
         occurrences all number
    4
    0
    Pyrexia
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 31 (0.00%)
    3 / 14 (21.43%)
         occurrences all number
    0
    4
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Productive cough
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Pneumonitis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Lung disorder
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Dyspnoea exertional
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Dyspnoea
         subjects affected / exposed
    3 / 31 (9.68%)
    3 / 14 (21.43%)
         occurrences all number
    4
    3
    Cough
         subjects affected / exposed
    5 / 31 (16.13%)
    3 / 14 (21.43%)
         occurrences all number
    7
    3
    Psychiatric disorders
    Bulimia nervosa
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Blood potassium increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Weight increased
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Weight decreased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Lipase increased
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    14
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Compression fracture
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Infusion related reaction
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    6
    0
    Ligament sprain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Neuralgia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Ataxia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Balance disorder
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 14 (14.29%)
         occurrences all number
    3
    2
    Syncope
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Polyneuropathy
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    4 / 31 (12.90%)
    1 / 14 (7.14%)
         occurrences all number
    4
    1
    Paraesthesia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Taste disorder
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 31 (12.90%)
    1 / 14 (7.14%)
         occurrences all number
    4
    5
    Neutropenia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Eosinophilia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Eye disorders
    Chalazion
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Periorbital swelling
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Abdominal pain upper
         subjects affected / exposed
    4 / 31 (12.90%)
    0 / 14 (0.00%)
         occurrences all number
    4
    0
    Angular cheilitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 14 (14.29%)
         occurrences all number
    3
    2
    Nausea
         subjects affected / exposed
    5 / 31 (16.13%)
    1 / 14 (7.14%)
         occurrences all number
    6
    1
    Odynophagia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Stomatitis
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 14 (0.00%)
         occurrences all number
    4
    0
    Vomiting
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 14 (14.29%)
         occurrences all number
    3
    2
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 14 (7.14%)
         occurrences all number
    3
    1
    Erythema
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Dry skin
         subjects affected / exposed
    2 / 31 (6.45%)
    3 / 14 (21.43%)
         occurrences all number
    2
    3
    Dermatitis acneiform
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Acne
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Urticaria
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 14 (14.29%)
         occurrences all number
    1
    2
    Rash maculo-papular
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    3
    Rash
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 14 (14.29%)
         occurrences all number
    3
    2
    Purpura
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Vitiligo
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Calculus urethral
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Renal colic
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Urinary tract pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Hyperadrenocorticism
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Hyperthyroidism
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Hypothyroidism
         subjects affected / exposed
    4 / 31 (12.90%)
    1 / 14 (7.14%)
         occurrences all number
    4
    1
    Adrenocorticotropic hormone deficiency
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 14 (7.14%)
         occurrences all number
    2
    2
    Back pain
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Muscle spasms
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 14 (7.14%)
         occurrences all number
    4
    1
    Myalgia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    Pain in extremity
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Onychomycosis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Balanoposthitis infective
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 14 (14.29%)
         occurrences all number
    3
    3
    COVID-19
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 14 (7.14%)
         occurrences all number
    3
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    Cystitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Dermo-hypodermitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Localised infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Oral infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Otitis externa
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Rash pustular
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    3 / 31 (9.68%)
    1 / 14 (7.14%)
         occurrences all number
    3
    1
    Sinusitis
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 14 (0.00%)
         occurrences all number
    3
    0
    Skin infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Tracheitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 14 (7.14%)
         occurrences all number
    2
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Folate deficiency
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
         subjects affected / exposed
    4 / 31 (12.90%)
    1 / 14 (7.14%)
         occurrences all number
    4
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Steroid diabetes
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Dyslipidaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2019
    Amendment 1.0 23 October 2019
    26 Nov 2019
    Amendment 2.0 26 November 2019
    03 Dec 2020
    Amendment 3.0 03 December 2020
    05 Aug 2021
    Amendment 4.0 05 August 2021

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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