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| Name | Class |
|---|---|
| Orion Corporation, Orion Pharma | INDUSTRY |
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This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue their treatment.
This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue their treatment.
All subjects will receive ABX464 given at 50 mg o.d irrespective of their previous treatment received in the ABX464-101 study (i.e. ABX464 or Placebo).
The actual treatment received by a subject throughout the previous study (ABX464-101) will not be known at the time the subjects enter this follow-up study. This treatment group will be communicated (throughout the investigators) to the subjects at the end of the ABX464-101 study (planned in Q3/2018).
The enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation and also based on investigator's judgement.
Subjects will be treated with ABX464 for an overall period of 48 months. Subjects will be followed up weekly during the first month, every two weeks during the second month and then on a monthly basis until M24, then quaterly from M24 to M48.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABX464 Treatment arm | Experimental | All subjects will receive ABX464 at 50 mg o.d for an overall period of 48 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABX464 | Drug | All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-emergent Adverse Events | Number of treatment-emergent adverse events in ABX464 treated subjects | Through subject study treatment, up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Mayo Score | The change from Day 0 up to Month 48 in Total Mayo Score. total mayo score is an index and consists of 4 items: stool frequency, rectal bleeding, flexible sigmoidoscopic examination, and a physician global assessment of disease activity. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The total mayo score scale ranging is from 0 to 12 The change from baseline of this score is part of the clinical response definition: to get a clinical response, a reduction in Total Mayo score of at least 2 points is required. A higher (in negative) change shows a better clinical response. |
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Inclusion Criteria:
A subject will be eligible for inclusion in this study only if ALL of the following criteria apply:
Subjects previously enrolled in the ABX464-101 clinical study who have completed the initial 2-month treatment phase;
Subjects able and willing to comply with study visits and procedures;
Subjects with hematological and biochemical laboratory parameters as follows at the D56 visit of the ABX464-101 study:
Subjects should understand, sign and date the written voluntary informed consent form at the enrolment visit prior to any protocol-specific procedures being performed;
Subjects should be affiliated to a social security regimen (for French sites only);
Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 3 months after end of study or early termination. Contraception should be in place at least 3 months prior to study participation. Women must be either postmenopausal (at least 12 months of amenorrhea), surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include: true abstinence, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), hormonal contraception (estrogen and progestogen or progestogen only) associated with inhibition of ovulation, bilateral tubal occlusion, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the subject. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle.
Exclusion Criteria:
The following criterion should be checked at the time of screening. If this exclusion criterion applies, the subject will not be included in the study:
▪ Any condition, which in the opinion of the investigator, could compromise the subject's safety or the adherence to the study protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Paul GINESTE | Abivax S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology - University hospitals Leuven | Leuven | 3000 | Belgium |
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| Label | URL |
|---|---|
| preliminary results at M24 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABX464 Treatment Arm | All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ABX464 Treatment Arm | All subjects will receive ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Treatment-emergent Adverse Events | Number of treatment-emergent adverse events in ABX464 treated subjects | Posted | Number | events | Through subject study treatment, up to 48 months |
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Adverse event were collected from first day of dosing (baseline) up to last safety visit (up to 49 months : 48 months on treatment and one month safety follow-up)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABX464 Treatment Arm | All subjects received ABX464 at 50 mg o.d for an overall period of 48 months. ABX464: All subjects received ABX464 given at 50 mg o.d for an overall period of 48 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment | The event was considered not related to study treatment and resolved without sequelae 5 days after onset date. No action was taken with study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Clinical Operations | Abivax | 01 53 83 08 41 | paul.gineste@abivax.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2022 | May 24, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2022 | May 24, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000623073 | ABX464 |
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open-label, follow-up study
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| Up to Month 48 |
| Partial Mayo Score | The change from Day 0 up to Month 48 in Partial Mayo Score; Partial Mayo score is an index and consists of 3 items: stool frequency, rectal bleeding and a physician global assessment of disease activity. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The partial mayo score scale ranging is from 0 to 9. A higher (in negative) change from baseline shows a better clinical response | Up to Month 48 |
| Number of Subjects With Clinical Response at Month 48 | Clinical response was defined as: reduction in Total Mayo Score (TMS) of at least 2 points and >= 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of >= 1 point or absolute rectal bleeding sub-score of <= 1 point. | up to 48 months |
| Number of Subjects With Clinical Remission at Month 48 | Clinical remission was achieved when all the following criteria were met in the components of the Mayo clinical Score: rectal bleeding sub-score = 0 central endoscopy sub-score <= 1 stool frequency sub-score <= 1 | up to 48 months |
| Number of Subject With Endoscopic Improvement at Month 48 | oEndoscopic improvement was achieved if the Mayo central endoscopic sub-score is 0 or 1. | up to 48 Months |
| Number of Subjects With Endoscopic Remission at Month 48 | Endoscopic remission was defined as Mayo central endoscopic sub-score = 0 | up to 48 months |
| Fecal Calprotectin | The change from Day 0 up to Month 48 in fecal calprotectin A higher (in negative) change shows a better efficacy | Up to Month 48 |
| CRP Levels | The change from Day 0 up to Month 48 in CRP levels | Up to Month 48 |
| Number of Treatment-emergent Serious Adverse Events | The number of incidences of treatment-emergent serious adverse events | Through subject study treatment, up to 48 months |
| Number of Treatment-emergent Adverse Events of Special Interest | The number of incidences of treatment-emergent adverse events of special interest | Through subject study treatment, up to 48 months |
| Number of Adverse Events Leading to Investigational Product Discontinuation | The number of incidences of adverse events leading to investigational product discontinuation | Through subject study treatment, up to 48 months |
| Number of Specific Laboratory Abnormalities | The number of incidences of specific laboratory abnormalities | Through first year of subject study treatment, 12 months |
| SF-36 Quality of Life Questionnaire (SF-36 Physical Component) | Change from Day 0 up to 24 months in SF-36 Questionnaire scores; The SF-36 questionnaire is a self-administered questionnaire containing 36 items. It measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health. These items are grouped in 2 distincts components: a physical component (SF-36 physical) and a mental component (SF-36 mental). This outcome describes the SF-36 physical component. Each item score ranging is from 0 to 100. A higher positive value in change indicate a better health status. The higher the change from baseline, the better improvement | Up to 24 months |
| SF-36 Quality of Life Questionnaire (SF-36 Mental Component) | Change from Day 0 up to 24 months in SF-36 Questionnaire scores; The SF-36 questionnaire is a self-administered questionnaire containing 36 items. It measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health. These items are grouped in 2 distincts components: a physical component (SF-36 physical) and a mental component (SF-36 mental). This outcome describes the SF-36 mental component. Each item score ranging is from 0 to 100. A higher positive value in change indicate a better health status. The higher the change from baseline, the better improvement | Up to 24 months |
| Erythrocyte Sedimentation Rate (ESR) Levels | The change from Day 0 up to Month 48 in ESR levels | up to 48 Months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Total Mayo Score | The change from Day 0 up to Month 48 in Total Mayo Score. total mayo score is an index and consists of 4 items: stool frequency, rectal bleeding, flexible sigmoidoscopic examination, and a physician global assessment of disease activity. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The total mayo score scale ranging is from 0 to 12 The change from baseline of this score is part of the clinical response definition: to get a clinical response, a reduction in Total Mayo score of at least 2 points is required. A higher (in negative) change shows a better clinical response. | Non responder Imputation (NRI) population | Posted | Mean | Standard Deviation | units on a scale | Up to Month 48 |
|
|
|
| Secondary | Partial Mayo Score | The change from Day 0 up to Month 48 in Partial Mayo Score; Partial Mayo score is an index and consists of 3 items: stool frequency, rectal bleeding and a physician global assessment of disease activity. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). The partial mayo score scale ranging is from 0 to 9. A higher (in negative) change from baseline shows a better clinical response | Non responder imputation population | Posted | Mean | Standard Deviation | units on a scale | Up to Month 48 |
|
|
|
| Secondary | Number of Subjects With Clinical Response at Month 48 | Clinical response was defined as: reduction in Total Mayo Score (TMS) of at least 2 points and >= 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of >= 1 point or absolute rectal bleeding sub-score of <= 1 point. | Non responder imputation population | Posted | Count of Participants | Participants | up to 48 months |
|
|
|
| Secondary | Number of Subjects With Clinical Remission at Month 48 | Clinical remission was achieved when all the following criteria were met in the components of the Mayo clinical Score: rectal bleeding sub-score = 0 central endoscopy sub-score <= 1 stool frequency sub-score <= 1 | non responder imputation population | Posted | Count of Participants | Participants | up to 48 months |
|
|
|
| Secondary | Number of Subject With Endoscopic Improvement at Month 48 | oEndoscopic improvement was achieved if the Mayo central endoscopic sub-score is 0 or 1. | Non responder imputation population | Posted | Count of Participants | Participants | up to 48 Months |
|
|
|
| Secondary | Number of Subjects With Endoscopic Remission at Month 48 | Endoscopic remission was defined as Mayo central endoscopic sub-score = 0 | non responder imputation population | Posted | Count of Participants | Participants | up to 48 months |
|
|
|
| Secondary | Fecal Calprotectin | The change from Day 0 up to Month 48 in fecal calprotectin A higher (in negative) change shows a better efficacy | Non responder imputation population | Posted | Mean | Standard Deviation | ug/g | Up to Month 48 |
|
|
|
| Secondary | CRP Levels | The change from Day 0 up to Month 48 in CRP levels | Non responder imputation population | Posted | Mean | Standard Deviation | mg/L | Up to Month 48 |
|
|
|
| Secondary | Number of Treatment-emergent Serious Adverse Events | The number of incidences of treatment-emergent serious adverse events | Observed cases population | Posted | Number | events | Through subject study treatment, up to 48 months |
|
|
|
| Secondary | Number of Treatment-emergent Adverse Events of Special Interest | The number of incidences of treatment-emergent adverse events of special interest | Observed cases population | Posted | Number | events | Through subject study treatment, up to 48 months |
|
|
|
| Secondary | Number of Adverse Events Leading to Investigational Product Discontinuation | The number of incidences of adverse events leading to investigational product discontinuation | Observed cases population | Posted | Number | event | Through subject study treatment, up to 48 months |
|
|
|
| Secondary | Number of Specific Laboratory Abnormalities | The number of incidences of specific laboratory abnormalities | Observed Cases | Posted | Number | events | Through first year of subject study treatment, 12 months |
|
|
|
| Secondary | SF-36 Quality of Life Questionnaire (SF-36 Physical Component) | Change from Day 0 up to 24 months in SF-36 Questionnaire scores; The SF-36 questionnaire is a self-administered questionnaire containing 36 items. It measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health. These items are grouped in 2 distincts components: a physical component (SF-36 physical) and a mental component (SF-36 mental). This outcome describes the SF-36 physical component. Each item score ranging is from 0 to 100. A higher positive value in change indicate a better health status. The higher the change from baseline, the better improvement | Non responder imputation population | Posted | Mean | Standard Deviation | units on a scale | Up to 24 months |
|
|
|
| Secondary | SF-36 Quality of Life Questionnaire (SF-36 Mental Component) | Change from Day 0 up to 24 months in SF-36 Questionnaire scores; The SF-36 questionnaire is a self-administered questionnaire containing 36 items. It measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health. These items are grouped in 2 distincts components: a physical component (SF-36 physical) and a mental component (SF-36 mental). This outcome describes the SF-36 mental component. Each item score ranging is from 0 to 100. A higher positive value in change indicate a better health status. The higher the change from baseline, the better improvement | Non responder imputation population | Posted | Mean | Standard Deviation | units on a scale | Up to 24 months |
|
|
|
| Secondary | Erythrocyte Sedimentation Rate (ESR) Levels | The change from Day 0 up to Month 48 in ESR levels | Non responder imputation population | Posted | Mean | Standard Deviation | mm/hour | up to 48 Months |
|
|
|
| Post-Hoc | UC Worsening | Proportion of subjects with UC worsening based on adverse events | Posted | Count of Participants | Participants | Up to Month 48 |
|
|
|
| 0 |
| 22 |
| 3 |
| 22 |
| 20 |
| 22 |
|
| enteropathic spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment | The subject admitted to hospital due to spondyloarthropathy caused by inflammatory bowel disease (HLA-B27+). The event considered not related to study treatment and resolved without sequelae. No action was taken with study treatment. |
|
| benign ovarian tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment | subject underwent total hysterectomy. Event considered not related to study treatment and resolved without sequelae. Study treatment was temporarily discontinued. |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| colitis ulcerative | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
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| nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |