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Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABX464
Sponsored by
Abivax S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring moderate to severe ulcerative colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have completed the 16-week induction treatment period (ABX464-103);
  • Patients are able and willing to comply with study visits and procedures as per protocol;
  • Patients should understand, sign and date the written voluntary informed consent form prior to any protocol-specific procedures are performed;
  • Patients should be affiliated to a social security regimen (for French sites only);
  • Females and males receiving the study treatment (potentially in combination with immunosuppressant) and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to screening. Women must be surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) or in the postmenopausal state (no menses for 12 months without an alternative medical cause) 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) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. 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. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male patients should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male patients must not donate sperm as long as contraception is required.

Criteria that should be met by patients at week 48 to be eligible for 48 additional weeks of study treatment.

  • Patients should be in clinical response. Clinical response is defined as: a reduction in Modified Mayo Score ≥ 2 points and ≥ 30 % from baseline (induction) with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.
  • Patients able and willing to continue the study treatment and who are compliant with study visits and procedures and who signed the update of the written voluntary informed consent.

Exclusion Criteria:

  • Patients who had major protocol deviation(s) in the induction study;
  • Patients who permanently discontinued study the treatment in induction study (ABX464-103) because of an adverse event (AE) regardless of relatedness to investigational product;
  • Patients who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study;
  • Patients with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study;
  • Patients who are participating or plan to participate in other investigational studies (other than induction study) during the study.

Sites / Locations

  • Medizinische Universität Innsbruck
  • Klinikum Klagenfurt am Wörthersee
  • Ordensklinikum Linz GmbH - Barmherzige Schwestern
  • AKH - Medizinische Universität Wien
  • Gomel Regional Clinical Hospital
  • Minsk city diagnostic center
  • Regional Clinical Hospital
  • Vitebsk Regional Clinical Hospital
  • Vitebsk regoinal clinical specialized center
  • AZ Sint-Lucas
  • C. H. U. St-Pierre
  • University Hospitals Leuven - campus Gasthuisberg
  • Brandon Medical Arts Clinic
  • South Edmonton Gastroenterology
  • LHSC - Victoria Hospital
  • The Ottawa Hospital - General Campus
  • Mount Sinai Hospital
  • Fakultni nemocnice u sv. Anny v Brne
  • Hepato-Gastroenterologie HK s.r.o.
  • MUDr. GREGAR s.r.o.
  • Fakultni nemocnice Ostrava
  • Nemocnice Na Bulovce
  • Thomayerova nemocnice
  • Nemocnice Slany
  • CHU Amiens - Hopital Sud
  • CHU Besançon - Hôpital Jean Minjoz
  • CHU Clermont Ferrand - Hôpital d'Estaing
  • Hôpital Beaujon
  • CHU de Grenoble - Hôpital Nord
  • Centre Hospitalier Départemental Les Oudairies
  • CHU Lille - Hôpital Claude Huriez
  • Hôpital Nord - CHU Marseille
  • Hopital Saint Eloi
  • CHU Nantes - Hôtel Dieu
  • CHU Nice - Hôpital de l'Archet 2
  • CHU Reims - Hôpital Robert Debré
  • CHU Rennes - Hôpital Pontchaillou
  • CHU de Rouen - Hôpital Charles Nicolle
  • CHU Saint Etienne - Hôpital Nord
  • CHU Strasbourg - Hôpital Hautepierre
  • Hopital Rangueil
  • Hôpital de Brabois Adultes
  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt
  • Universitaetsklinikum Halle (Saale)
  • Medizinische Hochschule Hannover
  • Johanna-Etienne-Krankenhaus
  • Tumorzentrum Nordthueringen MVZ GmbH
  • Dr. Tasso Bieler
  • Universitaetsklinikum Ulm
  • DRC Gyogyszervizsgalo Kozpont Kft.
  • Obudai Egeszsegugyi Centrum Kft.
  • Pannonia Maganorvosi Centrum
  • Semmelweis Egyetem
  • Debreceni Egyetem
  • Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
  • Petz Aladar Megyei Oktato Korhaz
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Fondazione Poliambulanza Istituto Ospedaliero
  • Azienda Ospedaliero Universitaria Mater Domini
  • I.R.C.C.S Policlinico San Donato
  • Ospedale Sacro Cuore Don Calabria
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Istituto Clinico Humanitas
  • Szpital Uniwersytecki nr 2 im.dr J. Biziela
  • Uniwersyteckie Centrum Kliniczne
  • Centrum Medyczne Plejady
  • Santa Familia Centrum Badan, Profilaktyki i Leczenia
  • Wojskowy Szpital Kliniczny w Lublinie
  • Trialmed CRS
  • Centrum Medyczne Grunwald
  • KO-MED Centra Kliniczne Pulawy
  • Gabinet Lekarski Bartosz Korczowski
  • Centrum Zdrowia MDM
  • Nzoz Vivamed
  • Centrum Zdrowia Tuchow Sp. z o.o.
  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
  • Centrum Medyczne Oporow
  • LexMedica
  • Clinical Center " Dr Dragisa Misovic Dedinje"
  • Clinical Center Bezanijska Kosa
  • General Hospital Uzice
  • Alian s.r.o.
  • Gastromedic, s.r.o.
  • Gastro I, s.r.o.
  • Endomed, s.r.o.
  • Accout Center s.r.o.
  • General Hospital Celje
  • University Medical Centre Maribor
  • General Hospital Murska Sobota
  • Centro Médico Teknon
  • Hospital Universitario Reina Sofia
  • Hospital Universitario de Gran Canaria Dr. Negrin
  • Hospital Quironsalud Malaga
  • CNE Cherkasy Regional Hospital of Cherkasy Regional Council
  • I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
  • Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
  • CHI Kharkiv City Clinical Hospital #13
  • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
  • Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
  • CI Kherson CCH
  • Khmelnytska Regional Hospital
  • Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
  • Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
  • Ternopil University Hospital
  • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
  • M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
  • MCIC MC LLC Health Clinic
  • CI City Clinical Hospital #6 Dept of Gastroenterology
  • CNCE "City Hospital 9" Zaporizhzhia CC
  • A. Novak Transcarpathian Regional Clinical Hospital
  • Fairfield General Hospital
  • Guy's Hospital
  • University College London Hospitals
  • Nottingham University Hospitals Queen's Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABX464 50mg

Arm Description

All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.

Outcomes

Primary Outcome Measures

Proportion of patients with clinical remission at week 48 compared to baseline of induction study (ABX464-103)
Clinical remission (based on the Mayo scoring system) is defined as: a rectal bleeding sub-score = 0, and an endoscopy sub-score ≤1 (excluding friability), and at least 1-point decrease in stool frequency sub-score from baseline to achieve a stool frequency sub-score ≤1

Secondary Outcome Measures

Change in Modified Mayo Score and in partial Modified Mayo Score
Change in Modified Mayo Score at weeks 48 and 96 and in partial Modified Mayo Score at every study visit among all patients. Modified Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation and Physician's global assessment. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). Partial Mayo score uses the 3 non-invasive components of the full Mayo Score (stool frequency, rectal bleeding and Physician's global assessment) and excludes the score for the endoscopic findings. Therefore the maximum score is reduced from 12 to 9 points.
Endoscopic changes at week 48
Proportion of patients with endoscopic changes by segment at week 48 among all patients. Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability). Endoscopic remission is defined as a Mayo endoscopic sub score of 0.
Sustained endoscopic changes at week 48
Proportion of patients with sustained endoscopic changes at week 48 and 96. Sustained endoscopic changes is defined as the number of patients with endoscopic changes at week 48 among patients who had endoscopic changes during the Induction study (at week 8 or week 16 of study ABX464-103).
Glucocorticoid-free clinical remission
Proportion of patients with glucocorticoid-free clinical remission at week 48. Glucocorticoid-free clinical remission is defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 8 weeks prior to week 48.
Rectal bleeding
Change to baseline in stool and rectal bleeding frequency at every study visit.
Fecal calprotectin and C-Reactive Proteine
Change to baseline in fecal calprotectin and C-Reactive Proteine levels at week 24, 48, 60, 72, 84 and 96.
Clinical response at week 48
Proportion of patients with clinical response at week 48 and 96. Clinical response is defined as: a reduction in Mayo Score ≥ 3 points and ≥ 30 % from baseline with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.
miRNA-124 expression
Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at week 48 and in total blood at week 24 and week 48.
Inflammatory Bowel Disease Questionnaire
This questionnaire is a validated and reliable tool to measure health-related quality of life in adult patients with inflammatory bowel disease, ulcerative colitis, or Crohn's disease. It contains 32 questions, which are divided into four health domains: bowel symptoms (10 questions), systemic symptoms (5 questions), emotional function (12 questions), and social function (5 questions). For each question there are graded responses on a 7-point Likert scale, ranging from 1 (representing the "worst" aspect) to 7 (representing the "best" aspect). Thus, the total IBDQ score ranges from 32 to 224, with higher scores reflecting better well-being. For study purpose, scores and changes in the Inflammatory Bowel Disease Questionnaire domains will be collected and compared from baseline to week 24 and 48.
Histopathological evaluation of the effect of ABX464 50 mg on the rectal/sigmoidal infiltrate based on Gebeos score
Week 48 biopsies will be compared to biopsies taken during the induction study (ABX464-103) to assess the disease evolution at a tissue level, based on the Geboes Score. The scoring system is composed of 6 major grades that assess the structural changes (0), chronic inflammation (1), lamina propria neutrophils (2), neutrophils in the epithelium (3), crypt destruction (4) and erosion and ulcers (5).
Histopathological evaluation of the effect of ABX464 50 mg on the rectal/sigmoidal infiltrate based on Nancy index scoring system
Week 48 biopsies will be compared to biopsies taken during the induction study (ABX464-103) to assess the disease evolution at a tissue level, based on Nancy index scoring system. It is a 5-level classification from 0 (absence of significant histological disease) to 4 (severely active disease). Classification in each category depends on the presence or absence of ulceration, acute inflammatory cells infiltrate and chronic inflammatory cells infiltrate.
Histopathological evaluation of the effect of ABX464 50 mg on the rectal/sigmoidal infiltrate based on the Robarts Histological index
Week 48 biopsies will be compared to biopsies taken during the induction study (ABX464-103) to assess the disease evolution at a tissue level, based on the Robarts Histological Index. The score ranges from 0 (no disease activity) to 33 (severe disease activity) is based on evaluation of 4 parameters: chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in the epithelium and erosion and ulceration.
Incidence and description of Adverse Events
Number and rate of all adverse events, causally-related adverse events, all serious adverse events and causally-related serious adverse events classified by severity. Incidence of treatment-emergent serious adverse events, hospitalizations, total inpatient days. Incidence of adverse events leading to investigational product discontinuation. Number of clinically significant laboratory abnormalities.

Full Information

First Posted
July 5, 2019
Last Updated
December 21, 2021
Sponsor
Abivax S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04023396
Brief Title
Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
Official Title
A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abivax S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase 2b study to evaluate the long-term efficacy and safety study of ABX464 50mg as maintenance therapy in patients with moderate to severe Ulcerative Colitis.
Detailed Description
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 ABX464-103 clinical study (induction study) and who are willing to continue their treatment. All subjects will receive ABX464 given at 50mg o.d regardless of their previous treatment and dose received in the ABX464-103 study (i.e. ABX464 100mg, ABX464 50mg, ABX464 25mg or Placebo). The enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation. Subjects will be treated with ABX464 for an overall period of 48 weeks. Subjects will be followed up on a monthly basis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
moderate to severe ulcerative colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
open-label, follow-up study
Masking
None (Open Label)
Allocation
N/A
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABX464 50mg
Arm Type
Experimental
Arm Description
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
Intervention Type
Drug
Intervention Name(s)
ABX464
Intervention Description
ABX464 All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
Primary Outcome Measure Information:
Title
Proportion of patients with clinical remission at week 48 compared to baseline of induction study (ABX464-103)
Description
Clinical remission (based on the Mayo scoring system) is defined as: a rectal bleeding sub-score = 0, and an endoscopy sub-score ≤1 (excluding friability), and at least 1-point decrease in stool frequency sub-score from baseline to achieve a stool frequency sub-score ≤1
Time Frame
week 48
Secondary Outcome Measure Information:
Title
Change in Modified Mayo Score and in partial Modified Mayo Score
Description
Change in Modified Mayo Score at weeks 48 and 96 and in partial Modified Mayo Score at every study visit among all patients. Modified Mayo Score evaluates ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation and Physician's global assessment. Each parameter of the score ranges from zero (normal or inactive disease) to 3 (severe activity). Partial Mayo score uses the 3 non-invasive components of the full Mayo Score (stool frequency, rectal bleeding and Physician's global assessment) and excludes the score for the endoscopic findings. Therefore the maximum score is reduced from 12 to 9 points.
Time Frame
From baseline to week 96
Title
Endoscopic changes at week 48
Description
Proportion of patients with endoscopic changes by segment at week 48 among all patients. Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability). Endoscopic remission is defined as a Mayo endoscopic sub score of 0.
Time Frame
weeks 48 and 96
Title
Sustained endoscopic changes at week 48
Description
Proportion of patients with sustained endoscopic changes at week 48 and 96. Sustained endoscopic changes is defined as the number of patients with endoscopic changes at week 48 among patients who had endoscopic changes during the Induction study (at week 8 or week 16 of study ABX464-103).
Time Frame
weeks 48 and 96
Title
Glucocorticoid-free clinical remission
Description
Proportion of patients with glucocorticoid-free clinical remission at week 48. Glucocorticoid-free clinical remission is defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 8 weeks prior to week 48.
Time Frame
From baseline to week 48
Title
Rectal bleeding
Description
Change to baseline in stool and rectal bleeding frequency at every study visit.
Time Frame
from baseline to week 96
Title
Fecal calprotectin and C-Reactive Proteine
Description
Change to baseline in fecal calprotectin and C-Reactive Proteine levels at week 24, 48, 60, 72, 84 and 96.
Time Frame
baseline, week 24, week 48
Title
Clinical response at week 48
Description
Proportion of patients with clinical response at week 48 and 96. Clinical response is defined as: a reduction in Mayo Score ≥ 3 points and ≥ 30 % from baseline with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.
Time Frame
baseline, weeks 48 and 96
Title
miRNA-124 expression
Description
Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at week 48 and in total blood at week 24 and week 48.
Time Frame
baseline, week 24 and week 48
Title
Inflammatory Bowel Disease Questionnaire
Description
This questionnaire is a validated and reliable tool to measure health-related quality of life in adult patients with inflammatory bowel disease, ulcerative colitis, or Crohn's disease. It contains 32 questions, which are divided into four health domains: bowel symptoms (10 questions), systemic symptoms (5 questions), emotional function (12 questions), and social function (5 questions). For each question there are graded responses on a 7-point Likert scale, ranging from 1 (representing the "worst" aspect) to 7 (representing the "best" aspect). Thus, the total IBDQ score ranges from 32 to 224, with higher scores reflecting better well-being. For study purpose, scores and changes in the Inflammatory Bowel Disease Questionnaire domains will be collected and compared from baseline to week 24 and 48.
Time Frame
baseline, week 24, week 48
Title
Histopathological evaluation of the effect of ABX464 50 mg on the rectal/sigmoidal infiltrate based on Gebeos score
Description
Week 48 biopsies will be compared to biopsies taken during the induction study (ABX464-103) to assess the disease evolution at a tissue level, based on the Geboes Score. The scoring system is composed of 6 major grades that assess the structural changes (0), chronic inflammation (1), lamina propria neutrophils (2), neutrophils in the epithelium (3), crypt destruction (4) and erosion and ulcers (5).
Time Frame
week 48
Title
Histopathological evaluation of the effect of ABX464 50 mg on the rectal/sigmoidal infiltrate based on Nancy index scoring system
Description
Week 48 biopsies will be compared to biopsies taken during the induction study (ABX464-103) to assess the disease evolution at a tissue level, based on Nancy index scoring system. It is a 5-level classification from 0 (absence of significant histological disease) to 4 (severely active disease). Classification in each category depends on the presence or absence of ulceration, acute inflammatory cells infiltrate and chronic inflammatory cells infiltrate.
Time Frame
week 48
Title
Histopathological evaluation of the effect of ABX464 50 mg on the rectal/sigmoidal infiltrate based on the Robarts Histological index
Description
Week 48 biopsies will be compared to biopsies taken during the induction study (ABX464-103) to assess the disease evolution at a tissue level, based on the Robarts Histological Index. The score ranges from 0 (no disease activity) to 33 (severe disease activity) is based on evaluation of 4 parameters: chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in the epithelium and erosion and ulceration.
Time Frame
week 48
Title
Incidence and description of Adverse Events
Description
Number and rate of all adverse events, causally-related adverse events, all serious adverse events and causally-related serious adverse events classified by severity. Incidence of treatment-emergent serious adverse events, hospitalizations, total inpatient days. Incidence of adverse events leading to investigational product discontinuation. Number of clinically significant laboratory abnormalities.
Time Frame
From baseline to week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have completed the 16-week induction treatment period (ABX464-103); Patients are able and willing to comply with study visits and procedures as per protocol; Patients should understand, sign and date the written voluntary informed consent form prior to any protocol-specific procedures are performed; Patients should be affiliated to a social security regimen (for French sites only); Females and males receiving the study treatment (potentially in combination with immunosuppressant) and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to screening. Women must be surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) or in the postmenopausal state (no menses for 12 months without an alternative medical cause) 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) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. 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. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male patients should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male patients must not donate sperm as long as contraception is required. Criteria that should be met by patients at week 48 to be eligible for 48 additional weeks of study treatment. Patients should be in clinical response. Clinical response is defined as: a reduction in Modified Mayo Score ≥ 2 points and ≥ 30 % from baseline (induction) with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point. Patients able and willing to continue the study treatment and who are compliant with study visits and procedures and who signed the update of the written voluntary informed consent. Exclusion Criteria: Patients who had major protocol deviation(s) in the induction study; Patients who permanently discontinued study the treatment in induction study (ABX464-103) because of an adverse event (AE) regardless of relatedness to investigational product; Patients who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study; Patients with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study; Patients who are participating or plan to participate in other investigational studies (other than induction study) during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Severine VERMEIRE, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
Country
Austria
Facility Name
Klinikum Klagenfurt am Wörthersee
City
Klagenfurt
Country
Austria
Facility Name
Ordensklinikum Linz GmbH - Barmherzige Schwestern
City
Linz
Country
Austria
Facility Name
AKH - Medizinische Universität Wien
City
Vienna
Country
Austria
Facility Name
Gomel Regional Clinical Hospital
City
Gomel
Country
Belarus
Facility Name
Minsk city diagnostic center
City
Minsk
Country
Belarus
Facility Name
Regional Clinical Hospital
City
Minsk
Country
Belarus
Facility Name
Vitebsk Regional Clinical Hospital
City
Vitebsk
Country
Belarus
Facility Name
Vitebsk regoinal clinical specialized center
City
Vitebsk
Country
Belarus
Facility Name
AZ Sint-Lucas
City
Brugge
Country
Belgium
Facility Name
C. H. U. St-Pierre
City
Brussels
Country
Belgium
Facility Name
University Hospitals Leuven - campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Brandon Medical Arts Clinic
City
Brandon
Country
Canada
Facility Name
South Edmonton Gastroenterology
City
Edmonton
Country
Canada
Facility Name
LHSC - Victoria Hospital
City
London
Country
Canada
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
Country
Canada
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK s.r.o.
City
Hradec Kralove
Country
Czechia
Facility Name
MUDr. GREGAR s.r.o.
City
Olomouc
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava-Kunčice
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Praha
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Praha
Country
Czechia
Facility Name
Nemocnice Slany
City
Slany
Country
Czechia
Facility Name
CHU Amiens - Hopital Sud
City
Amiens
Country
France
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besançon
Country
France
Facility Name
CHU Clermont Ferrand - Hôpital d'Estaing
City
Clermont-Ferrand
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
Country
France
Facility Name
CHU de Grenoble - Hôpital Nord
City
Grenoble
Country
France
Facility Name
Centre Hospitalier Départemental Les Oudairies
City
La Roche-sur-Yon
Country
France
Facility Name
CHU Lille - Hôpital Claude Huriez
City
Lille
Country
France
Facility Name
Hôpital Nord - CHU Marseille
City
Marseille
Country
France
Facility Name
Hopital Saint Eloi
City
Montpellier
Country
France
Facility Name
CHU Nantes - Hôtel Dieu
City
Nantes
Country
France
Facility Name
CHU Nice - Hôpital de l'Archet 2
City
Nice
Country
France
Facility Name
CHU Reims - Hôpital Robert Debré
City
Reims
Country
France
Facility Name
CHU Rennes - Hôpital Pontchaillou
City
Rennes
Country
France
Facility Name
CHU de Rouen - Hôpital Charles Nicolle
City
Rouen
Country
France
Facility Name
CHU Saint Etienne - Hôpital Nord
City
Saint-Étienne
Country
France
Facility Name
CHU Strasbourg - Hôpital Hautepierre
City
Strasbourg
Country
France
Facility Name
Hopital Rangueil
City
Toulouse
Country
France
Facility Name
Hôpital de Brabois Adultes
City
Vandœuvre-lès-Nancy
Country
France
Facility Name
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
Country
Germany
Facility Name
Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth
City
Düsseldorf
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
Country
Germany
Facility Name
Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt
City
Halle
Country
Germany
Facility Name
Universitaetsklinikum Halle (Saale)
City
Halle
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hanover
Country
Germany
Facility Name
Johanna-Etienne-Krankenhaus
City
Neuss
Country
Germany
Facility Name
Tumorzentrum Nordthueringen MVZ GmbH
City
Nordhausen
Country
Germany
Facility Name
Dr. Tasso Bieler
City
Riesa
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft.
City
Balatonfured
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem
City
Debrecen
Country
Hungary
Facility Name
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
City
Debrecen
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Győr
Country
Hungary
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
Country
Italy
Facility Name
Fondazione Poliambulanza Istituto Ospedaliero
City
Brescia
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Mater Domini
City
Catanzaro
Country
Italy
Facility Name
I.R.C.C.S Policlinico San Donato
City
Milano
Country
Italy
Facility Name
Ospedale Sacro Cuore Don Calabria
City
Negrar
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
City
Palermo
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
City
Pisa
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Facility Name
Szpital Uniwersytecki nr 2 im.dr J. Biziela
City
Bydgoszcz
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Kraków
Country
Poland
Facility Name
Santa Familia Centrum Badan, Profilaktyki i Leczenia
City
Lodz
Country
Poland
Facility Name
Wojskowy Szpital Kliniczny w Lublinie
City
Lublin
Country
Poland
Facility Name
Trialmed CRS
City
Piotrkow Trybunalski
Country
Poland
Facility Name
Centrum Medyczne Grunwald
City
Poznan
Country
Poland
Facility Name
KO-MED Centra Kliniczne Pulawy
City
Pulawy
Country
Poland
Facility Name
Gabinet Lekarski Bartosz Korczowski
City
Rzeszow
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
Country
Poland
Facility Name
Nzoz Vivamed
City
Warszawa
Country
Poland
Facility Name
Centrum Zdrowia Tuchow Sp. z o.o.
City
Wierzchosławice
Country
Poland
Facility Name
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
City
Wroclaw
Country
Poland
Facility Name
Centrum Medyczne Oporow
City
Wroclaw
Country
Poland
Facility Name
LexMedica
City
Wroclaw
Country
Poland
Facility Name
Clinical Center " Dr Dragisa Misovic Dedinje"
City
Belgrad
Country
Serbia
Facility Name
Clinical Center Bezanijska Kosa
City
Belgrad
Country
Serbia
Facility Name
General Hospital Uzice
City
Užice
Country
Serbia
Facility Name
Alian s.r.o.
City
Bardejov
Country
Slovakia
Facility Name
Gastromedic, s.r.o.
City
Nové Zámky
Country
Slovakia
Facility Name
Gastro I, s.r.o.
City
Prešov
Country
Slovakia
Facility Name
Endomed, s.r.o.
City
Vranov Nad Topľou
Country
Slovakia
Facility Name
Accout Center s.r.o.
City
Šahy
Country
Slovakia
Facility Name
General Hospital Celje
City
Celje
Country
Slovenia
Facility Name
University Medical Centre Maribor
City
Maribor
Country
Slovenia
Facility Name
General Hospital Murska Sobota
City
Murska Sobota
Country
Slovenia
Facility Name
Centro Médico Teknon
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Dr. Negrin
City
Las Palmas De Gran Canaria
Country
Spain
Facility Name
Hospital Quironsalud Malaga
City
Málaga
Country
Spain
Facility Name
CNE Cherkasy Regional Hospital of Cherkasy Regional Council
City
Cherkasy
Country
Ukraine
Facility Name
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
City
Dnipro
Country
Ukraine
Facility Name
Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
CHI Kharkiv City Clinical Hospital #13
City
Kharkiv
Country
Ukraine
Facility Name
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
City
Kharkiv
Country
Ukraine
Facility Name
Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
City
Kharkiv
Country
Ukraine
Facility Name
CI Kherson CCH
City
Kherson
Country
Ukraine
Facility Name
Khmelnytska Regional Hospital
City
Khmelnytskyi
Country
Ukraine
Facility Name
Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
City
Kyiv
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
City
Lviv
Country
Ukraine
Facility Name
Ternopil University Hospital
City
Ternopil'
Country
Ukraine
Facility Name
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
City
Vinnytsia
Country
Ukraine
Facility Name
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
City
Vinnytsia
Country
Ukraine
Facility Name
MCIC MC LLC Health Clinic
City
Vinnytsia
Country
Ukraine
Facility Name
CI City Clinical Hospital #6 Dept of Gastroenterology
City
Zaporizhzhia
Country
Ukraine
Facility Name
CNCE "City Hospital 9" Zaporizhzhia CC
City
Zaporizhzhia
Country
Ukraine
Facility Name
A. Novak Transcarpathian Regional Clinical Hospital
City
Úzhgorod
Country
Ukraine
Facility Name
Fairfield General Hospital
City
Bury
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
Country
United Kingdom
Facility Name
Nottingham University Hospitals Queen's Medical Centre
City
Nottingham
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36075249
Citation
Vermeire S, Sands BE, Tilg H, Tulassay Z, Kempinski R, Danese S, Bunganic I, Nitcheu J, Santo J, Scherrer D, Biguenet S, Ehrlich HJ, Steens JM, Gineste P, Sandborn WJ. ABX464 (obefazimod) for moderate-to-severe, active ulcerative colitis: a phase 2b, double-blind, randomised, placebo-controlled induction trial and 48 week, open-label extension. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):1024-1035. doi: 10.1016/S2468-1253(22)00233-3. Epub 2022 Sep 6.
Results Reference
derived

Learn more about this trial

Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

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