Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
- Registration Number
- NCT04023396
- Lead Sponsor
- Abivax S.A.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 217
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABX464 50mg ABX464 All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
- Primary Outcome Measures
Name Time Method Proportion of Patients With Clinical Remission at Week 48 Compared to Baseline of Induction Study (ABX464-103) week 48 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
Name Time Method miRNA-124 Expression baseline, week 24 and week 48 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.
Proportion of Patients With Clinical Response at Weeks 48 and 96 Compared to Baseline of Induction Study Weeks 48 and 96 Proportion of patients with clinical response at week 48 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.
Endoscopic Improvement at Weeks 48 and 96 week 48 and week 96 Proportion of patients with endoscopic improvement at week 48 among all patients.
Proportion of patients with endoscopic improvement at week 96 among all patients.
Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability).Endoscopic Remission at Weeks 48 and 96 week 48 and week 96 Proportion of patients with endoscopic remission at week 48 among all patients. Proportion of patients with endoscopic remission at week 96 among all patients. Endoscopic remission is defined as a Mayo endoscopic sub score of 0.
Incidence and Description of Adverse Events From baseline to week 96 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.
Trial Locations
- Locations (120)
Medizinische Hochschule Hannover
🇩🇪Hanover, Germany
AKH - Medizinische Universität Wien
🇦🇹Vienna, Austria
Gomel Regional Clinical Hospital
🇧🇾Gomel, Belarus
Regional Clinical Hospital
🇧🇾Minsk, Belarus
Vitebsk regoinal clinical specialized center
🇧🇾Vitebsk, Belarus
Brandon Medical Arts Clinic
🇨🇦Brandon, Canada
South Edmonton Gastroenterology
🇨🇦Edmonton, Canada
LHSC - Victoria Hospital
🇨🇦London, Canada
Mount Sinai Hospital
🇨🇦Toronto, Canada
Fakultni nemocnice u sv. Anny v Brne
🇨🇿Brno, Czechia
Hepato-Gastroenterologie HK s.r.o.
🇨🇿Hradec Kralove, Czechia
MUDr. GREGAR s.r.o.
🇨🇿Olomouc, Czechia
Fakultni nemocnice Ostrava
🇨🇿Ostrava-Kunčice, Czechia
Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth
🇩🇪Düsseldorf, Germany
Nemocnice Na Bulovce
🇨🇿Praha, Czechia
Thomayerova nemocnice
🇨🇿Praha, Czechia
CHU Amiens - Hopital Sud
🇫🇷Amiens, France
CHU Clermont Ferrand - Hôpital d'Estaing
🇫🇷Clermont-Ferrand, France
Hôpital Beaujon
🇫🇷Clichy, France
CHU de Grenoble - Hôpital Nord
🇫🇷Grenoble, France
Centre Hospitalier Départemental Les Oudairies
🇫🇷La Roche-sur-Yon, France
CHU Lille - Hôpital Claude Huriez
🇫🇷Lille, France
Hôpital Nord - CHU Marseille
🇫🇷Marseille, France
Hopital Saint Eloi
🇫🇷Montpellier, France
CHU Nantes - Hôtel Dieu
🇫🇷Nantes, France
CHU Nice - Hôpital de l'Archet 2
🇫🇷Nice, France
CHU Reims - Hôpital Robert Debré
🇫🇷Reims, France
CHU Rennes - Hôpital Pontchaillou
🇫🇷Rennes, France
CHU de Rouen - Hôpital Charles Nicolle
🇫🇷Rouen, France
CHU Saint Etienne - Hôpital Nord
🇫🇷Saint-Étienne, France
Klinikum der Johann Wolfgang Goethe-Universitaet
🇩🇪Frankfurt, Germany
Hôpital de Brabois Adultes
🇫🇷Vandœuvre-lès-Nancy, France
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Tumorzentrum Nordthueringen MVZ GmbH
🇩🇪Nordhausen, Germany
Dr. Tasso Bieler
🇩🇪Riesa, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Obudai Egeszsegugyi Centrum Kft.
🇭🇺Budapest, Hungary
Debreceni Egyetem
🇭🇺Debrecen, Hungary
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
🇭🇺Debrecen, Hungary
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
Fondazione Poliambulanza Istituto Ospedaliero
🇮🇹Brescia, Italy
Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Roma, Italy
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Centrum Medyczne Plejady
🇵🇱Kraków, Poland
CNCE "City Hospital 9" Zaporizhzhia CC
🇺🇦Zaporizhzhia, Ukraine
AZ Sint-Lucas
🇧🇪Brugge, Belgium
DRC Gyogyszervizsgalo Kozpont Kft.
🇭🇺Balatonfured, Hungary
Szpital Uniwersytecki nr 2 im.dr J. Biziela
🇵🇱Bydgoszcz, Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
🇵🇱Wroclaw, Poland
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
🇺🇦Vinnytsia, Ukraine
Klinikum Klagenfurt am Wörthersee
🇦🇹Klagenfurt, Austria
University Hospitals Leuven - campus Gasthuisberg
🇧🇪Leuven, Belgium
Trialmed CRS
🇵🇱Piotrkow Trybunalski, Poland
Ordensklinikum Linz GmbH - Barmherzige Schwestern
🇦🇹Linz, Austria
Minsk city diagnostic center
🇧🇾Minsk, Belarus
Clinical Center " Dr Dragisa Misovic Dedinje"
🇷🇸Belgrad, Serbia
Gastro I, s.r.o.
🇸🇰Prešov, Slovakia
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital
🇺🇦Kharkiv, Ukraine
Santa Familia Centrum Badan, Profilaktyki i Leczenia
🇵🇱Lodz, Poland
Centrum Medyczne Grunwald
🇵🇱Poznan, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital
🇺🇦Kyiv, Ukraine
A. Novak Transcarpathian Regional Clinical Hospital
🇺🇦Úzhgorod, Ukraine
KO-MED Centra Kliniczne Pulawy
🇵🇱Pulawy, Poland
General Hospital Uzice
🇷🇸Užice, Serbia
General Hospital Murska Sobota
🇸🇮Murska Sobota, Slovenia
CI Kherson CCH
🇺🇦Kherson, Ukraine
Vitebsk Regional Clinical Hospital
🇧🇾Vitebsk, Belarus
C. H. U. St-Pierre
🇧🇪Brussels, Belgium
The Ottawa Hospital - General Campus
🇨🇦Ottawa, Canada
Nemocnice Slany
🇨🇿Slany, Czechia
CHU Besançon - Hôpital Jean Minjoz
🇫🇷Besançon, France
CHU Strasbourg - Hôpital Hautepierre
🇫🇷Strasbourg, France
Hopital Rangueil
🇫🇷Toulouse, France
Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt
🇩🇪Halle, Germany
Universitaetsklinikum Halle (Saale)
🇩🇪Halle, Germany
Johanna-Etienne-Krankenhaus
🇩🇪Neuss, Germany
Pannonia Maganorvosi Centrum
🇭🇺Budapest, Hungary
Petz Aladar Megyei Oktato Korhaz
🇭🇺Győr, Hungary
Azienda Ospedaliero Universitaria Mater Domini
🇮🇹Catanzaro, Italy
I.R.C.C.S Policlinico San Donato
🇮🇹Milano, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
🇮🇹Pisa, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Wojskowy Szpital Kliniczny w Lublinie
🇵🇱Lublin, Poland
Gabinet Lekarski Bartosz Korczowski
🇵🇱Rzeszow, Poland
Centrum Zdrowia Tuchow Sp. z o.o.
🇵🇱Wierzchosławice, Poland
Centrum Zdrowia MDM
🇵🇱Warszawa, Poland
Nzoz Vivamed
🇵🇱Warszawa, Poland
LexMedica
🇵🇱Wroclaw, Poland
Clinical Center Bezanijska Kosa
🇷🇸Belgrad, Serbia
Endomed, s.r.o.
🇸🇰Vranov Nad Topľou, Slovakia
Alian s.r.o.
🇸🇰Bardejov, Slovakia
Gastromedic, s.r.o.
🇸🇰Nové Zámky, Slovakia
Accout Center s.r.o.
🇸🇰Šahy, Slovakia
Hospital Quironsalud Malaga
🇪🇸Málaga, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
🇪🇸Las Palmas De Gran Canaria, Spain
University Medical Centre Maribor
🇸🇮Maribor, Slovenia
General Hospital Celje
🇸🇮Celje, Slovenia
Centro Médico Teknon
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
CNE Cherkasy Regional Hospital of Cherkasy Regional Council
🇺🇦Cherkasy, Ukraine
CHI Kharkiv City Clinical Hospital #13
🇺🇦Kharkiv, Ukraine
I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital
🇺🇦Dnipro, Ukraine
Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
🇺🇦Ivano-Frankivs'k, Ukraine
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
🇺🇦Kharkiv, Ukraine
Khmelnytska Regional Hospital
🇺🇦Khmelnytskyi, Ukraine
Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
🇺🇦Lviv, Ukraine
Ternopil University Hospital
🇺🇦Ternopil', Ukraine
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
🇺🇦Vinnytsia, Ukraine
CI City Clinical Hospital #6 Dept of Gastroenterology
🇺🇦Zaporizhzhia, Ukraine
Fairfield General Hospital
🇬🇧Bury, United Kingdom
MCIC MC LLC Health Clinic
🇺🇦Vinnytsia, Ukraine
University College London Hospitals
🇬🇧London, United Kingdom
Nottingham University Hospitals Queen's Medical Centre
🇬🇧Nottingham, United Kingdom
Guy's Hospital
🇬🇧London, United Kingdom
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Austria