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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05535946
Registration number
NCT05535946
Ethics application status
Date submitted
7/09/2022
Date registered
10/09/2022
Date last updated
24/04/2024
Titles & IDs
Public title
ABTECT - Maintenance
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Scientific title
A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of ABX464 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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0
ABX464-107
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
0
0
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Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABX464
Treatment: Drugs - Placebo
Experimental: ABX464 50mg - Responder subjects at the end of induction - Subjects will be orally dosed during 44 weeks
Experimental: ABX464 25mg - Responder subjects at the end of induction - Subjects will be orally dosed during 44 weeks
Placebo Comparator: Placebo - Responder subjects at the end of induction - Subjects will be orally dosed during 44 weeks
Experimental: ABX464 50mg - Non responder subjects at the end of induction - Subjects will be orally dosed during 44 weeks
Experimental: ABX464 25mg - Non responder subjects at the end of induction - Subjects will be orally dosed during 44 weeks
Treatment: Drugs: ABX464
Administered once daily in the morning with food
Treatment: Drugs: Placebo
Administered once daily in the morning with food
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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0
Rate of subjects in clinical remission [SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1 (friability is scored as 2)] at Week 44
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Assessment method [1]
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The study primary objective is to evaluate the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission at Week 44.
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Timepoint [1]
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Week 44
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Secondary outcome [1]
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Proportion of subjects with endoscopic improvement (Mayo Endoscopic Subscore (MES) = 0 or 1) at Week 44
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Assessment method [1]
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To evaluate the efficacy of ABX464 versus placebo on endoscopic improvement.
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Timepoint [1]
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Week 44
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Secondary outcome [2]
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0
Proportion of subjects with symptomatic remission (SFS = 0 or 1 and RBS = 0) at Week 44
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Assessment method [2]
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0
To evaluate the efficacy of ABX464 versus placebo on symptomatic remission
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Timepoint [2]
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Week 44
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Secondary outcome [3]
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Proportion of subjects with corticosteroid-free clinical remission (clinical remission at Week 44 and corticosteroid free for at least 12 weeks prior to Week 44 in the subpopulation with corticosteroids at maintenance study entry)
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Assessment method [3]
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To evaluate the efficacy of ABX464 versus placebo on corticosteroid-free clinical remission.
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Timepoint [3]
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Week 44
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Secondary outcome [4]
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Proportion of subjects with sustained clinical remission at Week 44
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Assessment method [4]
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To evaluate the efficacy of ABX464 versus placebo to sustain clinical remission.
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Timepoint [4]
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Week 44
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Secondary outcome [5]
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Proportion of subjects with HEMI per Geboes scoring at Week 44
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Assessment method [5]
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To evaluate the efficacy of ABX464 on histologic-endoscopic mucosal improvement (HEMI) versus placebo
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Timepoint [5]
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Week 44
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Secondary outcome [6]
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Proportion of subjects with endoscopic remission (MES = 0) at Week 44.
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Assessment method [6]
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To evaluate the efficacy of ABX464 versus placebo on endoscopic remission.
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Timepoint [6]
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Week 44
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Eligibility
Key inclusion criteria
- Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106),
and patients' clinical response status must be available.
- Subjects with a valid endoscopy performed at the end of the induction study and
results from central reader available at Day 1.
- Subjects must understand, sign and date the written voluntary informed consent form at
the visit prior to any protocol-specific procedures. For under-aged subjects, national
requirements regarding consent should also be met.
- Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner
must agree to use highly effective contraception methods as stated in Section 4.4.
(Contraception) of this protocol.
- Subjects must be able and willing to comply with study visits and procedures as per
protocol.
- Subjects should be affiliated to a health insurance policy whenever required by a
participating country or state
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects who permanently discontinued the study treatment during the induction study
(either ABX464-105 or ABX464-106).
- Subjects who have developed any major illness/condition or evidence of an unstable
clinical condition (except UC) during the induction study that, in the investigator's
judgment, will substantially increase the risk to the participant if he or she
participates in the study.
- Subjects who plan to participate in other investigational studies during the
maintenance study.
- Male or female planning a pregnancy within the coming 12 months
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2025
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Actual
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Sample size
Target
1050
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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Concord Repatriation General Hospital - Concord
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Liverpool Hospital - Liverpool
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Royal Brisbane and Women's Hospital - Herston
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Coral Sea Clinical Research Institute - North Mackay
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Mater Hospital Brisbane - South Brisbane
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Princess Alexandra Hospital - Woolloongabba
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Flinders Medical Centre - Bedford Park
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Box Hill Hospital - Box Hill
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St Vincent's Hospital Melbourne - Fitzroy
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Footscray Hospital - Footscray
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Austin Health - Heidelberg
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The Alfred Hospital - Melbourne
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Royal Melbourne Hospital - Parkville
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2148 - Blacktown
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2139 - Concord
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2170 - Liverpool
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4029 - Herston
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4740 - North Mackay
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4101 - South Brisbane
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4102 - Woolloongabba
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5042 - Bedford Park
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3128 - Box Hill
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3065 - Fitzroy
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3011 - Footscray
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3084 - Heidelberg
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3004 - Melbourne
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Recruitment postcode(s) [14]
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3050 - Parkville
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Recruitment outside Australia
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State/province [113]
0
0
Nord
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
Puy De Dome
Query!
Country [115]
0
0
France
Query!
State/province [115]
0
0
Pyrenees Atlantiques
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Rhone
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
Somme
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Val De Marne
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Vendée
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Paris
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Baden Wuerttemberg
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Bayern
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Niedersachsen
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Rheinland Pfalz
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Schleswig Holstein
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Berlin
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Hamburg
Query!
Country [128]
0
0
Greece
Query!
State/province [128]
0
0
Alexandroupolis
Query!
Country [129]
0
0
Greece
Query!
State/province [129]
0
0
Athens
Query!
Country [130]
0
0
Greece
Query!
State/province [130]
0
0
Corfu
Query!
Country [131]
0
0
Greece
Query!
State/province [131]
0
0
Heraklion
Query!
Country [132]
0
0
Greece
Query!
State/province [132]
0
0
Thessaloníki
Query!
Country [133]
0
0
Hungary
Query!
State/province [133]
0
0
Budapest
Query!
Country [134]
0
0
Hungary
Query!
State/province [134]
0
0
Békéscsaba
Query!
Country [135]
0
0
Hungary
Query!
State/province [135]
0
0
Debrecen
Query!
Country [136]
0
0
Hungary
Query!
State/province [136]
0
0
Gyongyos
Query!
Country [137]
0
0
Hungary
Query!
State/province [137]
0
0
Szekszard
Query!
Country [138]
0
0
Hungary
Query!
State/province [138]
0
0
Szombathely
Query!
Country [139]
0
0
India
Query!
State/province [139]
0
0
Andhra Pradesh
Query!
Country [140]
0
0
India
Query!
State/province [140]
0
0
Delhi
Query!
Country [141]
0
0
India
Query!
State/province [141]
0
0
Gujarat
Query!
Country [142]
0
0
India
Query!
State/province [142]
0
0
Haryana
Query!
Country [143]
0
0
India
Query!
State/province [143]
0
0
Karnataka
Query!
Country [144]
0
0
India
Query!
State/province [144]
0
0
Kerala
Query!
Country [145]
0
0
India
Query!
State/province [145]
0
0
Maharashtra
Query!
Country [146]
0
0
India
Query!
State/province [146]
0
0
Punjab
Query!
Country [147]
0
0
India
Query!
State/province [147]
0
0
Rajasthan
Query!
Country [148]
0
0
India
Query!
State/province [148]
0
0
Tamilnadu
Query!
Country [149]
0
0
India
Query!
State/province [149]
0
0
Uttar Pradesh
Query!
Country [150]
0
0
India
Query!
State/province [150]
0
0
West Bengal
Query!
Country [151]
0
0
India
Query!
State/province [151]
0
0
Chandigarh
Query!
Country [152]
0
0
Ireland
Query!
State/province [152]
0
0
Glaway
Query!
Country [153]
0
0
Ireland
Query!
State/province [153]
0
0
Westmeath
Query!
Country [154]
0
0
Ireland
Query!
State/province [154]
0
0
Dublin
Query!
Country [155]
0
0
Ireland
Query!
State/province [155]
0
0
Galway
Query!
Country [156]
0
0
Ireland
Query!
State/province [156]
0
0
Louth
Query!
Country [157]
0
0
Israel
Query!
State/province [157]
0
0
Afula
Query!
Country [158]
0
0
Israel
Query!
State/province [158]
0
0
Be'er Sheva
Query!
Country [159]
0
0
Israel
Query!
State/province [159]
0
0
Haifa
Query!
Country [160]
0
0
Israel
Query!
State/province [160]
0
0
Holon
Query!
Country [161]
0
0
Israel
Query!
State/province [161]
0
0
Jerusalem
Query!
Country [162]
0
0
Israel
Query!
State/province [162]
0
0
Kfar- Sava
Query!
Country [163]
0
0
Israel
Query!
State/province [163]
0
0
Petach Tikva
Query!
Country [164]
0
0
Israel
Query!
State/province [164]
0
0
Ramat Gan
Query!
Country [165]
0
0
Israel
Query!
State/province [165]
0
0
Tel Aviv
Query!
Country [166]
0
0
Italy
Query!
State/province [166]
0
0
Foggia
Query!
Country [167]
0
0
Italy
Query!
State/province [167]
0
0
Milano
Query!
Country [168]
0
0
Italy
Query!
State/province [168]
0
0
Verona
Query!
Country [169]
0
0
Italy
Query!
State/province [169]
0
0
Alessandria
Query!
Country [170]
0
0
Italy
Query!
State/province [170]
0
0
Bologna
Query!
Country [171]
0
0
Italy
Query!
State/province [171]
0
0
Brescia
Query!
Country [172]
0
0
Italy
Query!
State/province [172]
0
0
Cagliari
Query!
Country [173]
0
0
Italy
Query!
State/province [173]
0
0
Catania
Query!
Country [174]
0
0
Italy
Query!
State/province [174]
0
0
Catanzaro
Query!
Country [175]
0
0
Italy
Query!
State/province [175]
0
0
Napoli
Query!
Country [176]
0
0
Italy
Query!
State/province [176]
0
0
Padova
Query!
Country [177]
0
0
Italy
Query!
State/province [177]
0
0
Palermo
Query!
Country [178]
0
0
Italy
Query!
State/province [178]
0
0
Pavia
Query!
Country [179]
0
0
Italy
Query!
State/province [179]
0
0
Pisa
Query!
Country [180]
0
0
Italy
Query!
State/province [180]
0
0
Roma
Query!
Country [181]
0
0
Italy
Query!
State/province [181]
0
0
Udine
Query!
Country [182]
0
0
Italy
Query!
State/province [182]
0
0
Vicenza
Query!
Country [183]
0
0
Japan
Query!
State/province [183]
0
0
Aichi-Ken
Query!
Country [184]
0
0
Japan
Query!
State/province [184]
0
0
Chiba-Ken
Query!
Country [185]
0
0
Japan
Query!
State/province [185]
0
0
Ehime-Ken
Query!
Country [186]
0
0
Japan
Query!
State/province [186]
0
0
Fukuoka-Ken
Query!
Country [187]
0
0
Japan
Query!
State/province [187]
0
0
Gunma-Ken
Query!
Country [188]
0
0
Japan
Query!
State/province [188]
0
0
Hiroshima-Ken
Query!
Country [189]
0
0
Japan
Query!
State/province [189]
0
0
Hokkaido
Query!
Country [190]
0
0
Japan
Query!
State/province [190]
0
0
Hyogo-Ken
Query!
Country [191]
0
0
Japan
Query!
State/province [191]
0
0
Ibaraki-Ken
Query!
Country [192]
0
0
Japan
Query!
State/province [192]
0
0
Ishikawa-Ken
Query!
Country [193]
0
0
Japan
Query!
State/province [193]
0
0
Kagawa-Ken
Query!
Country [194]
0
0
Japan
Query!
State/province [194]
0
0
Kagoshima-Ken
Query!
Country [195]
0
0
Japan
Query!
State/province [195]
0
0
Kanagawa-Ken
Query!
Country [196]
0
0
Japan
Query!
State/province [196]
0
0
Kumamoto-Ken
Query!
Country [197]
0
0
Japan
Query!
State/province [197]
0
0
Mie-Ken
Query!
Country [198]
0
0
Japan
Query!
State/province [198]
0
0
Niigata-Ken
Query!
Country [199]
0
0
Japan
Query!
State/province [199]
0
0
Oita-Ken
Query!
Country [200]
0
0
Japan
Query!
State/province [200]
0
0
Okayama-Ken
Query!
Country [201]
0
0
Japan
Query!
State/province [201]
0
0
Okinawa-Ken
Query!
Country [202]
0
0
Japan
Query!
State/province [202]
0
0
Osaka-Fu
Query!
Country [203]
0
0
Japan
Query!
State/province [203]
0
0
Saga-Ken
Query!
Country [204]
0
0
Japan
Query!
State/province [204]
0
0
Saitama-Ken
Query!
Country [205]
0
0
Japan
Query!
State/province [205]
0
0
Shizuoka-Ken
Query!
Country [206]
0
0
Japan
Query!
State/province [206]
0
0
Tokyo-To
Query!
Country [207]
0
0
Korea, Republic of
Query!
State/province [207]
0
0
Chungcheongbuk-do
Query!
Country [208]
0
0
Korea, Republic of
Query!
State/province [208]
0
0
Gangwon-do
Query!
Country [209]
0
0
Korea, Republic of
Query!
State/province [209]
0
0
Gyeonggi-do
Query!
Country [210]
0
0
Korea, Republic of
Query!
State/province [210]
0
0
Gyeongsangbuk-do
Query!
Country [211]
0
0
Korea, Republic of
Query!
State/province [211]
0
0
Busan
Query!
Country [212]
0
0
Korea, Republic of
Query!
State/province [212]
0
0
Daegu
Query!
Country [213]
0
0
Korea, Republic of
Query!
State/province [213]
0
0
Daejeon
Query!
Country [214]
0
0
Korea, Republic of
Query!
State/province [214]
0
0
Incheon
Query!
Country [215]
0
0
Korea, Republic of
Query!
State/province [215]
0
0
Seoul
Query!
Country [216]
0
0
Lithuania
Query!
State/province [216]
0
0
Kaunas
Query!
Country [217]
0
0
Lithuania
Query!
State/province [217]
0
0
Klaipeda
Query!
Country [218]
0
0
Mexico
Query!
State/province [218]
0
0
Guanajuato
Query!
Country [219]
0
0
Mexico
Query!
State/province [219]
0
0
Nuevo León
Query!
Country [220]
0
0
Mexico
Query!
State/province [220]
0
0
Veracruz
Query!
Country [221]
0
0
Netherlands
Query!
State/province [221]
0
0
Amsterdam
Query!
Country [222]
0
0
Netherlands
Query!
State/province [222]
0
0
Nijmegen
Query!
Country [223]
0
0
Netherlands
Query!
State/province [223]
0
0
Rotterdam
Query!
Country [224]
0
0
Netherlands
Query!
State/province [224]
0
0
Sittard-Geleen
Query!
Country [225]
0
0
Netherlands
Query!
State/province [225]
0
0
Tilburg
Query!
Country [226]
0
0
Netherlands
Query!
State/province [226]
0
0
Uden
Query!
Country [227]
0
0
Netherlands
Query!
State/province [227]
0
0
Utrecht
Query!
Country [228]
0
0
New Zealand
Query!
State/province [228]
0
0
Christchurch
Query!
Country [229]
0
0
New Zealand
Query!
State/province [229]
0
0
Dunedin
Query!
Country [230]
0
0
New Zealand
Query!
State/province [230]
0
0
Grafton
Query!
Country [231]
0
0
New Zealand
Query!
State/province [231]
0
0
Hamilton
Query!
Country [232]
0
0
New Zealand
Query!
State/province [232]
0
0
Tauranga
Query!
Country [233]
0
0
Poland
Query!
State/province [233]
0
0
Belchatow
Query!
Country [234]
0
0
Poland
Query!
State/province [234]
0
0
Bialystok
Query!
Country [235]
0
0
Poland
Query!
State/province [235]
0
0
Bydgoszcz
Query!
Country [236]
0
0
Poland
Query!
State/province [236]
0
0
Gdynia
Query!
Country [237]
0
0
Poland
Query!
State/province [237]
0
0
Kalisz
Query!
Country [238]
0
0
Poland
Query!
State/province [238]
0
0
Kielce
Query!
Country [239]
0
0
Poland
Query!
State/province [239]
0
0
Knurów
Query!
Country [240]
0
0
Poland
Query!
State/province [240]
0
0
Kraków
Query!
Country [241]
0
0
Poland
Query!
State/province [241]
0
0
Lublin
Query!
Country [242]
0
0
Poland
Query!
State/province [242]
0
0
Nowy Targ
Query!
Country [243]
0
0
Poland
Query!
State/province [243]
0
0
Olsztyn
Query!
Country [244]
0
0
Poland
Query!
State/province [244]
0
0
Opole
Query!
Country [245]
0
0
Poland
Query!
State/province [245]
0
0
Oswiecim
Query!
Country [246]
0
0
Poland
Query!
State/province [246]
0
0
Poznan
Query!
Country [247]
0
0
Poland
Query!
State/province [247]
0
0
Rzeszów
Query!
Country [248]
0
0
Poland
Query!
State/province [248]
0
0
Sosnowiec
Query!
Country [249]
0
0
Poland
Query!
State/province [249]
0
0
Staszów
Query!
Country [250]
0
0
Poland
Query!
State/province [250]
0
0
Szczecin
Query!
Country [251]
0
0
Poland
Query!
State/province [251]
0
0
Tarnów
Query!
Country [252]
0
0
Poland
Query!
State/province [252]
0
0
Warsaw
Query!
Country [253]
0
0
Poland
Query!
State/province [253]
0
0
Warszawa
Query!
Country [254]
0
0
Poland
Query!
State/province [254]
0
0
Wroclaw
Query!
Country [255]
0
0
Poland
Query!
State/province [255]
0
0
Zamosc
Query!
Country [256]
0
0
Poland
Query!
State/province [256]
0
0
Lódz
Query!
Country [257]
0
0
Poland
Query!
State/province [257]
0
0
Leczna
Query!
Country [258]
0
0
Poland
Query!
State/province [258]
0
0
Swidnica
Query!
Country [259]
0
0
Portugal
Query!
State/province [259]
0
0
Braga
Query!
Country [260]
0
0
Portugal
Query!
State/province [260]
0
0
Guimarães
Query!
Country [261]
0
0
Portugal
Query!
State/province [261]
0
0
Lisboa
Query!
Country [262]
0
0
Portugal
Query!
State/province [262]
0
0
Santa Maria Da Feira
Query!
Country [263]
0
0
Portugal
Query!
State/province [263]
0
0
Viana Do Castelo
Query!
Country [264]
0
0
Romania
Query!
State/province [264]
0
0
Bucharest
Query!
Country [265]
0
0
Romania
Query!
State/province [265]
0
0
Bucuresti
Query!
Country [266]
0
0
Romania
Query!
State/province [266]
0
0
Cluj-Napoca
Query!
Country [267]
0
0
Romania
Query!
State/province [267]
0
0
Craiova
Query!
Country [268]
0
0
Romania
Query!
State/province [268]
0
0
Oradea
Query!
Country [269]
0
0
Romania
Query!
State/province [269]
0
0
Ploiesti
Query!
Country [270]
0
0
Serbia
Query!
State/province [270]
0
0
Belgrade
Query!
Country [271]
0
0
Serbia
Query!
State/province [271]
0
0
Kragujevac
Query!
Country [272]
0
0
Serbia
Query!
State/province [272]
0
0
Subotica
Query!
Country [273]
0
0
Serbia
Query!
State/province [273]
0
0
Zrenjanin
Query!
Country [274]
0
0
Slovakia
Query!
State/province [274]
0
0
Banská Bystrica
Query!
Country [275]
0
0
Slovakia
Query!
State/province [275]
0
0
Bratislava
Query!
Country [276]
0
0
Slovakia
Query!
State/province [276]
0
0
Košice
Query!
Country [277]
0
0
Slovakia
Query!
State/province [277]
0
0
Nitra
Query!
Country [278]
0
0
Slovakia
Query!
State/province [278]
0
0
Prešov
Query!
Country [279]
0
0
Slovakia
Query!
State/province [279]
0
0
Šahy
Query!
Country [280]
0
0
Spain
Query!
State/province [280]
0
0
Cordoba
Query!
Country [281]
0
0
Spain
Query!
State/province [281]
0
0
La Coruña
Query!
Country [282]
0
0
Spain
Query!
State/province [282]
0
0
Las Palmas
Query!
Country [283]
0
0
Spain
Query!
State/province [283]
0
0
Madrid
Query!
Country [284]
0
0
Spain
Query!
State/province [284]
0
0
Barcelona
Query!
Country [285]
0
0
Spain
Query!
State/province [285]
0
0
Girona
Query!
Country [286]
0
0
Spain
Query!
State/province [286]
0
0
Huelva
Query!
Country [287]
0
0
Spain
Query!
State/province [287]
0
0
Pontevedra
Query!
Country [288]
0
0
Spain
Query!
State/province [288]
0
0
Sevilla
Query!
Country [289]
0
0
Spain
Query!
State/province [289]
0
0
Valencia
Query!
Country [290]
0
0
Spain
Query!
State/province [290]
0
0
Zaragoza
Query!
Country [291]
0
0
Switzerland
Query!
State/province [291]
0
0
Basel
Query!
Country [292]
0
0
Switzerland
Query!
State/province [292]
0
0
Bern
Query!
Country [293]
0
0
Switzerland
Query!
State/province [293]
0
0
Zuerich
Query!
Country [294]
0
0
Turkey
Query!
State/province [294]
0
0
Ankara
Query!
Country [295]
0
0
Turkey
Query!
State/province [295]
0
0
Antalya
Query!
Country [296]
0
0
Turkey
Query!
State/province [296]
0
0
Istanbul
Query!
Country [297]
0
0
Turkey
Query!
State/province [297]
0
0
Izmir
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Turkey
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Kocaeli
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Turkey
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Malatya
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Turkey
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Mersin
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Country [301]
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United Kingdom
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Cambridgeshire
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Country [302]
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United Kingdom
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Devon
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United Kingdom
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Greater London
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United Kingdom
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Greater Manchester
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Country [305]
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United Kingdom
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Middlesex
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United Kingdom
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Somerset
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United Kingdom
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West Yorkshire
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Country [308]
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United Kingdom
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Belfast
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abivax S.A.
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Address
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Ethics approval
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Summary
Brief summary
This is a multicenter, randomized study to evaluate the long-term efficacy and safety of
ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with
moderately to severely active ulcerative colitis who have inadequate response, no response, a
loss of response, or an intolerance to either conventional therapies [corticosteroids,
immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced
therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor
modulators, and/or JAK inhibitors].
This study is the maintenance phase of both previous induction studies ABX464-105 and
ABX464-106.
All eligible subjects who have completed either one of the induction studies above mentioned,
will be given the opportunity to take part in the present ABX464-107 maintenance study and
will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated
to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical
response at the end of induction.
This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in
the End of Study (EOS) visit.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05535946
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Severine Vermeire, MD, PhD
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Address
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UZ Leuven, Belgium
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Contact person for public queries
Name
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Sharon Skare,, CPhil
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Address
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Phone
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+33153830961
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05535946
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