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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05535946




Registration number
NCT05535946
Ethics application status
Date submitted
7/09/2022
Date registered
10/09/2022
Date last updated
7/08/2024

Titles & IDs
Public title
ABTECT - Maintenance
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
Secondary ID [1] 0 0
ABX464-107
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABX464
Treatment: Drugs - Placebo

Placebo comparator: ABX464 50mg - Responder subjects at the end of induction - Subjects will be orally dosed during 44 weeks

Placebo comparator: 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

Experimental: Long Term Extension - At the end of the maintenance phase (week 44), subjects can continue their allocated treatment for up to 4 years. Once the maintenance phase is unblinded, subjects receiving placebo in the maintenance phase will be allocated to obefazimod 25 mg or can terminate the study.


Treatment: Drugs: ABX464
Administered once daily, preferably in the morning, with food

Treatment: Drugs: Placebo
Administered once daily, preferably in the morning, with food
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of subjects in clinical remission at Week 44
Timepoint [1] 0 0
Week 44
Primary outcome [2] 0 0
Number and percentage of all treatment-emergent adverse events (TEAEs)
Timepoint [2] 0 0
Week 44
Primary outcome [3] 0 0
Number and percentage of all serious adverse events (SAEs)
Timepoint [3] 0 0
Week 44
Primary outcome [4] 0 0
Number and percentage of all causally related TEAEs/SAEs
Timepoint [4] 0 0
Week 44
Secondary outcome [1] 0 0
Proportion of subjects with endoscopic improvement at Week 44
Timepoint [1] 0 0
Week 44
Secondary outcome [2] 0 0
Proportion of subjects with corticosteroid-free clinical remission
Timepoint [2] 0 0
Week 44
Secondary outcome [3] 0 0
Proportion of subjects with sustained clinical remission at Week 44
Timepoint [3] 0 0
Week 44
Secondary outcome [4] 0 0
Proportion of subjects with HEMI per Geboes scoring at Week 44
Timepoint [4] 0 0
Week 44
Secondary outcome [5] 0 0
Proportion of subjects with endoscopic remission at Week 44
Timepoint [5] 0 0
Week 44
Secondary outcome [6] 0 0
LTE Phase - Proportion of subjects in clinical remission at Year 1
Timepoint [6] 0 0
LTE Year 1
Secondary outcome [7] 0 0
LTE Phase - Proportion of subjects in clinical remission at Year 4
Timepoint [7] 0 0
LTE Year 4
Secondary outcome [8] 0 0
LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry
Timepoint [8] 0 0
LTE Year 1
Secondary outcome [9] 0 0
LTE Phase - Proportion of subjects with corticosteroid-free clinical remission in the subpopulation with corticosteroids at maintenance study entry)
Timepoint [9] 0 0
LTE Year 4
Secondary outcome [10] 0 0
LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 1
Timepoint [10] 0 0
LTE Year 1
Secondary outcome [11] 0 0
LTE Phase - Proportion of subjects with endoscopic improvement at LTE Year 4
Timepoint [11] 0 0
LTE Year 4
Secondary outcome [12] 0 0
LTE Phase - Proportion of subjects with endoscopic remission at LTE year 1
Timepoint [12] 0 0
LTE year 1
Secondary outcome [13] 0 0
LTE Phase - Proportion of subjects with endoscopic remission at LTE year 4
Timepoint [13] 0 0
LTE year 4
Secondary outcome [14] 0 0
LTE Phase - Proportion of subjects with CS-free symptomatic remission by visit
Timepoint [14] 0 0
4 years
Secondary outcome [15] 0 0
LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 1
Timepoint [15] 0 0
LTE Year 1
Secondary outcome [16] 0 0
LTE Phase - Proportion of subjects with HEMI per Geboes scoring at LTE Year 4
Timepoint [16] 0 0
LTE Year 4
Secondary outcome [17] 0 0
LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 1
Timepoint [17] 0 0
LTE Year 1
Secondary outcome [18] 0 0
LTE Phase - Proportion of subjects with HEMR per Geboes scoring at LTE Year 4
Timepoint [18] 0 0
LTE Year 4
Secondary outcome [19] 0 0
LTE Phase - Proportion of subjects with sustained clinical remission at LTE Year 1, in the sub-population of subjects with clinical remission at Week 44
Timepoint [19] 0 0
LTE Year 1
Secondary outcome [20] 0 0
LTE Phase - Proportion of subjects with sustained clinical remission at LTE year 4, in the sub-population of subjects with clinical remission at Week 44
Timepoint [20] 0 0
LTE year 4
Secondary outcome [21] 0 0
LTE Phase - Proportion of subjects with sustained endoscopic improvement at LTE Year 1, in the sub-population of subjects with endoscopic improvement at Week 44
Timepoint [21] 0 0
LTE Year 1
Secondary outcome [22] 0 0
LTE Phase - Proportion of subjects with sustained endoscopic improvement at LTE Year 4, in the sub-population of subjects with endoscopic improvement at Week 44
Timepoint [22] 0 0
LTE year 4
Secondary outcome [23] 0 0
LTE Phase - Proportion of subjects with symptomatic remission by visit
Timepoint [23] 0 0
4 years
Secondary outcome [24] 0 0
LTE Phase - Proportion of subjects with sustained symptomatic remission by visit
Timepoint [24] 0 0
4 years
Secondary outcome [25] 0 0
LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 1
Timepoint [25] 0 0
LTE Year 1
Secondary outcome [26] 0 0
LTE Phase - Proportion of subjects with CS-free clinical remission at LTE Year 4
Timepoint [26] 0 0
LTE Year 4

Eligibility
Key inclusion criteria
Inclusion Criteria in maintenance phase:

* 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 comply with contraception requirements as described in Section 4.4. (Contraception) of the 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

Inclusion criteria in LTE phase:

* Subject must have completed the maintenance phase
* Investigator and subject must assess and agree that the subject has received, and will continue to receive benefit from being in the study
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria in maintenance phase:

* 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 (eg. primary sclerosis cholangitis, Crohn's disease, colectomy, diverting ileostomy, colon cancer or colonic adenomas [low or high grade dysplasia]).
* Subjects with evidence of an unstable clinical condition (eg. toxic megacolon, fulminant colitis, bowel perforation, uncontrolled ischemic disease, congestive heart failure with NYHA class 3 or 4 symptoms) during the induction study that, in the investigator's judgment, will substantially increase the risk to the subject 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, or pregnant female subjects
* Introduction during induction study of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).
* Any changes in the laboratory values during the induction period that could jeopardize subject's safety in the opinion of the investigator. If any doubts, the investigator should contact the sponsor study medical monitor.
* Subject who is planning to receive live vaccine during the study.
* Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

Exclusion criteria for LTE phase:

* Subject continues to satisfy exclusion criteria listed above for the maintenance phase
* Introduction during maintenance phase of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2030
Actual
Sample size
Target
1050
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Coral Sea Clinical Research Institute - North Mackay
Recruitment hospital [6] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [9] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [10] 0 0
Footscray Hospital - Footscray
Recruitment hospital [11] 0 0
Austin Health - Heidelberg
Recruitment hospital [12] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [13] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4740 - North Mackay
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
3011 - Footscray
Recruitment postcode(s) [11] 0 0
3084 - Heidelberg
Recruitment postcode(s) [12] 0 0
3004 - Melbourne
Recruitment postcode(s) [13] 0 0
3050 - Parkville
Recruitment outside Australia
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United States of America
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Belfast

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abivax S.A.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, randomized, placebo-controlled 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.
Trial website
https://clinicaltrials.gov/study/NCT05535946
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Severine Vermeire, MD, PhD
Address 0 0
UZ Leuven, Belgium
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Laurence Desroys du Roure, PharmD
Address 0 0
Country 0 0
Phone 0 0
+33630031132
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05535946