Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05507203




Registration number
NCT05507203
Ethics application status
Date submitted
17/08/2022
Date registered
18/08/2022
Date last updated
26/07/2024

Titles & IDs
Public title
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
Scientific title
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
ABX464-105
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

Experimental: ABX464 50mg - Subjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks

Experimental: ABX464 25mg - Subjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks

Placebo comparator: Placebo - Subjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks


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

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

Outcomes
Primary outcome [1] 0 0
Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Proportion of subjects who achieve endoscopic improvement at week 8
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Proportion of subjects who achieve clinical response per MMS at week 8
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Proportion of subjects with symptomatic remission at week 8
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Proportion of subjects with HEMI per Geboes at week 8
Timepoint [4] 0 0
8 weeks

Eligibility
Key inclusion criteria
* Men or women at least 16 years old; Adolescent subjects will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only subjects = 18 years old will be enrolled. To be eligible, adolescent subjects must weight = 40 kg and meet the definition of Tanner Stage 5 at the screening visit.
* 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.
* Documented diagnosis of UC confirmed by endoscopy and histology. Should endoscopy/histology results not be available at screening, results from endoscopies or biopsies taken at screening may be used.
* Active disease defined by modified Mayo score (MMS) = 5 with rectal bleeding subscore (RBS) = 1 and endoscopy subscore (MES) of 2 or 3 (confirmed by central reader).
* Subjects with documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids, immunosuppressant, biologic or biosimilar therapies, S1P receptor modulators and/or JAK inhibitors and/or new drugs approved during the study (note: failure to only 5-ASA or sulfasalazine is not accepted).
* Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to comply with the contraception requirements described in the protocol.
* Subjects 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with UC limited to an isolated proctitis (= 15cm from anal verge) determined by endoscopy central reading.
* Subjects with primary sclerosing cholangitis or autoimmune hepatitis.
* Subjects who have failed on 5-ASA or sulfasalazine therapy only.
* Subjects with CD or presence or history of fistula, indeterminate colitis, infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis).
* History or current evidence of toxic megacolon, fulminant colitis, bowel perforation.
* History of colonic cancer or colonic low grade or high grade dysplasia adenomatous polyps, and/or at the screening endoscopy, evidence of colonic cancer or evidence of low grade or high grade dysplasia adenomatous polyps (fully removed or not).
* Recent or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma.
* Subjects on antidiarrheals including those working on motility (e.g., loperamide, diphenoxylate with atropine, etc.).
* Subjects on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii).
* Subjects who do not meet the washout period requirements prior to the screening endoscopy
* Subjects with the following hematological and biochemical laboratory parameters obtained during the screening period:

* Hemoglobin = 8.0 g dL-1
* Absolute neutrophil count < 750 mm-3
* Platelets < 100,000 mm-3
* Creatinine clearance < 60 mL.min-1 (Cockroft-Gault formula)
* Total serum bilirubin > 1.5 x ULN
* Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x ULN
* Subjects with the following conditions (infection):

* Subjects with chronic or recurrent grade 3 or grade 4 infection within the last 2 months prior to screening or a history of opportunistic infection while not on immunosuppressive therapy.
* Herpes zoster reactivation within the last 2 months prior to screening.
* Subjects with active infection at screening or any major episode of infection that required hospitalization or treatment with intravenous antibiotics within 1 month of screening or during screening. Fungal infection of nail beds is allowed.
* Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridium difficile toxin at screening. If C. difficile is positive, subject may be treated and retested = 2 weeks after completing treatment.
* Subjects with HIV infection.
* Subjects having acute or chronic hepatitis B infection at screening (positive for hepatitis B surface antigen [HbsAg], or negative for HbsAg and positive for anti-hepatitis B core antibody in conjunction with detectable HBV DNA, or detectable HBV DNA).
* Subjects having acute or chronic hepatitis C infection at screening as defined by positive for hepatitis C antibody (subjects successfully treated and without recurrence = 1 year with no detectable HCV RNA [assessed centrally] are eligible).
* Active tuberculosis (TB) or untreated latent TB are ruled out. For subjects with positive or intermediate QuantiFERON test see study protocol.
* Subjects with an uncontrolled ischemic heart disease and/or a history of congestive heart failure with New York Heart Association (NYHA) class 3 or 4 symptoms.
* Subjects with a family or personal history of congenital or acquired long QT syndrome, or subjects with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval [Fridericia or Bazett correction] >450 milliseconds for male and > 460 milliseconds for female).
* Subjects with a history of torsade de pointe (TdP).
* Acute or chronic of clinically relevant pulmonary, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable central nervous system pathology such as seizure disorder, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history (note: treated autoimmune hypothyroidy and autoimmune diabetes are allowed).
* Serious illness requiring hospitalization within 4 weeks prior to screening (except UC flare).
* Subjects previously treated with ABX464.
* Subjects with a known hypersensitivity to the active substance or to any of the excipients.
* WOCBP subject who is pregnant or breast-feeding at screening, or intends to become pregnant during the study, or male subject with WOCBP partner who intends to be pregnant during the study.
* Illicit drug or alcohol abuse or dependence.
* Subjects who received live vaccine within 3 months prior to screening and/or who's planning to receive such a vaccine during the study duration.
* Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer, and during the study.
* Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
* Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.

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
10/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
612
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,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
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Flinders Medical Centre - Bedford Park
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
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Ciudad Autonoma Buenos Aires
Country [27] 0 0
Austria
State/province [27] 0 0
Graz
Country [28] 0 0
Austria
State/province [28] 0 0
Innsbruck
Country [29] 0 0
Austria
State/province [29] 0 0
Salzburg
Country [30] 0 0
Austria
State/province [30] 0 0
St Veit an der Glan
Country [31] 0 0
Belgium
State/province [31] 0 0
Brasschaat
Country [32] 0 0
Belgium
State/province [32] 0 0
Brugge
Country [33] 0 0
Belgium
State/province [33] 0 0
Bruxelles
Country [34] 0 0
Belgium
State/province [34] 0 0
Leuven
Country [35] 0 0
Belgium
State/province [35] 0 0
Liège
Country [36] 0 0
Belgium
State/province [36] 0 0
Yvoir
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Pleven
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Sofia
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Stara Zagora
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
China
State/province [41] 0 0
Anhui
Country [42] 0 0
China
State/province [42] 0 0
Beijing
Country [43] 0 0
China
State/province [43] 0 0
Fujian
Country [44] 0 0
China
State/province [44] 0 0
Guangdong
Country [45] 0 0
China
State/province [45] 0 0
Guangxi
Country [46] 0 0
China
State/province [46] 0 0
Hubei
Country [47] 0 0
China
State/province [47] 0 0
Hunan
Country [48] 0 0
China
State/province [48] 0 0
Jiangsu
Country [49] 0 0
China
State/province [49] 0 0
Jiangxi
Country [50] 0 0
China
State/province [50] 0 0
Jilin
Country [51] 0 0
China
State/province [51] 0 0
Shandong
Country [52] 0 0
China
State/province [52] 0 0
Shanghai
Country [53] 0 0
China
State/province [53] 0 0
Sichuan
Country [54] 0 0
China
State/province [54] 0 0
Zhejiang
Country [55] 0 0
Czechia
State/province [55] 0 0
Brno
Country [56] 0 0
Czechia
State/province [56] 0 0
Hradec Králové
Country [57] 0 0
Czechia
State/province [57] 0 0
Olomouc
Country [58] 0 0
Czechia
State/province [58] 0 0
Ostrava
Country [59] 0 0
Czechia
State/province [59] 0 0
Slaný
Country [60] 0 0
France
State/province [60] 0 0
Ardennes
Country [61] 0 0
France
State/province [61] 0 0
Cote D'or
Country [62] 0 0
France
State/province [62] 0 0
Doubs
Country [63] 0 0
France
State/province [63] 0 0
Gironde
Country [64] 0 0
France
State/province [64] 0 0
Herault
Country [65] 0 0
France
State/province [65] 0 0
Loire Atlantique
Country [66] 0 0
France
State/province [66] 0 0
Loire
Country [67] 0 0
France
State/province [67] 0 0
Puy De Dome
Country [68] 0 0
France
State/province [68] 0 0
Pyrénées Atlantique
Country [69] 0 0
France
State/province [69] 0 0
Val De Marne
Country [70] 0 0
France
State/province [70] 0 0
Paris
Country [71] 0 0
Germany
State/province [71] 0 0
Baden Wuerttemberg
Country [72] 0 0
Germany
State/province [72] 0 0
Bayern
Country [73] 0 0
Germany
State/province [73] 0 0
Brandenburg
Country [74] 0 0
Germany
State/province [74] 0 0
Hessen
Country [75] 0 0
Germany
State/province [75] 0 0
Niedersachsen
Country [76] 0 0
Germany
State/province [76] 0 0
Schleswig Holstein
Country [77] 0 0
Germany
State/province [77] 0 0
Berlin
Country [78] 0 0
Greece
State/province [78] 0 0
Alexandroupolis
Country [79] 0 0
Greece
State/province [79] 0 0
Athens
Country [80] 0 0
Greece
State/province [80] 0 0
Corfu
Country [81] 0 0
Greece
State/province [81] 0 0
Heraklion
Country [82] 0 0
Greece
State/province [82] 0 0
Thessaloníki
Country [83] 0 0
Hungary
State/province [83] 0 0
Budapest
Country [84] 0 0
Hungary
State/province [84] 0 0
Békéscsaba
Country [85] 0 0
Hungary
State/province [85] 0 0
Szombathely
Country [86] 0 0
India
State/province [86] 0 0
Gujarat
Country [87] 0 0
India
State/province [87] 0 0
Haryana
Country [88] 0 0
India
State/province [88] 0 0
Karnataka
Country [89] 0 0
India
State/province [89] 0 0
Kerala
Country [90] 0 0
India
State/province [90] 0 0
Maharashtra
Country [91] 0 0
India
State/province [91] 0 0
Punjab
Country [92] 0 0
India
State/province [92] 0 0
Rajasthan
Country [93] 0 0
Italy
State/province [93] 0 0
Foggia
Country [94] 0 0
Italy
State/province [94] 0 0
Verona
Country [95] 0 0
Italy
State/province [95] 0 0
Brescia
Country [96] 0 0
Italy
State/province [96] 0 0
Catania
Country [97] 0 0
Italy
State/province [97] 0 0
Milano
Country [98] 0 0
Italy
State/province [98] 0 0
Palermo
Country [99] 0 0
Italy
State/province [99] 0 0
Pavia
Country [100] 0 0
Italy
State/province [100] 0 0
Vicenza
Country [101] 0 0
Korea, Republic of
State/province [101] 0 0
Gangwon-do
Country [102] 0 0
Korea, Republic of
State/province [102] 0 0
Gyeonggi-do
Country [103] 0 0
Korea, Republic of
State/province [103] 0 0
Gyeongsangbuk-do
Country [104] 0 0
Korea, Republic of
State/province [104] 0 0
Busan
Country [105] 0 0
Korea, Republic of
State/province [105] 0 0
Daegu
Country [106] 0 0
Korea, Republic of
State/province [106] 0 0
Daejeon
Country [107] 0 0
Korea, Republic of
State/province [107] 0 0
Incheon
Country [108] 0 0
Korea, Republic of
State/province [108] 0 0
Seoul
Country [109] 0 0
Netherlands
State/province [109] 0 0
Amsterdam
Country [110] 0 0
Netherlands
State/province [110] 0 0
Nijmegen
Country [111] 0 0
Netherlands
State/province [111] 0 0
Rotterdam
Country [112] 0 0
Netherlands
State/province [112] 0 0
Sittard
Country [113] 0 0
Netherlands
State/province [113] 0 0
Tilburg
Country [114] 0 0
Netherlands
State/province [114] 0 0
Uden
Country [115] 0 0
Poland
State/province [115] 0 0
Belchatow
Country [116] 0 0
Poland
State/province [116] 0 0
Katowice
Country [117] 0 0
Poland
State/province [117] 0 0
Kraków
Country [118] 0 0
Poland
State/province [118] 0 0
Opole
Country [119] 0 0
Poland
State/province [119] 0 0
Poznan
Country [120] 0 0
Poland
State/province [120] 0 0
Sosnowiec
Country [121] 0 0
Poland
State/province [121] 0 0
Szczecin
Country [122] 0 0
Poland
State/province [122] 0 0
Warsaw
Country [123] 0 0
Poland
State/province [123] 0 0
Warszawa
Country [124] 0 0
Poland
State/province [124] 0 0
Wroclaw
Country [125] 0 0
Poland
State/province [125] 0 0
Zamosc
Country [126] 0 0
Poland
State/province [126] 0 0
Lódz
Country [127] 0 0
Poland
State/province [127] 0 0
Leczna
Country [128] 0 0
Portugal
State/province [128] 0 0
Braga
Country [129] 0 0
Portugal
State/province [129] 0 0
Guimarães
Country [130] 0 0
Portugal
State/province [130] 0 0
Santa Maria Da Feira
Country [131] 0 0
Portugal
State/province [131] 0 0
Viana Do Castelo
Country [132] 0 0
Spain
State/province [132] 0 0
Cordoba
Country [133] 0 0
Spain
State/province [133] 0 0
La Coruña
Country [134] 0 0
Spain
State/province [134] 0 0
Barcelona
Country [135] 0 0
Spain
State/province [135] 0 0
Madrid
Country [136] 0 0
Spain
State/province [136] 0 0
Sevilla
Country [137] 0 0
Spain
State/province [137] 0 0
Valencia
Country [138] 0 0
Switzerland
State/province [138] 0 0
Basel
Country [139] 0 0
Switzerland
State/province [139] 0 0
Bern
Country [140] 0 0
Switzerland
State/province [140] 0 0
Zuerich
Country [141] 0 0
Turkey
State/province [141] 0 0
Istanbul
Country [142] 0 0
Turkey
State/province [142] 0 0
Kocaeli
Country [143] 0 0
Turkey
State/province [143] 0 0
Mersin
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Greater London
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Greater Manchester
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Middlesex
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Somerset
Country [148] 0 0
United Kingdom
State/province [148] 0 0
West Yorkshire
Country [149] 0 0
United Kingdom
State/province [149] 0 0
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 efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission 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 \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].
Trial website
https://clinicaltrials.gov/study/NCT05507203
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT05507203