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/NCT05507216




Registration number
NCT05507216
Ethics application status
Date submitted
17/08/2022
Date registered
18/08/2022
Date last updated
26/07/2024

Titles & IDs
Public title
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
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
ABX464-106
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 weigh = 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 and 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 the current 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
21/12/2022
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)
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
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
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
Missouri
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 Dakota
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
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Dakota
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
Argentina
State/province [27] 0 0
Ciudad Autonoma Buenos Aires
Country [28] 0 0
Argentina
State/province [28] 0 0
Tucuman
Country [29] 0 0
Belgium
State/province [29] 0 0
Antwerpen
Country [30] 0 0
Belgium
State/province [30] 0 0
Gent
Country [31] 0 0
Belgium
State/province [31] 0 0
Roeselare
Country [32] 0 0
Brazil
State/province [32] 0 0
Bahia
Country [33] 0 0
Brazil
State/province [33] 0 0
Ceará
Country [34] 0 0
Brazil
State/province [34] 0 0
Distrito Federal
Country [35] 0 0
Brazil
State/province [35] 0 0
Paraná
Country [36] 0 0
Brazil
State/province [36] 0 0
Rio Grande Do Sul
Country [37] 0 0
Brazil
State/province [37] 0 0
Sao Paulo
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Pleven
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Sofia
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Veliko Tarnovo
Country [41] 0 0
Canada
State/province [41] 0 0
British Columbia
Country [42] 0 0
Canada
State/province [42] 0 0
Nova Scotia
Country [43] 0 0
Canada
State/province [43] 0 0
Quebec
Country [44] 0 0
Croatia
State/province [44] 0 0
Koprivnica
Country [45] 0 0
Croatia
State/province [45] 0 0
Osijek
Country [46] 0 0
Croatia
State/province [46] 0 0
Zadar
Country [47] 0 0
Croatia
State/province [47] 0 0
Zagreb
Country [48] 0 0
Czechia
State/province [48] 0 0
Ostrava
Country [49] 0 0
Czechia
State/province [49] 0 0
Praha
Country [50] 0 0
Czechia
State/province [50] 0 0
Zlín
Country [51] 0 0
France
State/province [51] 0 0
Alpes Maritimes
Country [52] 0 0
France
State/province [52] 0 0
Bouches-du-Rhône
Country [53] 0 0
France
State/province [53] 0 0
Calvados
Country [54] 0 0
France
State/province [54] 0 0
Haute Garonne
Country [55] 0 0
France
State/province [55] 0 0
Hauts De Seine
Country [56] 0 0
France
State/province [56] 0 0
Ille Et Vilaine
Country [57] 0 0
France
State/province [57] 0 0
Isere
Country [58] 0 0
France
State/province [58] 0 0
Moselle
Country [59] 0 0
France
State/province [59] 0 0
Nord
Country [60] 0 0
France
State/province [60] 0 0
Rhone
Country [61] 0 0
France
State/province [61] 0 0
Somme
Country [62] 0 0
France
State/province [62] 0 0
Vendée
Country [63] 0 0
Germany
State/province [63] 0 0
Baden Wuerttemberg
Country [64] 0 0
Germany
State/province [64] 0 0
Bayern
Country [65] 0 0
Germany
State/province [65] 0 0
Rheinland Pfalz
Country [66] 0 0
Germany
State/province [66] 0 0
Berlin
Country [67] 0 0
Germany
State/province [67] 0 0
Hamburg
Country [68] 0 0
Hungary
State/province [68] 0 0
Budapest
Country [69] 0 0
Hungary
State/province [69] 0 0
Debrecen
Country [70] 0 0
Hungary
State/province [70] 0 0
Dunaujvaros
Country [71] 0 0
Hungary
State/province [71] 0 0
Gyöngyös
Country [72] 0 0
Hungary
State/province [72] 0 0
Kaposvár
Country [73] 0 0
Hungary
State/province [73] 0 0
Szekszárd
Country [74] 0 0
India
State/province [74] 0 0
Andhra Pradesh
Country [75] 0 0
India
State/province [75] 0 0
Delhi
Country [76] 0 0
India
State/province [76] 0 0
Gujarat
Country [77] 0 0
India
State/province [77] 0 0
Karnataka
Country [78] 0 0
India
State/province [78] 0 0
Kerala
Country [79] 0 0
India
State/province [79] 0 0
Maharashtra
Country [80] 0 0
India
State/province [80] 0 0
Tamilnadu
Country [81] 0 0
India
State/province [81] 0 0
West Bengal
Country [82] 0 0
India
State/province [82] 0 0
Chandigarh
Country [83] 0 0
Ireland
State/province [83] 0 0
Westmeath
Country [84] 0 0
Ireland
State/province [84] 0 0
Dublin
Country [85] 0 0
Ireland
State/province [85] 0 0
Galway
Country [86] 0 0
Ireland
State/province [86] 0 0
Louth
Country [87] 0 0
Israel
State/province [87] 0 0
Afula
Country [88] 0 0
Israel
State/province [88] 0 0
Be'er Sheva
Country [89] 0 0
Israel
State/province [89] 0 0
Haifa
Country [90] 0 0
Israel
State/province [90] 0 0
Jerusalem
Country [91] 0 0
Israel
State/province [91] 0 0
Kfar Saba
Country [92] 0 0
Israel
State/province [92] 0 0
Petah tikva
Country [93] 0 0
Israel
State/province [93] 0 0
Ramat Gan
Country [94] 0 0
Israel
State/province [94] 0 0
Re?ovot
Country [95] 0 0
Italy
State/province [95] 0 0
Milano
Country [96] 0 0
Italy
State/province [96] 0 0
Alessandria
Country [97] 0 0
Italy
State/province [97] 0 0
Bologna
Country [98] 0 0
Italy
State/province [98] 0 0
Catanzaro
Country [99] 0 0
Italy
State/province [99] 0 0
Napoli
Country [100] 0 0
Italy
State/province [100] 0 0
Roma
Country [101] 0 0
Japan
State/province [101] 0 0
Aichi-Ken
Country [102] 0 0
Japan
State/province [102] 0 0
Chiba-Ken
Country [103] 0 0
Japan
State/province [103] 0 0
Ehime-Ken
Country [104] 0 0
Japan
State/province [104] 0 0
Fukuoka-Ken
Country [105] 0 0
Japan
State/province [105] 0 0
Gunma-Ken
Country [106] 0 0
Japan
State/province [106] 0 0
Hiroshima-Ken
Country [107] 0 0
Japan
State/province [107] 0 0
Hokkaido
Country [108] 0 0
Japan
State/province [108] 0 0
Hyogo-Ken
Country [109] 0 0
Japan
State/province [109] 0 0
Ibaraki-Ken
Country [110] 0 0
Japan
State/province [110] 0 0
Ishikawa-Ken
Country [111] 0 0
Japan
State/province [111] 0 0
Kagawa-Ken
Country [112] 0 0
Japan
State/province [112] 0 0
Kagoshima-Ken
Country [113] 0 0
Japan
State/province [113] 0 0
Kanagawa-Ken
Country [114] 0 0
Japan
State/province [114] 0 0
Kumamoto-Ken
Country [115] 0 0
Japan
State/province [115] 0 0
Mie-Ken
Country [116] 0 0
Japan
State/province [116] 0 0
Niigata-Ken
Country [117] 0 0
Japan
State/province [117] 0 0
Oita-Ken
Country [118] 0 0
Japan
State/province [118] 0 0
Okayama-Ken
Country [119] 0 0
Japan
State/province [119] 0 0
Okinawa-Ken
Country [120] 0 0
Japan
State/province [120] 0 0
Osaka-Fu
Country [121] 0 0
Japan
State/province [121] 0 0
Saga-Ken
Country [122] 0 0
Japan
State/province [122] 0 0
Saitama-Ken
Country [123] 0 0
Japan
State/province [123] 0 0
Shizuoka-Ken
Country [124] 0 0
Japan
State/province [124] 0 0
Tokyo-To
Country [125] 0 0
Lithuania
State/province [125] 0 0
Kaunas
Country [126] 0 0
Lithuania
State/province [126] 0 0
Klaipeda
Country [127] 0 0
Mexico
State/province [127] 0 0
Guanajuato
Country [128] 0 0
Mexico
State/province [128] 0 0
Nuevo León
Country [129] 0 0
Mexico
State/province [129] 0 0
Veracruz
Country [130] 0 0
New Zealand
State/province [130] 0 0
Christchurch
Country [131] 0 0
New Zealand
State/province [131] 0 0
Dunedin
Country [132] 0 0
New Zealand
State/province [132] 0 0
Grafton
Country [133] 0 0
New Zealand
State/province [133] 0 0
Hamilton
Country [134] 0 0
New Zealand
State/province [134] 0 0
Tauranga
Country [135] 0 0
Poland
State/province [135] 0 0
Bydgoszcz
Country [136] 0 0
Poland
State/province [136] 0 0
Gdynia
Country [137] 0 0
Poland
State/province [137] 0 0
Kalisz
Country [138] 0 0
Poland
State/province [138] 0 0
Kielce
Country [139] 0 0
Poland
State/province [139] 0 0
Knurów
Country [140] 0 0
Poland
State/province [140] 0 0
Kraków
Country [141] 0 0
Poland
State/province [141] 0 0
Lublin
Country [142] 0 0
Poland
State/province [142] 0 0
Nowy Targ
Country [143] 0 0
Poland
State/province [143] 0 0
Olsztyn
Country [144] 0 0
Poland
State/province [144] 0 0
Oswiecim
Country [145] 0 0
Poland
State/province [145] 0 0
Rzeszów
Country [146] 0 0
Poland
State/province [146] 0 0
Staszów
Country [147] 0 0
Poland
State/province [147] 0 0
Wierzchoslawice
Country [148] 0 0
Poland
State/province [148] 0 0
Swidnica
Country [149] 0 0
Romania
State/province [149] 0 0
Bucharest
Country [150] 0 0
Romania
State/province [150] 0 0
Bucuresti
Country [151] 0 0
Romania
State/province [151] 0 0
Cluj-Napoca
Country [152] 0 0
Romania
State/province [152] 0 0
Craiova
Country [153] 0 0
Romania
State/province [153] 0 0
Oradea
Country [154] 0 0
Romania
State/province [154] 0 0
Ploiesti
Country [155] 0 0
Serbia
State/province [155] 0 0
Belgrade
Country [156] 0 0
Serbia
State/province [156] 0 0
Subotica
Country [157] 0 0
Slovakia
State/province [157] 0 0
Banská Bystrica
Country [158] 0 0
Slovakia
State/province [158] 0 0
Bratislava
Country [159] 0 0
Slovakia
State/province [159] 0 0
Košice
Country [160] 0 0
Slovakia
State/province [160] 0 0
Martin
Country [161] 0 0
Slovakia
State/province [161] 0 0
Nitra
Country [162] 0 0
Slovakia
State/province [162] 0 0
Prešov
Country [163] 0 0
Slovakia
State/province [163] 0 0
Rimavská Sobota
Country [164] 0 0
Slovakia
State/province [164] 0 0
Šahy
Country [165] 0 0
Spain
State/province [165] 0 0
La Coruña
Country [166] 0 0
Spain
State/province [166] 0 0
Las Palmas
Country [167] 0 0
Spain
State/province [167] 0 0
Madrid
Country [168] 0 0
Spain
State/province [168] 0 0
Barcelona
Country [169] 0 0
Spain
State/province [169] 0 0
Girona
Country [170] 0 0
Spain
State/province [170] 0 0
Huelva
Country [171] 0 0
Spain
State/province [171] 0 0
Pontevedra
Country [172] 0 0
Spain
State/province [172] 0 0
Sevilla
Country [173] 0 0
Spain
State/province [173] 0 0
Valencia
Country [174] 0 0
Spain
State/province [174] 0 0
Zaragoza
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Cambridgeshire
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Devon
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Greater London

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/NCT05507216
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/NCT05507216