CompletedNCT05507203Updated Sep 10, 2026Results posted

ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1

A Phase 3 interventional study of ABX464 and Placebo in Ulcerative Colitis, sponsored by Abivax S.A.. Completed at 264 sites in 24 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Abivax S.A. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 639
Allocation: Randomized
Ages: 16 Years and older
Sex: All

Study 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].

Conditions studied

Ulcerative Colitis

Browse trials for

Colitis, Ulcerative 1,485

Who can participate

Ages eligible: 16 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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.

Exclusion criteria

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

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 639 participants (actual)

Study arms

Experimental
ABX464 50mg
Subjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks
Drug: ABX464
Experimental
ABX464 25mg
Subjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks
Drug: ABX464
Placebo comparator
Placebo
Subjects will be orally dosed daily in a fed condition ideally at the same time in the morning) for 8 weeks
Drug: Placebo

Interventions

DrugABX464
Administered once daily in the morning with food
Also known as: Obefazimod
DrugPlacebo
Administered once daily in the morning with food

What researchers measure

Primary outcomes

Proportion of Subjects Who Achieve Clinical Remission Per Modified Mayo Score at Week 8
To compare the efficacy of ABX464 versus placebo on clinical remission. Clinical remission is defined as stool frequency subscore (SFS) = 0 or 1 and rectal bleeding subscore (RBS) = 0, and Mayo Endoscopic Score (MES) = 0 or 1 (MES of 1 modified to exclude friability).
Time frame: 8 weeks

Secondary outcomes

Proportion of Subjects Who Achieve Endoscopic Improvement at Week 8
To compare the efficacy of ABX464 versus placebo on endoscopic improvement. Endoscopic improvement is defined as Mayo Endoscopic Score (MES) = 0 or 1 (MES of 1 modified to exclude friability).
Time frame: 8 weeks
Proportion of Subjects Who Achieve Clinical Response Per MMS at Week 8
To compare the efficacy of ABX464 versus placebo on clinical response as per Modified Mayo Score (MMS). MMS is the Modified Mayo Score. Modified Mayo score is a composite measure of ulcerative disease activity consisting of three components: stool frequency, rectal bleeding and endoscopic subscores. Each component is scored from 0 (normal or inactive disease) to 3 (severe activity). The total range score ranges from 0 to 9, with higher scores indicating more severe disease activity. Clinical Response is defined as a reduction from baseline in MMS ≥ 2 points and a relative reduction from baseline in MMS ≥ 30%, and a reduction from baseline in Rectal Bleeding Score (RBS) ≥ 1 point and/or RBS = 0 or 1.
Time frame: 8 weeks
Proportion of Subjects With HEMI Per Geboes at Week 8
To compare the efficacy of ABX464 versus placebo on histologic-endoscopic mucosal improvement (HEMI). HEMI is defined as endoscopic improvement associated with histologic improvement per Geboes score.
Time frame: 8 weeks

Results

Posted Sep 10, 2026

Participant flow

Participant flow — Overall Study
Milestone	ABX464 50mg	ABX464 25mg	Placebo
Started	318	161	160
Completed	291	155	143
Not completed	27	6	17
Withdrew: Adverse event	18	0	6
Withdrew: Lost to follow-up	1	1	1
Withdrew: Never dosed	0	1	1
Withdrew: Non-compliance with study drug	2	0	0
Withdrew: Protocol violation	1	0	1
Withdrew: Physician decision	1	0	1
Withdrew: Withdrawal by subject	4	4	7

Outcome measures

PrimaryProportion of Subjects Who Achieve Clinical Remission Per Modified Mayo Score at Week 8

To compare the efficacy of ABX464 versus placebo on clinical remission. Clinical remission is defined as stool frequency subscore (SFS) = 0 or 1 and rectal bleeding subscore (RBS) = 0, and Mayo Endoscopic Score (MES) = 0 or 1 (MES of 1 modified to exclude friability).

Time frame:: 8 weeks
Reported as:: Count of participants · Participants

Proportion of Subjects Who Achieve Clinical Remission Per Modified Mayo Score at Week 8
Participants	ABX464 50mg	ABX464 25mg	Placebo
Proportion of Subjects Who Achieve Clinical Remission Per Modified Mayo Score at Week 8	69	38	4

SecondaryProportion of Subjects Who Achieve Endoscopic Improvement at Week 8

To compare the efficacy of ABX464 versus placebo on endoscopic improvement. Endoscopic improvement is defined as Mayo Endoscopic Score (MES) = 0 or 1 (MES of 1 modified to exclude friability).

Time frame:: 8 weeks
Reported as:: Count of participants · Participants

Proportion of Subjects Who Achieve Endoscopic Improvement at Week 8
Participants	ABX464 50mg	ABX464 25mg	Placebo
Proportion of Subjects Who Achieve Endoscopic Improvement at Week 8	106	60	9

SecondaryProportion of Subjects Who Achieve Clinical Response Per MMS at Week 8

To compare the efficacy of ABX464 versus placebo on clinical response as per Modified Mayo Score (MMS). MMS is the Modified Mayo Score. Modified Mayo score is a composite measure of ulcerative disease activity consisting of three components: stool frequency, rectal bleeding and endoscopic subscores. Each component is scored from 0 (normal or inactive disease) to 3 (severe activity). The total range score ranges from 0 to 9, with higher scores indicating more severe disease activity. Clinical Response is defined as a reduction from baseline in MMS ≥ 2 points and a relative reduction from baseline in MMS ≥ 30%, and a reduction from baseline in Rectal Bleeding Score (RBS) ≥ 1 point and/or RBS = 0 or 1.

Time frame:: 8 weeks
Reported as:: Count of participants · Participants

Proportion of Subjects Who Achieve Clinical Response Per MMS at Week 8
Participants	ABX464 50mg	ABX464 25mg	Placebo
Proportion of Subjects Who Achieve Clinical Response Per MMS at Week 8	194	105	45

SecondaryProportion of Subjects With HEMI Per Geboes at Week 8

To compare the efficacy of ABX464 versus placebo on histologic-endoscopic mucosal improvement (HEMI). HEMI is defined as endoscopic improvement associated with histologic improvement per Geboes score.

Time frame:: 8 weeks
Reported as:: Count of participants · Participants

Proportion of Subjects With HEMI Per Geboes at Week 8
Participants	ABX464 50mg	ABX464 25mg	Placebo
Proportion of Subjects With HEMI Per Geboes at Week 8	73	38	5

Adverse events

Collected over up to 12 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ABX464 50mg	0/318 (0%)	14/318 (4.4%)	90/318 (28.3%)
ABX464 25mg	0/160 (0%)	1/160 (0.6%)	34/160 (21.3%)
Placebo	0/158 (0%)	3/158 (1.9%)	28/158 (17.7%)

Most frequent serious events

Showing 10 of 14

Most frequent serious events
Event	ABX464 50mg	ABX464 25mg	Placebo
Colitis UlcerativeGastrointestinal disorders	3/318	0/160	2/158
Anal InflammationGastrointestinal disorders	0/318	0/160	1/158
AppendicitisInfections and infestations	0/318	1/160	0/158
Myocardial infarctionCardiac disorders	1/318	0/160	0/158
Type 2 diabetes mellitusMetabolism and nutrition disorders	1/318	0/160	0/158
Pancreatitis acuteGastrointestinal disorders	1/318	0/160	0/158
Prostate Cancer stage INeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/318	0/160	0/158
Procedural dizzinessInjury, poisoning and procedural complications	1/318	0/160	0/158
PneumoniaInfections and infestations	1/318	0/160	0/158
PancreatitisGastrointestinal disorders	1/318	0/160	0/158

Most frequent other events

Most frequent other events
Event	ABX464 50mg	ABX464 25mg	Placebo
HeadacheNervous system disorders	66/318	25/160	9/158
AnaemiaBlood and lymphatic system disorders	10/318	6/160	9/158
NauseaGastrointestinal disorders	18/318	5/160	1/158
Colitis UlcerativeGastrointestinal disorders	6/318	0/160	8/158
ArthralgiaMusculoskeletal and connective tissue disorders	8/318	1/160	8/158

Baseline characteristics

The Full Analysis Set includes all randomized participants who received at least one dose of study drug. One participant in the ABX464 25 mg group and 2 in the placebo group were randomized but did not receive any dose of study drug.

Age, Categorical
Age, Categorical(Participants)	ABX464 50mg	ABX464 25mg	Placebo	Total
<=18 years	1	0	1	2
Between 18 and 65 years	292	148	146	586
>=65 years	25	12	11	48

Age, Continuous
Age, Continuous(years)	ABX464 50mg	ABX464 25mg	Placebo	Total
Mean	42.7 ± 14.3	41.5 ± 13.54	43.1 ± 13.59	42.5 ± 13.93

Sex: Female, Male
Sex: Female, Male(Participants)	ABX464 50mg	ABX464 25mg	Placebo	Total
Female	129	56	66	251
Male	189	104	92	385

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	ABX464 50mg	ABX464 25mg	Placebo	Total
American Indian or Alaska Native	0	0	1	1
Asian	87	34	45	166
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	5	3	2	10
White	219	114	106	439
More than one race	1	1	0	2
Unknown or Not Reported	6	8	4	18

Baseline weight
Baseline weight(kg)	ABX464 50mg	ABX464 25mg	Placebo	Total
Mean	72.41 ± 18.581	72.58 ± 17.269	71.28 ± 16.392	72.17 ± 17.713

Duration of ulcerative colitis
Duration of ulcerative colitis(years)	ABX464 50mg	ABX464 25mg	Placebo	Total
Mean	7.98 ± 7.348	7.8 ± 7.151	7.51 ± 7.761	7.82 ± 7.395

Number of participants with at least one prior AT-IR
Number of participants with at least one prior AT-IR(Participants)	ABX464 50mg	ABX464 25mg	Placebo	Total
Count of participants	149	70	69	288

Number of participants with inadequate response to JAK inhibitors among participants with AT-IR
Number of participants with inadequate response to JAK inhibitors among participants with AT-IR(Participants)	ABX464 50mg	ABX464 25mg	Placebo	Total
Count of participants	22	15	15	52

3 further baseline measures are reported on the registry.

Study locations

264 sites

Digestive Health Specialists of the Southeast
Dothan, Alabama 36305, United States
Lakeview Clinical Research
Guntersville, Alabama 35976, United States
Birmingham Digestive Health Research
Homewood, Alabama 35209, United States
GI Alliance
Sun City, Arizona 85351, United States
Del Sol Research Management, LLC
Tucson, Arizona 85715, United States
Gastro Care Institute
Lancaster, California 93534, United States
California Medical Research Associates Inc.
Northridge, California 91324, United States
Clinnova Research Solutions
Orange, California 92868, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado 80907, United States
Clinical Research Of Brandon, LLC
Brandon, Florida 33511, United States
Access Research Institute
Brooksville, Florida 34613, United States
Nature Coast Clinical Research - Inverness
Inverness, Florida 34452, United States
Auzmer Research
Lakeland, Florida 33813, United States
Medical Professional Clinical Research Center
Miami, Florida 33165, United States
Advanced Research Institute, Inc.
New Port Richey, Florida 34653, United States
Endoscopic Research, Inc.
Orlando, Florida 32803, United States
Orlando Health-Orlando Regional Medical Center
Orlando, Florida 32806, United States
Advanced Research Institute, Inc.
Orlando, Florida 32825, United States
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida 32503, United States
Theia Clinical Research Centers, LLC
Temple Terrace, Florida 33617, United States
One Health Research Clinic Atlanta, LLC
Norcross, Georgia 30093, United States
Eagle Clinical Research
Chicago, Illinois 60621, United States
GI Alliance
Glenview, Illinois 60026, United States
GI Alliance
Gurnee, Illinois 60031, United States
Indiana University School of Medicine
Indianapolis, Indiana 46202, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas 66160, United States
Lucida Clinical Trials LLC
New Bedford, Massachusetts 02740, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756, United States
Rochester Clinical Research
Rochester, New York 14609, United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina 28207, United States
Care Access Research Lumberton
Lumberton, North Carolina 28358, United States
Wexner Medical Center
Columbus, Ohio 43210, United States
DSI Research LLC
Springboro, Ohio 45066, United States
Gastroenterology Center of the MidSouth PC
Germantown, Tennessee 38138, United States
GI Alliance - Southlake
Austin, Texas 76092, United States
Central Texas Clinical Research, LLC
Austin, Texas 78705, United States
Novel Research LLC
Bellaire, Texas 77401, United States
Texas Digestive Disease Consultants
Cedar Park, Texas 78613, United States
Baylor Scott and White
Dallas, Texas 75246, United States
Cook Children's Medical Center
Fort Worth, Texas 76104, United States
GI Alliance - Garland
Garland, Texas 75044, United States
Baylor College Of Medicine
Houston, Texas 77030, United States
Houston Methodist Hospital
Houston, Texas 77030, United States
Biopharma Informatic, Inc. Research Center
Houston, Texas 77043, United States
Biopharma Informatic, LLC
Houston, Texas 77084, United States
Gastro Health & Nutrition
Katy, Texas 78754, United States
Lubbock Digestive Disease Associates
Lubbock, Texas 79410, United States
GI Alliance -Gurnee
Mansfield, Texas 76063, United States
Digestive Research of Central Texas, LLC
Waco, Texas 76301, United States
GI Alliance - Webster
Webster, Texas 77598, United States
Care Access Research LLC
Ogden, Utah 84403, United States
University of Utah
Salt Lake City, Utah 84112, United States
Blue Ridge Medical Research
Lynchburg, Virginia 24502, United States
University of Washington
Seattle, Washington 98195, United States
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires B1878GEG, Argentina
STAT Research S.A.
Ciudad Autonoma Buenos Aires, C1013AAB, Argentina
Hospital Privado Centro Medico de Cordoba S.A
Córdoba, X5016KEH, Argentina
Canberra Hospital
Canberra, Australian Capital Territory 2605, Australia
Concord Repatriation General Hospital
Concord, New South Wales 2139, Australia
Liverpool Hospital
Liverpool, New South Wales 2170, Australia
Coral Sea Clinical Research Institute
North Mackay, Queensland 4740, Australia
Mater Misericordiae Ltd
South Brisbane, Queensland 4101, Australia
Box Hill Hospital
Box Hill, Victoria 3128, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria 3065, Australia
The Alfred Hospital
Melbourne, Victoria 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria 3050, Australia
Royal Perth Hospital
Perth, Western Australia 6000, Australia
LKH - Universitaetsklinikum Graz
Graz, 8036, Austria
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020, Austria
KH der Barmherzigen Brüder St.Veit an der Glan
Sankt Veit an der Glan, 9300, Austria
AKH - Medizinische Universität Wien
Vienna, 1090, Austria
AZ Sint-Lucas
Bruges, 8310, Belgium
C. H. U. St-Pierre
Brussels, 1000, Belgium
HUB Erasme
Brussels, 1070, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU UCL Namur
Yvoir, 5530, Belgium
Medical center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
DCC "Alexandrovska", EOOD
Sofia, 1431, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, 1527, Bulgaria
UMHAT Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, 6000, Bulgaria
Gastroenterology and Internal Medicine Research Institute
Edmonton, Alberta T5R 1W2, Canada
Scott Shulman Medicine Professional Corporation
North Bay, Ontario P1B 2H3, Canada
McGill University Health Centre- Montreal General Hospital
Montreal, Quebec H3G 1A4, Canada
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui 230022, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui 241001, China
Peking University First Hospital
Beijing, Beijing Municipality 100034, China
Peking University Third Hospital
Beijing, Beijing Municipality 100191, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian 350005, China
The 900th Hospital of The Chinese People's Liberation Army Joint Logistics Support Force
Fuzhou, Fujian 350025, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian 361004, China
The First People's Hospital of Foshan
Foshan, Guangdong 528000, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong 510515, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong 510655, China
The First Affiliated Hospital of Sun Yat-sen University
Yuexiu, Guangdong 510080, China
Liuzhou People's Hospital
Liuzhou, Guangxi Zhuang 545006, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan 471003, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan 473000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450000, China
The 2nd Xiangya Hospital of Central South University
Changsha, Hu'nan 410011, China

Showing the first 100 of 264 sites across 24 countries.

References and documents

Study documents

Study protocol · Apr 10, 2024
Statistical analysis plan · Jul 15, 2025

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT05507203
Lead sponsor: Abivax S.A.
Responsible party: Sponsor
First posted: Aug 18, 2022
Start date: Nov 16, 2022
Primary completion: Jun 24, 2025
Completion: Jun 25, 2025
Results posted: Sep 10, 2026
Last update: Sep 10, 2026

Study contacts

Severine Vermeire, MD, PhD

principal investigator · UZ Leuven, Belgium

Bruce Sands, MD, PhD

principal investigator · Mount Sinai Health System Digestive Disease Institute, New York USA

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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