Active, not recruiting
Phase 3
ABTECT - Maintenance
Condition(s) studied
Ulcerative Colitis
Investigational drug(s) / intervention(s)
ABX464Placebo
ABX464: Administered once daily, preferably in the morning, with food
Placebo: Administered once daily, preferably in the morning, with food
Study 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.
Eligibility
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
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).
Primary outcome measure(s)
- Rate of subjects in clinical remission at Week 44 — Week 44
The Part 1 primary objective is to compare the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission \[SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1\] at Week 44.
- Number and percentage of all treatment-emergent adverse events (TEAEs) — Week 44
The Part 2 primary objective is safety
- Number and percentage of all serious adverse events (SAEs) — Week 44
The Part 2 primary objective is safety
- Number and percentage of all causally related TEAEs/SAEs — Week 44
The Part 2 primary objective is safety
Trial sites (413)
| Facility | City | Region | Status |
| Digestive Health Specialists of the Southeast |
Dothan |
Alabama |
|
| Research Solutions of Arizona, PC |
Litchfield Park |
Arizona |
|
| GI Alliance |
Sun City |
Arizona |
|
| University of Arizona |
Tucson |
Arizona |
|
| University of Arkansas for Medical Sciences |
Little Rock |
Arkansas |
|
| Citrus Valley Gastroenterology |
Covina |
California |
|
| University of California (San Diego) |
La Jolla |
California |
|
| United Medical Doctors |
Murrieta |
California |
|
| California Medical Research Associates Inc. |
Northridge |
California |
|
| Clinnova Research Solutions |
Orange |
California |
|
| Clinical Applications Laboratories |
San Diego |
California |
|
| Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals |
Aurora |
Colorado |
|
| Danbury Hospital |
Danbury |
Connecticut |
|
| West Central Gastroenterology d/b/a Gastro Florida |
Clearwater |
Florida |
|
| Nature Coast Clinical Research, LLC |
Inverness |
Florida |
|
| Auzmer Research |
Lakeland |
Florida |
|
| Infinite Clinical Research Inc |
Miami |
Florida |
|
| Research Associates of South Florida, LLC |
Miami |
Florida |
|
| University of Miami |
Miami |
Florida |
|
| MedOne Clinical Research LLC |
Miami |
Florida |
|
| Nicklaus Children's Hospital |
Miami |
Florida |
|
| Medical Professional Clinical Research Center |
Miami |
Florida |
|
| Wellness Clinical Research |
Miami Lakes |
Florida |
|
| Ocala GI Research |
Ocala |
Florida |
|
| Arnold Palmer Hospital For Children |
Orlando |
Florida |
|
| Advanced Research Institute, Inc. |
Orlando |
Florida |
|
| GCP Clinical Research, LLC |
Tampa |
Florida |
|
| Guardian Angel Research Center |
Tampa |
Florida |
|
| Alliance Clinical Research |
Tampa |
Florida |
|
| Atlanta Center for Gastroenterology, P.C. |
Decatur |
Georgia |
|
| Northwestern University Feinberg School of Medicine |
Chicago |
Illinois |
|
| University of Chicago Medical Center |
Chicago |
Illinois |
|
| GI Alliance |
Gurnee |
Illinois |
|
| Iowa Digestive Disease Center |
Clive |
Iowa |
|
| The University of Iowa |
Iowa City |
Iowa |
|
| University of Kansas Medical Center Research Institute, Inc. |
Kansas City |
Kansas |
|
| University of Maryland Medical Center |
Baltimore |
Maryland |
|
| Boston Medical Center |
Boston |
Massachusetts |
|
| Lucida Clinical Trials LLC |
New Bedford |
Massachusetts |
|
| Henry Ford Hospital |
Sterling Heights |
Michigan |
|
+ 373 more sites — see the full list on the official registry below.
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