ABTECT - Maintenance

Purpose

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.

Condition

  • Ulcerative Colitis

Eligibility

Eligible Ages
Over 16 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Among both induction studies, subjects assessed as responders will be randomized as follows into Part 1 of the maintenance study according to their induction treatment: - ABX464 Dose 50 mg QD - ABX464 Dose 25 mg QD - Placebo. All subjects with clinical response who were dosed with placebo in the induction studies will be randomized into the placebo group. Among both induction studies, subjects assessed as non-responders will be randomized as follows into Part 2 of the maintenance study according to their induction treatment: - ABX464 Dose 50 mg QD (all subjects who received 50 mg in induction) - ABX464 Dose 25 mg QD (all subjects who received 25 mg in induction) - Subjects who were allocated to placebo in the induction study will be randomized to obefazimod 50 mg or 25 mg in a blinded manner.
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
All eligible subjects will be randomized to either the double blind, placebo-controlled Part #1 (ABX464 50mg or 25mg or placebo) or randomized to double-blind Part #2 (ABX464 50mg or 25mg) depending on their clinical response at the end of induction.

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
ABX464 50mg - Responder subjects at the end of induction 		Subjects will be orally dosed during 44 weeks
  • Drug: ABX464
    Administered once daily, preferably in the morning, with food
    Other names:
    • Obefazimod
Placebo Comparator
ABX464 25mg - Responder subjects at the end of induction 		Subjects will be orally dosed during 44 weeks
  • Drug: ABX464
    Administered once daily, preferably in the morning, with food
    Other names:
    • Obefazimod
Placebo Comparator
Placebo - Responder subjects at the end of induction 		Subjects will be orally dosed during 44 weeks
  • Drug: Placebo
    Administered once daily, preferably in the morning, with food
Experimental
ABX464 50mg - Non responder subjects at the end of induction 		Subjects will be orally dosed during 44 weeks
  • Drug: ABX464
    Administered once daily, preferably in the morning, with food
    Other names:
    • Obefazimod
Experimental
ABX464 25mg - Non responder subjects at the end of induction 		Subjects will be orally dosed during 44 weeks
  • Drug: ABX464
    Administered once daily, preferably in the morning, with food
    Other names:
    • Obefazimod
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.
  • Drug: ABX464
    Administered once daily, preferably in the morning, with food
    Other names:
    • Obefazimod

Recruiting Locations

Research Solutions of Arizona, PC
Litchfield Park, Arizona 85340
Contact:
Connie Hsu, MD

GI Alliance
Sun City, Arizona 85351
Contact:
Chirag Trivedi, MD

Del Sol Research Management, LLC
Tucson, Arizona 85715
Contact:
Bassel Kisso, MD

Citrus Valley Gastroenterology
Covina, California 91723
Contact:
Sartaj Arora, MD

United Medical Doctors
Murrieta, California 92563
Contact:
John Hong, MD

California Medical Research Associates Inc.
Northridge, California 91324
Contact:
Calin Arimie, MD

Clinnova Research Solutions
Orange, California 92868
Contact:
Amit Bhanvadia, MD

Clinical Applications Laboratories
San Diego, California 92103
Contact:
Vijayalakshmi Pratha, MD

Danbury Hospital
Danbury, Connecticut 06810
Contact:
Adam Gorelick, MD

West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida 33762
Contact:
Tejinder Glamour, MD

Nature Coast Clinical Research, LLC
Inverness, Florida 34452
Contact:
Paul Hellstern, MD

Auzmer Research
Lakeland, Florida 33813
Contact:
Niaz Ausaf, MD

Wellness Clinical Research
Miami Lakes, Florida 33016
Contact:
Lucky Flores, MD

Medical Professional Clinical Research Center
Miami, Florida 33165
Contact:
Carlos Selema, MD

GCP Clinical Research, LLC
Tampa, Florida 33609
Contact:
Alan Weintraub, MD

GI Alliance
Gurnee, Illinois 60031
Contact:
Jonathan Rosenberg, MD

The University of Iowa
Iowa City, Iowa 52242
Contact:
Steven Polyak, MD

Mount Sinai
New York, New York 10029
Contact:
Jean-Frederic Colombel, MD

Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina 28207
Contact:
John Gardiner Roddey, MD

DSI Research LLC
Springboro, Ohio 45066
Contact:
Anjali Morey, MD

Susquehanna Research Group, LLC
Harrisburg, Pennsylvania 17110
Contact:
Adnan Ahmad, MD

Frontier Clinical Research, LLC
Uniontown, Pennsylvania 15401
Contact:
Frederick Ruthardt, MD

Rapid City Medical Center, LLC
Rapid City, South Dakota 57701
Contact:
Blake Jones, MD

Texas Clinical Research Institute, LLC
Arlington, Texas 76012
Contact:
M. Tarek Al-Assi, MD

Central Texas Clinical Research, LLC
Austin, Texas 78705
Contact:
Cynthia Brinson, MD

Inquest Clinical Research
Baytown, Texas 77521
Contact:
Haider Afzal, MD

Texas Digestive Disease Consultants
Cedar Park, Texas 78613
Contact:
Junaid Siddiqui, MD

Baylor Scott and White
Dallas, Texas 75246
Contact:
Themistocles Dassopoulos, MD

Cook Children's Medical Center
Fort Worth, Texas 76104
Contact:
Clifton Huang, MD

Biopharma Informatic, LLC
Houston, Texas 77084
Contact:
James Maher Jr, MD

Gastro Health & Nutrition
Katy, Texas 77494
Contact:
Dharmendra Verma, MD

Digestive System Healthcare
Pasadena, Texas 77505
Contact:
Rukan Daccak, MD

GI Alliance - Southlake
Southlake, Texas 76092
Contact:
Timothy Ritter, MD

Tyler Research Institute, LLC
Tyler, Texas 75701
Contact:
George Aaron DuVall, MD

University of Utah
Salt Lake City, Utah 84112
Contact:
John Valentine, MD

Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
Roanoke, Virginia 24014
Contact:
Nirish Shah, MD

The Vancouver Clinic
Vancouver, Washington 98664
Contact:
Jason Etzel, MD

More Details

NCT ID
NCT05535946
Status
Recruiting
Sponsor
Abivax S.A.

Study Contact

Laurence Desroys du Roure, PharmD
+33630031132
laurence.desroysduroure@abivax.com

Detailed Description

All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 study which consists of 2 treatment phases. This study consists of a 44-week maintenance treatment phase (Part 1 and Part 2), followed by a 4-year Long Term Extension (LTE) treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit. The maintenance phase is a 44-week double blind, placebo-controlled, phase. Subjects who are clinical responders after 8 weeks induction will be randomized to Part 1, and those who are non-clinical responders will be randomized to Part 2. At the end of the 44-week maintenance phase, subjects will continue their allocated treatment until the maintenance phase is unblinded. Once the study is unblinded, all subjects receiving obefazimod will continue their allocated treatment. Subjects receiving placebo will be allocated to obefazimod 25 mg or can terminate the study.

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Vanderbilt University Medical Center