The trial is taking place at:
T

Tyler Research Institute | Tyler, TX

Veeva-enabled site

ABTECT - Maintenance

A

ABIVAX

Status and phase

Enrolling
Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: Placebo
Drug: ABX464

Study type

Interventional

Funder types

Industry

Identifiers

NCT05535946
ABX464-107

Details and patient eligibility

About

This is a multicenter, randomized 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. 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 maintenance study and will be randomized to either a double blind, placebo-controlled part (Part #1) or allocated to ABX464 50mg or 25mg open label treatment arms (Part #2) depending on their clinical response at the end of induction. This study consists of a 44-week treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.

Enrollment

1,050 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* 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 use highly effective contraception methods as stated in Section 4.4. (Contraception) of this 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

Exclusion criteria

* 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 or evidence of an unstable clinical condition (except UC) during the induction study that, in the investigator's judgment, will substantially increase the risk to the participant 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 within the coming 12 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

1,050 participants in 5 patient groups, including a placebo group

ABX464 50mg - Responder subjects at the end of induction
Experimental group
Description:
Subjects will be orally dosed during 44 weeks
Treatment:
Drug: ABX464
ABX464 25mg - Responder subjects at the end of induction
Experimental group
Description:
Subjects will be orally dosed during 44 weeks
Treatment:
Drug: ABX464
Placebo - Responder subjects at the end of induction
Placebo Comparator group
Description:
Subjects will be orally dosed during 44 weeks
Treatment:
Drug: Placebo
ABX464 50mg - Non responder subjects at the end of induction
Experimental group
Description:
Subjects will be orally dosed during 44 weeks
Treatment:
Drug: ABX464
ABX464 25mg - Non responder subjects at the end of induction
Experimental group
Description:
Subjects will be orally dosed during 44 weeks
Treatment:
Drug: ABX464

Trial contacts and locations

574

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Central trial contact

Sharon Skare,, CPhil

Data sourced from clinicaltrials.gov

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