ABTECT-Maintenance – ABX464 Treatment Evaluation for ulcerative Colitis Therapy

Phase 1

• Conditions: Moderately to severely active ulcerative colitis, Moderately to severely active ulcerative colitis; MedDRA version: 20.0Level: PTClassification code: 10009900Term: Colitis ulcerative Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2022-500537-84-00
• Lead Sponsor: Abivax

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1036

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 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.

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 ulcerative colitis) 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified