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Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis

NCT03368118 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-05-29

Study results available
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Summary

This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue their treatment.

Conditions

Interventions

DRUG

ABX464

All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months.

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    collaborator INDUSTRY

  • Abivax S.A.

    lead INDUSTRY

Principal Investigators

  • Paul GINESTE · Abivax S.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-20
Primary Completion
2022-07-12
Completion
2022-08-15

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03368118 on ClinicalTrials.gov