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

NCT03368118 | Completed Phase 2 Results DMC

• 1 other identifier: ABX464-102
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Ulcerative Colitis

Keywords

ABX464; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Number of Treatment-emergent Adverse Events

  Number of treatment-emergent adverse events in ABX464 treated subjects

  Through subject study treatment, up to 48 months

Secondary Outcomes (15)

• Total Mayo Score

  Up to Month 48

• Partial Mayo Score

  Up to Month 48

• Number of Subjects With Clinical Response at Month 48

  up to 48 months

• Number of Subjects With Clinical Remission at Month 48

  up to 48 months

• Number of Subject With Endoscopic Improvement at Month 48

  up to 48 Months

Study Arms (1)

ABX464 Treatment arm

EXPERIMENTAL

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

Drug: ABX464

Interventions

ABX464 DRUG

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

ABX464 Treatment arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects previously enrolled in the ABX464-101 clinical study who have completed the initial 2-month treatment phase;
• Subjects able and willing to comply with study visits and procedures;
• Subjects with hematological and biochemical laboratory parameters as follows at the D56 visit of the ABX464-101 study:
• Hemoglobin \> 9.0 g dL-1;
• Absolute neutrophil count ≥ 750 mm-3;
• Platelets ≥ 100,000 mm-3;
• Total serum creatinine ≤ 1.3 x ULN (upper limit of normal);
• Creatinine clearance \> 50 mL min-1 by the Cockcroft-Gault equation;
• Total serum bilirubin \< 1.5 x ULN;
• Alkaline phosphatase, AST (SGOT) and ALT (SGPT) \< 1.5 x ULN;
• Subjects should understand, sign and date the written voluntary informed consent form at the enrolment visit prior to any protocol-specific procedures being performed;
• Subjects should be affiliated to a social security regimen (for French sites only);
• Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 3 months after end of study or early termination. Contraception should be in place at least 3 months prior to study participation. Women must be either postmenopausal (at least 12 months of amenorrhea), surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include: true abstinence, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), hormonal contraception (estrogen and progestogen or progestogen only) associated with inhibition of ovulation, bilateral tubal occlusion, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the subject. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle.

You may not qualify if:

• ▪ Any condition, which in the opinion of the investigator, could compromise the subject's safety or the adherence to the study protocol.

Sponsors & Collaborators

• Abivax S.A.: lead
• Orion Corporation, Orion Pharma: collaborator

Study Sites (1)

Department of Gastroenterology - University hospitals Leuven

Leuven, 3000, Belgium

Location

Related Links

• preliminary results at M24

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

ABX464

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Vice President Clinical Operations
• Organization: Abivax

paul.gineste@abivax.com

01 53 83 08 41

Study Officials

• Paul GINESTE

  Abivax S.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, follow-up study

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: December 11, 2017
• Study Start: January 20, 2018
• Primary Completion: July 12, 2022
• Study Completion: August 15, 2022
• Last Updated: May 29, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-05

Locations

BE (1)