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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2022
• Main ID: NCT03368118
• Date of registration: 13/11/2017
• Prospective Registration: Yes
• Primary sponsor: Abivax S.A.
• Public title: Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis
• Scientific title: A Follow-up Phase IIa Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 Given at 50 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative Colitis.
• Date of first enrolment: January 20, 2018
• Target sample size: 22
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03368118
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium

Contacts

• Name: Paul GINESTE
• Affiliation: Abivax S.A.

Key inclusion & exclusion criteria

Inclusion Criteria:

A subject will be eligible for inclusion in this study only if ALL of the following
criteria apply:

- 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.

Exclusion Criteria:

The following criterion should be checked at the time of screening. If this exclusion
criterion applies, the subject will not be included in the study:

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: ABX464

Primary Outcome(s)

Number of incidences of treatment-emergent adverse events [Time Frame: Through study completion, 48 months + 1 additional month after study completion]

Secondary Outcome(s)

CRP levels and ESR [Time Frame: Up to Month 48]

Incidence of adverse events leading to investigational product discontinuation [Time Frame: Through study completion, 48 months]

Incidence of treatment-emergent serious adverse events [Time Frame: Through study completion, 48 months]

Total Mayo Score [Time Frame: Up to Month 48]

Fecal calprotectin [Time Frame: Up to Month 48]

Incidence of treatment-emergent adverse events of special interest [Time Frame: Through study completion, 48 months]

Incidence of specific laboratory abnormalities [Time Frame: Through study completion, 12 months]

UC worsening [Time Frame: Up to Month 48]

Partial Mayo Score [Time Frame: Up to Month 48]

SF-36 Quality of Life questionnaire [Time Frame: Through study completion, 48 months]

Secondary ID(s)

ABX464-102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Orion Corporation, Orion Pharma