Investigate the efficacy and safety of study drug ABX464 50 mg once daily in patients with moderate to severe Active Ulcerative Colitis.

Phase 1

• Conditions: Moderate to severe Ulcerative Colitis.; MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-003284-35-ES
• Lead Sponsor: ABIVAX

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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:
oHemoglobin > 9.0 g dL-1;
oAbsolute neutrophil count = 750 mm-3;
oPlatelets = 100,000 mm-3;
oTotal serum creatinine = 1.3 x ULN (upper limit of normal);
oCreatinine clearance > 50 mL min-1 by the
Cockcroft-Gault equation within 60 days of entry;
oTotal serum bilirubin < 1.5 x ULN;
oAlkaline phosphatase, AST (SGOT) and ALT (SGPT) < 1.5 x
ULN;

-Subjects should understand, sign and date the written voluntary informed consent form at the screening 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 2 weeks prior to study participation. Women must be 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) or hormonal contraception associated with inhibition of ovulation, 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

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

Study & Design

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