Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 4 January 2022
• Main ID: NCT04023396
• Date of registration: 05/07/2019
• Prospective Registration: Yes
• Primary sponsor: Abivax S.A.
• Public title: Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
• Scientific title: A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
• Date of first enrolment: January 13, 2020
• Target sample size: 217
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT04023396
• 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

Austria, Belarus, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Poland, Serbia, Slovakia, Slovenia, Spain, Ukraine, United Kingdom

Contacts

• Name: Severine VERMEIRE, MD
• Affiliation: Universitaire Ziekenhuizen Leuven

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must have completed the 16-week induction treatment period (ABX464-103);

- Patients are able and willing to comply with study visits and procedures as per
protocol;

- Patients should understand, sign and date the written voluntary informed consent form
prior to any protocol-specific procedures are performed;

- Patients should be affiliated to a social security regimen (for French sites only);

- Females and males receiving the study treatment (potentially in combination with
immunosuppressant) and their partners must agree to use a highly effective
contraceptive method during the study and for 6 months (180 days) after end of study
or early termination. Contraception should be in place at least 2 weeks prior to
screening. Women must be surgically sterile (bilateral oophorectomy, bilateral
salpingectomy, or hysterectomy) or in the postmenopausal state (no menses for 12
months without an alternative medical cause) 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 aiming at inhibition of ovulation, intrauterine hormone
releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is
defined when this is in line with the preferred and usual lifestyle of the patient. 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. Female and male patients must not
be planning pregnancy during the trial and for 6 months post completion of their
participation in the trial. In addition, male patients should use condom during the
trial and for 6 months (180 days) post completion of their participation in the study.
Male patients must not donate sperm as long as contraception is required.

Criteria that should be met by patients at week 48 to be eligible for 48 additional weeks
of study treatment.

- Patients should be in clinical response. Clinical response is defined as: a reduction
in Modified Mayo Score = 2 points and = 30 % from baseline (induction) with an
accompanying decrease in rectal bleeding sub-score = 1 point or absolute rectal
bleeding sub-score = 1 point.

- Patients able and willing to continue the study treatment and who are compliant with
study visits and procedures and who signed the update of the written voluntary
informed consent.

Exclusion Criteria:

- Patients who had major protocol deviation(s) in the induction study;

- Patients who permanently discontinued study the treatment in induction study
(ABX464-103) because of an adverse event (AE) regardless of relatedness to
investigational product;

- Patients who have developed any major illness/condition or evidence of an unstable
clinical condition (except UC) that, in the investigator's judgment, will
substantially increase the risk to the participant if he or she participates in the
study;

- Patients with any other severe acute or chronic medical or psychiatric condition or
laboratory or electrocardiogram (ECG) abnormality that may increase the risk
associated with study participation or investigational product administration or may
interfere with the interpretation of study results and, in the judgment of the
investigator, would make the patient inappropriate for entry into this study;

- Patients who are participating or plan to participate in other investigational studies
(other than induction study) during the study.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: ABX464

Primary Outcome(s)

Proportion of patients with clinical remission at week 48 compared to baseline of induction study (ABX464-103) [Time Frame: week 48]

Secondary Outcome(s)

Endoscopic changes at week 48 [Time Frame: weeks 48 and 96]

Glucocorticoid-free clinical remission [Time Frame: From baseline to week 48]

Histopathological evaluation of the effect of ABX464 50 mg on the rectal/sigmoidal infiltrate based on Nancy index scoring system [Time Frame: week 48]

Change in Modified Mayo Score and in partial Modified Mayo Score [Time Frame: From baseline to week 96]

miRNA-124 expression [Time Frame: baseline, week 24 and week 48]

Histopathological evaluation of the effect of ABX464 50 mg on the rectal/sigmoidal infiltrate based on the Robarts Histological index [Time Frame: week 48]

Fecal calprotectin and C-Reactive Proteine [Time Frame: baseline, week 24, week 48]

Histopathological evaluation of the effect of ABX464 50 mg on the rectal/sigmoidal infiltrate based on Gebeos score [Time Frame: week 48]

Inflammatory Bowel Disease Questionnaire [Time Frame: baseline, week 24, week 48]

Clinical response at week 48 [Time Frame: baseline, weeks 48 and 96]

Sustained endoscopic changes at week 48 [Time Frame: weeks 48 and 96]

Rectal bleeding [Time Frame: from baseline to week 96]

Incidence and description of Adverse Events [Time Frame: From baseline to week 52]

Secondary ID(s)

ABX464-104

Source(s) of Monetary Support

Please refer to primary and secondary sponsors