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

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ClinicalTrials.gov Identifier: NCT03368118
Recruitment Status : Active, not recruiting
First Posted : December 11, 2017
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Abivax S.A.

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: ABX464 Phase 2

Detailed Description:

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.

All subjects will receive ABX464 given at 50 mg o.d irrespective of their previous treatment received in the ABX464-101 study (i.e. ABX464 or Placebo).

The actual treatment received by a subject throughout the previous study (ABX464-101) will not be known at the time the subjects enter this follow-up study. This treatment group will be communicated (throughout the investigators) to the subjects at the end of the ABX464-101 study (planned in Q3/2018).

The enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation and also based on investigator's judgement.

Subjects will be treated with ABX464 for an overall period of 12 months. Subjects will be followed up weekly during the first month, every two weeks during the second month and then on a monthly basis.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open-label, follow-up study
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : January 20, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABX464 Treatment arm
All subjects will receive ABX464 at 50 mg o.d for an overall period of 12 months.
Drug: ABX464
All subjects will receive ABX464 given at 50 mg o.d for an overall period of 12 months.




Primary Outcome Measures :
  1. Number of incidences of treatment-emergent adverse events [ Time Frame: Through study completion, 12 months + 1 additional month after study completion ]
    Number of incidences of treatment-emergent adverse events in ABX464 treated subjects.


Secondary Outcome Measures :
  1. Total Mayo Score [ Time Frame: Up to week 54 ]
    The change from Day 0 up to week 54 in Total Mayo Score

  2. Partial Mayo Score [ Time Frame: Up to week 54 ]
    The change from Day 0 up to week 54 in Partial Mayo Score

  3. UC worsening [ Time Frame: Up to week 54 ]
    The time of UC worsening

  4. Fecal calprotectin [ Time Frame: Up to week 54 ]
    The change from Day 0 up to week 54 in fecal calprotectin, CRP levels and ESR

  5. CRP levels and ESR [ Time Frame: Up to week 54 ]
    The change from Day 0 up to week 54 in CRP levels and ESR

  6. Incidence of treatment-emergent serious adverse events [ Time Frame: Through study completion, 12 months ]
    The number of incidences of treatment-emergent serious adverse events

  7. Incidence of treatment-emergent adverse events of special interest [ Time Frame: Through study completion, 12 months ]
    The number of incidences of treatment-emergent adverse events of special interest

  8. Incidence of adverse events leading to investigational product discontinuation [ Time Frame: Through study completion, 12 months ]
    The number of incidences of adverse events leading to investigational product discontinuation

  9. Incidence of specific laboratory abnormalities [ Time Frame: Through study completion, 12 months ]
    The number of incidences of specific laboratory abnormalities

  10. SF-36 Quality of Life questionnaire [ Time Frame: Through study completion, 12 months ]
    The scores and changes from Day 0 in SF-36 Questionnaire scores



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368118


Locations
Belgium
Department of Gastroenterology - University hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Abivax S.A.
Orion Corporation, Orion Pharma
Investigators
Study Director: Paul GINESTE Abivax S.A.

Responsible Party: Abivax S.A.
ClinicalTrials.gov Identifier: NCT03368118     History of Changes
Other Study ID Numbers: ABX464-102
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abivax S.A.:
ABX464
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases