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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03368118
Recruitment Status : Active, not recruiting
First Posted : December 11, 2017
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Abivax S.A.

Tracking Information
First Submitted Date  ICMJE November 13, 2017
First Posted Date  ICMJE December 11, 2017
Last Update Posted Date March 31, 2022
Actual Study Start Date  ICMJE January 20, 2018
Actual Primary Completion Date March 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2021)
Number of incidences of treatment-emergent adverse events [ Time Frame: Through study completion, 48 months + 1 additional month after study completion ]
Number of incidences of treatment-emergent adverse events in ABX464 treated subjects.
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2021)
  • Total Mayo Score [ Time Frame: Up to Month 48 ]
    The change from Day 0 up to Month 48 in Total Mayo Score
  • Partial Mayo Score [ Time Frame: Up to Month 48 ]
    The change from Day 0 up to Month 48 in Partial Mayo Score
  • UC worsening [ Time Frame: Up to Month 48 ]
    The time of UC worsening
  • Fecal calprotectin [ Time Frame: Up to Month 48 ]
    The change from Day 0 up to Month 48 in fecal calprotectin, CRP levels and ESR
  • CRP levels and ESR [ Time Frame: Up to Month 48 ]
    The change from Day 0 up to Month 48 in CRP levels and ESR
  • Incidence of treatment-emergent serious adverse events [ Time Frame: Through study completion, 48 months ]
    The number of incidences of treatment-emergent serious adverse events
  • Incidence of treatment-emergent adverse events of special interest [ Time Frame: Through study completion, 48 months ]
    The number of incidences of treatment-emergent adverse events of special interest
  • Incidence of adverse events leading to investigational product discontinuation [ Time Frame: Through study completion, 48 months ]
    The number of incidences of adverse events leading to investigational product discontinuation
  • Incidence of specific laboratory abnormalities [ Time Frame: Through study completion, 12 months ]
    The number of incidences of specific laboratory abnormalities
  • SF-36 Quality of Life questionnaire [ Time Frame: Through study completion, 48 months ]
    The scores and changes from Day 0 in SF-36 Questionnaire scores
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
  • Total Mayo Score [ Time Frame: Up to week 54 ]
    The change from Day 0 up to week 54 in Total Mayo Score
  • Partial Mayo Score [ Time Frame: Up to week 54 ]
    The change from Day 0 up to week 54 in Partial Mayo Score
  • UC worsening [ Time Frame: Up to week 54 ]
    The time of UC worsening
  • Fecal calprotectin [ Time Frame: Up to week 54 ]
    The change from Day 0 up to week 54 in fecal calprotectin, CRP levels and ESR
  • CRP levels and ESR [ Time Frame: Up to week 54 ]
    The change from Day 0 up to week 54 in CRP levels and ESR
  • Incidence of treatment-emergent serious adverse events [ Time Frame: Through study completion, 12 months ]
    The number of incidences of treatment-emergent serious adverse events
  • 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
  • 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
  • Incidence of specific laboratory abnormalities [ Time Frame: Through study completion, 12 months ]
    The number of incidences of specific laboratory abnormalities
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis
Official Title  ICMJE 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.
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.
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 48 months. Subjects will be followed up weekly during the first month, every two weeks during the second month and then on a monthly basis until M24, then quaterly from M24 to M48.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
open-label, follow-up study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: ABX464
All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months.
Study Arms  ICMJE Experimental: ABX464 Treatment arm
All subjects will receive ABX464 at 50 mg o.d for an overall period of 48 months.
Intervention: Drug: ABX464
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 14, 2021)
22
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2017)
30
Estimated Study Completion Date  ICMJE October 2022
Actual Primary Completion Date March 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03368118
Other Study ID Numbers  ICMJE ABX464-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Abivax S.A.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abivax S.A.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Orion Corporation, Orion Pharma
Investigators  ICMJE
Study Director: Paul GINESTE Abivax S.A.
PRS Account Abivax S.A.
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP