ABTECT - Maintenance

Phase 3

Recruiting

• Conditions: lcerative colitis

• Registration Number: JPRN-jRCT2031230257
• Lead Sponsor: jRCT Inquiries IQVIA Contact person

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Subjects must have completed the induction treatment study (ABX464-105 or ABX464 106), and subjects' clinical response status must be available.
2.Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1.
3.Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.
4.Women of childbearing potential (WOCBP) subjects and male subjects with WOCBP partner must agree to use highly effective contraception methods as stated in Section 4.4. (Contraception) of this protocol.
5.Subjects must be able and willing to comply with study visits and procedures as per protocol.

Exclusion Criteria

1.Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106).
2.Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) during the induction study that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
3.Subjects who plan to participate in other investigational studies during the maintenance study.
4.Pregnant or breast-feeding women or male subject of a pregnant partner,
5.Male or female subjects planning a pregnancy within the coming 12 months.
6.Subjects who have not adhered to abstinence of prohibited and/or concomitant medications.
7.Any changes in the laboratory values during the induction period that correspond with the following:
-Hemoglobin <= 8.0 g dL-1
-Absolute neutrophil count < 750 mm-3
-Platelets < 100,000 mm-3
-Creatinine clearance < 60 mL.min-1 (Cockcroft-Gault formula)
-Total serum bilirubin > 1.5 x ULN
-Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x

Study & Design

• Study Type: Interventional
• Study Design: Not specified