臨床研究等提出・公開システム

A randomized, double-blind, multicenter phase III study to evaluate the long-term efficacy and safety of ABX464 25 mg or 50 mg once daily as a maintenance therapy in subjects with moderately to severely active ulcerative colitis.

ABTECT - Maintenance

Shono Masushi

IQVIA Services Japan G.K

Keikyu Dai-1 Building, 4-10-18 Takanawa, Minato-ku, Tokyo, 108-0074

ABTECT_JapanCRA@iqvia.com

jRCT Inquiries IQVIA Contact person

IQVIA Services Japan G.K

Keikyu Dai-1 Building, 4-10-18 Takanawa, Minato-ku, Tokyo, 108-0074

+81-3-6859-9500

ABTECT_JapanCRA@iqvia.com

Not Recruiting

Aug. 03, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Inclusion Criteria for the Maintenance Study
1.Male or female (at birth) at least 16 years old, except in EU/EEA, Israel, Serbia and Ukraine, where subjects must be at least 18 years old at the time of eligibility assessment. Where enrolment of adolescents is allowed, adolescent subjects must weigh > 40 kg and meet the definition of Tanner stage 5 at screening.
2.Subjects must have completed the induction treatment study (ABX464-105 or ABX464 106), and subjects'clinical response status must be available.
3.Subjects with a valid endoscopy performed at the end of the induction study and results from central reader available at Day 1.
4.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.
5.WOCBP subjects and male subjects with a WOCBP partner must agree to comply with contraception requirements as described in Section 4.4 of this protocol.
6.Subjects must be able and willing to comply with study visits and procedures as per protocol.

Inclusion Criteria for the LTE
1.Subject must have completed the maintenance phase.
2.Investigator and subject must assess and agree that the subject has received, and will continue to receive benefit from being in the study.

Exclusion Criteria for the Maintenance study
1.Subjects who permanently discontinued the study drug during the induction study (either ABX464-105 or ABX464-106).
2.Subjects who have developed any major illness/condition (eg. primary sclerosis cholangitis, Crohn's disease, colectomy, diverting ileostomy, colon cancer or colonic adenomas [low or high grade dysplasia]).
3.Subjects with evidence of an unstable clinical condition (eg. toxic megacolon, fulminant colitis, bowel perforation, uncontrolled ischemic disease, congestive heart failure with NYHA class 3 or 4 symptoms) during the induction study that, in the investigator's judgment, will substantially increase the risk to the subject if he or she participates in the study.
4.Subjects who plan to participate in other investigational studies during the maintenance study.
5.Male or female subjects planning a pregnancy, or pregnant female subjects.
6.Introduction during induction study of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).
7.Any changes in the laboratory values during the induction period that could jeopardize subject's safety in the opinion of the investigator. If any doubts, the investigator should contact the sponsor study medical monitor.
8.Subject who is planning to receive live vaccine during the study.
9.Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

Exclusion Criteria for the LTE
1.Subject continues to satisfy exclusion criteria listed above for the maintenance phase.
2.Introduction during maintenance phase of prohibited medications, dosages, surgical or non-medicinal procedures indicated for UC (except antidiarrheals and motility agents for acute diarrhea).

Both

Ulcerative colitis

Drug: ABX464
- Administered once daily, preferably in the morning, with food
- Other Names: Obefazimod

Drug: Placebo
- Administered once daily, preferably in the morning, with food

Part 1
- Proportion of subjects in clinical remission at Week 44.

Part 2
- To assess the safety and tolerability of obefazimod at Week 44.

+81-45-722-8655

Mar. 31, 2023

No

Argentina/Australia/Austria/Belgium/Bulgaria/Brazil/Canada/China/Czech Republic/France/Germany/Greece/Hungary/India/Israel/Italy/Korea/Mexico/Netherlands/New Zealand/Poland/Portugal/Romania/Serbia/Slovakia/Slovenia/Spain/Switzerland/Turkey/UK USA