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A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF)

Efficacy and safety of apraglutide in SBS-IF

Kashiyama Akinori

CMIC Co., Ltd.

Hamamatsucho Building, 1-1-1, Minato-ku, Shibaura, Tokyo,

ClinicalTrialInformation@cmic.co.jp

Kashiyama Akinori

CMIC Co., Ltd.

Hamamatsucho Building, 1-1-1, Minato-ku, Shibaura, Tokyo,

+81-3-6779-8000

ClinicalTrialInformation@cmic.co.jp

Complete

April. 01, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Male and female subjects with SBS-IF, receiving PS,
secondary to surgical resection of the small intestine
with <200 cm from duodeno-jejunal flexure, based on
available medical/surgical records and with either:
a. CIC and neither jejunostomy nor ileostomy with
the latest intestinal resection being at least
12 months prior to screening OR
b. Jejunostomy or ileostomy with the latest
intestinal resection being at least 6 months
prior to screening.

Major abdominal surgery (more than 10% intestinal
resection or surgery that changes anatomy group) in
the last 6 months prior to screening. Surgery for
feeding tube placement allowed.

Both

short bowel syndrome and intestinal failure (SBS-IF)

Apraglutide 2.5 mg or 5 mg SC once weekly

Relative change from baseline in actual weekly PS
volume at Week 24

- Subjects who achieve a reduction of at least 1 day per week of PS from baseline at Week 24
- Relative change from baseline in actual weekly PS volume at Week 24 in stoma subjects
- Subjects who achieve a reduction of at least 1 day per week of PS from baseline at Week 48 in CIC
subjects.
- CIC subjects reaching enteral autonomy at Week 48

+81-22-717-7122

Mar. 02, 2021

No

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