Clinical trial NCT04775706: Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects
Official title: A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 (Sonefpeglutide) in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Short Bowel Syndrome
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal failure (SBS-IF).

Detailed description: The study consists of a screening period, a run-in period, a 6-months core treatment period, a 7-months extension treatment period and a 1-month safety follow-up period.

Eligibility criteria: Inclusion Criteria:

1. Men or women, aged 18 years of age or older with SBS resulting in intestinal failure at the time of signing the informed consent form (ICF) (or country's legal age of majority if the legal age is \<18 years)
2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
3. Diagnosis of SBS with the latest intestinal resection being at least 6 months prior to Screening and considered stable regarding the PN/IV need. No restorative surgery planned in the study period.

Exclusion Criteria:

1. Any history of colon cancer.
2. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free for at least 5 years
3. History of alcohol or drug abuse (within 1 year of screening)

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: for 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Hospital & Health Sciences System (UI Health)
state: Illinois
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
state: Region Nordjylland
city: Copenhagen
country: Denmark
facility: Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Clichy
country: France
facility: Hopital Beaujon
city: Lyon
country: France
facility: Les Hospices Civils de Lyon
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Poznań
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu Uniwersytecki Osrodek Wczesnych Faz Ul. Długa 1 /2
state: Poznan
city: Lodz
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi
state: Łódzkie
Study officials:
References: