Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects
Primary Purpose
Short Bowel Syndrome
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HM15912 Active
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Short Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Men or women, aged 18 years of age or older with intestinal failure resulting in SBS at the time of signing the informed consent form (ICF) (or country's legal age of majority if the legal age is <18 years)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- Diagnosis of SBS defined as remaining small bowel in continuity of estimated <200 cm (equal to 79 inches) and 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:
- Any history of colon cancer.
- 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
- History of alcohol or drug abuse (within 1 year of screening)
Sites / Locations
- University of Illinois Hospital & Health Sciences System (UI Health)
- University of Illniois Hospital & Health Sciences System
- Mount Sinai School of Medicine
- UZ Leuven
- Copenhagen University Hospital
- Aalborg Universitetshospital
- Hopital BeaujonRecruiting
- Asklepios Klinik St. GeorgRecruiting
- Universitätsklinikum TübingenRecruiting
- Samsung Medical CenterRecruiting
- Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w PoznaniuRecruiting
- Medicome Sp. z o.o.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active
Matching Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs)
after multiple subcutaneous (SC) doses
Secondary Outcome Measures
Full Information
NCT ID
NCT04775706
First Posted
February 25, 2021
Last Updated
January 5, 2023
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT04775706
Brief Title
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 in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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 safety follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active
Arm Type
Experimental
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HM15912 Active
Intervention Description
Randomized, double-blind, placebo-controlled
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Randomized, double-blind, placebo-controlled
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Description
after multiple subcutaneous (SC) doses
Time Frame
for 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women, aged 18 years of age or older with intestinal failure resulting in SBS at the time of signing the informed consent form (ICF) (or country's legal age of majority if the legal age is <18 years)
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Diagnosis of SBS defined as remaining small bowel in continuity of estimated <200 cm (equal to 79 inches) and 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:
Any history of colon cancer.
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
History of alcohol or drug abuse (within 1 year of screening)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wonkyung Lee
Phone
+82 2 410 9238
Email
wonkyung.lee@hanmi.co.kr
Facility Information:
Facility Name
University of Illinois Hospital & Health Sciences System (UI Health)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert E Carroll
Facility Name
University of Illniois Hospital & Health Sciences System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert E Carroll
First Name & Middle Initial & Last Name & Degree
Robert E Carroll
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iyer Kishore
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Vanuytsel
First Name & Middle Initial & Last Name & Degree
Tim Vanuytsel
Facility Name
Copenhagen University Hospital
City
Copenhagen
State/Province
Region Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Palle Bekker Jeppesen
Facility Name
Aalborg Universitetshospital
City
Aalborg
State/Province
Region Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Vinter-Jensen
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joly-Gomez Francisca
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maasberg Sebastian
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fusco Stefano
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-Meen Seo
Facility Name
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
City
Poznań
State/Province
Poznan
ZIP/Postal Code
60-780
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matysiak Konrad
Facility Name
Medicome Sp. z o.o.
City
Oświęcim
ZIP/Postal Code
32-600
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mroziak Beata
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects
We'll reach out to this number within 24 hrs