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Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04775706
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : January 9, 2023
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Study Description
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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).

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: HM15912 Active Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 3, 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active Drug: HM15912 Active
Randomized, double-blind, placebo-controlled
Placebo Comparator: Matching Placebo Drug: Placebo
Randomized, double-blind, placebo-controlled


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: for 24 weeks ]
    after multiple subcutaneous (SC) doses


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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)
  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 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:

  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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775706


Contacts
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Contact: Wonkyung Lee +82 2 410 9238 wonkyung.lee@hanmi.co.kr

Locations
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United States, Illinois
University of Illinois Hospital & Health Sciences System (UI Health) Not yet recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Robert E Carroll         
University of Illniois Hospital & Health Sciences System Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Robert E Carroll         
Principal Investigator: Robert E Carroll         
United States, New York
Mount Sinai School of Medicine Not yet recruiting
New York, New York, United States, 10029
Principal Investigator: Iyer Kishore         
Belgium
UZ Leuven Not yet recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Tim Vanuytsel         
Principal Investigator: Tim Vanuytsel         
Denmark
Copenhagen University Hospital Not yet recruiting
Copenhagen, Region Hovedstaden, Denmark, 2100
Principal Investigator: Palle Bekker Jeppesen         
Aalborg Universitetshospital Not yet recruiting
Aalborg, Region Nordjylland, Denmark, 9000
Principal Investigator: Lars Vinter-Jensen         
France
Hopital Beaujon Recruiting
Clichy, France, 92110
Principal Investigator: Joly-Gomez Francisca         
Germany
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, 20099
Principal Investigator: Maasberg Sebastian         
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Principal Investigator: Fusco Stefano         
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Principal Investigator: Jeong-Meen Seo         
Poland
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu Recruiting
Poznań, Poznan, Poland, 60-780
Principal Investigator: Matysiak Konrad         
Medicome Sp. z o.o. Recruiting
Oświęcim, Poland, 32-600
Principal Investigator: Mroziak Beata         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
More Information
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT04775706    
Other Study ID Numbers: HM-GLP2-201
DOLPHINS-2 ( Other Identifier: Hanmi Pharm. Co., Ltd. )
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Short Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications