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

January 18, 2024 updated by: Hanmi Pharmaceutical Company Limited

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
          • Tim Vanuytsel
        • Principal Investigator:
          • Tim Vanuytsel
  • Denmark
    • Region Hovedstaden
      • Copenhagen, Region Hovedstaden, Denmark, 2100
        • Not yet recruiting
        • Copenhagen University Hospital
        • Principal Investigator:
          • Palle Bekker Jeppesen
    • Region Nordjylland
      • Aalborg, Region Nordjylland, Denmark, 9000
        • Not yet recruiting
        • Aalborg Universitetshospital
        • Principal Investigator:
          • Lars Vinter-Jensen
  • France
      • Bordeaux, France, 33000
        • Recruiting
        • Centre hospitalier Universitaire de Bordeaux
        • Principal Investigator:
          • Florian Poullenot
      • Clichy, France, 92110
        • Recruiting
        • Hôpital Beaujon
        • Principal Investigator:
          • Joly-Gomez Francisca
      • Lyon, France, 69002
        • Not yet recruiting
        • Les Hospices Civils de Lyon
        • Principal Investigator:
          • Charlotte Bergoin
      • Nice, France, 06300
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Nice
        • Principal Investigator:
          • Stephane Schneider
  • Germany
      • Hamburg, Germany, 20099
        • Recruiting
        • Asklepios Klinik St. Georg
        • Principal Investigator:
          • Maasberg Sebastian
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen
        • Principal Investigator:
          • Fusco Stefano
  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Sanghoon Lee
  • Poland
      • Oświęcim, Poland, 32-600
        • Recruiting
        • Medicome Sp. z o.o.
        • Principal Investigator:
          • Mroziak Beata
    • Poznan
      • Poznań, Poznan, Poland, 60-355
        • Recruiting
        • Uniwersytecki Szpital Kliniczny
        • Principal Investigator:
          • Matysiak Konrad
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • University of Illinois Hospital & Health Sciences System (UI Health)
        • Principal Investigator:
          • Robert E Carroll
    • New York
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Mount Sinai School of Medicine
        • Principal Investigator:
          • Iyer Kishore
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • The Cleveland Clinic Foundation
        • Principal Investigator:
          • Donald Kirby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs)
Time Frame: for 24 weeks
after multiple subcutaneous (SC) doses
for 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-GLP2-201
  • DOLPHINS-2 (Other Identifier: Hanmi Pharm. Co., Ltd.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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