Study of HM15912 in subjects with Short Bowel Syndrome-associated Intestinal Failure

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hanmi Pharm. Co. Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

2 Feb 2022 → ongoing

Decision date (initial)

2024-08-06

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Hanmi Pharmaceutical Co., Ltd. Korea, Republic of

External identifiers

EU CT number

2024-515160-32-00

EudraCT number

2021-000176-11

ClinicalTrials.gov

NCT04775706

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Efficacy, Safety, Therapy, Dose response

1) To assess safety and tolerability of HM15912 after multiple subcutaneous (SC) doses for 24 weeks
2) To assess the pharmacokinetic (PK) profile of HM15912

Secondary objectives 1

1. To assess the pharmacodynamic (PD) profile of HM15912

Conditions and MedDRA coding

Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Men or women aged 18 years or older with confirmed diagnosis of SBS.
2. Had their most recent bowel surgery at least 6 months before joining the study.
3. Subjects must either have no growth of cancer cells in their large intestine or have had any growths removed during a bowel examination within 6 months before joining the study.
4. Subjects must have an opening on their abdomen, commonly called stoma, created by an operation that connects their small intestine to the outside of their body.

Exclusion criteria 3

1. History of colon cancer, or any other current or prior medical conditions that would make it difficult to participate in the study.
2. History of alcohol or drug abuse
3. Have a body weight >100 kg and repeated blood pressure measurements > 140 mm Hg.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Primary endpoints to assessment of safety and tolerability of HM15912 after multiple subcutaneous (SC) doses for 24 weeks: • Incidence of adverse events (AEs) • Incidence of injection site reactions • Incidence of clinical laboratory abnormalities • Clinically significant findings on physical examination • Changes from baseline in vital signs and 12-lead electrocardiogram (ECG) parameters
2. Primary endpoints to assessment of the pharmacokinetic (PK) profile of HM15912: • Maximum serum concentration (Cmax) • Time to maximum serum concentration (tmax) • Elimination half-life (t1/2) • Volume of distribution (Vd/F) • Clearance (CL/F) • Area under the concentration-time curve from time zero to the last observable concentration (AUClast), AUC from time zero over the dosing interval at the 1st and 6th dosing, respectively (AUCtau and AUCtau,ss), and AUC extrapolated to infinity

Secondary endpoints 1

1. Change in weekly parenteral nutrition/intravenous fluid (PN/IV) volume from baseline to Week 25 Note: The baseline PN/IV volume (L/week) is the average of actual PN/IV volume received during the last 2 weeks of the Stabilization period.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hanmi Pharm. Co. Ltd.

Sponsor organisation

Hanmi Pharm. Co. Ltd.

Address

14 Wiryeseongdae-Ro

City

Songpa

Postcode

05545

Country

Korea, Republic of

Scientific contact point

Organisation

Hanmi Pharm. Co. Ltd.

Contact name

Medical Director

Public contact point

Organisation

Hanmi Pharm. Co. Ltd.

Contact name

Medical Director

Third parties 7

Locations

5 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 127 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications