EASE SBS 3 (Evaluation of the efficacy and safety of Glepaglutide in the treatment of short bowel syndrome (SBS)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Zealand Pharma A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

11 Jun 2021 → 23 Mar 2026

Decision date (initial)

2024-09-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513373-43-00

EudraCT number

2020-005502-25

WHO UTN

U1111-1261-3358

ClinicalTrials.gov

NCT04881825

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the long-term safety of glepaglutide treatment

Secondary objectives 2

1. To evaluate the maintenance of response with regards to efficacy endpoints with glepaglutide 10 mg once weekly (OW)
2. To assess the long-term immunogenicity of glepaglutide and its impact on pharmacokinetics (PK), safety, and efficacy maintenance

Conditions and MedDRA coding

Short bowel syndrome

Regulatory references

Plan to share IPD

No

IPD plan description

n/a

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Signed informed consent
2. Completed the full treatment period of the extension trial EASE SBS 2.

Exclusion criteria 6

1. Any condition, disease, or circumstance that in the Investigator’s opinion would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial.
2. Not having a colonoscopy performed at EOT in EASE SBS 2 (for patients with remnant colon). Note: The results of the colonoscopy must not give rise to any safety concerns. A colonoscopy performed within 6 months prior to EOT and not giving rise to any safety concerns is accepted. For patients with a remnant colon, which is not connected to the passage of foods and is thereby dormant, a computerized tomography (CT) scan or magnetic resonance imaging (MRI) will suffice at the discretion of the Investigator.
3. Use of GLP-1, GLP-2, human growth hormone (HGH), dipeptidyl peptidase-4 (DPP-4) inhibitors, somatostatin, or analogs thereof within 3 months. Note: Prior use of glepaglutide trial drug is allowed.
4. Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods. Please refer to Section 11.4.4. for the definition of highly effective contraception.
5. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
6. An employee of the sponsor or Investigator or otherwise dependent on them.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence and type of AEs, with onset or worsening following Visit 1

Secondary endpoints 8

1. Incidence and type of serious adverse events (SAEs) and AEs of special interest (AESIs) (with onset or worsening following Visit 1)
2. Changes from baseline in: - Vital signs - Electrocardiogram
3. Changes from baseline in: - Hematology - Biochemistry - Urinalysis
4. Immunogenicity (anti-glepaglutide antibodies, antibody reactivity to ZP18481-34, -cross reactivity to glucagon-like peptide-2 (GLP-2), glepaglutide neutralizing antibodies)
5. The secondary efficacy endpoints are: Reduction in weekly PS volume (prescribed) from baseline
6. The secondary efficacy endpoints are: Reduction of at least 20% in weekly PS volume (prescribed) from baseline
7. The secondary efficacy endpoints are: Reduction in days on PS ≥ 1 day/week from baseline
8. The secondary efficacy endpoints are: Reduction in weekly PS volume of 100% (weaned off)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Zealand Pharma A/S

Sponsor organisation

Zealand Pharma A/S

Address

Sydmarken 11

City

Soeborg

Postcode

2860

Country

Denmark

Scientific contact point

Organisation

Zealand Pharma A/S

Contact name

Zealand Pharma

Public contact point

Organisation

Zealand Pharma A/S

Contact name

Zealand Pharma

Third parties 1

Locations

6 EU/EEA countries · 12 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 31 files

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

Application history

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