EASE SBS 5 (Efficacy And Safety Evaluation of Glepaglutide in Treatment of 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

22 Jan 2026 → ongoing

Decision date (initial)

2025-12-18

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Zealand Pharma A/S

External identifiers

EU CT number

2024-512486-14-00

WHO UTN

U1111-1302-6092

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To confirm the efficacy of glepaglutide 10 mg TW in patients with SBS-IF

Secondary objectives 2

1. To evaluate the efficacy of glepaglutide 10mg TW in patients with SBS-IF on other efficacy endpoints
2. To evaluate the safety and tolerability of glepaglutide in patients with SBS-IF.

Conditions and MedDRA coding

Short Bowel Syndrome

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. • signed informed consent;
2. • age of 18 to 90 years;
3. • a diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening);
4. • stable PS need of ≥3 days per week;
5. • no restorative surgery planned during the trial period;
6. • having a stoma or colon in continuity

Exclusion criteria 4

1. • more than 2 SBS- or PS-related hospitalizations within 6 months before screening;
2. • poorly controlled IBD that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial;
3. • a history of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately treated in situ cervical cancer) unless the patient has been disease-free for at least 5 years; ongoing bowel obstruction;
4. • BMI <18.5 kg/m2.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Change in weekly PS volume from baseline to Week 24

Secondary endpoints 10

1. 1. Reduction of at least 20% in weekly PS volume from baseline to Week 52
2. 2. Reduction in days on PS ≥1 day/week from baseline to Week 52
3. 3. Reduction of 100% weekly PS volume (weaned-off) from baseline to Week 52
4. 4. Achieving ‘much better’ PGIC status at Week 24
5. 5. Clinical response, defined as achieving at least 20% reduction in weekly PS volume from baseline to both Week 20 and Week 24
6. 6. Reduction in days on PS ≥1 day/week from baseline to Week 24
7. 7. Reduction of 100% weekly PS volume (weaned-off) from baseline to Week 24
8. 8. Change in weekly PS volume from baseline to Week 12
9. 9. Change in weekly PS volume from baseline to Week 8
10. 10. TEAEs from baseline to Week 52

Investigational products

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

Test 1

Placebo 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

Clinical Trial Information Desk

Public contact point

Organisation

Zealand Pharma A/S

Contact name

Clinical Trial Information Desk

Third parties 14

Locations

14 EU/EEA countries · 29 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 137 files

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

Application history

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