Teduglutide for Chinese adults with short bowel syndrome

An Open-label, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of 0.05 mg/kg/Day Subcutaneous Teduglutide Following Treatment of Short Bowel Syndrome for 24 Weeks in Chinese Adults Who Are Dependent on Parenteral Support

This trial will test whether a daily injection of teduglutide for 24 weeks helps Chinese adults with short bowel syndrome who rely on parenteral support reduce their need for that support.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Takeda (Industry-sponsored)
• Locations: 4 sites (Changping, Beijing Municipality and 3 other locations)
• Trial ID: NCT06973304 on ClinicalTrials.gov

What this trial studies

This phase 3 interventional study gives Chinese adults with short bowel syndrome a daily subcutaneous injection of teduglutide for 24 weeks to see if it reduces parenteral support requirements. Investigators will measure changes in parenteral support use and study how teduglutide is absorbed, distributed, metabolized, and excreted. Safety will be monitored during treatment and for 24 weeks after the last dose, and total participation is about 65 weeks including screening and follow-up. Eligible participants must have required parenteral support for at least 12 continuous months and have a stable PS requirement before starting treatment.

Who should consider this trial

Good fit: Adults in China with short bowel syndrome who have needed parenteral support for at least 12 continuous months and use PS at least three times per week or four liters per week with a stable requirement are ideal candidates.

Not a fit: People who do not depend on parenteral support, have had less than 12 months of PS dependence, have unstable PS needs, or have contraindications to teduglutide are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, teduglutide could reduce patients' reliance on parenteral support, improving nutrient absorption and quality of life.

How similar studies have performed: Previous trials of teduglutide in non‑Chinese populations have demonstrated reductions in parenteral support and improved intestinal absorption, and this trial aims to confirm those results in Chinese adults.

Eligibility criteria

Inclusion Criteria:

1. Males or females 18 years of age or older at the time of signing the informed consent.
2. Intestinal failure due to SBS as a consequence of major intestinal resection (example, due to injury, volvulus, vascular disease, cancer, Crohn's disease).
3. Has undergone intestinal resection resulting in at least 12 continuous months of PS dependency prior to signing the informed consent.
4. Requires PS at least 3 times per week or at least 4 liters per week during the 2 weeks prior to baseline to meet caloric, fluid, or electrolyte needs due to ongoing malabsorption.
5. Has a stable PS requirement for at least 4 consecutive weeks immediately prior to the start of teduglutide treatment. Stability is defined as follows:

   1. Actual PS usage is similar to prescribed PS.
   2. Baseline (Visit 2) 48-hour intake (I)/output (O) volumes should fall within +-25% of the respective 48-hour I/O volumes at the last optimization visit.
   3. The 48-hour urine output volume must not be less than 2 liters and should not exceed 4 liters at the last optimization visit, the stabilization visit, and the baseline visit.
6. Participants with a history of Crohn's disease must be in endoscopic remission for at least 12 weeks prior to the baseline visit.

Exclusion Criteria:

1. Pregnant or lactating female.
2. Participation in a clinical study using an experimental drug within 30 days or 5 half-lives, whichever is longer, prior to screening, or concurrent participation in any other clinical study.
3. Use of glucagon-like peptide (GLP)-2 or human growth hormone or analogs of these hormones within the past 6 months prior to the baseline visit.
4. Use of octreotide, GLP-1 analogs, or dipeptidyl peptidase-4 inhibitors within 30 days prior to the baseline visit.
5. Previous use of teduglutide.
6. Active inflammatory bowel disease (IBD) or any participant with IBD requiring immunosuppressant therapy (example, azathioprine,anti-tumor necrosis factor \[anti-TNF\]) drugs) that had been introduced or changed within the past 6 months prior to the baseline visit.
7. Intestinal malabsorption due to a genetic condition, such as cystic fibrosis, microvillus inclusion disease, familial adenomatous polyposis.
8. Chronic intestinal pseudo-obstruction or severe dysmotility.
9. Clinically significant intestinal stenosis or obstruction, or evidence of such on upper gastrointestinal (UGI)/small bowel follow-through (SBFT), within the past 6 months prior to the baseline visit.
10. Major gastrointestinal (GI) surgical intervention, including significant intestinal resection, within the past 3 months (insertion of feeding tube, anastomotic ulcer repair, minor intestinal resections less than or equal to \[\<=\] 10 centimeter \[cm\], or endoscopic procedure is allowed) prior to the baseline visit.
11. Unstable cardiac disease, (example, congestive heart failure, cyanotic disease, or congenital heart disease).
12. Moderate or severe renal impairment, defined as creatinine clearance less than 50 milliliters per minute (mL/min).
13. Currently diagnosed with cancer or a history of any cancer except surgically cured skin cancer within the past 5 years.
14. Severe hepatobiliary disease including any of the following:

    1. Total bilirubin level at least 2 times the upper limit of normal (ULN), except for increased indirect (unconjugated) bilirubin in a patient with Gilbert's syndrome.
    2. AST at least 5\*ULN.
    3. ALT at least 5\*ULN
15. Active clinically significant pancreatic disease, including clinical signs of pancreatitis associated with elevations in serum amylase or lipase at least 2\*ULN.
16. More than 4 SBS-related or PS-related hospital admissions (example, central line-associated bloodstream infection, bowel obstruction, severe fluid/electrolyte disturbances) within the past 12 months prior to the baseline visit.
17. Unscheduled hospitalization within 30 days prior to screening.
18. Non-herpetic viral diseases:

    1. Presence of hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV RNA (ribonucleic acid) (nucleic acid test or polymerase chain reaction).
    2. Presence of (Hepatitis B Surface Antigen Positive \[HBsAg+\]). For participants who are negative for HBsAg but are positive for either surface antibodies and/or core antibodies, hepatitis B virus (HBV) deoxyribonucleic acid (DNA) polymerase chain reaction will be performed; if any test result meets or exceeds detection sensitivity, the subject will be excluded.
    3. Positive results for human immunodeficiency virus (HIV) by serology, regardless of viral load.
19. Any condition, disease, illness, or circumstance that in the investigator's opinion puts the participant at any undue risk, prevents completion of the study, or interferes with analysis of the study results. Example of potential disease state/illnesses that may be excluded are listed in the protocol.

Where this trial is running

Changping, Beijing Municipality and 3 other locations

• Beijing Tsinghua Changgung Hospital — Changping, Beijing Municipality, China (Recruiting)
• Peking Union Medical College Hospital — Dongcheng, Beijing Municipality, China (Recruiting)
• Affiliated Jinling Hospital, Medical School of Nanjing University — Nanjing, Jiangsu, China (Recruiting)
• Zhongshan Hospital, Xiamen University — Siming, Xiamen, China (Recruiting)

Study contacts

• Study coordinator: Takeda Contact

Conditions Short Bowel Syndrome; Drug Therapy