Evaluating PJ009 for treating short bowel syndrome in patients needing parenteral nutrition

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition

This study is testing if a new treatment called PJ009 can help people aged 14 and older with short bowel syndrome who need special nutrition through IV feeding feel better and improve their health.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd. (industry)
• Locations: 8 sites (Beijing, Beijing Municipality and 7 other locations)
• Trial ID: NCT06512584 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of PJ009 in patients aged 14 and older who have short bowel syndrome (SBS) and require parenteral nutrition. Participants will receive daily subcutaneous injections of either PJ009 or a placebo for 24 weeks, followed by an open-label extension where those on placebo will switch to PJ009 for an additional 12 weeks. The study will monitor the participants' nutritional intake and health through regular clinic visits and diary entries. It is designed as a multicenter, randomized, double-blind, placebo-controlled trial to ensure robust results.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 14 and older who have been dependent on parenteral nutrition for at least six months due to major intestinal resection.

Not a fit: Patients who have previously used teduglutide or have allergies to its components may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with short bowel syndrome by reducing their dependence on parenteral nutrition.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific treatment is being evaluated for the first time in this context.

Eligibility criteria

Inclusion Criteria:

1. Male and female aged ≥ 14 years;
2. SBS patients dependent on PN/IV support for at least 6 consecutive months due to major intestinal resection;
3. At least 3 PN/IV support sessions per week are required 1 week before screening or 2 weeks before baseline;
4. Be on stable PN/IV support for at least 4 consecutive weeks before administration;
5. For subjects with a history of Crohn's disease (CD), clinical assessment of remission for at least 12 weeks prior to administration;
6. Be able to understand and provide signed informed consent, for those under 18 years old, the guardian should also sign the informed consent;
7. Be able to complete experiments in accordance with the protocol.

Exclusion Criteria:

1. Have used teduglutide in the past or may be allergic to teduglutide or its components;
2. Have used natural GLP-2 or its analogs, human growth hormone or its analogs within 6 months before screening;
3. Have used glutamine, octreotide, GLP-1 analogs or dipeptidyl peptidase-IV inhibitors within 30 days before screening;
4. With active Crohn's disease or those who need to change biological therapy within 6 months before screening;
5. With active inflammatory bowel disease (IBD) or IBD patients who have received immunosuppressant therapy changes in the past 3 months;
6. With unstable absorption due to cystic fibrosis, untreated megacolon disease or known DNA abnormalities (such as familial adenomatous polyposis, Fanconi syndrome);
7. With clinically obvious intestinal obstruction or active stenosis within 6 months before screening;
8. Have undergone major gastrointestinal surgical intervention within 3 months before screening, such as continuous transverse enteroplasty or other intestinal lengthening surgery (esophageal intubation or endoscopic surgery is allowed);
9. Severe active, uncontrolled, untreated systemic diseases (such as cardiovascular, respiratory, renal, infectious, endocrine, liver or central nervous system diseases, etc.);
10. Have malignant tumors within 5 years before screening (except for fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery);
11. With severe liver function impairment:

    1. Total bilirubin ≥ 2.0 × upper limit of normal (ULN); for patients with Gilbert's syndrome, direct bilirubin ≥ 2.0 × ULN;
    2. Aspartate transaminase (AST) ≥ 5.0 × ULN, alanine transaminase (ALT) ≥5.0 × ULN;
12. With renal function impairment:

    1. Serum creatinine ≥2.0 × ULN;
    2. Creatinine clearance \< 60 ml/min (calculated according to the Cockcroft-Gault formula, see Appendix 3 for details);
13. Pancreatic abnormalities:

    1. Serum amylase ≥ 2.0 × ULN;
    2. Serum lipase ≥ 2.0 × ULN;
14. More than 4 SBS or PN-related hospitalizations (such as catheter sepsis, intestinal obstruction, severe water and electrolyte disorders) within 12 months before screening;
15. Unplanned hospitalization within 30 days before screening;
16. Pregnant or lactating women, women or men who have fertility plans or do not agree to take effective contraceptive measures during the trial;
17. Participated in any clinical trial (excluding antibody treatment-related clinical trials) within 30 days before screening or participated in any antibody treatment-related clinical trials within 3 months before screening;
18. Other condition the investigator believes would be unsuitable for participation in this clinical study.

Where this trial is running

Beijing, Beijing Municipality and 7 other locations

• Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Chongqing General Hospital — Chongqing, Chongqing Municipality, China (NOT_YET_RECRUITING)
• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• The Third Xiangya Hospital of Central South University — Changsha, Hu'Nan, China (NOT_YET_RECRUITING)
• General Hospital of Eastern Theater Command — Nanjing, Jiangsu, China (RECRUITING)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (NOT_YET_RECRUITING)
• Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Huanlong Qin — Shanghai 10th People's Hospital
• Study coordinator: Jing Sun

Conditions: Short Bowel Syndrome