Actively Recruiting
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study
Led by Chongqing Peg-Bio Biopharm Co., Ltd. · Updated on 2026-03-02
72
Participants Needed
8
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of PJ009 in treating patients aged 14 and older with short bowel syndrome (SBS) who require parenteral nutrition. This randomized, double-blind, placebo-controlled Phase 3 study aims to determine if PJ009 can improve outcomes compared to a placebo. The study also assesses immunogenicity and pharmacokinetics of PJ009 in these patients. Participants will receive daily subcutaneous injections of PJ009 or a placebo based on their weight for 24 weeks. After this period, those who received placebo will switch to PJ009 for an additional 12 weeks, while those on PJ009 will continue the same treatment until the end of 36 weeks. The trial includes a screening, optimization, and stabilization period lasting up to 16 weeks before treatment begins, followed by the double-blind treatment and an open-label extension phase. During the study, participants will visit the clinic at scheduled times including weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, and 36 for assessments. They will keep a diary tracking their parenteral nutrition, enteral nutrition, and urine output. Researchers will measure the percentage of responders between weeks 20 and 24 to evaluate treatment effect. Safety follow-ups will be conducted four weeks after the last dose to monitor participants' health throughout the study.
CONDITIONS
Brief Title
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female aged 14 years or older
- Short bowel syndrome patients dependent on parenteral nutrition or intravenous support for at least 6 consecutive months due to major intestinal resection
- At least 3 parenteral nutrition or intravenous support sessions per week within 1 week before screening or 2 weeks before baseline
- Stable parenteral nutrition or intravenous support for at least 4 consecutive weeks before treatment
- For those with a history of Crohn's disease, clinical remission for at least 12 weeks before treatment
- Ability to understand and provide signed informed consent; for those under 18, guardian consent is also required
- Ability to complete study procedures following the protocol
You will not qualify if you...
- Prior use of teduglutide or allergy to teduglutide or its components
- Use of natural GLP-2 or its analogs, human growth hormone or its analogs within 6 months before screening
- Use of glutamine, octreotide, GLP-1 analogs, or dipeptidyl peptidase-IV inhibitors within 30 days before screening
- Active Crohn's disease or need to change biological therapy within 6 months before screening
- Active inflammatory bowel disease or recent changes in immunosuppressant therapy within 3 months
- Unstable absorption due to cystic fibrosis, untreated megacolon, or known DNA abnormalities like familial adenomatous polyposis or Fanconi syndrome
- Clinically obvious intestinal obstruction or active stenosis within 6 months before screening
- Major gastrointestinal surgery within 3 months before screening (except minor procedures like esophageal intubation or endoscopic surgery)
- Severe active, uncontrolled systemic diseases including cardiovascular, respiratory, renal, infectious, endocrine, liver, or central nervous system diseases
- Malignant tumors within 5 years before screening, except certain fully treated localized cancers
- Severe liver function impairment as defined by specific lab values
- Renal function impairment as defined by specific lab values
- Pancreatic abnormalities with elevated serum amylase or lipase
- More than 4 hospitalizations related to SBS or parenteral nutrition within 12 months before screening
- Unplanned hospitalization within 30 days before screening
- Pregnant or lactating women, or those planning fertility without effective contraception
- Participation in other clinical trials within specified timeframes before screening
- Other conditions deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Up to 16 weeks
Participants undergo an optimization period if applicable, lasting up to 8 weeks, followed by a stabilization period of 4 to 8 weeks before starting treatment.
Visits as needed during optimization and stabilization
Duration - 24 weeks
Participants receive daily subcutaneous injections of PJ009 or placebo for 24 weeks to evaluate the efficacy and safety of the drug.
Visits during treatment period
Duration - 12 weeks
Participants receive PJ009 in an open label extension for 12 weeks following the double-blind treatment period.
Visits during open label extension
Duration - 4 weeks
Safety follow-up assessments are conducted 4 weeks after the last dose in the open label extension to monitor participant safety.
1 follow-up visit
Trial Site Locations
Total: 8 locations
1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Not Yet Recruiting
2
Chongqing General Hospital
Chongqing, Chongqing Municipality, China, 401147
Not Yet Recruiting
3
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Not Yet Recruiting
4
The Third Xiangya Hospital of Central South University
Changsha, Hu'Nan, China, 410013
Not Yet Recruiting
5
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China, 210016
Actively Recruiting
6
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Not Yet Recruiting
7
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200072
Not Yet Recruiting
8
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
Not Yet Recruiting
Research Team
J
Jing Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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