This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC (Trulance)

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Plecanatide in Children and Adolescents Age 6 to <18 Years of Age With Functional Constipation (FC)

The goal of this clinical trial is to learn if plecanatide can treat functional constipation in children and adolescents aged 6 to less than 18 years. It will also learn about the safety and pharmacokinetics of plecanatide in this population. The main questions it aims to answer are:

• Does plecanatide increase the number of spontaneous bowel movements compared to placebo after 8 weeks of treatment?
• What medical problems do participants experience when taking plecanatide? Researchers will compare low-dose plecanatide and high-dose plecanatide to placebo to see if plecanatide improves bowel movement frequency, stool consistency, and constipation-related symptoms.

Participants will:

• Complete a screening period with daily electronic diary entries to record bowel movements, symptoms, and rescue medication use
• Take plecanatide or placebo by mouth once daily for 8 weeks
• Continue daily electronic diary entries throughout the study
• Attend clinic visits for physical exams, laboratory tests, and assessments of symptoms and safety
• Provide blood samples for pharmacokinetic and safety evaluations
• Complete questionnaires about constipation symptoms and quality of life

Study Overview

• Status: Active, not recruiting
• Conditions: Functional Constipation (FC)
• Intervention / Treatment: Drug: plecanatide; Drug: Placebo

Detailed Description

This Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of plecanatide administered orally once daily in pediatric participants with functional constipation (FC). Approximately 180 participants will be enrolled at up to 30 investigational sites in the United States and randomized in a 1:1:1 ratio to receive low-dose plecanatide, high-dose plecanatide, or matching placebo. Randomization will be stratified by age group (6 to 11 years and 12 to less than 18 years) and sex.

Background and Rationale Functional constipation is a common condition in children and adolescents and is characterized by infrequent bowel movements, hard stool consistency, and associated symptoms such as straining and abdominal discomfort. Available treatment options in the pediatric population are limited, and there remains a need for additional therapies.

Plecanatide is an orally administered guanylate cyclase-C (GC-C) agonist that acts locally in the gastrointestinal tract to increase intestinal fluid secretion and transit. Clinical studies in adults with chronic idiopathic constipation have demonstrated improvements in bowel movement frequency and stool consistency, as well as an acceptable safety profile. The current study is designed to evaluate plecanatide in a pediatric population using a weight-based dosing approach intended to achieve exposure levels comparable to those associated with efficacy in adults.

Study Design The study consists of three periods: a Screening/Baseline Period, an 8-week Treatment Period, and a Post-treatment Follow-up Period. The total duration of participation is approximately 14 weeks (98 days).

During the Screening/Baseline Period (up to 28 days), participants and/or caregivers complete daily assessments using an electronic diary (eDiary) to record bowel movements, stool characteristics, and constipation-related symptoms. Data from the eDiary are used to establish baseline values and confirm eligibility prior to randomization.

Participants who meet all eligibility criteria are randomized on Day 1 and enter the Treatment Period. Study drug is administered once daily for 8 weeks. Participants are required to continue daily eDiary entries throughout the Treatment Period to capture bowel movement frequency, stool consistency, symptom severity, and use of rescue medication.

Following completion of the Treatment Period, participants enter a 2-week Post-treatment Follow-up Period, during which eDiary assessments continue. A final study visit is conducted at the end of follow-up.

Treatment and Randomization Participants are randomized via an interactive web-based system to receive low-dose plecanatide, high-dose plecanatide, or placebo. Dose assignment is based on treatment group and participant body weight at the time of randomization in order to achieve predefined weight-based dosing ranges.

Study drug is administered orally once daily, preferably in the morning, with or without food. Participants who are unable to swallow tablets may have the study drug administered in a suitable alternative form as described in the protocol.

A rescue medication (bisacodyl) is provided for use if a participant has not had a bowel movement for at least 72 hours. Use of rescue medication is recorded in the eDiary and is subject to protocol-defined limitations.

Efficacy Evaluations Efficacy evaluations are based primarily on data collected through the eDiary and participant-reported outcome (PRO) instruments administered at study visits.

The primary efficacy variable is the change from baseline in spontaneous bowel movement (SBM) frequency at Week 8. Secondary efficacy variables include responder endpoints based on SBM and complete spontaneous bowel movement (CSBM) frequency, stool consistency assessed using the Bristol Stool Form Scale (BSFS) or modified BSFS, and changes from baseline in constipation-related symptoms. Additional assessments include time to first bowel movement, use of rescue medication, and global and symptom-specific PRO measures.

Safety Evaluations Safety is monitored throughout the study by assessment of adverse events (AEs), clinical laboratory parameters, vital signs, physical examinations, and electrocardiograms (ECGs).

Gastrointestinal events, including diarrhea, are of particular interest due to the mechanism of action of plecanatide. Criteria for dose interruption or discontinuation are specified in the protocol for participants experiencing clinically significant adverse events.

Treatment-emergent adverse events, serious adverse events, and discontinuations due to adverse events will be summarized descriptively by treatment group.

Pharmacokinetic Assessments Pharmacokinetic evaluations include measurement of plasma concentrations of plecanatide and its metabolite at specified time points following dosing. Given the minimal systemic absorption observed in prior studies, PK analyses are exploratory and are intended to further characterize exposure in the pediatric population.

Statistical Considerations Approximately 30 participants per treatment group within each age cohort are planned. The sample size is considered sufficient for evaluation of the primary objective in this Phase 2b study.

The primary efficacy analysis will be performed on the intent-to-treat population using a mixed-effects model for repeated measures, including treatment group, time, and relevant baseline covariates. Secondary endpoints will be analyzed using appropriate statistical methods based on endpoint type.

Safety analyses will be performed on the safety population and will be summarized descriptively.

Data Collection and Study Conduct Study data are collected using electronic case report forms (eCRFs) and participant eDiaries. Compliance with study procedures, including study drug administration and diary completion, is monitored throughout the study.

The study is conducted in accordance with the principles of Good Clinical Practice (GCP), applicable regulatory requirements, and institutional review board or ethics committee approval. Written informed consent and, where applicable, assent are obtained prior to participation.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • AppleMedical Research Group, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:• Male or female children and adolescents aged 6 to <18 years at time of consent.

• Diagnosis of functional constipation (FC) based on Rome IV criteria for children/adolescents.
• Participant and/or legally authorized representative able to provide informed consent/assent.
• Participant/caregiver willing and able to comply with study procedures, including electronic diary (eDiary).
• Completion of ≥5 out of 7 daily diary entries during each of the 2 baseline weeks.
• Stable diet for at least 14 days prior to screening.
• Females of childbearing potential must use highly effective contraception and have negative pregnancy tests.

Exclusion Criteria:

• Weight <15 kg at screening/randomization.
• History of anorectal malformations, neurological deficits, or anatomical abnormalities affecting bowel function.
• Use of prohibited medications within 15 days prior to randomization (e.g., anticholinergics, 5-HT agents, opioids, other laxatives).
• Use of any laxatives other than study-provided Dulcolax®.
• Pregnant or breastfeeding participants.
• Active eating disorder within the past 6 months.
• Clinically significant medical conditions (hepatic, renal, gastrointestinal, endocrine, infectious) that may interfere with study.
• Known hypersensitivity to plecanatide.
• History of drug or alcohol abuse within 12 months.
• Participation in another clinical trial within 30 days.
• Non-compliance with eDiary requirements (<5/7 entries per week).
• Use of rescue medication more than 2 days per week during baseline.
• ≥3 spontaneous bowel movements (SBMs) per week during baseline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose Plecanatide; Participants will receive weight-based low-dose plecanatide administered orally once daily for 8 weeks.	Drug: plecanatide; Plecanatide is administered orally once daily for 8 weeks. Participants receive weight-based dosing corresponding to assigned treatment arm (low-dose or high-dose) to achieve target exposure ranges. Tablets may be taken with or without food and may be swallowed whole or administered in an alternative form if necessary, as specified in the protocol.
Experimental: High Dose Plecanatide; Participants will receive weight-based high-dose plecanatide orally once daily for 8 weeks.	Drug: plecanatide; Plecanatide is administered orally once daily for 8 weeks. Participants receive weight-based dosing corresponding to assigned treatment arm (low-dose or high-dose) to achieve target exposure ranges. Tablets may be taken with or without food and may be swallowed whole or administered in an alternative form if necessary, as specified in the protocol.
Placebo Comparator: Placebo; Participants will receive matching placebo orally once daily for 8 weeks.	Drug: Placebo; Placebo tablets matching plecanatide in appearance are administered orally once daily for 8 weeks. Placebo is used to maintain blinding and is administered under the same conditions as active study drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency at Week 8	Spontaneous bowel movements (SBMs) are defined as bowel movements that occur without the use of rescue medication within the preceding 24 hours. Weekly SBM frequency will be calculated based on daily electronic diary entries. The endpoint is the change from baseline in the number of SBMs per week at Week 8.	Baseline to week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Who Are SBM Responders at Week 8	An SBM responder is defined as a participant who achieves an increase from baseline of ≥1 spontaneous bowel movement (SBM) per week. The proportion of responders will be assessed at Week 8 based on electronic diary data.	week 8
Change From Baseline in Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency at Week 8	Complete spontaneous bowel movements (CSBMs) are defined as SBMs associated with a sensation of complete evacuation. Weekly CSBM frequency will be calculated based on daily electronic diary entries. The endpoint is the change from baseline in the number of CSBMs per week at Week 8.	Baseline to week 8
Change From Baseline in Stool Consistency as Measured by the Bristol Stool Form Scale (BSFS) at Week 8	Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS) recorded in the electronic diary. Scores range from 1 (hard stools) to 7 (watery stools). The endpoint is the change from baseline in mean BSFS score at Week 8.	Baseline to week 8
Time to First Spontaneous Bowel Movement (SBM)	Time to first spontaneous bowel movement (SBM) is defined as the time from first dose of study drug to the first SBM recorded in the electronic diary.	up to 8 weeks
Use of Rescue Medication Over 8 Weeks	Rescue medication use is defined as the number of days participants use rescue medication (bisacodyl) due to lack of bowel movement. Use will be recorded daily in the electronic diary.	Baseline and Weeks 1 through 8
Incidence of Treatment-Emergent Adverse Events (TEAEs)	A treatment-emergent adverse event (TEAE) is any adverse event that begins or worsens after the first dose of study drug through the end of the follow-up period.	Up to 10 weeks

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): October 18, 2027
• Study Completion (Estimated): October 18, 2027

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: pediatric; children; CIC; constipation; functional constipation; chronic constipation; FC; chronic idiopathic constipation; plecanatide; trulance
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation; plecanatide
• Other Study ID Numbers: SP304202-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No