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CompletedNCT05652205Updated May 14, 2026Results posted

A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation

A Phase 3 interventional study of Placebo for Linaclotide and Linaclotide in Functional Constipation (FC) and Chronic Idiopathic Constipation (CIC), sponsored by AbbVie. Completed at 48 sites in 4 countries. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by AbbVie · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
123
Allocation
Randomized
Ages
2 Years to 5 Years
Sex
All
01

Study summary

Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC.

Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients, ages 2 to 5, who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. All participants in Part 2 will receive linaclotide. Approximately 116 participants aged 2 to 5 years with FC will be enrolled in this study at around 45 sites worldwide.

Participants will receive daily doses of oral Linaclotide capsules or matching placebo for 12 weeks in Part 1 of the study. In Part 2, the open label long-term safety extension, participants with FC who completed study intervention in Part 1 of Study M21-572 or the Phase 2 Study LIN-MD-67 will receive linaclotide for 24 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

02

Conditions studied

  • Functional Constipation (FC)
  • Chronic Idiopathic Constipation (CIC)

Keywords

  • Functional Constipation (FC)
  • Linaclotide
  • AGN-182139
  • Linzess
03

In context

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Caregiver/parent/guardian/legally authorized representative (LAR) is willing and able to comply with procedures required in this protocol, prior to the initiation of any screening or study-specific procedures. In addition, the caregiver/parent/guardian/LAR who will be completing the electronic diary (eDiary) must be able to read and understand the assessments in the eDiary device and undergo training.

  • Participant meets modified Rome IV criteria for FC: For at least 1 month before Screening (Visit 1), the participant has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) per week. In addition, at least once per week, participant must meet 1 or more of the following:

    • History of retentive posturing or excessive volitional stool retention.
    • History of painful or hard bowel movements (BMs).
    • Presence of a large fecal mass in the rectum.
    • History of large diameter stools.
    • At least 1 episode of fecal incontinence per week after the acquisition of toileting skills, if applicable.

Exclusion criteria

Exclusion Criteria:

  • Participant history of:

    • Celiac disease, or positive serological test for celiac disease or the condition is suspected but has not been ruled out by endoscopic biopsy
    • Cystic fibrosis
    • Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to Screening (Visit 1)
    • Down's syndrome or any other chromosomal disorder
    • Active anal fissure (i.e., participant reports having streaks of blood on the stool or on toilet paper and/or pain/crying with BM within 2 weeks prior to Screening). (Note: anal fissures that have resolved at least 2 weeks prior to screening would not be exclusionary.) However, if in the investigator's opinion, an anal fissure(s) may be the primary cause of participant's modified Rome IV FC criteria, the participant would not be eligible to participate in the study.
    • Anatomic malformations (e.g., imperforate anus, anal stenosis, anterior displaced anus)
    • Intestinal nerve or muscle disorders (e.g., Hirschprung disease, visceral myopathies, visceral neuropathies)
    • Neuropathic conditions (e.g., spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma)
    • Lead toxicity, hypercalcemia
    • Inflammatory bowel disease
    • Childhood functional abdominal pain syndrome
    • Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study
    • Lactose intolerance that is associated with symptoms which could confound the assessments in this study
    • History of cancer. (Note: participants with a history of cancer are allowed provided that the malignancy has been in a complete remission before Randomization (Visit 2). A complete remission is defined as the disappearance of all signs of cancer in response to treatment.)
  • Has conditions that could interfere with drug absorption including but not limited to short bowel syndrome.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
123 participants (actual)

Study arms

  • Placebo comparator
    Part 1: Placebo for Linaclotide

    Participants received placebo for linaclotide orally once daily (QD) for 12 weeks.

    Drug: Placebo for Linaclotide

  • Experimental
    Part 1: Linaclotide

    Participants received 72 µg linaclotide orally once daily (QD) for 12 weeks.

    Drug: Linaclotide

  • Experimental
    Part 2: Linaclotide

    Participants who received 72 µg linaclotide or placebo in Part 1 of this study or who entered Part 2 of this study from Study LIN-MD-67 (NCT04110145) were assigned to receive open-label linaclotide 72 µg orally once daily (QD) for 24 weeks at the start of Part 2.

    Drug: Linaclotide

Interventions

  • DrugPlacebo for Linaclotide

    Capsule; oral

  • DrugLinaclotide

    Capsule; oral

06

What researchers measure

Primary outcomes

  1. Change From Baseline in 12-week Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) Observed by the Primary Caregiver During the Double-blind Study Intervention Period

    An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM. The caregiver/parent/guardian/legally authorized representative (LAR) will complete the electronic diary (eDiary), providing data for the SBM frequency rate up to the last dose date equivalent to the 12-week SBM frequency rate. Baseline values for efficacy endpoints related to daily eDiary responses were derived from the eDiary in the preintervention period, specifically the time period from 14 days before randomization and up to the time of randomization.

    Time frame: Baseline to Week 12

  2. Number of Participants With Treatment-Emergent Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient/clinical investigation subject administered a pharmaceutical product which doesn't necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

    Time frame: From the time of study drug administration until 30 days or 5 half-lives after the last dose, up to 126 days in Period 1 and 226 days in Period 2

Secondary outcomes

  1. Change From Baseline in 12-week Stool Consistency Observed by the Primary Caregiver During the Double-blind Study Intervention Period

    The caregiver/parent/guardian/legally authorized representative (LAR) rated and recorded in an eDiary the consistency of the stool for each BM using the Bristol Stool Form 7-point scale in which 1=Separate hard lumps, like nuts (hard to pass); 2=Sausage-shaped, but lumpy; 3=Like a sausage but with cracks on its surface; 4=Like a sausage or snake, smooth and soft; 5=Soft blobs with clear cut edges (easy to pass); 6=Fluffy pieces with ragged edges, a mushy stool; and 7=Watery, no solid pieces, entirely liquid. A response of "I don't know" was considered as a missing score. Lower scores indicate firmer stool consistency. A subject's stool consistency score for the study intervention period is the average of the non-missing BSFS scores for the primary caregiver-observed SBMs during that specific period.

    Time frame: Baseline to Week 12

  2. Change From Baseline in 12-week Straining Observed by the Primary Caregiver During the Double-blind Study Intervention Period

    The caregiver/parent/guardian/LAR rated and recorded in an eDiary the amount of straining they observed when the child passed the BM using two 3-point rating scales:. 1) For the bowel movement #X you were with the child for, did he/she grunt like he/she was straining? 0 = No, not at all; 1 = Yes, a little; 2 = Yes, a lot; I don't know. 2) For the bowel movement #X you were with the child for, did he/she make a face like he/she was straining? 0 = No, not at all; 1 = Yes, a little; 2 = Yes, a lot; I don't know. "I don't know" was considered a missing response. Higher scores indicate more straining. The subject's straining score was the average of the nonmissing average straining scores for all the primary caregiver-observed SBMs during the specific period.

    Time frame: Baseline to Week 12

  3. Change From Baseline in 12-week Proportion of Days With Fecal Incontinence During the Double-blind Study Intervention Period (for Those With Toileting Skills)

    Caregivers of children who have acquired toileting skills for BMs were asked about their child's fecal incontinence episodes. Toileting skills were assessed as part of the first daily diary, modified daily diary, or clinic diary and responses were carried through to the completion of the study.

    Time frame: Baseline to Week 12

07

Results

Posted May 14, 2026

Participant flow

This trial was conducted at 28 sites in 2 countries. Participant Flow data are from the ITT 1 and 2 populations (all participants who received at least one dose of linaclotide in Parts 1 or 2, respectively).

Part 1 (Day 1 to Week 12)
Participant flow — Part 1 (Day 1 to Week 12)
MilestonePart 1: Placebo for LinaclotidePart 1: LinaclotidePart 2: Linaclotide
Started61620
Completed54570
Not completed750
Withdrew: Other, not specified210
Withdrew: Lost to follow-up210
Withdrew: Lack of efficacy100
Withdrew: Withdrawal by subject230
Part 2 (Day 1 to Week 24)
Participant flow — Part 2 (Day 1 to Week 24)
MilestonePart 1: Placebo for LinaclotidePart 1: LinaclotidePart 2: Linaclotide
Started00103
Completed0085
Not completed0018
Withdrew: Adverse event001
Withdrew: Other, not specified002
Withdrew: Lost to follow-up005
Withdrew: Withdrawal by subject0010

Outcome measures

PrimaryChange From Baseline in 12-week Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) Observed by the Primary Caregiver During the Double-blind Study Intervention Period

An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM. The caregiver/parent/guardian/legally authorized representative (LAR) will complete the electronic diary (eDiary), providing data for the SBM frequency rate up to the last dose date equivalent to the 12-week SBM frequency rate. Baseline values for efficacy endpoints related to daily eDiary responses were derived from the eDiary in the preintervention period, specifically the time period from 14 days before randomization and up to the time of randomization.

Time frame:
Baseline to Week 12
Reported as:
Least squares mean · SBMs/week
Change From Baseline in 12-week Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) Observed by the Primary Caregiver During the Double-blind Study Intervention Period
SBMs/weekPart 1: Placebo for LinaclotidePart 1: Linaclotide
Change From Baseline in 12-week Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) Observed by the Primary Caregiver During the Double-blind Study Intervention Period1.418 ± 0.21971.738 ± 0.2188
Statistical analysis
  • Part 1: Placebo for Linaclotide vs Part 1: Linaclotide · Mixed Effect Model Repeated Measurement · p = =0.2929 · Ls mean difference: 0.319 · 95% CI -0.2758 to 0.9146Difference = Linaclotide - Placebo
PrimaryNumber of Participants With Treatment-Emergent Adverse Events

An adverse event (AE) is defined as any untoward medical occurrence in a patient/clinical investigation subject administered a pharmaceutical product which doesn't necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Time frame:
From the time of study drug administration until 30 days or 5 half-lives after the last dose, up to 126 days in Period 1 and 226 days in Period 2
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events
ParticipantsPart 1: Placebo for LinaclotidePart 1: LinaclotidePart 2: Linaclotide
Any TEAE151639
TESAE001
SecondaryChange From Baseline in 12-week Stool Consistency Observed by the Primary Caregiver During the Double-blind Study Intervention Period

The caregiver/parent/guardian/legally authorized representative (LAR) rated and recorded in an eDiary the consistency of the stool for each BM using the Bristol Stool Form 7-point scale in which 1=Separate hard lumps, like nuts (hard to pass); 2=Sausage-shaped, but lumpy; 3=Like a sausage but with cracks on its surface; 4=Like a sausage or snake, smooth and soft; 5=Soft blobs with clear cut edges (easy to pass); 6=Fluffy pieces with ragged edges, a mushy stool; and 7=Watery, no solid pieces, entirely liquid. A response of "I don't know" was considered as a missing score. Lower scores indicate firmer stool consistency. A subject's stool consistency score for the study intervention period is the average of the non-missing BSFS scores for the primary caregiver-observed SBMs during that specific period.

Time frame:
Baseline to Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in 12-week Stool Consistency Observed by the Primary Caregiver During the Double-blind Study Intervention Period
units on a scalePart 1: Placebo for LinaclotidePart 1: Linaclotide
Change From Baseline in 12-week Stool Consistency Observed by the Primary Caregiver During the Double-blind Study Intervention Period0.622 ± 0.11620.998 ± 0.1139
Statistical analysis
  • Part 1: Placebo for Linaclotide vs Part 1: Linaclotide · Mixed Effect Model Repeated Measurement · p = =0.0199 · Ls mean difference: 0.376 · 95% CI 0.0593 to 0.6918Difference = Linaclotide - Placebo
SecondaryChange From Baseline in 12-week Straining Observed by the Primary Caregiver During the Double-blind Study Intervention Period

The caregiver/parent/guardian/LAR rated and recorded in an eDiary the amount of straining they observed when the child passed the BM using two 3-point rating scales:. 1) For the bowel movement #X you were with the child for, did he/she grunt like he/she was straining? 0 = No, not at all; 1 = Yes, a little; 2 = Yes, a lot; I don't know. 2) For the bowel movement #X you were with the child for, did he/she make a face like he/she was straining? 0 = No, not at all; 1 = Yes, a little; 2 = Yes, a lot; I don't know. "I don't know" was considered a missing response. Higher scores indicate more straining. The subject's straining score was the average of the nonmissing average straining scores for all the primary caregiver-observed SBMs during the specific period.

Time frame:
Baseline to Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline in 12-week Straining Observed by the Primary Caregiver During the Double-blind Study Intervention Period
units on a scalePart 1: Placebo for LinaclotidePart 1: Linaclotide
Change From Baseline in 12-week Straining Observed by the Primary Caregiver During the Double-blind Study Intervention Period-0.526 ± 0.0590-0.542 ± 0.0574
Statistical analysis
  • Part 1: Placebo for Linaclotide vs Part 1: Linaclotide · Mixed Model for Repeated Measures (MMRM) · p = =0.8425 · Ls mean difference: -0.016 · 95% CI -0.1763 to 0.1439Difference = Linaclotide - Placebo
SecondaryChange From Baseline in 12-week Proportion of Days With Fecal Incontinence During the Double-blind Study Intervention Period (for Those With Toileting Skills)

Caregivers of children who have acquired toileting skills for BMs were asked about their child's fecal incontinence episodes. Toileting skills were assessed as part of the first daily diary, modified daily diary, or clinic diary and responses were carried through to the completion of the study.

Time frame:
Baseline to Week 12
Reported as:
Least squares mean · proportion of days
Change From Baseline in 12-week Proportion of Days With Fecal Incontinence During the Double-blind Study Intervention Period (for Those With Toileting Skills)
proportion of daysPart 1: Placebo for LinaclotidePart 1: Linaclotide
Change From Baseline in 12-week Proportion of Days With Fecal Incontinence During the Double-blind Study Intervention Period (for Those With Toileting Skills)0.024 ± 0.01390.018 ± 0.0146
Statistical analysis
  • Part 1: Placebo for Linaclotide vs Part 1: Linaclotide · Mixed Model for Repeated Measures (MMRM) · p = = 0.7606 · Ls mean difference: -0.006 · 95% CI -0.045 to 0.0329Linaclotide - Placebo

Adverse events

Collected over Study procedure-related AEs collected from informed consent until study drug start, up to 1 month. All adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 126 days in Period 1 and 226 days in Period 2. After 30 days or 5 half-lives following the last dose of study drug/completion of study Tx, only spontaneously reported SAEs were collected (nonserious AEs were not collected).. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part 1: Placebo for Linaclotide0/61 (0%)0/61 (0%)5/61 (8.2%)
Part 1: Linaclotide0/62 (0%)0/62 (0%)6/62 (9.7%)
Part 2: Linaclotide0/104 (0%)1/104 (1%)23/104 (22.1%)
Most frequent serious events
Most frequent serious events
EventPart 1: Placebo for LinaclotidePart 1: LinaclotidePart 2: Linaclotide
CONSTIPATIONGastrointestinal disorders0/610/621/104
Most frequent other events
Most frequent other events
EventPart 1: Placebo for LinaclotidePart 1: LinaclotidePart 2: Linaclotide
COUGHRespiratory, thoracic and mediastinal disorders3/610/621/104
INFLUENZAInfections and infestations0/611/625/104
DIARRHOEAGastrointestinal disorders2/611/624/104
EAR INFECTIONInfections and infestations0/610/624/104
VIRAL UPPER RESPIRATORY TRACT INFECTIONInfections and infestations0/610/624/104
PYREXIAGeneral disorders0/612/623/104
NASOPHARYNGITISInfections and infestations1/612/623/104
COVID-19Infections and infestations0/610/623/104
URINARY TRACT INFECTIONInfections and infestations0/610/623/104

Baseline characteristics

ITT1: all randomized participants who received at least one dose of double blind study drug in Part 1.

Age, Continuous
Age, Continuous(years)Part 1: Placebo for LinaclotidePart 1: LinaclotideTotal
Mean3.8 ± 1.093.6 ± 1.123.7 ± 1.11
Sex: Female, Male
Sex: Female, Male(Participants)Part 1: Placebo for LinaclotidePart 1: LinaclotideTotal
Female373976
Male242347
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Part 1: Placebo for LinaclotidePart 1: LinaclotideTotal
Hispanic or Latino232144
Not Hispanic or Latino384179
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Part 1: Placebo for LinaclotidePart 1: LinaclotideTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American151631
White444589
More than one race112
Unknown or Not Reported101
08

Study locations

48 sites
  • G & L Research, LLC /ID# 250658
    Foley, Alabama 36535, United States
  • Velocity Clinical Research - Phoenix /ID# 266280
    Phoenix, Arizona 85006, United States
  • HealthStar Research of Hot Springs PLLC /ID# 249481
    Hot Springs, Arkansas 71913, United States
  • Applied Research Center of Arkansas /ID# 249764
    Little Rock, Arkansas 72212-4187, United States
  • Advanced Research Center /ID# 249412
    Anaheim, California 92805, United States
  • Kindred Medical Institute - Corona /ID# 249485
    Corona, California 92879-3104, United States
  • Medical Ctr for Clin Research /ID# 254386
    San Diego, California 92108, United States
  • Prohealth Research Center /ID# 249420
    Doral, Florida 33166, United States
  • KIDZ Medical Services - Hollywood /ID# 250823
    Hollywood, Florida 33021-6030, United States
  • Nemours Children's Health System /ID# 250881
    Jacksonville, Florida 32207, United States
  • Kissimmee Clinical Research /ID# 252206
    Kissimmee, Florida 34741, United States
  • South Miami Medical & Research Group Inc. /ID# 249418
    Miami, Florida 33155, United States
  • Valencia Medical & Research Center /ID# 250452
    Miami, Florida 33165, United States
  • Palmetto Professional Research /ID# 250875
    Miami, Florida 33172, United States
  • South Florida Research Ph I-IV /ID# 252350
    Miami Springs, Florida 33166-7225, United States
  • Velocity Clinical Research Macon /ID# 266516
    Macon, Georgia 31210-6583, United States
  • Rophe Adult & Pediatric Medicine /ID# 250663
    Union City, Georgia 30291, United States
  • Michael W. Simon, MD, PSC /ID# 250664
    Lexington, Kentucky 40517, United States
  • Velocity Clinical Research - Lafayette /ID# 266751
    Lafayette, Louisiana 70508, United States
  • Frederick County Pediatrics /ID# 249483
    New Market, Maryland 21774-6154, United States
  • Michigan Center of Medical Research /ID# 251088
    Farmington Hills, Michigan 48334, United States
  • MNGI Digestive Health, P. A. /ID# 249676
    Minneapolis, Minnesota 55413-2195, United States
  • Velocity Clinical Research- Hastings Nebraska /ID# 252132
    Hastings, Nebraska 68901-2640, United States
  • Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 250876
    Newark, New Jersey 07103-2425, United States
  • Univ NC Chapel Hill /ID# 252044
    Chapel Hill, North Carolina 27514-4220, United States
  • UH Cleveland Medical Center /ID# 250893
    Cleveland, Ohio 44106, United States
  • IPS Research Company /ID# 250822
    Oklahoma City, Oklahoma 73106, United States
  • Frontier Clinical Research, LLC - Scottdale /ID# 250656
    Scottdale, Pennsylvania 15683, United States
  • Frontier Clinical Research - Smithfield /ID# 250657
    Smithfield, Pennsylvania 15478, United States
  • Coastal Pediatric Research - West Ashley B /ID# 249413
    Charleston, South Carolina 29414, United States
  • Tribe Clinical Research LLC /ID# 255656
    Greenville, South Carolina 29607-4021, United States
  • Coastal Pediatric Research - Summerville /ID# 249423
    Summerville, South Carolina 29486, United States
  • Tullahoma Pediatrics /ID# 250892
    Tullahoma, Tennessee 37388, United States
  • Houston Clinical Research Associates /ID# 250779
    Houston, Texas 77090-2633, United States
  • Prime Clinical Research - Mansfield - East Broad Street /ID# 266236
    Mansfield, Texas 76063, United States
  • ClinPoint Trials /ID# 250448
    Waxahachie, Texas 75165-1430, United States
  • Carilion Medical Center /ID# 249790
    Roanoke, Virginia 24014, United States
  • Frontier Clinical Research - Kingwood /ID# 251154
    Kingwood, West Virginia 26537-9797, United States
  • University Hospital Plovdiv /ID# 250814
    Tsentar, Plovdiv 4001, Bulgaria
  • UMHAT Kanev /ID# 250815
    Rousse, 7002, Bulgaria
  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 251234
    Sofia, 1407, Bulgaria
  • Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251233
    Sofia, 1606, Bulgaria
  • Nova Clinic /ID# 250816
    Varna, 9000, Bulgaria
  • Amphia Ziekenhuis /ID# 251698
    Breda, North Brabant 4818 CK, Netherlands
  • Amsterdam UMC, locatie AMC /ID# 251295
    Amsterdam, North Holland 1105 AZ, Netherlands
  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 251179
    London, Greater London E1 2ES, United Kingdom
  • Doncaster Royal Infirmary /ID# 252080
    Armthorpe Road, DN2 5LT, United Kingdom
  • Northern Licolnshire and Goole NHS Foundation Trust /ID# 252007
    Grimsby, DN33 2BA, United Kingdom
09

References and documents

Study documents

  • Study protocol · Feb 20, 2025
  • Statistical analysis plan · Apr 2, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05652205
Lead sponsor
AbbVie
Collaborators
Ironwood Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Dec 15, 2022
Start date
Dec 29, 2022
Primary completion
Sep 2, 2025
Completion
Sep 2, 2025
Results posted
May 14, 2026
Last update
May 14, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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