Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C

NCT04166058 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: LIN-MD-662019-001955-38
• Study Type: interventional
• Target: 381
• Locations: 4 countries
• Sites: 72

Brief Summary

LIN-MD-66 is a Phase 3 open-label study with 24 weeks (Functional Constipation participants) or 52 weeks (Irritable bowel syndrome with constipation participants) of linaclotide exposure that will enroll pediatric participants (6-17 years of age) with FC or IBS-C who completed study intervention in studies LIN-MD-62, LIN-MD-63, or LIN-MD-64 based on the individual study criteria.

Conditions

Irritable Bowel Syndrome With Constipation; Functional Constipation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs).

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not 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 participant 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.

  From first dose of study drug until 30 days following last dose of study drug [up to 24 weeks (FC participants) or 52 weeks (IBS-C participants)].

Study Arms (3)

72 μg linaclotide

ACTIVE COMPARATOR

An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

Drug: Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)

145 μg linaclotide

ACTIVE COMPARATOR

An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

Drug: Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers); Drug: Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)

290 μg linaclotide

ACTIVE COMPARATOR

An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

Drug: Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)

Interventions

Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers) DRUG

Participants who completed study LIN-MD-63 at their time of enrollment will be assigned a dose of 290 μg. Participants who received ≤ 145 μg linaclotide or placebo in study LIN-MD-63 at the time of completion will continue to receive 145 μg. Participants who completed study LIN-MD-64 at their time of enrollment will be assigned a dose of 290 μg if they choose to receive open-label or continue to receive blinded dose of 145 or 290 μg if they choose to remain on the same blinded dose.

145 μg linaclotide; 290 μg linaclotide

Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers) DRUG

Participants whom are between the ages of 6-11 years old at their time of enrollment will be assigned a dose of 72 μg. Participants whom are between the ages of 12-17 years old at their time of enrollment will be randomized at 1:1 ratio to 72 or 145 μg linaclotide.

145 μg linaclotide; 72 μg linaclotide

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participant weighs ≥ 18 kg at the time the parent/guardian/LAR and/or caregiver has provided signed consent.
• Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception.
• Participants must have completed study intervention in their lead-in study.
• \- Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit (Visit 1) and negative urine pregnancy test prior to the first dose on the Day 1 Visit (Visit 2).

You may not qualify if:

• Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class.
• Participant received an investigational drug, other than linaclotide, during the 30 days before the Screening Visit (Visit 1) or is planning to receive an investigational drug (other than that administered during this study) or use an investigational device at any time during the study.
• Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
• Participant has required manual disimpaction any time prior to study intervention or disimpaction during in-patient hospitalization within 1 year prior to study intervention.
• Participant has any of the following conditions:
• a) Down's syndrome or any other chromosomal disorder
• b) Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus)
• c) Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies)
• d) Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma)
• e) Neurodevelopmental disabilities (early-onset, chronic disorders that share the essential feature of a predominant disturbance in the acquisition of cognitive, motor, language, or social skills, which has a significant and continuing impact on the developmental progress of an individual) producing a cognitive delay that precludes comprehension by the participant.
• Participant has a mechanical bowel obstruction or pseudo-obstruction.
• Participant currently has both unexplained and clinically significant alarm symptoms (lower GI bleeding \[rectal bleeding or heme-positive stool\], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process.
• Participant has had surgery that meets any of the following criteria:
• a) Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit (Visit 1).
• b) Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit (Visit 1)

Sponsors & Collaborators

• AbbVie: lead
• Ironwood Pharmaceuticals, Inc.: collaborator

Study Sites (72)

Central Research Associates /ID# 237953

Birmingham, Alabama, 35205, United States

Location

G & L Research, LLC /ID# 238093

Foley, Alabama, 36535, United States

Location

The Center for Clinical Trials Inc. /ID# 234605

Saraland, Alabama, 36571, United States

Location

HealthStar Research of Hot Springs PLLC /ID# 234608

Hot Springs, Arkansas, 71913, United States

Location

Preferred Research Partners /ID# 237109

Little Rock, Arkansas, 72211, United States

Location

Applied Research Center of Arkansas /ID# 238069

Little Rock, Arkansas, 72212-4187, United States

Location

Advanced Research Center /ID# 237960

Anaheim, California, 92805, United States

Location

Kindred Medical Institute, LLC /ID# 237367

Corona, California, 92879, United States

Location

Duplicate_Center for Clinical Trials LLC /ID# 234629

Paramount, California, 90723, United States

Location

Medical Ctr for Clin Research /ID# 236911

San Diego, California, 92108, United States

Location

Lynn Institute of Denver /ID# 238086

Aurora, Colorado, 80012, United States

Location

Childrens National Medical Center /ID# 234417

Washington D.C., District of Columbia, 20010-2916, United States

Location

Prohealth Research Center /ID# 234659

Doral, Florida, 33166, United States

Location

Dolphin Medical Research /ID# 234676

Doral, Florida, 33172, United States

Location

Amedica Research Institute Inc /ID# 234666

Hialeah, Florida, 33013, United States

Location

Nemours Childrens Specialty Care /ID# 237991

Jacksonville, Florida, 32207, United States

Location

Elite Clinical Research /ID# 234651

Miami, Florida, 33144, United States

Location

My Preferred Research LLC /ID# 237943

Miami, Florida, 33155, United States

Location

South Miami Medical & Research Group Inc. /ID# 234654

Miami, Florida, 33155, United States

Location

Valencia Medical & Research Center /ID# 234671

Miami, Florida, 33165, United States

Location

Advanced Research for Health Improvement /ID# 238253

Naples, Florida, 34102-5430, United States

Location

Pediatric & Adult Research Center /ID# 234681

Orlando, Florida, 32825, United States

Location

Nemours Children's Hospital /ID# 234429

Orlando, Florida, 32827-7884, United States

Location

Oviedo Medical Research /ID# 234692

Oviedo, Florida, 32765, United States

Location

Treken Primary Care /ID# 234645

Atlanta, Georgia, 30315, United States

Location

Children's Healthcare of Atlanta - Ferry Rd /ID# 237005

Atlanta, Georgia, 30342-1605, United States

Location

Children's Ctr Digestive, US /ID# 237574

Atlanta, Georgia, 30342, United States

Location

River Birch Research Alliance /ID# 237963

Blue Ridge, Georgia, 30513, United States

Location

Clinical Research Institute /ID# 234702

Stockbridge, Georgia, 30281, United States

Location

Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236342

Stockbridge, Georgia, 30281, United States

Location

KU Wichita Center for Clinical Research /ID# 234500

Wichita, Kansas, 67214, United States

Location

Michael W. Simon, MD, PSC /ID# 236516

Lexington, Kentucky, 40517, United States

Location

Virgo Carter Pediatrics /ID# 234518

Silver Spring, Maryland, 20910, United States

Location

MNGI Digestive Health, P. A. /ID# 234437

Minneapolis, Minnesota, 55413-2195, United States

Location

GI associates and Endoscopy Ce /ID# 237969

Flowood, Mississippi, 39232, United States

Location

David M. Headley, MD, P.A. /ID# 238216

Port Gibson, Mississippi, 39150-2024, United States

Location

Private Practice - Dr. Craig Spiegel /ID# 234545

Bridgeton, Missouri, 63044, United States

Location

Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 234566

East Orange, New Jersey, 07018, United States

Location

University of New Mexico /ID# 236983

Albuquerque, New Mexico, 87102-4517, United States

Location

Columbia University Irving Medical Center /ID# 235686

New York, New York, 10032, United States

Location

Advantage Clinical Trials /ID# 237932

The Bronx, New York, 10468, United States

Location

East Carolina University - Brody School of Medicine /ID# 237509

Greenville, North Carolina, 27834, United States

Location

PMG Research of Piedmont Healthcare-Statesville /ID# 238257

Statesville, North Carolina, 28625, United States

Location

Univ Oklahoma HSC /ID# 237546

Oklahoma City, Oklahoma, 73104, United States

Location

IPS Research Company /ID# 237669

Oklahoma City, Oklahoma, 73106, United States

Location

Frontier Clinical Research, LLC - Scottdale /ID# 238022

Scottdale, Pennsylvania, 15683, United States

Location

Duplicate_Frontier Clinical Research /ID# 237923

Smithfield, Pennsylvania, 15478, United States

Location

Rhode Island Hospital /ID# 237861

Providence, Rhode Island, 02903, United States

Location

Coastal Pediatric Research - West Ashley B /ID# 234678

Charleston, South Carolina, 29414, United States

Location

Coastal Pediatric Research - Summerville /ID# 234674

Summerville, South Carolina, 29486, United States

Location

The Jackson Clinic, PA /ID# 236772

Jackson, Tennessee, 38305, United States

Location

Accellacare of Knoxville /ID# 234462

Jefferson City, Tennessee, 37760, United States

Location

Cook Children's Med. Center /ID# 237536

Fort Worth, Texas, 76104, United States

Location

Valley Institute of Research /ID# 234475

Harlingen, Texas, 78550, United States

Location

Vilo Research Group Inc /ID# 238228

Houston, Texas, 77017-2337, United States

Location

Cullen Research /ID# 234482

Houston, Texas, 77051, United States

Location

Pioneer Research Solutions - Houston /ID# 236935

Houston, Texas, 77099-4307, United States

Location

AIM Trials /ID# 236364

Plano, Texas, 75093, United States

Location

Sun Research Institute /ID# 236932

San Antonio, Texas, 78215, United States

Location

ClinPoint Trials /ID# 236615

Waxahachie, Texas, 75165-1430, United States

Location

Duplicate_Chrysalis Clinical Research /ID# 234515

St. George, Utah, 84790, United States

Location

Office of Maria Ona /ID# 234539

Franklin, Virginia, 23851, United States

Location

Health Research of Hampton Roads, Inc. (HRHR) /ID# 237252

Newport News, Virginia, 23606, United States

Location

Clinical Research Partners, LLC /ID# 237158

Richmond, Virginia, 23220-4459, United States

Location

Duplicate_Multicare Institute for Research and Innovation /ID# 236979

Tacoma, Washington, 98405, United States

Location

London Health Sciences Center- University Hospital /ID# 234309

London, Ontario, N6A 5W9, Canada

Location

Bluewater Clinical Research Group Inc /ID# 234618

Sarnia, Ontario, N7T 4X3, Canada

Location

Stouffville Medical Centre /ID# 234619

Stouffville, Ontario, L4A 1H2, Canada

Location

Hadassah Hebrew University Hospital - Ein Kerem /ID# 234735

Jerusalem, Jerusalem, 91120, Israel

Location

The Baruch Padeh Medical Center Poriya /ID# 234768

Tiberias, Northern District, 15208, Israel

Location

The Chaim Sheba Medical Center /ID# 236760

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Duplicate_Academisch Medisch Centrum /ID# 237116

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 18, 2019
• Study Start: November 19, 2019
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (65); NL (1); IL (3); CA (3)