Recruiting

Newer IBD Medications

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07198113

Conditions

Ulcerative Colitis, Pediatric

Inflammatory Bowel Diseases

Crohn Disease

Eligibility Criteria

Sex: All

Age: 1 - 18

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of the study is to compare the clinical effectiveness and safety of newer inflammatory bowel disease (IBD) medications in anti-tumor necrosis factor (TNF) refractory patients with pediatric IBD (PIBD). Refractory means that there was no clinical response to anti-tumor necrosis factor (TNF) drugs or that the if there was a response, it is no longer present. The main question this study aims to answer is:

Are the newer medications used to treat IBD just as safe and effective for treating IBD in children.

Participants will already be taking these newer medications as assigned by their regular health care provider.Participants' care will be managed by their regular healthcare provider as part of usual (standard) care for those with PIBD. While taking these medications, participants will be asked to answer questions about their symptoms and health periodically over the course of the study.

Conditions

Ulcerative Colitis, Pediatric

Inflammatory Bowel Diseases

Crohn Disease

Study ID

NCT07198113

Start date

Nov 1, 2025

Status verified date

Apr, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age < 18 years at study enrollment
  • Diagnosis of CD, UC, or IBD-U by standard diagnostic criteria
  • Prior non-response or loss of response to one or more anti-TNF agents
  • Planning to initiate treatment with any of the following comparator agents: vedolizumab (α4β7 integrin antibody), ustekinumab (anti-IL-12/23 antibody), risankizumab, guselkumab, or mirikizumab, (IL-23 inhibitors), tofacitinib (JAK inhibitor), and upadacitinib (JAK inhibitor). Biosimilars or generic medications for any of the above will also be allowed and handled/analyzed in an identical manner to originators.
  • Ability to provide child assent, if required per regulatory or local institutional guidelines, and parental informed consent in English or Spanish

Exclusion Criteria:

  • Plans to change care to a different center within 1 year
  • Prior use of a comparator agent (i.e., only patients starting their first comparator medication as monotherapy following anti-TNF will be eligible)
  • Contraindication to any of the treatments under investigation
  • Patients with UC or IBD-U who have undergone colectomy
  • Patients with current ostomy

Study Design

Enrollment

1100 participants

Anticipated

Interventions and Outcome Measures

Arms

Children with Crohn's disease (CD)

Pediatric CD patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations

Children with Ulcerative Colitis (UC)

Pediatric UC patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations

Retrospective Safety Analysis

Retrospective cohort focused on the long-term safety of non-anti-TNF biologics and small molecules that are FDA-approved for adult populations in for CD and or UC. Electronic health record (EHR) data (retrospective cohort) will be collected from medical charts and EHRs at participating institutions.

Primary outcome measure

  • Measure of Crohn's disease (CD) impact on patients' daily lives (TUMMY CD) [ Time Frame: Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 ]
  • Measures of ulcerative colitis (UC) impact on patients' daily lives (TUMMY UC) [ Time Frame: Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 ]
  • PROMIS Symptom Measure of Irritable Bowel Disease (IBD) [ Time Frame: Baseline, months 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 ]
  • Change in Pediatric PROMIS® Patient-Reported Outcome (PRO) Pain Interference Score for Crohn's Disease and Ulcerative Colitis (CD and UC) [ Time Frame: Baseline, months 6, 12, 18, 24, 30, 36 ]
  • Change in Pediatric PROMIS® Fatigue Score for Crohn's Disease and Ulcerative Colitis (CD and UC) [ Time Frame: Baseline, months 6, 12, 18, 24, 30, 36 ]
  • Change in Pediatric PROMIS® Anxiety Score for Crohn's Disease and Ulcerative Colitis (CD and UC) [ Time Frame: Baseline, months 6, 12, 18, 24, 30, 36 ]
  • Change in Pediatric PROMIS® Depression Score for Crohn's Disease and Ulcerative Colitis (CD and UC) [ Time Frame: Baseline, months 6, 12, 18, 24, 30, 36 ]
  • Change in sPCDAI Score for Crohn's Disease [ Time Frame: Each clinic visit (baseline through follow-up, up to 3 years) ]
  • Change in Pediatric Ulcerative Colitis Activity Index (PUCAI) Score [ Time Frame: Each clinic visit (baseline through follow-up, up to 3 years) ]

Central Contacts and Locations

Central contacts

Duke Clinical Research Institute COMPARE Call Center

833-850-2848COMPARE@dm.duke.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Ajay Gulati, MD

919-962-9900ajay_gulati@med.unc.edu

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Tiffany Linville, MD

704-381-8800pediatricresearch@atriumhealth.org

Duke Health System

Recruiting

Durham, North Carolina, United States, 27701

Contacts

Annette Babu

919-681-8739annette.babu@duke.edu

University of Pittsburgh Medical Center, Children's Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15222

Contacts

Whitney Sunseri, MD

412-692-5180

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • Ulcerative colitis, pediatric
  • Inflammatory bowel disease, pediatric
  • IBD
  • CD
  • UC
  • PIBD
  • Pediatrics
  • Children
  • Anti-TNF
  • Vedolizumab
  • Ustekinumab
  • Risankizumab
  • Guselkumab
  • Mirikizumab
  • Tofacitinib
  • Upadacitinib
  • Patient-reported outcomes (PROs)
  • Tumor necrosis factor antagonists
  • IL-23 agent
  • PCORI
  • PCORnet
  • DCRI
  • Duke
  • UNC
  • University of North Carolina
  • Observational cohort
  • Anti-tumor necrosis factor (TNF) refractory
  • Comparative Effectiveness Research (CER)
  • COMPARE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-04-17.