Zymfentra (Infliximab-dyyb) REal World Cohort STudy (ZEST)

May 22, 2026 updated by: University of North Carolina, Chapel Hill
The goal of this observational study is to learn about how effective Zymfentra (IFX=dyyb) is when treating patients with Crohn's disease (CD) and ulcerative colitis (UC) Does Zymfentra lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed Zymfentra (IFX-dyyb as part of their regular medical care for CD or UC will answer online survey questions about their bowel habits for 1 year.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School of Medicine
        • Principal Investigator:
          • Jill Gaidos, MD
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
        • Principal Investigator:
          • Steven Polyak, MD
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • Mercy Medical Center
        • Contact:
        • Principal Investigator:
          • Ray Cross, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Jessica Allegretti, MD
        • Contact:
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • New York University
        • Principal Investigator:
          • David Hudesman, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7080
        • Recruiting
        • University of North Carolina
        • Principal Investigator:
          • Hans Herfarth, MD, PhD
        • Contact:
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Atrium Health Center for Gastroenterology and Surgery
        • Contact:
        • Principal Investigator:
          • Maithili Chitnavis, MD
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest School of Medicine
        • Contact:
        • Principal Investigator:
          • Richard Bloomfeld, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Principal Investigator:
          • Loren Brook, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with UC, CD, or IBDU starting Zymfentra (Infliximab-dyyb) in the setting of standard-of-care

Description

Inclusion Criteria:

- 1. Adult patients, age 18 years or older, with Crohn's disease (CD), ulcerative colitis (UC) or Inflammatory Bowel Disease Unclassified (IBDU), who are either starting Zymfentra at week 10 (IFX-dyyb) in the setting of standard-of-care initiation with intravenous Infliximab (IFX) originator or IFX biosimilars induction therapy at weeks 0,2,6 or switching from intravenous IFX originator or IFX biosimilars during maintenance therapy to Zymfentra (IFX-dyyb) 2. Anticipation that the patient will be followed by the participating center for the next 12 months.

3. Diagnosis of CD, UC or IBDU must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below.

The following diagnostic criteria were developed by the NIDDK IBD Genetics Consortium and are provided as guidelines to complete documentation on individuals with CD, UC or IBDU:

A) Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, complicated perianal disease, extraintestinal manifestations, weight loss or failure to thrive.

AND B) Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration. When there has been a single episode of colitis (in some instances less than 6 weeks duration) resulting in colectomy and resolution of disease symptoms, pathology on the colectomy specimen should be consistent with idiopathic IBD and microbiology studies should be negative.

AND

C) One or more of the following providing objective evidence of inflammation:

Endoscopic: Mucosal edema, erythema, loss of normal submucosal vasculature, friability, ulceration, stricture formation, pseudopolyps, mucosal edema, erythema. Where there are only minor changes (mucosal edema, erythema, loss of normal submucosal vasculature, friability) mucosal biopsies should have been done to confirm the presence of IBD.

Radiologic: Mucosal thickening and/or nodularity, ulceration, stricture, pseudopolyps, fistula formation, pseudosacculation. Minor changes alone (mucosal thickening and/or nodularity) should not be sufficient to make a diagnosis of IBD.

Histologic: Mucosal erosion or ulceration, architectural changes of crypts, Paneth cell metaplasia (in colon), transmural inflammatory infiltrate*, fibrosis of muscularis propria*, noncaseating granuloma*.

* CD

Individuals with IBD should be classified into one of three categories, based on most recent diagnosis:

Crohn's disease (CD):

  1. Evidence of small intestinal inflammation with endoscopically, radiologically or histologically demonstrated ulcerations, fistulation, mucosal fissuring, nodularity or cobblestoning, stricture formation or histologically demonstrated transmural inflammation with or without granuloma formation.
  2. Isolated esophageal, gastric or duodenal inflammation with the finding of noncaseating granuloma.
  3. Colonic inflammation which is patchy (normal segments separating areas of inflammation, as described above) or associated with one or more of the following features: complete rectal sparing, multiple (>10) aphthoid ulcers, deep ulceration (into the muscularis propria), transmural inflammation, extensive fibrosis and wall thickening, fistulation, non-caseating granuloma. (N.B. See note below regarding patchiness of endoscopically observed inflammation in patients with partially treated ulcerative colitis.)
  4. The presence of complex suppurative perianal disease (i.e. more than a superficial fistula or uncomplicated superficial abscess).
  5. If there are fewer than 10 aphthoid ulcers in the cecum (and the rest of the colon appears normal) in a patient with small bowel disease then this should be called small bowel disease only. Similarly, if the colon is normal except for the presence of a fistula extending from inflamed small bowel, the patient should be said to have small bowel disease alone. If the cecum is involved with ulcers larger than aphthoid ulcers or ulcers that are deep or if the involvement has resulted in deformity of the cecum this would be considered to be colonic involvement.

Ulcerative Colitis (UC)

1) Superficial inflammation and/or ulceration (involving only the mucosa and submucosa) of the colon which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (N.B. Relative rectal sparing is allowed for patients receiving topical rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis).

2) In patients with proctitis or left-sided ulcerative colitis there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice.

3) No inflammation of the small intestine ("backwash ileitis" is allowed - non-stricturing superficial inflammation of the terminal ileal mucosa associated with severe pancolitis which resolves following medical or surgical treatment of the colitis).

4) No features of Crohn's disease listed above.

Inflammatory Bowel Disease Unclassified (IBDU):

  1. Confirmed IBD by A, B and C above.
  2. Physician unable to classify individual into either CD or UC based on above criteria and/or patient has features of both CD and UC with none of the feature's diagnostic of one or the other.

Exclusion Criteria:

  • 1.

Patients will be excluded if they meet any of the following criteria:

  1. Inability to provide informed consent.
  2. Non-English speaking
  3. Patients presenting for a one-time consultation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.
Time Frame: Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52.
The SCCAI is a 6-item that describes the symptoms and disease activity of a patient with UC at the time of assessment. A score of 0-4 is considered a clinical range of remission (but with more refined definitions of clinical remission with SCCAI ≤2 and very mild symptoms with a score >2 ≤4), 5-7 mild activity, 8-16 moderate activity and > 16 severe activity. A response will be defined as a decrease of the SCCAI score < 5 points in patients with a baseline SCCAI ≥5.
Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52.
Clinical remission as evaluated by the Simple Crohn's Disease Activity Index (sCDAI for the patient-reported outcomes.
Time Frame: Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52

The Short Crohn's Disease Activity Index (sCDAI) is a simplified version of the Crohn's Disease Activity Index (CDAI), used to assess disease severity in Crohn's disease patients. It reduces the number of variables required, making it easier and quicker to use in clinical practice. Recent data demonstrated, that collections of the parameters on a single day equally reflects reliable disease activity compared to a collection of data over 7 consecutive days, which is often hampered by missing data.

A score of < 150, 150-219, 220-450 and >450 reflects remission, mild, moderate and severe Crohn's disease activity.
Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response as measured by the Simple Endoscopic Score for Crohn's disease (SES-CD)
Time Frame: Through study completion, an average of 1 year
The Simple Endoscopic Score for Crohn's Disease (SES-CD) is a tool used to objectively measure the severity of Crohn's disease based on the extent and severity of ulcers, affected surface area, and luminal narrowing during an endoscopy. The total score is the sum of scores for these four features, and it is categorized as follows: 0-2 for remission, 3-6 for mild activity, 7-15 for moderate activity, and greater than 15 for severe activity. Mucosal healing will be defined by an SES-CD < 4
Through study completion, an average of 1 year
Response as measured by the endoscopic Mayo score for ulcerative colitis
Time Frame: Through study completion, an average of 1 year
The Mayo endoscopic score is a four-point scale (1 to 3) used to assess the severity of ulcerative colitis (UC) based on a colonoscopy. It evaluates the severity of inflammation through findings like erythema, vascular pattern, friability, erosions, and spontaneous bleeding, with higher scores indicating more severe disease. Mucosal healing will be defined by an endoscopic Mayo score <1.
Through study completion, an average of 1 year
Mucosal healing will be assessed in the setting of standard-of-care calprotectin levels.
Time Frame: Weeks 0, 14, 24, and 52.
Calprotectin is a surrogate marker of intestinal inflammation, and levels ≥ 250 mcg/g stool are associated with active mucosal inflammation, whereas levels <150 mcg are considered to represent mild or no mucosal inflammation
Weeks 0, 14, 24, and 52.
Response as measured by Patient-Reported Outcomes Measurement Information System (PROMIS)- Depression
Time Frame: Weeks 0, 24, and 52.
PROMIS measure of depression measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Higher scores mean more severe depression. Differences in PROMIS scores compared to baseline will be assessed.
Weeks 0, 24, and 52.
Response as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) -Anxiety Score
Time Frame: Weeks 0, 24, and 52.
PROMIS measure of anxiety measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Higher scores indicate greater anxiety severity Differences in PROMIS scores compared to baseline will be assessed.
Weeks 0, 24, and 52.
Response as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) -Social Satisfaction Score
Time Frame: Weeks 0, 24, and 52.
PROMIS measure of satisfaction measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Higher scores indicate greater satisfaction. Differences in PROMIS scores compared to baseline will be assessed.
Weeks 0, 24, and 52.
Response as measured by Likert scale urgency Score
Time Frame: Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52
Urgency will be measured by the 11-point Likert scale urgency question. Score range is 0-10. The higher the score, the worse the urgency.
Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52
Response as measured by Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale Score
Time Frame: Weeks 0, 24, and 52
Fatigue will be determined by the validated FACIT-F questionnaire. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. Score range is 0-52. The higher the score, the better the quality of life.
Weeks 0, 24, and 52
Response as measured by The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
Time Frame: Weeks 0,4,10,14,18,24,36 and 52.
The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL).
Weeks 0,4,10,14,18,24,36 and 52.
Response as measured by The Work Productivity and Activity Impairment questionnaire (WPAI)
Time Frame: Weeks 0, 24, and 52
The WPAI was designed to measure absenteeism, presenteeism and activity impairment attributable to ill-health over the preceding 7 days. The WPAI calculates percentage impairment (maximum 100%) with higher numbers representing greater work impairment.
Weeks 0, 24, and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Celltrion

Investigators

  • Principal Investigator: Hans Herfarth, MD, PhD, University of North Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2025

Primary Completion (Estimated)

November 3, 2028

Study Completion (Estimated)

November 3, 2028

Study Registration Dates

First Submitted

November 3, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-2184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 3 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina [UNC].

IPD Sharing Time Frame

Beginning 3 months and ending 36 months following article publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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