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Ulcerative Colitis (UC)ZESTNCT07237516

Zymfentra (Infliximab-dyyb) REal World Cohort STudy

An observational study of Ulcerative Colitis (UC) and Crohn's Disease (CD), run by University of North Carolina, Chapel Hill at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
200 participants
Where
11 sitesUnited States
Study dates
20 Nov 2025to 3 Nov 2028
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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:
  • 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
Show all 26Show fewer
  • 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):
  • 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.
  • Isolated esophageal, gastric or duodenal inflammation with the finding of noncaseating granuloma.
  • 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.)
  • The presence of complex suppurative perianal disease (i.e. more than a superficial fistula or uncomplicated superficial abscess).
  • 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):
  • Confirmed IBD by A, B and C above.
  • 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.

Who cannot join

  • 1.
  • Patients will be excluded if they meet any of the following criteria:
  • Inability to provide informed consent.
  • Non-English speaking
  • Patients presenting for a one-time consultation.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Susan Jackson contact

919-843-9071

susan_jackson@med.unc.edu

11 sites in 1 country

United States11 sites, 11 recruiting

  • Mercy Medical Center

    Baltimore, Maryland, 21202

    Liyah Courageux, 410-332-9525, lcourage@mdmercy.com

    Ray Cross, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Mia Silvestri, 617-525-7011, msilvestri@bwh.harvard.edu

    Jessica Allegretti, MD

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599-7080

    Jenn Barr, 919-966-0764, jenirene@email.unc.edu

    Hans Herfarth, MD, PhD

    Recruiting

  • Atrium Health Center for Gastroenterology and Surgery

    Charlotte, North Carolina, 28204

    Jessica Kearney-Bryan, 704-355-0244, Jessica.kearney-bryan@advocatehealth.org

    Maithili Chitnavis, MD

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45267

    Missy Randolph, 513-558-5529, randollj@ucmail.uc.edu

    Loren Brook, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Jessica Valestin, 319-353-4574, jessica-valestin@uiowa.edu

    Steven Polyak, MD

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Niurka Colina, 305-243-6405, Nxc610@miami.edu

    Oriana Damas, MD

    Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

    Elizabeth Ruggiero, 203-785-4138, Elizabeth.ruggiero@yale.edu

    Jill Gaidos, MD

    Recruiting

  • New York University

    New York, New York, 10016

    Nathasha Melukkaran, 646-754-3417, Nathasha.melukkaran@nyulangone.org

    David Hudesman, MD

    Recruiting

  • AdventHealth

    Orlando, Florida, 32804

    Haileigh Galloway, 407-303-5600, Haileigh.galloway@adventhealth.com

    Jennifer Seminerio-Diehl, MD

    Recruiting

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27157

    Cheyenne Barnett, (336)716-6965, Cheyenne.barnett@advocatehealth.org

    Richard Bloomfeld, MD

    Recruiting

Other trials in United States

About this study

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.

Keywords
Zymfentra, ZEST
Medical subject headings
Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical remission as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.

    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.

    Measured: Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52.

  2. Clinical remission as evaluated by the Simple Crohn's Disease Activity Index (sCDAI for the patient-reported outcomes.

    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.

    Measured: Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52

Secondary outcomes (10)

  1. Response as measured by the Simple Endoscopic Score for Crohn's disease (SES-CD)

    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

    Measured: Through study completion, an average of 1 year

  2. Response as measured by the endoscopic Mayo score for ulcerative colitis

    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.

    Measured: Through study completion, an average of 1 year

  3. Mucosal healing will be assessed in the setting of standard-of-care calprotectin levels.

    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

    Measured: Weeks 0, 14, 24, and 52.

  4. Response as measured by Patient-Reported Outcomes Measurement Information System (PROMIS)- Depression

    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.

    Measured: Weeks 0, 24, and 52.

  5. Response as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) -Anxiety Score

    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.

    Measured: Weeks 0, 24, and 52.

  6. Response as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) -Social Satisfaction Score

    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.

    Measured: Weeks 0, 24, and 52.

  7. Response as measured by Likert scale urgency Score

    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.

    Measured: Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52

  8. Response as measured by Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale Score

    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.

    Measured: Weeks 0, 24, and 52

  9. Response as measured by The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score

    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).

    Measured: Weeks 0,4,10,14,18,24,36 and 52.

  10. Response as measured by The Work Productivity and Activity Impairment questionnaire (WPAI)

    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.

    Measured: Weeks 0, 24, and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start20 Nov 2025
  3. Primary completion3 Nov 2028 (estimated)
  4. Study completion3 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07237516
Sponsor's protocol ID
25-2184
Acronym
ZEST
Status last verified
Aug 2026
First submitted
3 Nov 2025
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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 \[UNC\].

Publications

  • Popmihajlov Z, Pang L, Brown E, Joshi A, Su SC, Kaplan SS, Willis ED. A post hoc analysis utilizing the FDA toxicity grading scale to assess injection site adverse events following immunization with the live attenuated Zoster Vaccine (ZVL). Hum Vaccin Immunother. 2018;14(12):2916-2920. doi: 10.1080/21645515.2018.1502517. Epub 2018 Sep 5.

    PubMed 30024827

  • Youssef M, Hossein-Javaheri N, Hoxha T, Mallouk C, Tandon P. Work Productivity Impairment in Persons with Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis. J Crohns Colitis. 2024 Sep 3;18(9):1486-1504. doi: 10.1093/ecco-jcc/jjae057.

    PubMed 38647194

  • Dubinsky MC, Panaccione R, Lewis JD, Sands BE, Hibi T, Lee SD, Naegeli AN, Shan M, Green LA, Morris N, Arora V, Bleakman AP, Belin R, Travis S. Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. Crohns Colitis 360. 2022 Jun 3;4(3):otac016. doi: 10.1093/crocol/otac016. eCollection 2022 Jul.

    PubMed 36777426

  • Singh S, Ananthakrishnan AN, Nguyen NH, Cohen BL, Velayos FS, Weiss JM, Sultan S, Siddique SM, Adler J, Chachu KA; AGA Clinical Guidelines Committee. Electronic address: clinicalpractice@gastro.org. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis. Gastroenterology. 2023 Mar;164(3):344-372. doi: 10.1053/j.gastro.2022.12.007.

    PubMed 36822736

  • Higgins PD, Schwartz M, Mapili J, Krokos I, Leung J, Zimmermann EM. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut. 2005 Jun;54(6):782-8. doi: 10.1136/gut.2004.056358.

    PubMed 15888785

  • Peyrin-Biroulet L, Panes J, Sandborn WJ, Vermeire S, Danese S, Feagan BG, Colombel JF, Hanauer SB, Rycroft B. Defining Disease Severity in Inflammatory Bowel Diseases: Current and Future Directions. Clin Gastroenterol Hepatol. 2016 Mar;14(3):348-354.e17. doi: 10.1016/j.cgh.2015.06.001. Epub 2015 Jun 11.

    PubMed 26071941

  • Thia K, Faubion WA Jr, Loftus EV Jr, Persson T, Persson A, Sandborn WJ. Short CDAI: development and validation of a shortened and simplified Crohn's disease activity index. Inflamm Bowel Dis. 2011 Jan;17(1):105-11. doi: 10.1002/ibd.21400.

    PubMed 20629100

  • Barnes EL, Hanson JS, Regueiro MD, Saha S, Sands BE, Rubin DT, Dubinsky MC, Siegel CA, Gazis DR, Crawford JM, Long MD. Older Adult Patients Use More Aminosalicylate Monotherapy Compared With Younger Patients With Inflammatory Bowel Disease: TARGET-IBD. J Clin Gastroenterol. 2022 Jul 1;56(6):529-535. doi: 10.1097/MCG.0000000000001557. Epub 2021 Jun 11.

    PubMed 34115661

  • Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.

    PubMed 10146874

  • Tinsley A, Macklin EA, Korzenik JR, Sands BE. Validation of the functional assessment of chronic illness therapy-fatigue (FACIT-F) in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2011 Dec;34(11-12):1328-36. doi: 10.1111/j.1365-2036.2011.04871.x. Epub 2011 Oct 17.

    PubMed 21999576

  • Adegbola SO, Dibley L, Sahnan K, Wade T, Verjee A, Sawyer R, Mannick S, McCluskey D, Bassett P, Yassin N, Warusavitarne J, Faiz O, Phillips R, Tozer PJ, Norton C, Hart AL. Development and initial psychometric validation of a patient-reported outcome measure for Crohn's perianal fistula: the Crohn's Anal Fistula Quality of Life (CAF-QoL) scale. Gut. 2021 Sep;70(9):1649-1656. doi: 10.1136/gutjnl-2019-320553. Epub 2020 Dec 3.

    PubMed 33272978

  • Dubinsky MC, Clemow DB, Hunter Gibble T, Li X, Vermeire S, Hisamatsu T, Travis SPL. Clinical Effect of Mirikizumab Treatment on Bowel Urgency in Patients with Moderately to Severely Active Ulcerative Colitis and the Clinical Relevance of Bowel Urgency Improvement for Disease Remission. Crohns Colitis 360. 2022 Dec 13;5(1):otac044. doi: 10.1093/crocol/otac044. eCollection 2023 Jan.

    PubMed 36777368

  • Long MD, Afzali A, Fischer M, Hudesman D, Abdalla M, McCabe R, Cohen BL, Ungaro RC, Harlan W, Hanson J, Konijeti G, Polyak S, Ritter T, Salzberg B, Seminerio J, English E, Zhang X, Sharma PP, Herfarth HH. Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting. Inflamm Bowel Dis. 2023 Apr 3;29(4):570-578. doi: 10.1093/ibd/izac121.

    PubMed 35700276

  • Irvine EJ, Zhou Q, Thompson AK. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. Am J Gastroenterol. 1996 Aug;91(8):1571-8.

    PubMed 8759664

  • Bewtra M, Brensinger CM, Tomov VT, Hoang TB, Sokach CE, Siegel CA, Lewis JD. An optimized patient-reported ulcerative colitis disease activity measure derived from the Mayo score and the simple clinical colitis activity index. Inflamm Bowel Dis. 2014 Jun;20(6):1070-8. doi: 10.1097/MIB.0000000000000053.

    PubMed 24810138

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis (UC) and Crohn's Disease (CD), run by University of North Carolina, Chapel Hill at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Susan Jackson (919-843-9071, susan_jackson@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07237516, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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