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Ulcerative Colitis (Disorder)NCT07726888

Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis

An observational study of Ulcerative Colitis (Disorder) and Guselkumab, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.

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

In a real-world setting, this study systematically evaluates the clinical efficacy and safety of guselkumab (GUS) in the treatment of ulcerative colitis (UC), encompassing multi-dimensional outcomes including clinical remission, biochemical remission, endoscopic remission, histologic healing, and intestinal ultrasound… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis (Disorder), Guselkumab
What is being tested?
Guselkumab
Type of treatment
Injection or infusion
How many people
97 participants
Where
1 siteChina
Study dates
31 Jul 2026to 31 Dec 2028
How long will I take part?
48 Weeks
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: This study employs a prospective consecutive enrollment design to include patients with moderate-to-severe active ulcerative colitis who are expected to receive guselkumab treatment at the study center based on clinical indications. The inclusion and exclusion criteria are as previously stated.

Who may be able to join

  • Age ≥ 18 years.
  • Diagnosis of ulcerative colitis is established based on clinical manifestations, laboratory findings, colonoscopy, radiological imaging (CT or ultrasound), and histopathological examination.
  • Presence of moderate-to-severe disease activity, defined as a modified Mayo score (MMS) ≥ 5 points, accompanied by a rectal bleeding subscore (RBS) ≥ 1 and a Mayo endoscopic subscore (MES) ≥ 2.
  • Inadequate response or intolerance to at least one conventional therapy (5-aminosalicylates, corticosteroids, or immunosuppressants), as assessed by the investigator according to clinical practice.
  • Based on the research cohort requirements, the GUS real-world cohort may include patients who are biologic-naive, have failed first-line therapy, or have failed multiple lines of therapy.
  • Availability of baseline data for disease activity assessment, including symptom scores (partial Mayo score or PRO2), endoscopic evaluation (MES), biochemical markers (C-reactive protein or fecal calprotectin), or imaging parameters (CT or intestinal ultrasonography).
  • Patients enrolled in the prospective GUS cohort are required to provide written informed consent voluntarily.

Who cannot join

  • Diagnosed with other intestinal diseases, such as Crohn's disease, intestinal tuberculosis, infectious colitis, ischemic colitis or other chronic intestinal inflammatory diseases;
  • If there is an active intestinal infection, and the fecal culture or pathogen test shows positive within 8 weeks before the study (including Clostridium difficile, cytomegalovirus, etc.), and the re-examination turns negative without any signs of persistent infection, a re-evaluation can be conducted.
  • Combined with severe infections, malignant tumors, severe liver and kidney dysfunction, or accompanied by active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, and Graves' disease that may interfere with disease assessment
  • Those who have undergone total colorectal resection or stoma surgery in the past and whose disease activity cannot be evaluated, or are expected to undergo major intestinal surgery during the study period;
  • Has had a severe allergic reaction to monoclonal antibodies;
  • During pregnancy or lactation (can be recorded as an independent cohort but not included in the primary analysis);
  • Severe absence of baseline and follow-up data makes it impossible to determine efficacy or safety.
  • Currently participating in other interventional clinical trials that may interfere with the results of this study.

Trial locations and contacts

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

Yi Jiang, Doctor of Medicine contact

+8613676715542

wzjiangyi@yeah.net

guolong Ma, Master of Medicine contact

15868508303

maguolong2014@163.com

China1 site, 1 recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325026

    Yi Jiang, Doctor of Medicine, +8613676715542, wzjiangyi@yeah.net

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis:A Real-World Prospective Cohort Study.

In a real-world setting, this study systematically evaluates the clinical efficacy and safety of guselkumab (GUS) in the treatment of ulcerative colitis (UC), encompassing multi-dimensional outcomes including clinical remission, biochemical remission, endoscopic remission, histologic healing, and intestinal ultrasound changes.

Being tested
Guselkumab
Keywords
moderate-to-severe ulcerative colitis, Guselkumab, efficacy and safety, real-world study
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GuselkumabDrug

    All the patients receive GUS (IV) 200 mg induction therapy at weeks 0, 4, and 8, and who met the criteria for clinical symptom remission, biochemical remission, and improvement in intestinal ultrasound based on the clinical assessment at week 12, proceeded to receive GUS (SC) 100 mg every 8 weeks as maintenance therapy. Patients who did not meet the above criteria received GUS (SC) 200 mg every 4 weeks as maintenance therapy. At week 24, based on clinical and endoscopic evaluations, patients who achieved endoscopic remission were switched to GUS (SC) 100 mg every 8 weeks for maintenance, while those who did not achieve endoscopic remission continued to receive GUS (SC) 200 mg every 4 weeks for maintenance treatment.

Study groups in NCT07726888
Study groupRoleWhat they receive
Guselkumab treatment groupNot described
Receives: Drug: Guselkumab

What is being measured

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

  1. 48-week endoscopic remission

    Assessment was performed using the Mayo endoscopic subscore: endoscopic response was defined as a decrease in the Mayo endoscopic subscore by at least 1 point from baseline or a score of ≤1; endoscopic remission was defined as a Mayo endoscopic subscore of 0. For patients who completed the 48-week treatment, endoscopic scores were evaluated, and the number/proportion of patients achieving endoscopic remission was calculated.

    Measured: 48 weeks

  2. 48-week histological remission

    Investigators apply the Geboes score, and histological remission is defined as a Geboes score ≤ 2B.0. The Nancy Histological Index (NHI) is assessed concurrently, with histological remission defined as an NHI = 0 (indicating no active inflammation). Investigators performed histological scoring for patients who completed the 48-week treatment course and evaluated the number/proportion of patients achieving histological remission.

    Measured: 48 weeks

Secondary outcomes (11)

  1. 12-week clinical remission

    Clinical remission in UC is assessed using the partial Mayo score (pMayo) or PRO2. It's defined as either a pMayo score ≤ 2 with no individual subscore > 1, or meeting the symptomatic remission criteria of PRO2 (indicating improvement in both stool frequency and rectal bleeding scores to the mild or normal range).

    Measured: 12 weeks

  2. 12-week biochemical remission

    1. CRP normalization (≤5 mg/L) or reduction by ≥50% from baseline.
    2. Fecal calprotectin (FC) reduction to <250 μg/g or reduction by ≥50% from baseline.

    Measured: 12 weeks

  3. 12-week intestinal ultrasound response

    Response to intestinal ultrasound (IUS) was defined as meeting both of the following criteria: 1) a decrease in bowel wall thickness (BWT) by ≥25% or a reduction of ≥1 mm from baseline; and 2) a reduction in blood flow signal (Limberg score) by ≥1 grade.

    Measured: 12 weeks

  4. 24-week and 48-week intestinal ultrasound response

    Intestinal ultrasound (IUS) remission was defined as meeting both of the following criteria: 1) bowel wall thickness (BWT) ≤ 3 mm; and 2) no detectable blood flow signal (Limberg grade 0).

    Measured: 24 weeks; 48 weeks

  5. 24-week endoscopic response and remission

    Endoscopic response in UC was defined as a Mayo Endoscopic Score (MES) reduction of ≥1 point from baseline or a score of ≤1. Endoscopic remission was defined as an MES of 0.

    Measured: 24 weeks

  6. 24-week and 48-week Corticosteroid-free remission rate

    Corticosteroid-free remission, a core treatment target recommended by the STRIDE-II guidelines, reflects a patient's ability to maintain clinical remission without the aid of systemic glucocorticoids. It is defined as achieving clinical remission at the assessment timepoint without the use of oral or intravenous glucocorticoids for at least 12 weeks prior to assessment. The proportion of UC patients achieving corticosteroid-free remission was documented for evaluation of the sustainability and steroid-sparing capacity of the treatment.

    Measured: 24 weeks; 48 weeks

  7. 48-week drug persistence rate

    Drug persistence rate is defined as the proportion of patients who continue to receive a given drug after initiation of treatment. It reflects the tolerability, adherence, and long-term benefit of the therapy, and serves as a core indicator in real-world evidence (RWE) studies. Patients who discontinue treatment due to objective non-medical reasons (e.g., relocation, change of healthcare system) may be excluded in sensitivity analyses.

    Measured: 48 weeks

  8. Hospitalization and surgery rates at week 48

    1. Incidence of hospitalizations due to inadequate disease control and cumulative length of hospital stay.
    2. Incidence and timing of intestinal resection or related surgeries performed due to disease activity or complications.

    Measured: 48 weeks

  9. Impact of Prior Biologic Exposure on Efficacy

    The clinical, endoscopic, intestinal ultrasound (IUS), and biochemical improvements were compared between biologic-naïve patients and patients with prior biologic therapy failure or intolerance. This analysis was performed to determine whether previous biologic exposure influences treatment outcomes.

    Measured: Efficacy comparisons were compared at all key study visits: baseline, week 12, week 24, and week 48.

  10. Inflammatory Bowel Disease Questionnaire (IBD-Q) scores at week 48

    1. A total score increase of ≥16 points from baseline is considered a clinically significant improvement.
    2. Restoration to a normal or near-normal level (score ≥ 170) from an active disease state is considered achievement of quality of life remission.

    Measured: 48 weeks

  11. Exploratory Study (Comparing the Efficacy of GUS and VDZ)

    Patients with ulcerative colitis (UC) who had previously received vedolizumab (VDZ) treatment and had complete baseline and follow-up data were retrospectively enrolled from the study center. Propensity score matching analysis was performed to compare the effects of GUS and VDZ on multidimensional outcomes in moderate-to-severe UC in a real-world setting, including clinical response and remission, endoscopic remission, histological remission, and treatment persistence.

    Measured: Efficacy comparisons were compared at all key study visits: baseline, week 12, week 24, and week 48

Timeline

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

  1. First posted24 Jul 2026
  2. Study start31 Jul 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 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
97 participants (estimated)
Target duration
48 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT07726888
Sponsor's protocol ID
SAHoWMU-CR2025-01-232
Status last verified
Dec 2025
First submitted
21 Jul 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ilvemark JFKF, Hansen T, Goodsall TM, Seidelin JB, Al-Farhan H, Allocca M, Begun J, Bryant RV, Carter D, Christensen B, Dubinsky MC, Gecse KB, Kucharzik T, Lu C, Maaser C, Maconi G, Nylund K, Palmela C, Wilson SR, Novak K, Wilkens R. Defining Transabdominal Intestinal Ultrasound Treatment Response and Remission in Inflammatory Bowel Disease: Systematic Review and Expert Consensus Statement. J Crohns Colitis. 2022 May 10;16(4):554-580. doi: 10.1093/ecco-jcc/jjab173.

    PubMed 34614172

  • Kappelman MD, Adimadhyam S, Hou L, Wolfe AE, Smith S, Simon AL, Moyneur E, Reynolds JS, Toh S, Dobes A, Parlett LE, Haynes K, Selvan M, Ma Q, Nair V, Burris J, Dorand JE, Dawwas GK, Lewis JD, Long MD. Real-World Evidence Comparing Vedolizumab and Ustekinumab in Antitumor Necrosis Factor-Experienced Patients With Crohn's Disease. Am J Gastroenterol. 2023 Apr 1;118(4):674-684. doi: 10.14309/ajg.0000000000002068. Epub 2022 Nov 26.

    PubMed 36508681

  • Buisson A, Serrero M, Altwegg R, Guilmoteau T, Bouguen G, Nachury M, Amiot A, Vuitton L, Treton X, Caillo L, Pereira B, Fumery M. Real-World Comparison of the Effectiveness of Tofacitinib and Ustekinumab in Patients With Ulcerative Colitis: The TORUS Study. Clin Gastroenterol Hepatol. 2026 Apr;24(4):1141-1150. doi: 10.1016/j.cgh.2025.07.044. Epub 2025 Aug 18.

    PubMed 40835043

  • Rubin DT, Allegretti JR, Panes J, Shipitofsky N, Yarandi SS, Huang KG, Germinaro M, Wilson R, Zhang H, Johanns J, Feagan BG, Hisamatsu T, Lichtenstein GR, Bressler B, Peyrin-Biroulet L, Sands BE, Dignass A; QUASAR Study Group. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies. Lancet. 2025 Jan 4;405(10472):33-49. doi: 10.1016/S0140-6736(24)01927-5. Epub 2024 Dec 17.

    PubMed 39706209

  • Reich K, Armstrong AW, Foley P, Song M, Wasfi Y, Randazzo B, Li S, Shen YK, Gordon KB. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017 Mar;76(3):418-431. doi: 10.1016/j.jaad.2016.11.042. Epub 2017 Jan 2.

    PubMed 28057361

  • Blauvelt A, Papp KA, Griffiths CE, Randazzo B, Wasfi Y, Shen YK, Li S, Kimball AB. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017 Mar;76(3):405-417. doi: 10.1016/j.jaad.2016.11.041. Epub 2017 Jan 2.

    PubMed 28057360

  • Verstockt B, Salas A, Sands BE, Abraham C, Leibovitzh H, Neurath MF, Vande Casteele N; Alimentiv Translational Research Consortium (ATRC). IL-12 and IL-23 pathway inhibition in inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2023 Jul;20(7):433-446. doi: 10.1038/s41575-023-00768-1. Epub 2023 Apr 17.

    PubMed 37069321

  • Kapizioni C, Desoki R, Lam D, Balendran K, Al-Sulais E, Subramanian S, Rimmer JE, De La Revilla Negro J, Pavey H, Pele L, Brooks J, Moran GW, Irving PM, Limdi JK, Lamb CA; UK IBD BioResource Investigators; Parkes M, Raine T. Biologic Therapy for Inflammatory Bowel Disease: Real-World Comparative Effectiveness and Impact of Drug Sequencing in 13 222 Patients within the UK IBD BioResource. J Crohns Colitis. 2024 Jun 3;18(6):790-800. doi: 10.1093/ecco-jcc/jjad203.

    PubMed 38041850

  • Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Scholmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19.

    PubMed 33359090

  • Massironi S, Vigano C, Palermo A, Pirola L, Mulinacci G, Allocca M, Peyrin-Biroulet L, Danese S. Inflammation and malnutrition in inflammatory bowel disease. Lancet Gastroenterol Hepatol. 2023 Jun;8(6):579-590. doi: 10.1016/S2468-1253(23)00011-0. Epub 2023 Mar 15.

    PubMed 36933563

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis (Disorder) and Guselkumab, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.

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 7 inclusion and 8 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 Yi Jiang, Doctor of Medicine (+8613676715542, wzjiangyi@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

48-week endoscopic remission (time frame: 48 weeks). 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 NCT07726888, which also lists 10 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 20 Oct 2026.

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