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.
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
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.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325026
Yi Jiang, Doctor of Medicine, +8613676715542, wzjiangyi@yeah.net
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.
- Conditions
- Ulcerative Colitis (Disorder), Guselkumab
- 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 group | Role | What they receive |
|---|---|---|
| Guselkumab treatment group | Not described Receives: Drug: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
12-week biochemical remission
- CRP normalization (≤5 mg/L) or reduction by ≥50% from baseline.
- Fecal calprotectin (FC) reduction to <250 μg/g or reduction by ≥50% from baseline.
Measured: 12 weeks
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
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
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
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
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
Hospitalization and surgery rates at week 48
- Incidence of hospitalizations due to inadequate disease control and cumulative length of hospital stay.
- Incidence and timing of intestinal resection or related surgeries performed due to disease activity or complications.
Measured: 48 weeks
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.
Inflammatory Bowel Disease Questionnaire (IBD-Q) scores at week 48
- A total score increase of ≥16 points from baseline is considered a clinically significant improvement.
- 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
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.
- First posted24 Jul 2026
- Study start31 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Xian-Janssen Pharmaceutical Ltd.
- Responsible party
- Sponsor
- Investigators
- Yi Jiang, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
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 34614172Kappelman 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 36508681Buisson 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 40835043Rubin 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 39706209Reich 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 28057361Blauvelt 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 28057360Verstockt 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 37069321Kapizioni 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 38041850Turner 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 33359090Massironi 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