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

NCT07726888 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: SAHoWMU-CR2025-01-232
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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 changes.

Conditions

Ulcerative Colitis (Disorder); Guselkumab

Keywords

moderate-to-severe ulcerative colitis; Guselkumab; efficacy and safety; real-world study

Outcome Measures

Primary Outcomes (2)

• 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, we evaluate endoscopic scores, and calculate the number/proportion of patients achieving endoscopic remission.

  48 weeks

• 48-week histological remission

  We 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). We performed Histological scoring for patients who complete the 48-week treatment course, and evaluate the number/proportion of patients achieving histological remission.

  48 weeks

Secondary Outcomes (11)

• 12-week clinical remission

  12 weeks

• 12-week biochemical remission

  12 weeks

• 12-week intestinal ultrasound response

  12 weeks

• 24-week and 48-week intestinal ultrasound response

  24 weeks; 48 weeks

• 24-week endoscopic response and remission

  24 weeks

Study Arms (1)

Guselkumab treatment group

Drug: Guselkumab

Interventions

Guselkumab DRUG

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.

Guselkumab treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study employs a prospective consecutive enrollment design to include patients with moderate-to-severe active ulcerative colitis who excepts guselkumab treatment at our center based on clinical indications. The inclusion and exclusion criteria are as previously stated.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead
• Xian-Janssen Pharmaceutical Ltd.: collaborator

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325026, China

Location

Related Publications (10)

• 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.

  PMID: 34614172 RESULT

• 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.

  PMID: 36508681 RESULT

• 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.

  PMID: 40835043 RESULT

• 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.

  PMID: 39706209 RESULT

• 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.

  PMID: 28057361 RESULT

• 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.

  PMID: 28057360 RESULT

• 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.

  PMID: 37069321 RESULT

• 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.

  PMID: 38041850 RESULT

• 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.

  PMID: 33359090 RESULT

• 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.

  PMID: 36933563 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specimens including whole blood, serum or plasma, and colon tissue sections.

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Yi Jiang

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Jiang, Doctor of Medicine

CONTACT

+8613676715542; wzjiangyi@yeah.net

guolong Ma, Master of Medicine

CONTACT

15868508303; maguolong2014@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 24, 2026

Record last verified: 2025-12

Locations

CN (1)