Crohn's Disease
Conditions
Interventions
Experimental group:Guselkumab Injection
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be at least 18 years old; 2. Diagnosed with Crohn's disease (CD); 3. The study participant and/or their legal representative (if applicable) must sign the informed consent form (ICF) agreeing to source data verification as required locally; 4. Diagnosed with active CD, defined as a baseline CDAI score >220 and an average daily stool frequency >4 times or an average daily abdominal pain (AP) score >2; 5. The study participant has received at least two doses of UST according to the approved label (6 mg/kg IV for induction therapy followed by 90 mg SC at week 8); 6. Initially responded to UST induction therapy, then experienced UST loss of response (LoR)*; 7. During screening, the patient received UST as either first-line or second-line biologic therapy. Definition of UST LoR: (1) According to the investigator's assessment, the patient shows or has shown at least one of the following signs or symptoms indicative of CD relapse: 1) Increased stool frequency 2) Worsening daily AP 3) Occurrence or worsening of fever considered related to CD 4) Recurrent drainage from previously non-draining fistulas or new draining fistulas 5) Worsening rectal bleeding 6) Initiation or dose increase of anti-diarrheal medication or (2) Patients with CDAI >220 and an increase of =100 from week 8/16, or those who discontinued treatment due to lack of efficacy, can be enrolled in this study for data collection.
Exclusion criteria
Exclusion criteria: 1. Participants who respond well to UST treatment under a dosing regimen inconsistent with the approved recommended dosing regimen (e.g., multiple IV inductions); 2. CD participants requiring emergency surgery or endoscopic intervention, or elective surgery within 2 months; 3. Currently participating in an interventional clinical study; 4. Presence of CD complications, such as symptomatic strictures or short bowel syndrome; 5. Current or suspected abscess; 6. Pregnant or breastfeeding participants; 7. Having malignant tumors and undergoing anticancer treatment; 8. Untreated latent tuberculosis (TB) or active TB before or during screening; 9. Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. Exceptions: participants with hepatitis B undergoing antiviral therapy may be enrolled in this study; 10. Patients who have received IL-23p19 inhibitors (for example, participated in clinical trials of guselkumab, risankizumab, or mirikizumab, or prescribed mirikizumab or risankizumab); 11. Patients who have failed JAK inhibitor therapy (for example, prescribed upadacitinib or tofacitinib); 12. Patients who have received any of the following prescription drugs or treatments within the specified time periods: (1) IV corticosteroids within 3 weeks before baseline; (2) Cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks before baseline; (3) 6-mercaptopurine within 4 weeks before baseline; (4) Other immunomodulatory biologics (including approved and investigational biologics) within 12 weeks before baseline or within 5 half-lives before baseline, whichever is longer; (5) Any investigational drug within 4 weeks before baseline or within 5 half-lives before baseline, whichever is longer; (6) Non-autologous stem cell therapies (e.g., Prochymal), natalizumab, efalizumab, or B-cell or T-cell depleting biologics (e.g., rituximab, alemtuzumab, or visilizumab) within 12 months before baseline; (7) Apheresis of blood components (e.g., Adacolumn apheresis) or total parenteral nutrition therapy for CD within 3 weeks before baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving Clinical Remission At Week 48 Clinical remission is defined as less than (<) 150-point reduction in Crohn's Disease Activity Index (CDAI) score.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48 Clinical response is defined as greater than or equal to (>=) 100-point reduction from baseline in CDAI score.;Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24 Clinical remission is defined as =50% improvement from baseline in Simple Endoscopic Score for Crohn'sDisease (SES-CD) score;Percentage of Participants Achieving Endoscopic Remission at W24/W48 Endoscopic remission is defined as SES-CD less than or equal to (<=) 2 in any individual component; | — |
Countries
China
Contacts
Public ContactRui Feng
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed