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A study on the efficacy and safety of risankizumab in the treatment of Crohn’s disease

A study on the efficacy and safety of risankizumab in the treatment of Crohn’s disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121567
Enrollment
Unknown
Registered
2026-04-01
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

Guselkumab Treatment Group (CD Cohort):None
Healthy Control Group (Healthy Control Cohort):None

Sponsors

The Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. CD Group Subjects: (1) Voluntarily signed informed consent form (2) Adults aged 18-60 years (3) Diagnosed with CD according to the "Consensus Opinion on the Diagnosis and Treatment of Crohn's Disease (2018, Beijing)" (4) Currently receiving risankizumab treatment 2. Healthy Control Group: (1) Voluntarily signed informed consent form (2) Adults aged 18-60 years (3) Healthy volunteers

Exclusion criteria

Exclusion criteria: 1. The subject is unwilling or unable to provide screening biopsy, blood or feces; 2. The subject is pregnant; 3. has known bleeding disorders; 4. is diagnosed with undefined IBD; 5. has malignant tumors; 6. has acute gastrointestinal infections; 7. is diagnosed with colitis of unknown cause; 8. is diagnosed with autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus)

Design outcomes

Primary

MeasureTime frame
Clinical response rate, clinical remission rate, endoscopic response rate, endoscopic remission rate at Weeks 12-24;Clinical response rate, clinical remission rate, endoscopic response rate, endoscopic remission rate at Week 48;

Countries

China

Contacts

Public ContactYang Hongsheng

The Sixth Affiliated Hospital, Sun Yat-sen University

hensonyang@foxmail.com+86 20 3837 9764

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026