Crohn'sRecruiting
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
Phase 4 · Testing Guselkumab (GUS) · 5 sites · Xian-Janssen Pharmaceutical Ltd.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Guselkumab (GUS) (a drug) as a possible treatment. Condition(s) listed: Crohn Disease.
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Has a confirmed diagnosis of Crohn's disease (CD)
- Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220
- Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks
- Initially responded to UST induction therapy and then lose response to UST
- During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 78 participants are expected to take part.
- The study has 1 group.
- Start date: 2025-12-30.
- Main results expected around 2027-09-15 (estimate from the record).
- 5 study sites listed (5 marked recruiting) in China.
Groups in this study
- Guselkumab Treatment (listed as: experimental group)
Main thing being measured
- Percentage of Participants Achieving Clinical Remission At Week 48 (At Week 48)
In the researchers’ words
The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.
Words you might see
- Endoscopy: a camera exam inside the digestive tract.
- CDAI: Crohn's Disease Activity Index, a score of how active Crohn's disease is.
- Remission: a period when the disease is quiet or under control.
- Induction: the first phase of treatment, aimed at getting the disease under control.
- Maintenance: longer-term treatment aimed at keeping the disease under control.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
- Stricture: a narrowing (of the bowel or of a bile duct).
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Xian-Janssen Pharmaceutical Ltd. |
| Enrollment | 78 (estimated) |
| Start date | 2025-12-30 |
| Primary completion (est.) | 2027-09-15 |
| First posted | 2025-12-30 |
| Last updated | 2026-09-25 |
| Official title | Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab |
| ClinicalTrials.gov ID | NCT07310095 |
Interventions
- Guselkumab (GUS) (Drug)
Guselkumab will be administered intravenously or by subcutaneous injection.
Full eligibility criteria (from the record)
Inclusion Criteria: * Has a confirmed diagnosis of Crohn's disease (CD) * Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220 * Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks * Initially responded to UST induction therapy and then lose response to UST * During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic Exclusion Criteria: * Received UST dose optimization or multiple intravenous therapy in maintenance phase * Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months * Is currently enrolled in an interventional clinical study * Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome * Have a current or be suspected to have an abscess
Locations (5)
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital Sun Yat sen University | Guangzhou | China | Recruiting |
| The Sixth Affiliated Hospital Sun Yat sen University | Guangzhou | China | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University | Hefei | China | Recruiting |
| Ruijin Hospital | Shanghai | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.