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A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)

NCT ID: NCT07310095

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-16

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Guselkumab Treatment

Participants will receive Guselkumab intravenously (IV) every 4 weeks during the induction phase, followed by subcutaneous (SC) administration of Guselkumab every 4 weeks from Week 12 through Week 44 as maintenance therapy.

Group Type EXPERIMENTAL

Guselkumab (GUS)

Intervention Type DRUG

Guselkumab will be administered intravenously or by subcutaneous injection.

Interventions

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Guselkumab (GUS)

Guselkumab will be administered intravenously or by subcutaneous injection.

Intervention Type DRUG

Other Intervention Names

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TREMFYA

Eligibility Criteria

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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 and either mean daily stool frequency (SF) count \>= 4 or mean daily abdominal pain (AP) score \>=2
* Participants had received at least two doses of ustekinumab (UST) (induction of 6 milligram \[mg\]/kilogram \[kg\] intravenous \[IV\] followed by 90 mg subcutaneous \[SC\] at week 8) as the instruction manual
* 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

* Have responded well to treatment with UST in a dosing regime that is not in line with to the approved recommended dosing (for example, multiple intravenous induction) experienced optimized treatment with UST(not as instruction manual)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xi'an Janssen Pharmaceutical Clinical Trial

Role: STUDY_DIRECTOR

Xi'an Janssen Pharmaceutical

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

Other Identifiers

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CNTO1959CRD4007

Identifier Type: OTHER

Identifier Source: secondary_id

CNTO1959CRD4007

Identifier Type: -

Identifier Source: org_study_id