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

Janssen (J&J Innovative Medicine)

Status and phase: Not yet enrolling; Phase 4

Conditions: Crohn Disease

Treatments: Drug: Guselkumab (GUS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07310095

CNTO1959CRD4007 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Guselkumab Treatment

Experimental group

Description:

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.

Treatment:

Drug: Guselkumab (GUS)