A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Crohns Disease

Treatments: Drug: Guselkumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04397263

CR108801

CNTO1959CRD3003 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have Crohn's Disease (CD) or fistulizing CD of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
• Have moderate to severe CD as assessed by CDAI components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence
• Have screening laboratory test results within the protocol specified parameters
• A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
• Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion criteria

• Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
• Unstable doses of concomitant Crohn's disease therapy
• Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted time frame as specified in the protocol
• Prior exposure to p40 inhibitors or p19 inhibitors
• Any medical contraindications preventing study participation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

38 participants in 1 patient group

Guselkumab

Experimental group

Description:

Participants will receive guselkumab by intravenous (IV) infusion, followed by guselkumab by subcutaneous (SC) injection. Participants who are eligible and willing to continue guselkumab may enter the Long-term extension (LTE) phase and continue to receive guselkumab.

Treatment:

Drug: Guselkumab