A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR)

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Guselkumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04033445

CNTO1959UCO3001 (Other Identifier)

CR108657

2018-004002-25 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Full description

UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The study is designed to answer scientific questions pertaining to the efficacy and safety of guselkumab in the treatment of moderately to severely active UC. Overall, the study will evaluate long-term guselkumab treatment. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.

Enrollment: 1,064 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented diagnosis of ulcerative colitis (UC)
• Moderately to severely active UC, defined by modified Mayo score
• Demonstrated inadequate response or intolerance to medical therapies specified in the protocol
• Screening laboratory test results within the parameters specified in the protocol

Exclusion criteria

• Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease
• UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
• Presence of a stoma
• Presence or history of a fistula
• Receiving prohibited medications and/or treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,064 participants in 8 patient groups, including a placebo group

Induction Study 1: Guselkumab Dose 1

Experimental group

Description:

Participants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Treatment:

Drug: Guselkumab

Induction Study 1: Guselkumab Dose 2

Experimental group

Description:

Participants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Treatment:

Drug: Guselkumab

Induction Study 1: Placebo IV

Placebo Comparator group

Description:

Participants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Treatment:

Drug: Placebo

Induction Study 2: Guselkumab IV

Experimental group

Description:

Participants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Treatment:

Drug: Guselkumab

Induction Study 2: Placebo IV

Placebo Comparator group

Description:

Participants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Treatment:

Drug: Placebo

Maintenance Study: Maintenance Dose Regimen 1

Experimental group

Description:

Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).

Treatment:

Drug: Guselkumab

Maintenance Study: Maintenance Dose Regimen 2

Experimental group

Description:

Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).

Treatment:

Drug: Guselkumab

Maintenance Study: Placebo SC

Placebo Comparator group

Description:

Participants will receive matching placebo SC q4w.

Treatment:

Drug: Placebo