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A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

NCT03662542 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2023-12-12

Study results available
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Summary

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

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Guselkumab Dose 1

Guselkumab Dose 1 will be administered as IV infusion.

DRUG

Guselkumab Dose 2

Guselkumab Dose 2 will be administered as SC injection.

DRUG

Golimumab Dose 1

Golimumab Dose 1 will be administered as SC injection.

DRUG

Golimumab Dose 2

Golimumab Dose 2 will be administered as SC injection.

DRUG

Placebo

Placebo will be administered.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2020-12-01
Completion
2021-11-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Germany
  • Mexico
  • Poland
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03662542 on ClinicalTrials.gov