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

  • STATUS
    Recruiting
  • End date
    Nov 14, 2022
  • participants needed
    210
  • sponsor
    Janssen Research & Development, LLC
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Updated on 17 January 2021
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golimumab

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).

Details
Treatment Placebo, Guselkumab Dose 1, Guselkumab Dose 2, Golimumab Dose 1, Golimumab Dose 2
Clinical Study IdentifierNCT03662542
SponsorJanssen Research & Development, LLC
Last Modified on17 January 2021

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Ulcerative Colitis or Ulcerative Colitis (Pediatric)?
Do you have any of these conditions: Ulcerative Colitis (Pediatric) or Ulcerative Colitis?
Do you have any of these conditions: Ulcerative Colitis (Pediatric) or Ulcerative Colitis?
Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening
Moderately to severely active UC as defined by Mayo score
History of inadequate response to or failure to tolerate conventional therapy
Has screening laboratory test results within the study protocol defined parameters
A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin) pregnancy test result at screening and a negative urine pregnancy test result at Week 0

Exclusion Criteria

Has severe extensive colitis as defined in the study protocol
Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening)
Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients
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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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