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Trial record 2 of 3490 for:    vega study

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

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ClinicalTrials.gov Identifier: NCT03662542
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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).

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: Guselkumab Dose 1 Drug: Guselkumab Dose 2 Drug: Golimumab Dose 1 Drug: Golimumab Dose 2 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : November 17, 2020
Estimated Study Completion Date : August 11, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combination Therapy
Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
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.

Experimental: Monotherapy: Guselkumab
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
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: Placebo
Placebo will be administered.

Active Comparator: Monotherapy: Golimumab
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
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.




Primary Outcome Measures :
  1. Clinical Response at Week 12 [ Time Frame: Week 12 ]
    Clinical response as defined by Mayo score. The Mayo score is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease.


Secondary Outcome Measures :
  1. Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission as defined by Mayo score. The Mayo score is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662542


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03662542     History of Changes
Other Study ID Numbers: CR108527
2018-001510-15 ( EudraCT Number )
CNTO1959UCO2002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs