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Trial record 2 of 3871 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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662542
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE September 6, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE November 20, 2018
Actual Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
Clinical Response at Week 12 [ Time Frame: Week 12 ]
Clinical response as defined by Mayo score.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
Clinical Remission at Week 12 [ Time Frame: Week 12 ]
Clinical remission as defined by Mayo score.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Guselkumab Dose 1
    • Drug: Guselkumab Dose 2
    • Drug: Golimumab Dose 1
    • Drug: Golimumab Dose 2
    • Drug: Placebo
  • Experimental: Monotherapy: Guselkumab
    Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
    Interventions:
    • Drug: Guselkumab Dose 1
    • Drug: Guselkumab Dose 2
    • Drug: Placebo
  • Active Comparator: Monotherapy: Golimumab
    Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
    Interventions:
    • Drug: Golimumab Dose 1
    • Drug: Golimumab Dose 2
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2018)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 14, 2022
Actual Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Germany,   Mexico,   Poland,   Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03662542
Other Study ID Numbers  ICMJE CR108527
2018-001510-15 ( EudraCT Number )
CNTO1959UCO2002 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP