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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04033445
Recruitment Status : Suspended (Study will resume; protocol is being amended)
First Posted : July 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Guselkumab Drug: Placebo Phase 2 Phase 3

Detailed 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 guselkumab treatment through at least 64 weeks. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : June 29, 2022
Estimated Study Completion Date : November 29, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Guselkumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Induction Study 1: Guselkumab Dose 1
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.
 Drug: Guselkumab
Participants will receive guselkumab IV or SC.
Other Name: CNTO 1959
Experimental: Induction Study 1: Guselkumab Dose 2
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.
 Drug: Guselkumab
Participants will receive guselkumab IV or SC.
Other Name: CNTO 1959
Experimental: Induction Study 1: Guselkumab Dose 3
Participants will receive guselkumab dose 3 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.
 Drug: Guselkumab
Participants will receive guselkumab IV or SC.
Other Name: CNTO 1959
Placebo Comparator: Induction Study 1: Placebo IV
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.
 Drug: Placebo
Participants will receive matching placebo IV or SC.
Experimental: Induction Study 2: Guselkumab IV
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.
 Drug: Guselkumab
Participants will receive guselkumab IV or SC.
Other Name: CNTO 1959
Placebo Comparator: Induction Study 2: Placebo IV
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.
 Drug: Placebo
Participants will receive matching placebo IV or SC.
Experimental: Maintenance Study: Maintenance Dose Regimen 1
Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).
 Drug: Guselkumab
Participants will receive guselkumab IV or SC.
Other Name: CNTO 1959
Experimental: Maintenance Study: Maintenance Dose Regimen 2
Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).
 Drug: Guselkumab
Participants will receive guselkumab IV or SC.
Other Name: CNTO 1959
Placebo Comparator: Maintenance Study: Placebo SC
Participants will receive matching placebo SC q4w.
 Drug: Placebo
Participants will receive matching placebo IV or SC.


Outcome Measures
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Primary Outcome Measures :
  1. Induction Study 1: Clinical Response at Week 12 [ Time Frame: Week 12 ]
    Clinical response per modified Mayo score.

  2. Induction Study 2: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission per modified Mayo score.

  3. Maintenance Study: Clinical Remission at Week 52 [ Time Frame: Week 52 ]
    Clinical remission per modified Mayo score.


Secondary Outcome Measures :
  1. Induction Study 1: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission per modified Mayo score.

  2. Induction Study 1: Symptomatic Remission at Week 12 [ Time Frame: Week 12 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.

  3. Induction Study 1: Endoscopic Healing at Week 12 [ Time Frame: Week 12 ]
    Endoscopic healing per endoscopy subscore.

  4. Induction Study 1: Histo-endoscopic Healing at Week 12 [ Time Frame: Week 12 ]
    Histo-endoscopic healing per endoscopy subscore and histologic grading.

  5. Induction Study 2: Symptomatic Remission at Week 12 [ Time Frame: Week 12 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.

  6. Induction Study 2: Endoscopic Healing at Week 12 [ Time Frame: Week 12 ]
    Endoscopic healing per endoscopy subscore.

  7. Induction Study 2: Clinical Response at Week 12 [ Time Frame: Week 12 ]
    Clinical response per modified Mayo score.

  8. Induction Study 2: Histo-endoscopic Healing at Week 12 [ Time Frame: Week 12 ]
    Histo-endoscopic healing per endoscopy subscore and histologic grading.

  9. Induction Study 2: Symptomatic Remission at Week 4 [ Time Frame: Week 4 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.

  10. Maintenance Study: Symptomatic Remission at Week 52 [ Time Frame: Week 52 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.

  11. Maintenance Study: Endoscopic Healing at Week 52 [ Time Frame: Week 52 ]
    Endoscopic healing per endoscopy subscore.

  12. Maintenance Study: Corticosteroid-free Clinical Remission at Week 52 [ Time Frame: Week 52 ]
    Corticosteroid-free clinical remission per modified Mayo score.

  13. Maintenance Study: Clinical Response at Week 52 [ Time Frame: Week 52 ]
    Clinical response per modified Mayo score.

  14. Maintenance Study: Histo-endoscopic Healing at Week 52 [ Time Frame: Week 52 ]
    Histo-endoscopic healing per endoscopy subscore and histologic grading.

  15. Maintenance Study: Clinical Remission at Week 52 Among the Participants Who had Achieved Clinical Remission at Maintenance Baseline [ Time Frame: Week 52 ]
    Clinical remission per modified Mayo score.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Contacts and Locations
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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): NCT04033445


Locations
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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
More Information
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Additional Information:
To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04033445    
Other Study ID Numbers: CR108657
2018-004002-25 ( EudraCT Number )
CNTO1959UCO3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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