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

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ClinicalTrials.gov Identifier: NCT04033445
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : June 21, 2022
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: Placebo Drug: Guselkumab 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 long-term guselkumab treatment. 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 6, 2023
Estimated Study Completion Date : September 29, 2029

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.
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.
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.
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.
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.
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 44 [ Time Frame: Week 44 ]
    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 Mucosal Healing at Week 12 [ Time Frame: Week 12 ]
    Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.

  5. Induction Study 1: Endoscopic Normalization at Week 12 [ Time Frame: Week 12 ]
    Endoscopic normalization per endoscopy subscore.

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

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

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

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

  10. Induction Study 2: Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12 [ Time Frame: Week 12 ]
    IBDQ remission is defined as total IBDQ score greater than or equal to (>=) 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (IBD) that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

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

  12. Induction Study 2: Fatigue Response at Week 12 [ Time Frame: Week 12 ]
    Fatigue response is defined as an improvement from induction baseline in patient-reported outcomes measurement information system (PROMIS)-fatigue short form 7a. The PROMIS Fatigue Short Form 7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). PROMIS Fatigue Short Form 7a has a recall period of past 7 days.

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

  14. Induction Study 2: Endoscopic Normalization at Week 12 [ Time Frame: Week 12 ]
    Endoscopic normalization per endoscopy subscore.

  15. Maintenance Study: Symptomatic Remission at Week 44 [ Time Frame: Week 44 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.

  16. Maintenance Study: Endoscopic Healing at Week 44 [ Time Frame: Week 44 ]
    Endoscopic healing per endoscopy subscore.

  17. Maintenance Study: Corticosteroid-free Clinical Remission at Week 44 [ Time Frame: Week 44 ]
    Corticosteroid-free clinical remission per modified Mayo score.

  18. Maintenance Study: Clinical Response at Week 44 [ Time Frame: Week 44 ]
    Clinical response per modified Mayo score.

  19. Maintenance Study: Histo-Endoscopic Mucosal Healing at Week 44 [ Time Frame: Week 44 ]
    Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.

  20. Maintenance Study: IBDQ Remission at Week 44 [ Time Frame: Week 44 ]
    IBDQ remission is defined as total IBDQ score >= 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

  21. Maintenance Study: Fatigue Response at Week 44 [ Time Frame: Week 44 ]
    Fatigue response is defined as an improvement from induction baseline in PROMIS-fatigue short form 7a. The PROMIS Fatigue Short Form 7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). PROMIS Fatigue Short Form 7a has a recall period of past 7 days.

  22. Maintenance Study: Clinical Remission at Week 44 Among the Participants Who had Achieved Clinical Remission at Maintenance Baseline [ Time Frame: Week 44 ]
    Clinical remission per modified Mayo score.

  23. Maintenance Study: Endoscopic Normalization at Week 44 [ Time Frame: Week 44 ]
    Endoscopic normalization per endoscopy subscore.


Eligibility Criteria
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Information from the National Library of Medicine

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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


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

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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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: June 21, 2022
Last Verified: June 2022
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