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Trial record 3 of 6 for:    quasar

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 : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE July 24, 2019
First Posted Date  ICMJE July 26, 2019
Last Update Posted Date November 24, 2021
Actual Study Start Date  ICMJE September 26, 2019
Estimated Primary Completion Date June 29, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • Induction Study 1: Clinical Response at Week 12 [ Time Frame: Week 12 ]
    Clinical response per modified Mayo score.
  • Induction Study 2: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission per modified Mayo score.
  • Maintenance Study: Clinical Remission at Week 44 [ Time Frame: Week 44 ]
    Clinical remission per modified Mayo score.
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
  • Induction Study 1: Clinical Response at Week 12 [ Time Frame: Week 12 ]
    Clinical response per modified Mayo score.
  • Induction Study 2: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission per modified Mayo score.
  • Maintenance Study: Clinical Remission at Week 52 [ Time Frame: Week 52 ]
    Clinical remission per modified Mayo score.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2021)
  • Induction Study 1: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission per modified Mayo score.
  • Induction Study 1: Symptomatic Remission at Week 12 [ Time Frame: Week 12 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.
  • Induction Study 1: Endoscopic Healing at Week 12 [ Time Frame: Week 12 ]
    Endoscopic healing per endoscopy subscore.
  • Induction Study 1: Histo-Endoscopic Mucosal Healing at Week 12 [ Time Frame: Week 12 ]
    Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
  • Induction Study 1: Endoscopic Normalization at Week 12 [ Time Frame: Week 12 ]
    Endoscopic normalization per endoscopy subscore.
  • Induction Study 2: Symptomatic Remission at Week 12 [ Time Frame: Week 12 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.
  • Induction Study 2: Endoscopic Healing at Week 12 [ Time Frame: Week 12 ]
    Endoscopic healing per endoscopy subscore.
  • Induction Study 2: Clinical Response at Week 12 [ Time Frame: Week 12 ]
    Clinical response per modified Mayo score.
  • Induction Study 2: Symptomatic Remission at Week 4 [ Time Frame: Week 4 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.
  • 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.
  • Induction Study 2: Histo-Endoscopic Mucosal Healing at Week 12 [ Time Frame: Week 12 ]
    Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
  • 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.
  • Induction Study 2: Symptomatic Remission at Week 2 [ Time Frame: Week 2 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.
  • Induction Study 2: Endoscopic Normalization at Week 12 [ Time Frame: Week 12 ]
    Endoscopic normalization per endoscopy subscore.
  • Maintenance Study: Symptomatic Remission at Week 44 [ Time Frame: Week 44 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.
  • Maintenance Study: Endoscopic Healing at Week 44 [ Time Frame: Week 44 ]
    Endoscopic healing per endoscopy subscore.
  • Maintenance Study: Corticosteroid-free Clinical Remission at Week 44 [ Time Frame: Week 44 ]
    Corticosteroid-free clinical remission per modified Mayo score.
  • Maintenance Study: Clinical Response at Week 44 [ Time Frame: Week 44 ]
    Clinical response per modified Mayo score.
  • Maintenance Study: Histo-Endoscopic Mucosal Healing at Week 44 [ Time Frame: Week 44 ]
    Histo-endoscopic mucosal healing per endoscopy subscore and histologic grading.
  • 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.
  • 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.
  • 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.
  • Maintenance Study: Endoscopic Normalization at Week 44 [ Time Frame: Week 44 ]
    Endoscopic normalization per endoscopy subscore.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
  • Induction Study 1: Clinical Remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission per modified Mayo score.
  • Induction Study 1: Symptomatic Remission at Week 12 [ Time Frame: Week 12 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.
  • Induction Study 1: Endoscopic Healing at Week 12 [ Time Frame: Week 12 ]
    Endoscopic healing per endoscopy subscore.
  • Induction Study 1: Histo-endoscopic Healing at Week 12 [ Time Frame: Week 12 ]
    Histo-endoscopic healing per endoscopy subscore and histologic grading.
  • Induction Study 2: Symptomatic Remission at Week 12 [ Time Frame: Week 12 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.
  • Induction Study 2: Endoscopic Healing at Week 12 [ Time Frame: Week 12 ]
    Endoscopic healing per endoscopy subscore.
  • Induction Study 2: Clinical Response at Week 12 [ Time Frame: Week 12 ]
    Clinical response per modified Mayo score.
  • Induction Study 2: Histo-endoscopic Healing at Week 12 [ Time Frame: Week 12 ]
    Histo-endoscopic healing per endoscopy subscore and histologic grading.
  • Induction Study 2: Symptomatic Remission at Week 4 [ Time Frame: Week 4 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.
  • Maintenance Study: Symptomatic Remission at Week 52 [ Time Frame: Week 52 ]
    Symptomatic remission per stool frequency and rectal bleeding subscores.
  • Maintenance Study: Endoscopic Healing at Week 52 [ Time Frame: Week 52 ]
    Endoscopic healing per endoscopy subscore.
  • Maintenance Study: Corticosteroid-free Clinical Remission at Week 52 [ Time Frame: Week 52 ]
    Corticosteroid-free clinical remission per modified Mayo score.
  • Maintenance Study: Clinical Response at Week 52 [ Time Frame: Week 52 ]
    Clinical response per modified Mayo score.
  • Maintenance Study: Histo-endoscopic Healing at Week 52 [ Time Frame: Week 52 ]
    Histo-endoscopic healing per endoscopy subscore and histologic grading.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Official Title  ICMJE 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
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: Placebo
    Participants will receive matching placebo IV or SC.
  • Drug: Guselkumab
    Participants will receive guselkumab IV or SC.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Guselkumab
  • 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.
    Intervention: Drug: Guselkumab
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Guselkumab
  • 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.
    Intervention: Drug: Placebo
  • Experimental: Maintenance Study: Maintenance Dose Regimen 1
    Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).
    Intervention: Drug: Guselkumab
  • Experimental: Maintenance Study: Maintenance Dose Regimen 2
    Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).
    Intervention: Drug: Guselkumab
  • Placebo Comparator: Maintenance Study: Placebo SC
    Participants will receive matching placebo SC q4w.
    Intervention: 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: July 24, 2019)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 29, 2029
Estimated Primary Completion Date June 29, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Czechia,   France,   Germany,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Jordan,   Korea, Republic of,   Latvia,   Malaysia,   Netherlands,   New Zealand,   Poland,   Portugal,   Russian Federation,   Serbia,   Slovakia,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Romania
 
Administrative Information
NCT Number  ICMJE NCT04033445
Other Study ID Numbers  ICMJE CR108657
2018-004002-25 ( EudraCT Number )
CNTO1959UCO3001 ( 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
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
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 November 2021

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