A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR)
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ClinicalTrials.gov Identifier: NCT04033445 |
Recruitment Status :
Active, not recruiting
First Posted : July 26, 2019
Last Update Posted : May 31, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis | Drug: Placebo Drug: Guselkumab | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1064 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 : | September 21, 2023 |
Estimated Study Completion Date : | October 31, 2027 |

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.
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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. |
- 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.
- 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.

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

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

Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
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: | May 31, 2023 |
Last Verified: | May 2023 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |