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NCT Number: NCT04033445

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CEMIC (Centro de Educación Médica e Investigaciones Clínicas), Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Participants will receive matching placebo IV or SC.

Guselkumab

Drug

Participants will receive guselkumab IV or SC.

Primary outcomes

  1. Induction Study 1: Percentage of Participants With Clinical Response at Week I-12

    Time frame: At Week I-12

    Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.

  2. Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12

    Time frame: At Week I-12

    Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.

  3. Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44

    Time frame: At Week M-44

    Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for randomized arms only.

Secondary outcomes

  1. Induction Study 1: Percentage of Participants With Clinical Remission at Week I-12

    Time frame: At Week I-12

  2. Induction Study 1: Percentage of Participants With Symptomatic Remission at Week I-12

    Time frame: At Week I-12

  3. Induction Study 1: Percentage of Participants With Endoscopic Healing at Week I-12

    Time frame: At Week I-12

  4. Induction Study 1: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12

    Time frame: At Week I-12

  5. Induction Study 1: Percentage of Participants With Endoscopic Normalization at Week I-12

    Time frame: At Week I-12

  6. Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-12

    Time frame: At Week I-12

  7. Induction Study 2: Percentage of Participants With Endoscopic Healing at Week I-12

    Time frame: At Week I-12

  8. Induction Study 2: Percentage of Participants With Clinical Response at Week I-12

    Time frame: At Week I-12

  9. Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-4

    Time frame: At Week I-4

  10. Induction Study 2: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12

    Time frame: At Week I-12

  11. Induction Study 2: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12

    Time frame: At Week I-12

  12. Induction Study 2: Percentage of Participants With Fatigue Response at Week I-12

    Time frame: At Week I-12

  13. Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-2

    Time frame: At Week I-2

  14. Induction Study 2: Percentage of Participants With Endoscopic Normalization at Week I-12

    Time frame: At Week I-12

  15. Maintenance Study: Percentage of Participants With Symptomatic Remission at Week M-44

    Time frame: At Week M-44

  16. Maintenance Study: Percentage of Participants With Endoscopic Healing at Week M-44

    Time frame: At Week M-44

  17. Maintenance Study: Percentage of Participants With Corticosteroid-free Clinical Remission at Week M-44

    Time frame: At Week M-44

  18. Maintenance Study: Percentage of Participants With Clinical Response at Week M-44

    Time frame: At Week M-44

  19. Maintenance Study: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week M-44

    Time frame: At Week M-44

  20. Maintenance Study: Percentage of Participants With IBDQ Remission at Week M-44

    Time frame: At Week M-44

  21. Maintenance Study: Percentage of Participants With Fatigue Response at Week M-44

    Time frame: At Week M-44

  22. Maintenance Study: Percentage of Participants With Clinical Remission at Week 44 Among the Participants Who Had Achieved Clinical Remission at Maintenance Baseline

    Time frame: At Week M-44

  23. Maintenance Study: Percentage of Participants With Endoscopic Normalization at Week M-44

    Time frame: At Week M-44

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Acronym: QUASAR

Important dates

Study start
2019
Primary completion
2023
Study completion
2027
First posted
Jul 26, 2019
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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