Ulcerative Colitis
Conditions
Brief summary
Clinical Response, defined as a decrease from baseline of ≥ 2 points and at least 30% in 3 components of the modified Mayo Clinic Score (MCS), Stool Frequency, Rectal Bleeding, and Endoscopic Findings, in addition to a ≥ 1 point decrease from baseline in the Rectal Bleeding subscore or Rectal Bleeding subscore of ≤ 1 at Week 12
Detailed description
Clinical Remission, defined as a Stool Frequency subscore ≤ 1 and not greater than baseline, Rectal Bleeding subscore of 0, and Endoscopic Findings subscore ≤ 1 at Week 12, Endoscopic Response, defined as an Endoscopic Findings subscore ≤ 1 at Week 12, Histologic Endoscopic Mucosal Improvement, defined as an Endoscopic Findings subscore ≤ 1 and Geboes score < 3.1 (indicating neutrophil infiltration in < 5% of crypts, no crypt destruction and no erosions, ulcerations, or granulation tissue) at Week 12
Interventions
DRUGGS-5290 tablets 300 mg
DRUGPTM GS‑5290 tablets 150 mg
DRUGGS-5290 tablets 150 mg
DRUGPTM GS‑5290 tablets 300 mg
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Response, defined as a decrease from baseline of ≥ 2 points and at least 30% in 3 components of the modified Mayo Clinic Score (MCS), Stool Frequency, Rectal Bleeding, and Endoscopic Findings, in addition to a ≥ 1 point decrease from baseline in the Rectal Bleeding subscore or Rectal Bleeding subscore of ≤ 1 at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Remission, defined as a Stool Frequency subscore ≤ 1 and not greater than baseline, Rectal Bleeding subscore of 0, and Endoscopic Findings subscore ≤ 1 at Week 12, Endoscopic Response, defined as an Endoscopic Findings subscore ≤ 1 at Week 12, Histologic Endoscopic Mucosal Improvement, defined as an Endoscopic Findings subscore ≤ 1 and Geboes score < 3.1 (indicating neutrophil infiltration in < 5% of crypts, no crypt destruction and no erosions, ulcerations, or granulation tissue) at Week 12 | — |
Countries
Austria, Belgium, France, Germany, Hungary, Italy, Poland
Outcome results
None listed