A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)


Sponsor: Genentech, Inc.



Purpose of this study

The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

 

Inclusion Criteria:

 

  • Diagnosis of ulcerative colitis (UC) established at least 3 months
  • Moderately to severely active UC assessed by mMS
  • Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC

 

Exclusion Criteria:

 

  • Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
  • Diagnosis of Crohn's disease or indeterminate colitis
  • Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)
  • Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and/or IL-23

 

 

 

Primary Outcome Measures:

 

  • Percentage of Participants With Clinical Remission at Week 12 [Time Frame: At Week 12]
  • Clinical remission is defined as the Modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore of ≤ 1, rectal bleeding subscore of 0, and endoscopy subscore of ≤ 1.

 

 

Secondary Outcome Measures:

 

  • Percentage of Participants With Clinical Response at Week 12 [Time Frame: At Week 12]
  • Clinical response is defined as decrease from baseline in the mMS by ≥2 and ≥ 30% reduction from baseline, with either a decrease of ≥1 in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤1.
  • Percentage of Participants With Endoscopic Improvement at Week 12 [Time Frame: At Week 12]
  • Endoscopic improvement is defined as a Mayo endoscopy subscore of ≤ 1.
  • Percentage of Participants With Endoscopic Remission at Week 12 [Time Frame: At Week 12]
  • Endoscopic remission is defined as a Mayo endoscopy subscore of 0.
  • Number of Participants With Adverse Events (AEs) [Time Frame: Up to Weeks 65]
  • Serum Concentration of RO7837195 [Time Frame: Up to Weeks 65]
  • Percentage of Participants With Anti-drug Antibodies to RO7837195 [Time Frame: Up to Weeks 65]

 

 

Study Locations in Europe: Czechia, France, Germany, Italy, Poland, United Kingdom

 

 

Estimated Enrollment:  224 patients

 

 

Estimated Study Completion Date: 2028-10-31

 

More Information: NCT06979336