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

ConditionUlcerative Colitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • RO7837195

    Drug

    RO7837195 will be administered as per the schedule specified in the protocol.

  • RO7837195 Matched Placebo

    Drug

    RO7837195 matched placebo will be administered as per the schedule specified in the protocol.

Treatment groups

224 Participants
are divided into 5 treatment groups
Group A: RO7837195 Dose Regimen 1Experimental treatment 1 intervention
Group B: RO7837195 Dose Regimen 2Experimental treatment 1 intervention
Group C: RO7837195 Dose Regimen 3Experimental treatment 1 intervention
Group D: RO7837195 Dose Regimen 4Experimental treatment 1 intervention
Group E: RO7837195 Matched Placebo/ RO7837195Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants With Clinical Remission 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.

Time frame
At Week 12

Secondary outcomes

1

Percentage of Participants With Clinical Response 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.

Time frame
At Week 12
2

Percentage of Participants With Endoscopic Improvement at Week 12

Endoscopic improvement is defined as a Mayo endoscopy subscore of ≤ 1.

Time frame
At Week 12
3

Percentage of Participants With Endoscopic Remission at Week 12

Endoscopic remission is defined as a Mayo endoscopy subscore of 0.

Time frame
At Week 12
4

Number of Participants With Adverse Events (AEs)

Time frame
Up to Weeks 65

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov
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