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CompletedNCT06693908Updated Sep 21, 2026

A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis

A Phase 1 interventional study of Vixarelimab in Moderate to Severe Ulcerative Colitis, sponsored by Genentech, Inc.. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Genentech, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).

02

Conditions studied

  • Moderate to Severe Ulcerative Colitis
03

In context

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of UC established at least 3 months
  • Moderately to severely active UC
  • Participants must meet criteria for either advanced therapy failure or conventional therapy failure

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of Crohn's disease or indeterminate colitis
  • Suspicion of ischemic colitis, radiation colitis, microscopic colitis or infectious colitis
  • Prior colectomy
  • Prior treatment with systemic janus kinase (JAK) inhibitors
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Vixarelimab

    Participants will receive subcutaneous (SC) injections of vixarelimab during the treatment period.

    Drug: Vixarelimab

Interventions

  • DrugVixarelimab

    Vixarelimab will be administered as per the schedule specified.

    Also known as: RO7622888; KPL-716

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Fibroblast Products From Colonic Tissue

    Time frame: Baseline up to approximately 3 months

Secondary outcomes

  1. Serum Concentration of Vixarelimab

    Time frame: Up to approximately 3 months

  2. Number of Participants with Anti-drug Antibodies (ADA) to Vixarelimab

    Time frame: Up to approximately 3 months

  3. Number of Participants With Adverse Events (AEs), With Severity Determined According to Division of AIDS (DAIDS) Toxicity Grading Scale

    Time frame: Up to approximately 3 months

07

Study locations

1 site
  • Charité Research Organisation GmbH
    Berlin, 10117, Germany
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06693908
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Nov 18, 2024
Start date
Mar 31, 2025
Primary completion
Jul 13, 2026
Completion
Aug 18, 2026
Last update
Sep 21, 2026

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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