A Study to Evaluate the Activity, and Safety of Vixarelim... | NCT06693908

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

NCT06693908

Sponsor

Genentech, Inc.

Status

Active, not recruiting

Last Update Posted

Jul 1, 2026Actual

Enrollment

24Estimated

Phase

Phase 1Phase 2

Conditions

Moderate to Severe Ulcerative Colitis

Interventions

Vixarelimab

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2024-516287-29-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2025Actual

Primary Completion Date

Jul 13, 2026Estimated

Completion Date

Aug 18, 2026Estimated

First Submitted Date

Nov 15, 2024

First Submission Date that Met QC Criteria

Nov 15, 2024

First Posted Date

Nov 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2026

Last Update Posted Date

Jul 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vixarelimab	Experimental	Participants will receive subcutaneous (SC) injections of vixarelimab during the treatment period.	Drug: Vixarelimab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vixarelimab	Drug	Vixarelimab will be administered as per the schedule specified.	Vixarelimab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Fibroblast Products From Colonic Tissue		Baseline up to approximately 3 months

Secondary Outcomes

Measure	Description	Time Frame
Serum Concentration of Vixarelimab		Up to approximately 3 months
Number of Participants with Anti-drug Antibodies (ADA) to Vixarelimab		Up to approximately 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité Research Organisation GmbH		Berlin		10117	Germany

References Module

Citations

Not provided