NCT06693908

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
4mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Mar 2025Aug 2026

First Submitted

Initial submission to the registry

November 15, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

March 31, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2026

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

November 15, 2024

Last Update Submit

April 16, 2026

Conditions

Moderate to Severe Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Fibroblast Products From Colonic Tissue

    Baseline up to approximately 3 months

Secondary Outcomes (3)

  • Serum Concentration of Vixarelimab

    Up to approximately 3 months

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

    Up to approximately 3 months

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

    Up to approximately 3 months

Study Arms (1)

Vixarelimab

EXPERIMENTAL

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

Drug: Vixarelimab

Interventions

VixarelimabDRUG

Vixarelimab will be administered as per the schedule specified.

Also known as: RO7622888; KPL-716
Vixarelimab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Research Organisation GmbH

Berlin, 10117, Germany

RECRUITING

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GA45735 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.)global-roche-genentech-trials@gene.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2024

First Posted

November 18, 2024

Study Start

March 31, 2025

Primary Completion (Estimated)

June 9, 2026

Study Completion (Estimated)

August 16, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)