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Vixarelimab

Phase 1

Moderate to Severe Ulcerative Colitis | Small molecule | Gastrointestinal |Roche Holding AG|Last Updated: Jul 16, 2026

Target and mechanism

Molecular targetOSMR
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Vixarelimab · 1 trial · 1 indication

Phase 1 1
NCT06693908A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative ColitisModerate to Severe Ulcerative Colitis
ACTIVE NOT_RECRUITING24 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis
Moderate to Severe Ulcerative ColitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Fibroblast Products From Colonic Tissue
Baseline up to approximately 3 months

Secondary Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
VixarelimabDRUGVixarelimab will be administered as per the schedule specified.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 i...

Countries:Germany
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Recent Changes (Last 90 Days)

LOWJul 17, 2026NCT06693908enrollmentType: changed
LOWJul 17, 2026NCT06693908enrollmentType: changed
LOWJul 17, 2026NCT06693908enrollmentType: changed

Frequently asked questions about Vixarelimab

What is Vixarelimab used for in Moderate to Severe Ulcerative Colitis?

Vixarelimab is an investigational antibody being studied for the treatment of moderate to severe active ulcerative colitis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a clinical trial to assess its activity and safety in participants with this condition.

What does Vixarelimab target?

Vixarelimab is a monoclonal antibody, indicated by its -mab suffix, designed to target a specific molecular pathway involved in inflammation. As an antibody-based therapy, it is intended to modulate immune responses implicated in ulcerative colitis. The precise molecular target is not disclosed in the available information.

Who makes Vixarelimab?

Vixarelimab is being developed by Roche Holding AG, a multinational healthcare company traded under the ticker symbol RHHBY. Roche is conducting clinical research on this investigational drug for moderate to severe ulcerative colitis, with the drug currently in Phase 1 development.

What phase is Vixarelimab in?

Vixarelimab is in Phase 1 clinical development for moderate to severe ulcerative colitis. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is active but not recruiting participants, with a planned enrollment of 24 individuals.

What clinical trials is Vixarelimab in?

Vixarelimab is being evaluated in a single Phase 1 clinical trial registered as NCT06693908. This study, titled 'A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis,' is active but not recruiting. It is an uncontrolled, open-label trial enrolling 24 participants in Germany.

Is Vixarelimab the same as any other drug?

No alternative names for Vixarelimab have been identified. The drug is known by its single name, Vixarelimab, and is being developed by Roche Holding AG. It is a distinct investigational antibody therapy for moderate to severe ulcerative colitis, currently in Phase 1 clinical trials.