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Xilonix

Phase 3

Symptomatic Colorectal Cancer | Monoclonal antibody | Oncology |Johnson & Johnson|Last Updated: Jul 8, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment276

FDA Designations

No designations recorded

Clinical trial landscape

Xilonix · 2 trials · 4 indications

Phase 3 1Phase 2 1
NCT02138422A Phase 3 Study to Evaluate Xilonix as an Anticancer Therapy in Patients With Symptomatic Colorectal CancerSymptomatic Colorectal Cancer
COMPLETED276 Analytics
PHASE3COMPLETED
A Phase 3 Study to Evaluate Xilonix as an Anticancer Therapy in Patients With Symptomatic Colorectal Cancer
Symptomatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Response Rate
8 weeks
Change in Physician's Wound Assessment & Patient's Global Assessment
28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo administered intravenously every 2 weeks
XilonixACTIVE_COMPARATORXilonix administered intravenously every 2 weeks
open label-XilonixEXPERIMENTALOpen label-Xilonix

Interventions

NameTypeDescription
XilonixBIOLOGICAL -
PlaceboBIOLOGICAL -
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Eligibility Criteria

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

Inclusion Criteria: 1. Subjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have failed both an oxaliplatin (oxaliplatin may have been in the adjuvant setting) and an i...

Countries:PolandUnited States
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Frequently asked questions about Xilonix

What is Xilonix used for?

Xilonix is a monoclonal antibody that has been studied for symptomatic colorectal cancer and pyoderma gangrenosum. It is an investigational drug developed by Johnson & Johnson and is not approved by the FDA. Clinical trials have evaluated its use in these conditions.

What does Xilonix target?

Xilonix is a monoclonal antibody, but its specific molecular target has not been disclosed. It has been studied as an anticancer therapy in symptomatic colorectal cancer and for pyoderma gangrenosum, a skin condition.

Who makes Xilonix?

Xilonix is developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational monoclonal antibody and has not received regulatory approval.

What phase is Xilonix in?

Xilonix has completed a Phase 2 clinical trial for pyoderma gangrenosum and a Phase 3 clinical trial for symptomatic colorectal cancer. Both trials are completed, and the drug remains investigational, with no FDA approval.

What clinical trials is Xilonix in?

Xilonix has been studied in two completed clinical trials. NCT01965613 was a Phase 2 open-label study in 10 patients with pyoderma gangrenosum in the United States. NCT02138422 was a Phase 3 study in 276 patients with symptomatic colorectal cancer in Poland.

Is Xilonix the same as any other drug?

Xilonix is the drug name used in clinical trials for this investigational monoclonal antibody. No alternative names have been reported for this drug in the context of its development for symptomatic colorectal cancer and pyoderma gangrenosum.