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gevokizumab

Phase 3

Acne Vulgaris | Monoclonal antibody | Dermatology |XOMA Royalty Corporation|Trials Updated: Feb 3, 2016

gevokizumab development status

Highest phase Phase 3 (NCT02318914)
Phase scored for XOMAPhase 2
Registered trials 14 across 4 sponsors since Dec 2011

gevokizumab target and mechanism

Molecular targetIL1B
Target classNegative Allosteric Modulator
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials5
Total Enrollment323

FDA Designations

No designations recorded

gevokizumab clinical trials

gevokizumab · 5 trials · 4 indications

Phase 2 5
NCT01950312The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear DiseaseAutoimmune Inner Ear Disease
COMPLETED10 Analytics
NCT01882491Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the HandOsteoarthritis
COMPLETED91 Analytics
NCT01882504Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma GangrenosumPyoderma Gangrenosum
COMPLETED8 Analytics
NCT01683396Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the HandOsteoarthritis
COMPLETED87 Analytics
NCT01498874Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne VulgarisAcne Vulgaris
COMPLETED127 Analytics
PHASE2COMPLETED
The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
Autoimmune Inner Ear DiseaseUnlock trial analytics
PHASE2COMPLETED
Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand
OsteoarthritisUnlock trial analytics
PHASE2COMPLETED
Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum
Pyoderma GangrenosumUnlock trial analytics
PHASE2COMPLETED
Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand
OsteoarthritisUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris
Acne VulgarisUnlock trial analytics

Study Endpoints

Primary Endpoints

Improved hearing threshold, as defined by an improvement in either the PTA (Pure Tone Average) of >=5 dB (Decibel), or 12% in the WRS (Word Recognition Score)
Day 28 to Day 84
Percent change from baseline in AUSCAN pain score at Day 84
Baseline and Day 84

The Australian/Canadian (AUSCAN) Osteoarthritis Hand Index is a self-report assessment of pain, stiffness, and function in patients with hand osteoarthritis.

Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer
Day 1 through Day 84
The mean absolute change from baseline in inflammatory facial lesion count at Day 84
Baseline and Day 84

Secondary Endpoints

The proportion of subjects with a successful treatment outcome at Day 84
Baseline and Day 84
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
gevokizumabEXPERIMENTALSolution for subcutaneous injection
PlaceboPLACEBO_COMPARATOR -
low dose gevokizumabEXPERIMENTAL -
high dose gevokizumabEXPERIMENTAL -

Interventions

NameTypeDescription
gevokizumabDRUG -
PlaceboDRUGSolution for subcutaneous injection
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Autoimmune Inner Ear Disease with active deterioration in at least one ear * Failure to respond to a trial of high-dose corticosteroid therapy * Contraceptive measures adequate to prevent pregnancy during the study Exclusion Criteria: * Evidence of retrocochlear pathology (v...

Countries:United States
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Frequently asked questions about gevokizumab

What is gevokizumab?

Gevokizumab is an investigational monoclonal antibody developed by XOMA Royalty Corporation. It has been studied in Phase 2 clinical trials for several inflammatory and immune-related conditions, including acne vulgaris, autoimmune inner ear disease, osteoarthritis, and pyoderma gangrenosum. It is not approved and remains in clinical development.

What does gevokizumab target?

Gevokizumab targets IL1B, also known as interleukin-1 beta. It is classified as a negative allosteric modulator of this target, meaning it binds in a way that reduces IL1B signaling rather than blocking the binding site directly. This mechanism is intended to dampen inflammatory pathways driven by IL1B.

Who makes gevokizumab?

Gevokizumab is developed by XOMA Royalty Corporation, which trades under the ticker XOMA. The company is the sponsor associated with the drug's clinical development program.

What phase is gevokizumab in?

Gevokizumab is in Phase 2 clinical development. It is an investigational monoclonal antibody and is not FDA approved. The completed Phase 2 studies evaluated the drug across several indications, and no active trials are currently listed for this asset.

What clinical trials is gevokizumab in?

Gevokizumab has been evaluated in completed Phase 2 trials. These include NCT01950312 in corticosteroid-resistant autoimmune inner ear disease, NCT01882504 in pyoderma gangrenosum, and NCT01882491 and NCT01683396 in erosive osteoarthritis of the hand. All four studies were randomized, double-blind, and placebo-controlled, with a combined enrollment of 178 participants.

What is gevokizumab used for in osteoarthritis?

Gevokizumab was studied in Phase 2 trials for erosive osteoarthritis of the hand. Two completed studies, NCT01882491 and NCT01683396, enrolled 91 and 87 participants respectively and were randomized, double-blind, and placebo-controlled. The drug is investigational and has not been approved for osteoarthritis or any other indication.