Recent Updates
Recently added Catalysts

gevokizumab

Phase 2

Acne Vulgaris | Small molecule | Dermatology |XOMA Royalty Corporation|Last Updated: Feb 3, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment127

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about gevokizumab

What is gevokizumab used for?

Gevokizumab is an investigational small molecule being studied for acne vulgaris, autoimmune inner ear disease, osteoarthritis, and pyoderma gangrenosum. It has been evaluated in Phase 2 clinical trials for these conditions, all of which are completed. The drug is not approved and remains in clinical development.

Who makes gevokizumab?

Gevokizumab is being developed by XOMA Royalty Corporation, which trades under the ticker XOMA. The company has conducted Phase 2 trials of the drug across multiple indications, including acne vulgaris and osteoarthritis.

What phase is gevokizumab in?

Gevokizumab is in Phase 2 clinical development. All four of its trials, which studied the drug in acne vulgaris, osteoarthritis, pyoderma gangrenosum, and autoimmune inner ear disease, are completed. It is investigational and not yet approved.

What clinical trials is gevokizumab in?

Gevokizumab has completed four Phase 2 trials: NCT01498874 for acne vulgaris (127 participants), NCT01683396 for osteoarthritis (87 participants), NCT01882504 for pyoderma gangrenosum (8 participants), and NCT01950312 for autoimmune inner ear disease (10 participants). All trials were conducted in the United States.

Is gevokizumab FDA approved?

Gevokizumab is not FDA approved. It is an investigational drug that has completed Phase 2 clinical trials for acne vulgaris, osteoarthritis, pyoderma gangrenosum, and autoimmune inner ear disease. Its development status remains in clinical testing.