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XOMA 052

Phase 2

Diabetes Mellitus Type 1 | Small molecule | Metabolic |XOMA Royalty Corporation|Last Updated: Mar 4, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

XOMA 052 · 6 trials · 4 indications

Phase 2 4Phase 1 2
NCT01788033Effects of XOMA 052 on Insulin Production in Type 1 DiabetesDiabetes Mellitus Type 1
COMPLETED22 Analytics
NCT01144975Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes MellitusType 2 Diabetes Mellitus
COMPLETED76 Analytics
NCT00998699Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 DiabetesType 1 Diabetes
COMPLETED22 Analytics
NCT01066715Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin MonotherapyType 2 Diabetes Mellitus
COMPLETED421 Analytics
PHASE2COMPLETED
Effects of XOMA 052 on Insulin Production in Type 1 Diabetes
Diabetes Mellitus Type 1
NCT0178803322
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PHASE2COMPLETED
Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus
NCT0114497576
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PHASE2COMPLETED
Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes
Type 1 Diabetes
NCT0099869922
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PHASE2COMPLETED
Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
Type 2 Diabetes Mellitus
NCT01066715421
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Study Endpoints

Primary Endpoints

Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, daily fasting blood glucose measured by the subject using a glucose monitor, and treatment-emergent adverse events.
Day 0 pre-dose through Day 420
Change in beta-cell function as measured by change in C-peptide level during thd MMTT (Mixed meal tolerance test) at Day 112 compared to baseline (Day 0 pre-dose)
Day 0 pre-dose and Day 112
Mean change from baseline (Day 0 pre-dose) in HbA1c at Day 182
Day 0 pre-dose and Day 182
Glycated hemoglobin (HbA1c) at Days 0 and 28.
Day 0 and Day 28
Safety assessed by pre- and post-treatment serial measurements of vital signs.
Part 1: Day 0 pre-treatment through Day 56. Part 2: Day 0 pre-treatment through Day 56. Part 3: Day 0 pre-treatment through Day 84.
Safety assessed by treatment-emergent adverse events.
Part 1: Day 0 post-treatment through Day 56. Part 2: Day 0 post-treatment through Day 56. Part 3: Day 0 post-treatment through Day 84.

Secondary Endpoints

Pharmacokinetic assessments of XOMA 052 from serum samples collected at time points specified in the protocol.
Day 0 pre-dose through Day 420
Anti-inflammatory activity measured by hs-CRP and cytokines collected at time points specified in the protocol.
Day 0 pre-dose through Day 420
Anti-diabetic activity measured by HbA1c, FPG, OGTT, C-peptide, and insulin collected at time points specified in the protocol.
Day 0 pre-dose through Day 420
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
XOMA 052ACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
1ACTIVE_COMPARATOR -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
XOMA 052DRUG0.3 mg/kg XOMA 052. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
PlaceboDRUG0.3 mg/kg Placebo. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosed with T2D (disease duration \>= 6 months) * HbA1c measurements \>= 7.0% and \<= 10.0% * On a stable regimen of metformin monotherapy * Age \>= 18 and \<= 75 * Stable diet and exercise regimen * BMI \<= 40 kg/m2 Exclusion Criteria: * Significant signs and symptoms of...

Countries:SwitzerlandMexicoUnited States
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Frequently asked questions about XOMA 052

What is XOMA 052 used for?

XOMA 052 is an investigational small molecule being studied for Type 1 and Type 2 diabetes mellitus. It is in Phase 2 clinical development for these metabolic conditions. The drug is not approved and remains under investigation.

Who makes XOMA 052?

XOMA 052 is being developed by XOMA Royalty Corporation, a biopharmaceutical company traded on NASDAQ under the ticker XOMA. The company has conducted Phase 2 trials of the drug in diabetes.

What phase is XOMA 052 in?

XOMA 052 is in Phase 2 clinical development. It has completed four Phase 2 trials, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials has XOMA 052 been in?

XOMA 052 has been studied in four completed Phase 2 trials: NCT00998699 and NCT01788033 in Type 1 diabetes in Switzerland, NCT01066715 in Type 2 diabetes in the United States, and NCT01144975 in Type 2 diabetes in Mexico. Total enrollment across these trials was 497 participants.

Is XOMA 052 the same as gevokizumab?

XOMA 052 is also known as gevokizumab. The drug has been studied under both names in clinical trials for diabetes. It is an investigational agent and not approved for any use.