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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 developed for metabolic conditions, specifically Type 2 Diabetes Mellitus and Type 1 Diabetes. It has been studied in clinical trials for its effects on insulin production in patients with these conditions. The drug is not approved and remains in clinical development.

Who makes XOMA 052?

XOMA 052 is developed by XOMA Royalty Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol XOMA. The company has sponsored clinical trials evaluating the drug in patients with Type 2 and Type 1 Diabetes.

What phase is XOMA 052 in?

XOMA 052 has completed Phase 1 and Phase 2 clinical trials. The most advanced studies were Phase 2 trials in Type 1 Diabetes, which have been completed. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is XOMA 052 in?

XOMA 052 has been studied in four completed clinical trials. These include NCT00513214 and NCT00541983, Phase 1 studies in Type 2 Diabetes, and NCT00998699 and NCT01788033, Phase 2 studies in Type 1 Diabetes. All trials have been completed with a total enrollment of 497 participants.

Is XOMA 052 the same as gevokizumab?

XOMA 052 is also known as gevokizumab, an investigational drug being studied for metabolic diseases. The drug has been evaluated in clinical trials for Type 2 Diabetes Mellitus and Type 1 Diabetes, focusing on its effects on insulin production.