Clinical trial NCT01258907: A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)
Official title: A Multicenter, Randomized, Double Blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER - Goal of Oxidized Ldl and Activated Macrophage Inhibition by Exposure to a Recombinant Antibody)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atherosclerosis
Keywords: BI-204
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: BioInvent International AB
First posted: 2010-12-13
Enrollment: 147
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT.


Eligibility criteria: Inclusion Criteria:

* Evidence of qualifying vessel (carotid or aortic) plaque inflammation
* Documented atherosclerotic vascular disease clinically stable for at least 3 months prior to screening or type 2 diabetes mellitus with elevated cardiovascular risk
* Use of a stable dose of statin therapy for at least 6 weeks prior to screening. Patients must be capable of maintaining statin therapy at a current dose level from screening until the last follow-up visit.
* For patients taking angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to screening and capable of continuing with that dose for the duration of the study

Exclusion Criteria:

* Occurrence of a cardiovascular event \< 6 months prior to screening
* Pregnant, planning to become pregnant during the study, or breastfeeding
* Clinically significant abnormal laboratory values or abnormal ECG or vital signs
* History of anaphylactic reactions
* Newly discovered Type 2 diabetes mellitus (T2DM) (prior to study entry) or medical treatment for T2DM started \< 3 months prior to study entry
* Use of insulin, corticosteroids (oral, rectal, or injectable), or other immunosuppressive medications
* Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C
* Impaired renal function
* History of malignancy within 2 years prior to screening
* Current life-threatening condition other than vascular disease that may prevent a patient from completing the study
* Use of an investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
* Exposure to substantial radiation within 12 months prior to screening

Primary outcomes:
measure: Change in TBR as measured by FDG-PET/CT
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLDL1278A
timeFrame: Throughout study or until early discontinuation
measure: Effects of MLDL1278A on inflammatory and metabolic biomarkers
timeFrame: Throughout study or until early discontinuation
Other outcomes:
Locations:
city: Torrance
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: Haverhill
country: United States
state: Massachusetts
city: Royal Oak
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Newington
country: United States
state: New Hampshire
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: North Massapequa
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Genentech, Inc.
name: Joshua Lehrer-Graiwer, M.D.
role: STUDY_DIRECTOR
References: