A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic Clinical Trial

Official title:

A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01127321
• Other study ID #: MI-CP209
• Status: Terminated
• Phase: Phase 1
• First received: April 14, 2010
• Last updated: August 11, 2014
• Start date: May 2010
• Est. completion date: July 2012

Study information

• Verified date: August 2014
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).

Description:

This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of MEDI-570 in adult subjects with moderately to severely active SLE.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meet or have met at least 4 of the 11 revised American College of Rheumatology (ACR) classification criteria for systemic lupus erythematosus (SLE)

• Score greater than or equal to (>=) 6 points on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Screening

• Ability to complete the study period, including follow-up period through Day 169

• Willingness to forego other forms of experimental treatment during the study.

Exclusion Criteria:

• History of cancer except basal cell carcinoma treated with apparent success with curative therapy >=1 year before randomization into the study

• Evidence of active or latent tuberculosis (TB)

• History of primary immunodeficiency

• Evidence of infection at any time with hepatitis B or C virus or human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at Screening

• History of sepsis or serious, recurrent, chronic infection, current signs and symptoms of clinically significant chronic infection, or recent (within 6 months before Baseline visit) serious infection

• Any history or evidence of opportunistic infection within 6 months of Screening including severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)

• Receipt of cyclophosphamide (intravenous or oral) within 6 months of Screening

• Have any absolute contraindications to skin punch biopsies, for example, a history of coagulation disorders.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Other:
• Placebo
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.

Biological:
• MEDI-570 0.03 MG
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
• MEDI-570 0.1 MG
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
• MEDI-570 0.3 MG
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
• MEDI-570 1 MG
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.

Locations

Country	Name	City	State
Canada	Research Site	London	Ontario
Mexico	Research Site	Chihuahua
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mexico
Peru	Research Site	Lima
Peru	Research Site	Trujillo
South Africa	Research Site	Cape Town
South Africa	Research Site	Johannesburg
United States	Research Site	Atlanta	Georgia
United States	Research Site	Columbus	Ohio
United States	Research Site	Ft. Lauderdale	Florida
United States	Research Site	Lansing	Michigan
United States	Research Site	Long Beach	California
United States	Research Site	New York	New York
United States	Research Site	Ocala	Florida
United States	Research Site	San Leandro	California
United States	Research Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  Mexico,  Peru,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.	Day 1 to Day 169	Yes
Secondary	Pharmacokinetic Parameters for MEDI-570	Following pharmacokinetic parameters were to be evaluated by using non-compartmental analysis: t1/2 = terminal phase elimination half-life which is the time measured for the serum concentration to decrease by one half; tmax = time to maximum observed serum concentration; Cmax = maximum observed serum concentration; AUC (0-t) = area under the serum concentration-time curve from time 0 to last measurable concentration; AUC (0-infinity) = area under the serum concentration-time curve from time 0 to extrapolated infinite time obtained from AUC (0-t) plus AUC (t-infinity); Vz/F = apparent volume of distribution, which is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug; CL/F = apparent clearance which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.	Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169	No
Secondary	Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit		Predose on Day 1; Day 85, 113, and 169	Yes

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