Clinical trial NCT01127321: A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
Official title: A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lupus Erythematosus, Systemic
Keywords: Systemic lupus erythematosus
SLE
MEDI-570
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2010-05-20
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 to Day 169
Secondary outcomes:
measure: Pharmacokinetic Parameters for MEDI-570
timeFrame: Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169
measure: Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit
timeFrame: Predose on Day 1; Day 85, 113, and 169
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Research Site
state: California
city: San Leandro
country: United States
facility: Research Site
state: California
city: Ft. Lauderdale
country: United States
facility: Research Site
state: Florida
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: New York
country: United States
facility: Research Site
state: New York
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: London
country: Canada
facility: Research Site
state: Ontario
city: Chihuahua
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Trujillo
country: Peru
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
Study officials:
affiliation: MedImmune Ltd
name: David Close, PhD
role: STUDY_DIRECTOR
References: