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

MedImmune

Status and phase: Terminated; Phase 1

Conditions: Lupus Erythematosus, Systemic

Treatments: Biological: MEDI-570 1 MG; Biological: MEDI-570 0.3 MG; Biological: MEDI-570 0.03 MG; Other: Placebo; Biological: MEDI-570 0.1 MG

Study type: Interventional

Funder types: Industry

Identifiers

NCT01127321

MI-CP209

Details and patient eligibility

About

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).

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

MEDI-570 0.03 MG

Experimental group

Description:

A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.

Treatment:

Biological: MEDI-570 0.03 MG

MEDI-570 0.1 MG

Experimental group

Description:

A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.

Treatment:

Biological: MEDI-570 0.1 MG

MEDI-570 0.3 MG

Experimental group

Description:

A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.

Treatment:

Biological: MEDI-570 0.3 MG

MEDI-570 1 MG

Experimental group

Description:

A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.

Treatment:

Biological: MEDI-570 1 MG