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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01127321
• Date of registration: 14/04/2010
• Prospective Registration: Yes
• Primary sponsor: MedImmune LLC
• Public title: A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
• Scientific title: A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE
• Date of first enrolment: May 2010
• Target sample size: 44
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01127321
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Canada, Mexico, Peru, South Africa, United States

Contacts

• Name: David Close, PhD
• Affiliation: MedImmune Ltd

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Other: Placebo

Biological: MEDI-570 0.3 MG

Biological: MEDI-570 0.1 MG

Biological: MEDI-570 0.03 MG

Biological: MEDI-570 1 MG

Primary Outcome(s)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [Time Frame: Day 1 to Day 169]

Secondary Outcome(s)

Pharmacokinetic Parameters for MEDI-570 [Time Frame: Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169]

Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit [Time Frame: Predose on Day 1; Day 85, 113, and 169]

Secondary ID(s)

MI-CP209

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AstraZeneca

Results

• Results available: Yes
• Date Posted: 26/08/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01127321