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

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01127321
• Collaborator: AstraZeneca (Industry)
• Enrollment: 44
• Locations: 17
• Arms: 5
• Duration (Months): 26
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Systemic	Other: Placebo; Biological: MEDI-570 0.03 MG; Biological: MEDI-570 0.1 MG; Biological: MEDI-570 0.3 MG; Biological: MEDI-570 1 MG	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.	Other: Placebo; A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
Experimental: MEDI-570 0.03 MG A single open-label dose of MEDI-570, 0.03 milligram (mg) 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.
Experimental: MEDI-570 0.1 MG A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.	Biological: MEDI-570 0.1 MG; A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
Experimental: MEDI-570 0.3 MG A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.	Biological: MEDI-570 0.3 MG; A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
Experimental: MEDI-570 1 MG A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.	Biological: MEDI-570 1 MG; A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.

Outcome Measures

Primary Outcome Measures

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

   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.

Secondary Outcome Measures

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

   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.

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Long Beach	California	United States
2	Research Site	San Leandro	California	United States
3	Research Site	Ft. Lauderdale	Florida	United States
4	Research Site	Ocala	Florida	United States
5	Research Site	Atlanta	Georgia	United States
6	Research Site	Lansing	Michigan	United States
7	Research Site	New York	New York	United States
8	Research Site	Winston-Salem	North Carolina	United States
9	Research Site	Columbus	Ohio	United States
10	Research Site	London	Ontario	Canada
11	Research Site	Chihuahua		Mexico
12	Research Site	Guadalajara		Mexico
13	Research Site	Mexico		Mexico
14	Research Site	Lima		Peru
15	Research Site	Trujillo		Peru
16	Research Site	Cape Town		South Africa
17	Research Site	Johannesburg		South Africa

Sponsors and Collaborators

• MedImmune LLC
• AstraZeneca

Investigators

• Study Director: David Close, PhD, MedImmune Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MedImmune LLC
• ClinicalTrials.gov Identifier: NCT01127321
• Other Study ID Numbers: MI-CP209
• First Posted: May 20, 2010
• Last Update Posted: Aug 26, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by MedImmune LLC: Systemic lupus erythematosus; SLE; MEDI-570
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic

Study Results

Participant Flow

Pre-assignment Detail	Due to premature termination of the study, planned treatment cohorts, MEDI-570, 3 milligram (mg) and MEDI-570, 10 mg, were not administered. A total of 17 participants were randomized in the study. An additional 27 participants were screened but not randomized in the study.

Arm/Group Title	Placebo	MEDI-570 0.03 MG	MEDI-570 0.1 MG	MEDI-570 0.3 MG	MEDI-570 1 MG
Arm/Group Description	A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.	A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.	A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.	A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.	A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Period Title: Overall Study
STARTED	3	1	1	7	5
COMPLETED	3	1	1	7	5
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo	MEDI-570 0.03 MG	MEDI-570 0.1 MG	MEDI-570 0.3 MG	MEDI-570 1 MG	Total
Arm/Group Description	A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.	A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.	A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.	A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.	A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.	Total of all reporting groups
Overall Participants	3	1	1	7	5	17
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.3 (10.6)	49.0 (NA)	41.0 (NA)	35.6 (22.2)	39.6 (13.8)	38.4 (16.1)
Sex: Female, Male (Count of Participants)
Female	3 100%	1 100%	1 100%	6 85.7%	5 100%	16 94.1%
Male	0 0%	0 0%	0 0%	1 14.3%	0 0%	1 5.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Description	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.
Time Frame	Day 1 to Day 169

Outcome Measure Data

Analysis Population Description

Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.

Arm/Group Title	Placebo	MEDI-570 0.03 MG	MEDI-570 0.1 MG	MEDI-570 0.3 MG	MEDI-570 1 MG
Arm/Group Description	A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.	A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.	A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.	A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.	A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Measure Participants	3	1	1	7	5
TEAEs	3 100%	1 100%	1 100%	7 100%	4 80%
TESAEs	0 0%	0 0%	1 100%	2 28.6%	0 0%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Due to early termination of the study, the results were reported as individual participant's listings but not statistically summarized.

Arm/Group Title	Placebo	MEDI-570 0.03 MG	MEDI-570 0.1 MG	MEDI-570 0.3 MG	MEDI-570 1 MG
Arm/Group Description	A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.	A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.	A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.	A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.	A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Measure Participants	0	0	0	0	0

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.

Arm/Group Title	Placebo	MEDI-570 0.03 MG	MEDI-570 0.1 MG	MEDI-570 0.3 MG	MEDI-570 1 MG
Arm/Group Description	A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.	A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.	A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.	A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.	A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Measure Participants	3	1	1	7	5
Number [participants]	0 0%	0 0%	0 0%	1 14.3%	1 20%

Adverse Events

Time Frame	Day 1 to Day 169
Arm/Group Title	Placebo		MEDI-570 0.03 MG		MEDI-570 0.1 MG		MEDI-570 0.3 MG		MEDI-570 1 MG
Arm/Group Description	A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.		A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.		A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.		A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.		A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
All Cause Mortality
	Placebo		MEDI-570 0.03 MG		MEDI-570 0.1 MG		MEDI-570 0.3 MG		MEDI-570 1 MG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		MEDI-570 0.03 MG		MEDI-570 0.1 MG		MEDI-570 0.3 MG		MEDI-570 1 MG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)		1/1 (100%)		2/7 (28.6%)		0/5 (0%)
Hepatobiliary disorders
Cholelithiasis	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/7 (0%)	0	0/5 (0%)	0
Infections and infestations
Disseminated tuberculosis	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Gastroenteritis	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		MEDI-570 0.03 MG		MEDI-570 0.1 MG		MEDI-570 0.3 MG		MEDI-570 1 MG
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		1/1 (100%)		1/1 (100%)		7/7 (100%)		5/5 (100%)
Cardiac disorders
Diastolic dysfunction	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/7 (0%)	0	0/5 (0%)	0
Pericardial effusion	1/3 (33.3%)	1	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	0/5 (0%)	0
Pericarditis	1/3 (33.3%)	1	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	0/5 (0%)	0
Endocrine disorders
Hypothyroidism	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Gastrointestinal disorders
Diarrhoea	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/7 (0%)	0	1/5 (20%)	1
Gastritis	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Gastrointestinal ulcer	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/7 (0%)	0	0/5 (0%)	0
Mouth ulceration	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	2/5 (40%)	3
Nausea	1/3 (33.3%)	1	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	1/5 (20%)	1
Oesophageal ulcer	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/7 (0%)	0	0/5 (0%)	0
General disorders
Fatigue	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/7 (28.6%)	2	0/5 (0%)	0
General symptom	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Pain	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Infections and infestations
Acute sinusitis	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Bronchitis	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Candidiasis	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	2	0/7 (0%)	0	0/5 (0%)	0
Herpes zoster	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Influenza	1/3 (33.3%)	1	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Oral candidiasis	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	2	0/5 (0%)	0
Pneumonia	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Sinusitis	0/3 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	1/7 (14.3%)	2	0/5 (0%)	0
Upper respiratory tract infection	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Viral upper respiratory tract infection	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Injury, poisoning and procedural complications
Administration related reaction	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Investigations
Alanine aminotransferase increased	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/7 (0%)	0	0/5 (0%)	0
Blood creatine phosphokinase increased	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Cd4 lymphocytes decreased	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/7 (57.1%)	4	4/5 (80%)	4
Transaminases increased	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Musculoskeletal and connective tissue disorders
Arthritis	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Neck pain	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/7 (0%)	0	1/5 (20%)	1
Systemic lupus erythematosus	1/3 (33.3%)	1	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	1/5 (20%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm	1/3 (33.3%)	1	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	0/5 (0%)	0
Nervous system disorders
Dizziness	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Headache	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	3/7 (42.9%)	3	2/5 (40%)	2
Lethargy	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Psychiatric disorders
Mental disorder due to a general medical condition	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Renal and urinary disorders
Nephrolithiasis	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/7 (0%)	0	0/5 (0%)	0
Pyuria	0/3 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	0/7 (0%)	0	0/5 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Cough	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Pulmonary fibrosis	1/3 (33.3%)	1	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	0/5 (0%)	0
Pulmonary hypertension	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/7 (0%)	0	0/5 (0%)	0
Skin and subcutaneous tissue disorders
Acne	0/3 (0%)	0	0/1 (0%)	0	1/1 (100%)	1	0/7 (0%)	0	0/5 (0%)	0
Cutaneous lupus erythematosus	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Ecchymosis	1/3 (33.3%)	1	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	0/5 (0%)	0
Pruritus allergic	1/3 (33.3%)	1	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	0/5 (0%)	0
Rash erythematous	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Systemic lupus erythematosus rash	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Vasculitic rash	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	0/5 (0%)	0
Vascular disorders
Hot flush	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/7 (0%)	0	1/5 (20%)	1
Vasculitis	0/3 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/7 (14.3%)	1	1/5 (20%)	1

Limitations/Caveats

The study was terminated early by the sponsor due to business reasons.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.