Trial Outcomes & Findings for Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis (NCT NCT01585766)
NCT ID: NCT01585766
Last Updated: 2018-10-29
Results Overview
An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE were the events between administration of study drug (Day 1) and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
From study drug administration (Day 1) through the end of treatment period (Day 169)
Results posted on
2018-10-29
Participant Flow
This study was conducted from 30 Jul 2012 to 20 Jun 2016 in United States, Poland, Spain, and Ukraine.
A total of 56 participants were screened in this study. Out of which 28 participants were enrolled and randomized into the study.
Participant milestones
| Measure |
PLACEBO-IV-SC
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
3
|
4
|
3
|
6
|
|
Overall Study
COMPLETED
|
7
|
3
|
1
|
4
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
PLACEBO-IV-SC
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
PLACEBO-IV-SC
n=7 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=5 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=3 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=4 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=3 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
n=6 Participants
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.0 Years
STANDARD_DEVIATION 15.9 • n=99 Participants
|
42.4 Years
STANDARD_DEVIATION 7.8 • n=107 Participants
|
46.7 Years
STANDARD_DEVIATION 16.3 • n=206 Participants
|
46.5 Years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
56.0 Years
STANDARD_DEVIATION 6.1 • n=31 Participants
|
44.2 Years
STANDARD_DEVIATION 10.1 • n=30 Participants
|
45.4 Years
STANDARD_DEVIATION 12.0 • n=3 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: From study drug administration (Day 1) through the end of treatment period (Day 169)Population: Safety Population is defined as all participants who received any amount of study drug.
An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE were the events between administration of study drug (Day 1) and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0
Outcome measures
| Measure |
PLACEBO-IV-SC
n=7 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=5 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=3 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=4 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=3 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
n=6 Participants
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
6 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From study drug administration (Day 1) through the long term follow up period (up to 18 months after early discontinuation visit or 24 week treatment period).Population: Safety Population
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect in the offspring of a participant who received the study drug. The TESAEs were the events between administration of study drug (Day 1) and long term follow up period (up to 18 months after early discontinuation visit or 24-week treatment period) that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0
Outcome measures
| Measure |
PLACEBO-IV-SC
n=7 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=5 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=3 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=4 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=3 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
n=6 Participants
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From study drug administration (Day 1) through the end of treatment period (Day 169)Population: Safety Population
Any clinically significant change in laboratory evaluations were recorded as AEs. The following parameters were analyzed for laboratory evaluations: haematology, serum chemistry, and urinalysis. Number of participants with TEAEs related to laboratory evaluations were reported.
Outcome measures
| Measure |
PLACEBO-IV-SC
n=7 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=5 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=3 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=4 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=3 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
n=6 Participants
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hematology- Anaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hematology- White blood cell count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Serum chemistry- Liver function test increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Serum chemistry- Hyponatraemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From study drug administration (Day 1) through the end of treatment period (Day 169)Population: Safety Population
Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. The number of participants with TEAEs related to vital signs in participants were reported.
Outcome measures
| Measure |
PLACEBO-IV-SC
n=7 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=5 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=3 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=4 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=3 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
n=6 Participants
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities Reported as TEAEs
Blood pressure decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as TEAEs
Blood pressure increased
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Vital Sign Abnormalities Reported as TEAEs
Tachycardia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169Population: Safety Population
The time to reach the maximum observed serum concentration of MEDI-551.
Outcome measures
| Measure |
PLACEBO-IV-SC
n=5 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=4 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=6 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-551
|
0.14 Day
Interval 0.11 to 0.19
|
2.98 Day
Interval 2.87 to 6.97
|
0.07 Day
Interval 0.01 to 0.11
|
7.92 Day
Interval 7.82 to 8.02
|
0.12 Day
Interval 0.11 to 0.18
|
—
|
SECONDARY outcome
Timeframe: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169Population: Safety Population
The maximum observed serum concentration (Cmax) of MEDI-551.
Outcome measures
| Measure |
PLACEBO-IV-SC
n=5 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=4 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=6 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of MEDI-551
|
17.9 microgram per milliliter (mcg/mL)
Standard Deviation 13.2
|
6.67 microgram per milliliter (mcg/mL)
Standard Deviation 2.88
|
43.1 microgram per milliliter (mcg/mL)
Standard Deviation 11.4
|
24.7 microgram per milliliter (mcg/mL)
Standard Deviation 9.37
|
248 microgram per milliliter (mcg/mL)
Standard Deviation 66.8
|
—
|
SECONDARY outcome
Timeframe: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169Population: Safety Population
The area under the concentration time curve from time 0 (dosing time) to the last measurable concentration (AUC 0-last) of MEDI-551.
Outcome measures
| Measure |
PLACEBO-IV-SC
n=5 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=4 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=6 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-last) of MEDI-551
|
436 microgram*day per milliliter(mcg*day/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n=2). Two out of five participants received only one dose and 1 participant had insufficient data.
|
197 microgram*day per milliliter(mcg*day/mL)
Standard Deviation 92.6
|
1140 microgram*day per milliliter(mcg*day/mL)
Standard Deviation 278
|
788 microgram*day per milliliter(mcg*day/mL)
Standard Deviation 455
|
6850 microgram*day per milliliter(mcg*day/mL)
Standard Deviation 1340
|
—
|
SECONDARY outcome
Timeframe: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169Population: Safety Population
The area under the concentration-time curve from dosing extrapolated to infinity (AUC 0-infinity) of MEDI-551.
Outcome measures
| Measure |
PLACEBO-IV-SC
n=5 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=4 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=6 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity) of MEDI-551
|
440 mcg*day/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n=2). Two out of five participants received only one dose and 1 participant had insufficient data.
|
201 mcg*day/mL
Standard Deviation 91.5
|
1150 mcg*day/mL
Standard Deviation 286
|
794 mcg*day/mL
Standard Deviation 453
|
6950 mcg*day/mL
Standard Deviation 1430
|
—
|
SECONDARY outcome
Timeframe: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169Population: Safety Population
The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity post dose normalized by MEDI-551.
Outcome measures
| Measure |
PLACEBO-IV-SC
n=5 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=4 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=6 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Dose Normalized Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity/D) of MEDI-551
|
7.34 mcg*day/mL/mg
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n=2). Two out of five participants received only one dose and 1 participant had insufficient data.
|
3.35 mcg*day/mL/mg
Standard Deviation 1.52
|
5.75 mcg*day/mL/mg
Standard Deviation 1.43
|
2.65 mcg*day/mL/mg
Standard Deviation 1.51
|
5.79 mcg*day/mL/mg
Standard Deviation 1.19
|
—
|
SECONDARY outcome
Timeframe: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169Population: Safety Population
Systemic clearance (CL) for MEDI-551 IV cohorts and apparent clearance (CL/F) for MEDI-551 SC cohorts were calculated
Outcome measures
| Measure |
PLACEBO-IV-SC
n=5 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=4 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=6 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Clearance of MEDI-551
|
139 mL/day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n=2). Two out of five participants received only one dose and 1 participant had insufficient data.
|
351 mL/day
Standard Deviation 177
|
181 mL/day
Standard Deviation 44.5
|
457 mL/day
Standard Deviation 214
|
180 mL/day
Standard Deviation 41.5
|
—
|
SECONDARY outcome
Timeframe: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169Population: Safety Population
The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of MEDI-551.
Outcome measures
| Measure |
PLACEBO-IV-SC
n=5 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=4 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=6 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of MEDI-551
|
17.7 Day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n=2). Two out of five participants received only one dose and 1 participant had insufficient data.
|
12.3 Day
Standard Deviation 1.71
|
17.7 Day
Standard Deviation 6.27
|
15.1 Day
Standard Deviation 4.31
|
18.7 Day
Standard Deviation 2.03
|
—
|
SECONDARY outcome
Timeframe: Predose (Day 1) and Days 4, 8, 15, 29, 57, 85, 113, 141, and 169Population: Safety Population
Bioavailability (F%) is the fraction of the study drug absorbed through non-intravenous administration compared with the corresponding intravenous administration of the same drug.
Outcome measures
| Measure |
PLACEBO-IV-SC
n=3 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=3 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Absolute Subcutaneous Bioavailability (F%) of MEDI-551
|
58 Percentage of bioavailability
|
46 Percentage of bioavailability
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Days -28 to -1)Population: Safety Population
Baseline absolute CD20 count is measured as the average between screening and predose on Day 1.
Outcome measures
| Measure |
PLACEBO-IV-SC
n=7 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=5 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=3 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=4 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=3 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
n=6 Participants
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Absolute CD20 B-cell Count at Baseline
|
190 cells/mcL
Standard Deviation 99.1
|
173 cells/mcL
Standard Deviation 36.1
|
180 cells/mcL
Standard Deviation 108
|
183 cells/mcL
Standard Deviation 65.5
|
366 cells/mcL
Standard Deviation 257
|
201 cells/mcL
Standard Deviation 91.3
|
SECONDARY outcome
Timeframe: Baseline (Days -28 to -1) to long-term follow-up (LTFU) (Up to 18 months after EDV or 24 Week treatment period)Population: Safety Population. No participants in placebo-IV-SC group reached 90% CD20 B-cell depletion.
Time in days of first observation where CD20 counts fall to or below 10 percent (%) of baseline.
Outcome measures
| Measure |
PLACEBO-IV-SC
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=5 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=3 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=4 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=3 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
n=6 Participants
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Time to 90 Percent (%) CD20 B-cell Depletion
|
—
|
15.0 Day
Full Range 1.10 • Interval 13.0 to 16.0
|
88.0 Day
Full Range 50.3 • Interval 4.0 to 94.0
|
25.0 Day
Full Range 6.19 • Interval 15.0 to 29.0
|
15.0 Day
Full Range 4.04 • Interval 15.0 to 22.0
|
14.5 Day
Full Range 5.65 • Interval 4.0 to 17.0
|
SECONDARY outcome
Timeframe: Baseline (Days -28 to -1) to LTFU (Up to 18 months after EDV or 24 Week treatment period)Population: Safety Population. No participants were included in placebo-IV-SC group since no participant reached 90% depletion.
Time in days of last observation where CD20 counts remain at or below 10% of baseline. Participants whose samples are available were analyzed for this outcome measure.
Outcome measures
| Measure |
PLACEBO-IV-SC
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=4 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=2 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=4 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=3 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
n=5 Participants
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Duration of Suppression Greater Than or Equal to 90 % of CD20 B-cell Count
|
—
|
149 Day
Full Range 62.8 • Interval 69.0 to 200.0
|
100 Day
Full Range 28.3 • Interval 77.0 to 123.0
|
180 Day
Full Range 39.2 • Interval 140.0 to 229.0
|
211 Day
Full Range 17.3 • Interval 175.0 to 213.0
|
254 Day
Full Range 45.3 • Interval 244.0 to 332.0
|
SECONDARY outcome
Timeframe: Baseline (Days -28 to -1) to LTFU (Up to 18 months after EDV or 24 Week treatment period)Population: Safety Population
The maximum degree of depletion (intensity) measured during the course of the study for each participant by subtracting 100 from the lowest observed percent of baseline value.
Outcome measures
| Measure |
PLACEBO-IV-SC
n=7 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=5 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=3 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=4 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=3 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
n=6 Participants
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Maximum Change From Baseline in Absolute CD20 of Peripheral Blood B-cell Count to LTFU
|
25.0 Percentage of cells
Standard Deviation 31.2
|
99.8 Percentage of cells
Standard Deviation 0.0770
|
99.2 Percentage of cells
Standard Deviation 0.787
|
99.7 Percentage of cells
Standard Deviation 0.225
|
99.8 Percentage of cells
Standard Deviation 0.182
|
99.8 Percentage of cells
Standard Deviation 0.237
|
SECONDARY outcome
Timeframe: Days 1, 29, 85 and 169Population: Safety Population
A participant was considered anti-drug antibody positive across the study if they had a positive reading at any time point during the study.
Outcome measures
| Measure |
PLACEBO-IV-SC
n=7 Participants
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 30 Mg-IV
n=5 Participants
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 60 Mg-SC
n=3 Participants
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=4 Participants
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=3 Participants
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 600 Mg-IV
n=6 Participants
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Number of Participants Positive for Anti-Drug Antibodies to MEDI-551
Day 1 (Baseline)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Positive for Anti-Drug Antibodies to MEDI-551
Day 29
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Positive for Anti-Drug Antibodies to MEDI-551
Day 85
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Positive for Anti-Drug Antibodies to MEDI-551
Day 169
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
PLACEBO-IV-SC
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
MEDI-551 60 Mg-SC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI-551 100 Mg-IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI-551 300 Mg-SC
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
MEDI-551 30 Mg-IV
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
MEDI-551 600 Mg-IV
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLACEBO-IV-SC
n=7 participants at risk
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 60 Mg-SC
n=3 participants at risk
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=4 participants at risk
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=3 participants at risk
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 30 Mg-IV
n=5 participants at risk
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 600 Mg-IV
n=6 participants at risk
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/4 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
General disorders
Pyrexia
|
0.00%
0/7 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/4 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
1/3 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/6 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/7 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/4 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
20.0%
1/5 • Number of events 2 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/6 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Nervous system disorders
Multiple sclerosis relapse
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/4 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/6 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
Other adverse events
| Measure |
PLACEBO-IV-SC
n=7 participants at risk
Participants received either a fixed IV dose of placebo matching MEDI-551 on Days 1 and 15 or SC injection on Day 1.
|
MEDI-551 60 Mg-SC
n=3 participants at risk
Participants received SC injection of 60 mg MEDI-551 on Day 1.
|
MEDI-551 100 Mg-IV
n=4 participants at risk
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
|
MEDI-551 300 Mg-SC
n=3 participants at risk
Participants received SC injection of 300 mg MEDI-551 on Day 1.
|
MEDI-551 30 Mg-IV
n=5 participants at risk
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
|
MEDI-551 600 Mg-IV
n=6 participants at risk
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
25.0%
1/4 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
1/3 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/6 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
General disorders
Asthenia
|
0.00%
0/7 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
25.0%
1/4 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
1/3 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/6 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
General disorders
Gait disturbance
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
25.0%
1/4 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/6 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
General disorders
Pyrexia
|
0.00%
0/7 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
1/3 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
25.0%
1/4 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/6 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
50.0%
2/4 • Number of events 3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
1/3 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
20.0%
1/5 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Infections and infestations
Oral herpes
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
50.0%
2/4 • Number of events 5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/6 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
25.0%
1/4 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
20.0%
1/5 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/6 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
1/3 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
50.0%
2/4 • Number of events 3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
20.0%
1/5 • Number of events 2 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/6 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
1/3 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/4 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
1/3 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
16.7%
1/6 • Number of events 2 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
28.6%
2/7 • Number of events 8 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
25.0%
1/4 • Number of events 3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
40.0%
2/5 • Number of events 3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
50.0%
3/6 • Number of events 6 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Investigations
Blood pressure increased
|
14.3%
1/7 • Number of events 2 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
1/3 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/4 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
2/6 • Number of events 2 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/4 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
1/3 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Nervous system disorders
Multiple sclerosis relapse
|
14.3%
1/7 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/4 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.00%
0/7 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
25.0%
1/4 • Number of events 2 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
2/6 • Number of events 2 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
33.3%
1/3 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
25.0%
1/4 • Number of events 1 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/3 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/5 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
0.00%
0/6 • AEs were collected from the time of signature on informed consent through Day 169, SAEs were collected upto the long-term follow-up period (up to 18 months after early discontinuation visit or 24-week treatment period).
|
Additional Information
Armando Flor, MD, Director, Clinical Development
MedImmune
Phone: 301-398-1955
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER