Trial Outcomes & Findings for A Study to Evaluate the Effect of a Single-Dose Intravenous Administration of MEDI-528 (NCT NCT00483041)

Last Updated: 2014-03-07

Results Overview

The response of biologically active IL-9 in BAL fluid to the segmental allergen challenge, 1-2 days after the applying the allergen, prior to and 2 weeks after investigational product administration.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Baseline (2 to 4 weeks prior to Day 0) and Day 15

Results posted on

2014-03-07

Participant Flow

A total of 11 adult participants participated in the study between 19Jul2007 and 15Oct2008 at 2 sites in the United States of America.

Treatment assignments were determined using a block randomization procedure with a 1:1 ratio through an interactive voice response system. Only participants who had detectable levels of interleukin-9 in the Baseline Visit 2' bronchioalveolar lavage sample will be randomized.

Participant milestones

Participant milestones
Measure	PLACEBO Placebo administered as a single intravenous dose	MEDI528 9 mg MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
Overall Study STARTED	5	6
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	PLACEBO Placebo administered as a single intravenous dose	MEDI528 9 mg MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
Overall Study ABNORMAL LAB DATA AT SCREENING	0	1

Baseline Characteristics

A Study to Evaluate the Effect of a Single-Dose Intravenous Administration of MEDI-528

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PLACEBO n=5 Participants Placebo administered as a single intravenous dose	MEDI528 9 mg n=6 Participants MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion	Total n=11 Participants Total of all reporting groups
Age, Continuous	29.2 Years STANDARD_DEVIATION 7.8 • n=5 Participants	22.3 Years STANDARD_DEVIATION 2.7 • n=7 Participants	25.5 Years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (2 to 4 weeks prior to Day 0) and Day 15

Population: All subjects who were randomized (n=11), received at least one dose of investigational product (MEDI-528 or placebo; n=10), and completed the 2-day BAL and segmental allergen challenge procedures at baseline (2-4 weeks prior to Day 0) and on Days 14 and 15 (n=2; 1 subject in each treatment group).

The response of biologically active IL-9 in BAL fluid to the segmental allergen challenge, 1-2 days after the applying the allergen, prior to and 2 weeks after investigational product administration.

Outcome measures

Outcome measures
Measure	PLACEBO n=1 Participants Placebo administered as a single intravenous dose	MEDI528 9 mg/kg n=1 Participants MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL) Baseline	8.31 Picograms per milliliter 0	4.04 Picograms per milliliter 0
Listing of Total Interleukin-9 (IL-9) Counts by Enzyme-linked Immunosorbent Assay in Bronchoalveolar Lavage Fluid (BAL) Day 15	40.05 Picograms per milliliter	43.01 Picograms per milliliter

SECONDARY outcome

Timeframe: Days 0 - 126

Population: All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10).

Number of participants experiencing adverse events (includes both adverse events and serious adverse events)

Outcome measures

Outcome measures
Measure	PLACEBO n=5 Participants Placebo administered as a single intravenous dose	MEDI528 9 mg/kg n=5 Participants MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
Incidence of Adverse Events	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Days 0 - 126

Population: All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10).

Number of participants experiencing serious adverse events

Outcome measures

Outcome measures
Measure	PLACEBO n=5 Participants Placebo administered as a single intravenous dose	MEDI528 9 mg/kg n=5 Participants MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
Incidence of Serious Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 0, 28, 56, 84, and 126

Population: All participants who were randomized (n=11) and received at least one dose of investigational product (MEDI-528 or placebo; n=10). One subject in the 9 mg/kg group had no sample collected on Day 126.

Number of participants with ADA to MEDI-528