Trial Outcomes & Findings for Effect of Benralizumab in Atopic Dermatitis (NCT NCT03563066)

Last Updated: 2025-08-22

Results Overview

The primary objective is to evaluate the effect of benralizumab on the allergen-induced number of eosinophils in the skin assessed by histological examination compared to placebo. Intradermal saline challenge will be used as a control.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Day 65, 24 hours post-intradermal allergen challenge

Results posted on

2025-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	Benralizumab Fixed dose 30mg benralizumab. Benralizumab: Subcutaneous benralizumab injections once per month for 3 months on Days 0, 28 \& 56.	Placebo Control Will appear identical in form to benralizumab arm. Placebo Control: Subcutaneous placebo injections once per month for 3 months on Days 0, 28 \& 56.
Overall Study STARTED	9	11
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Benralizumab in Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Benralizumab n=9 Participants Fixed dose 30mg benralizumab. Benralizumab: Subcutaneous benralizumab injections once per month for 3 months on Days 0, 28 \& 56.	Placebo Control n=11 Participants Will appear identical in form to benralizumab arm. Placebo Control: Subcutaneous placebo injections once per month for 3 months on Days 0, 28 \& 56.	Total n=20 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 14 • n=5 Participants	39 years STANDARD_DEVIATION 14 • n=7 Participants	40 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 65, 24 hours post-intradermal allergen challenge

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Benralizumab n=9 Participants Fixed dose 30mg benralizumab. Benralizumab: Subcutaneous benralizumab injections once per month for 3 months on Days 0, 28 \& 56.	Placebo Control n=11 Participants Will appear identical in form to benralizumab arm. Placebo Control: Subcutaneous placebo injections once per month for 3 months on Days 0, 28 \& 56.
Number of Allergen-induced Eosinophils in the Skin	11.95 cells/mm2 Standard Deviation 28.51	71.15 cells/mm2 Standard Deviation 130.1

SECONDARY outcome

Timeframe: Day 65, at 24 hours post-intradermal allergen challenge

Population: Full analysis set

To evaluate the effect of Benralizumab on the allergen-induced late phase cutaneous response by measuring the skin wheal compared to placebo.

Outcome measures

Outcome measures
Measure	Benralizumab n=9 Participants Fixed dose 30mg benralizumab. Benralizumab: Subcutaneous benralizumab injections once per month for 3 months on Days 0, 28 \& 56.	Placebo Control n=11 Participants Will appear identical in form to benralizumab arm. Placebo Control: Subcutaneous placebo injections once per month for 3 months on Days 0, 28 \& 56.
Allergen-induced Late Phase Cutaneous Response	18.89 millimeters Standard Deviation 6.33	26.57 millimeters Standard Deviation 12.07

Adverse Events

Benralizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gail Gauvreau

McMaster University

Phone: 9055259140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place