NCT04605094

Efficacy and Safety Study of the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis

Terminated Phase 2 Results posted Last updated 31 August 2023

What this trial tests

Phase 2 trial testing Benralizumab in Atopic Dermatitis in 194 participants. Terminated before completion.

Timeline

12 November 2020

Primary endpoint
25 April 2022

13 September 2022

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	194
Start date	12 November 2020
Primary completion	25 April 2022
Estimated completion	13 September 2022
Sites	51 locations across France, Poland, South Korea, Bulgaria, Australia, United States, Spain, Czechia

Drugs / interventions tested

• Benralizumab (BENRALIZUMAB) — full drug profile →
• Placebo / Benralizumab — full drug profile →

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 12 to 130, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With an Investigator Global Assessment (IGA) 0/1 and a Decrease in IGA of ≥2 Points at Week 16 Relative to Baseline Primary · Baseline (Week 0) and at Week 16

The IGA is an instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease; 4 = severe disease. The IGA used clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. A higher score indicated greater severity. A responder at Week 16 was defined as having IGA 0/1 and a decrease in IGA of ≥2 points at Week 16 relative to baseline. Participants who withdrew from the study/required rescue therapy after Da

Group	Value	95% CI
Benralizumab	9.4	3.36 – 14.93
Placebo	17.3	10.40 – 25.12

Percentage of Participants Who Experienced 75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) at Week 16 Secondary · Baseline (Week 0) and at Week 16

The EASI assessed the severity and extent of AD. Severity of 4 AD disease characteristics (erythema, induration/papulation, excoriation \[scratching\], lichenification) each were assessed on a scale of 0 (absent) to 3 (severe) in each of 4 body regions (head/neck, trunk, upper limbs, and lower limbs). Total body total score=sum of the region total scores; ranged from 0 to 72. Participants were classified as responders if they achieved at least 75% reduction from baseline in their EASI total score at Week 16. Participants who withdrew from study/required rescue therapy after Day 28 were non-res

Group	Value	95% CI
Benralizumab	19.8	11.71 – 27.45
Placebo	24.5	16.27 – 33.19

Percentage of Participants Who Experienced 90% Reduction From Baseline in Eczema Area and Severity Index (EASI-90) at Week 16 Secondary · Baseline (Week 0) and at Week 16

The EASI assessed the severity and extent of AD. Severity of 4 AD disease characteristics (erythema, induration/papulation, excoriation \[scratching\], lichenification) each were assessed on a scale of 0 (absent) to 3 (severe) in each of 4 body regions (head/neck, trunk, upper limbs, and lower limbs). Total body total score=sum of the region total scores; ranged from 0 to 72. Participants were classified as responders if they achieved at least 90% reduction from baseline in their EASI total score at Week 16. Participants who withdrew from study/required rescue therapy after Day 28 were non-res

Group	Value	95% CI
Benralizumab	7.3	2.05 – 12.42
Placebo	15.3	8.33 – 22.50

Percentage of Participants With an Improvement of ≥4 or More Points in Peak Pruritus Weekly Score Secondary · At Week 16

The peak pruritus numeric rating scale (NRS) was a 1-item daily assessment of the worst itch the participant experienced over the past 24 hours. The score ranged from 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable" and so a reduction in score was considered an improvement. A responder was defined as having an improvement of 4 or more points relative to baseline. Participants who withdrew from the study/required rescue therapy after Day 28 were considered as non-responders from the time these events occurred. The Week 16 weekly scores were defined as the average of the dail

Group	Value	95% CI
Benralizumab	14.6	7.87 – 21.70
Placebo	14.3	7.28 – 20.90

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events in the on-study period were reported from the first dose of study treatment (Day 1) up to end of follow-up, approximately a maximum up to Week 60. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Benralizumab

Serious: 3/96 (3%)

Deaths: 0/96

Placebo

Serious: 0/98 (0%)

Deaths: 0/98

Placebo to Benralizumab

Serious: 2/87 (2%)

Deaths: 0/87

Serious adverse events (5 terms)

Reaction	System	Benralizumab	Placebo	Placebo to Benralizumab
Cardiac failure congestive	Cardiac disorders	—	—	—
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Migraine	Nervous system disorders	—	—	—
Paranasal sinus inflammation	Respiratory, thoracic and mediastinal disorders	—	—	—
Dermatitis atopic	Skin and subcutaneous tissue disorders	—	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Benralizumab	Placebo	Placebo to Benralizumab
COVID-19	Infections and infestations	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Conjunctivitis	Infections and infestations	—	—	—
Bronchitis	Infections and infestations	—	—	—
Headache	Nervous system disorders	—	—	—

Most-reported serious reactions: Cardiac failure congestive, Hodgkin's disease, Migraine, Paranasal sinus inflammation, Dermatitis atopic.

Data from ClinicalTrials.gov NCT04605094 adverse events section.

Sponsor's own description

The purpose of the study is to compare the efficacy and safety of benralizumab versus placebo and to compare benralizumab dosing regimens during extension period.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Atopic dermatitis: an expanding therapeutic pipeline for a complex disease.
   Bieber T. · · 2022 · cited 421× · PMID 34417579 · DOI 10.1038/s41573-021-00266-6
2. The translational revolution in atopic dermatitis: the paradigm shift from pathogenesis to treatment.
   Facheris P, Jeffery J, Del Duca E, Guttman-Yassky E. · · 2023 · cited 150× · PMID 36928371 · DOI 10.1038/s41423-023-00992-4
3. Current and emerging biologic therapies targeting eosinophilic disorders.
   Pitlick MM, Li JT, Pongdee T. · · 2022 · cited 37× · PMID 35983569 · DOI 10.1016/j.waojou.2022.100676
4. Unraveling Atopic Dermatitis: Insights into Pathophysiology, Therapeutic Advances, and Future Perspectives.
   Pareek A, Kumari L, Pareek A, Chaudhary S, et al · · 2024 · cited 27× · PMID 38474389 · DOI 10.3390/cells13050425
5. Type 2 immunity-driven diseases: Towards a multidisciplinary approach.
   Hassoun D, Malard O, Barbarot S, Magnan A, et al · · 2021 · cited 23× · PMID 34617355 · DOI 10.1111/cea.14029
6. A Systematic Review of Atopic Dermatitis: The Intriguing Journey Starting from Physiopathology to Treatment, from Laboratory Bench to Bedside.
   Radi G, Campanti A, Diotallevi F, Martina E, et al · · 2022 · cited 17× · PMID 36359220 · DOI 10.3390/biomedicines10112700
7. Advances in Biologic Therapies for Allergic Diseases: Current Trends, Emerging Agents, and Future Perspectives.
   Alska E, Łaszczych D, Napiórkowska-Baran K, Szymczak B, et al · · 2025 · cited 13× · PMID 40004611 · DOI 10.3390/jcm14041079
8. Lessons learned from targeting eosinophils in human disease.
   Kuang FL, Bochner BS. · · 2021 · cited 9× · PMID 33891135 · DOI 10.1007/s00281-021-00849-w