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NCT03183024

Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody

Completed Phase 4 Last updated 10 July 2019
What this trial tests

Phase 4 trial testing benralizumab in Chronic Idiopathic Urticaria in 12 participants. Completed in 6 November 2018.

Timeline
12 September 2017
Primary endpoint
6 November 2018
6 November 2018

Quick facts

Lead sponsorJonathan A. Bernstein, MD
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment12
Start date12 September 2017
Primary completion6 November 2018
Estimated completion6 November 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Jonathan A. Bernstein, MD — full company profile →

Who can join

Adults 19 to 70, any sex, with Chronic Idiopathic Urticaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment

Publications & conference data

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

  1. Eosinophil Knockout Humans: Uncovering the Role of Eosinophils Through Eosinophil-Directed Biological Therapies.
    Jacobsen EA, Jackson DJ, Heffler E, Mathur SK, et al · · 2021 · cited 95× · PMID 33646859 · DOI 10.1146/annurev-immunol-093019-125918
  2. Current and emerging treatments for chronic spontaneous urticaria.
    Johal KJ, Saini SS. · · 2020 · cited 26× · PMID 31494233 · DOI 10.1016/j.anai.2019.08.465
  3. Emerging Therapies in Chronic Spontaneous Urticaria.
    Min TK, Saini SS. · · 2019 · cited 21× · PMID 31172716 · DOI 10.4168/aair.2019.11.4.470
  4. Chronic Spontaneous Urticaria: How to Measure It and the Need to Define Treatment Success.
    Armstrong AW, Soong W, Bernstein JA. · · 2023 · cited 17× · PMID 37354293 · DOI 10.1007/s13555-023-00955-7
  5. Presence of positive skin prick tests to inhalant allergens and markers of T2 inflammation in subjects with chronic spontaneous urticaria (CSU): a systematic literature review.
    Wong MM, Keith PK. · · 2020 · cited 13× · PMID 32944029 · DOI 10.1186/s13223-020-00461-x
  6. The Role of Benralizumab in Eosinophilic Immune Dysfunctions: A Case Report-Based Literature Review.
    Gomes M, Mendes A, Ferreira F, Branco J, et al · · 2023 · cited 3× · PMID 37138643 · DOI 10.1155/2023/8832242

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03183024.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing