Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.

NCT07486583 | Not Yet Recruiting Phase 3

• 1 other identifier: MD-142-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of Autologous Whole Blood Therapy versus conventional treatment using fourfold dose of antihistamines in Autologus serum skin test (ASST) positive and negative Chronic Idiopathic Urticaria (CIU) patients and suggest its possible mechanism of action.

Conditions

Chronic Idiopathic Urticaria

Keywords

chronic idiopathic urticaria; antihistamines; desloratadine; autologous serum skin test; autologous whole blood therpy

Outcome Measures

Primary Outcomes (1)

• change in urticaria activity score (UAS7) from baseline to 8 weeks

  Change in 7-day urticaria activity score (UAS7) score from baseline to 8 weeks after treatment with either AWBT with fourfold antihistamines or fourfold of antihistamines alone in Chronic Idiopathic Urticaria (CIU) patients. urticaria activity score7 ranges from 0-42. A score of 0 means complete remission while score (28-42) means severe disease

  12 months

Secondary Outcomes (2)

• correlation between ASST result and treatment response

  12 months

• correlation between serum biomarkers and treatment response

  12 months

Study Arms (2)

AWBT plus antihistamines

EXPERIMENTAL

All patients will take desloratadine 10 mg at four-fold dose daily The AWBT test group patients will receive 8 doses of autologous whole blood therapy (AWBT) once weekly. The first dose will be 2.5ml and subsequent doses will be 5ml of venous blood, which will be drawn from any accessible vein under aseptic precautions. The blood will be re-injected immediately by deep intramuscular injection (IM) on alternate gluteal regions.

Biological: Autologous whole blood therapy; Drug: Desloratadine

antihistamines alone

ACTIVE COMPARATOR

All patients will take desloratadine 10 mg at four-fold dose daily

Drug: Desloratadine

Interventions

Autologous whole blood therapy BIOLOGICAL

The AWBT test group patients will receive 8 doses of autologous whole blood therapy (AWBT) once weekly. The first dose will be 2.5ml and subsequent doses will be 5ml of venous blood, which will be drawn from any accessible vein under aseptic precautions. The blood will be re-injected immediately by deep intramuscular injection (IM) on alternate gluteal regions.

AWBT plus antihistamines

Desloratadine DRUG

All patients will take desloratadine 10 mg at four-fold dose daily

AWBT plus antihistamines; antihistamines alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic idiopathic urticaria patients of both sexes aging 18 years of age or older who are unresponsive to four-fold of antihistamines.

You may not qualify if:

• other types of chronic urticaria
• Pregnancy
• Lactation
• Immunocompromised patients
• Patients on Systemic corticosteroid or immunosuppressive drugs used in the past 6 weeks
• History of Bronchial Asthma
• Patients on anticoagulants
• Patients on non-steroidal anti-inflammatory drugs

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo university

Cairo, Cairo Governorate, 11553, Egypt

Location

Related Publications (3)

• Kitsioulis NA, Xepapadaki P, Roussaki-Schulze AV, Papadopoulos N, Zafiriou E. Effectiveness of Autologous Whole-Blood Injections in Patients with Refractory Chronic Spontaneous Urticaria. Int Arch Allergy Immunol. 2017;172(3):161-166. doi: 10.1159/000458152. Epub 2017 Apr 6.

  PMID: 28380487 BACKGROUND

• Kocaturk E, Aktas S, Turkoglu Z, Kavala M, Zindanci I, Koc M, Can B, Sudogan S. Autologous whole blood and autologous serum injections are equally effective as placebo injections in reducing disease activity in patients with chronic spontaneous urticaria: a placebo controlled, randomized, single-blind study. J Dermatolog Treat. 2012 Dec;23(6):465-71. doi: 10.3109/09546634.2011.593485. Epub 2011 Jul 31.

  PMID: 21801101 BACKGROUND

• Chen Q, Luo J, Yang X, Chen W, Liu W, Song Z. Biomarkers of Autologous Whole Blood Injection Efficacy in Patients with Chronic Spontaneous Urticaria with Autoreactivity: A Preliminary Study. Int Arch Allergy Immunol. 2024;185(2):190-195. doi: 10.1159/000534662. Epub 2023 Nov 10.

  PMID: 37952519 BACKGROUND

MeSH Terms

Conditions

Chronic Urticaria

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sarah Elsayed, MSc, MBBCh

CONTACT

00201094077370; sarahelsaid651@gmail.com

Ahmed Mourad, MD

CONTACT

00201021534245; ahmedmourad@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistent lecturer

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: March 20, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: from January 2027 indefinitely
• Access Criteria: access will be provided to deidentified data including all study parameters

Locations

EG (1)