Chronic Idiopathic UrticariaPhase 3NCT07486583
Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.
A Phase 3 study testing Autologous whole blood therapy and Desloratadine in people with Chronic Idiopathic Urticaria, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Idiopathic Urticaria
- What is being tested?
- Autologous whole blood therapy and Desloratadine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2026to 30 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic idiopathic urticaria patients of both sexes aging 18 years of age or older who are unresponsive to four-fold of antihistamines.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medicine, Cairo university
Cairo, Cairo Governorate, 11553
Sarah Elsayed, MSc, MBBCh, 00201094077370, sarahelsaid651@gmail.com
Ahmed Mourad, MD, ahmedmourad@kasralainy.edu.eg
About this study
Official title: Autologous Whole Blood Therapy in Autologous Serum Skin Test (ASST) Positive and Negative Chronic Idiopathic Urticaria Patients, a Clinical and Biochemical Randomized Controlled Trial.
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.
Read the detailed description
To evaluate the efficacy of Autologous Whole Blood Therapy (AWBT) versus conventional treatment using fourfold dose of antihistamines in ASST positive and negative Chronic Idiopathic Urticaria (CIU) patients and suggest its possible mechanism of action. Also, assessment of serum levels of D-dimer, IFN-γ, IL-6, anti-IgE IgG before and after treatment.
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.
Patients will be advised to record the 7-day urticaria activity score (UAS 7) based on a simple questionnaire, on day 0, 4th week and 8th week of the treatment (End of Therapy (EOT)), and in the follow up period after 4 weeks following EOT (End of Study (EOS)). Dermatology life quality index (DLQI) will be assessed before treatment and at the end of therapy (8 weeks).
- Conditions
- Chronic Idiopathic Urticaria
- Being tested
- Autologous whole blood therapy, Desloratadine
- Keywords
- chronic idiopathic urticaria, antihistamines, desloratadine, autologous serum skin test, autologous whole blood therpy
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous whole blood therapyBiological
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.
DesloratadineDrug
All patients will take desloratadine 10 mg at four-fold dose daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Autologous whole blood therapy; Drug: Desloratadine |
| antihistamines alone | Active comparator | All patients will take desloratadine 10 mg at four-fold dose daily Receives: Drug: Desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
correlation between ASST result and treatment response
correlation between autologous serum skin test (ASST) result (positive/negative) and change in UAS7 score after 8 weeks of treatment. ASST positivity will be assessed as a binary variable(positive/negative), and treatment response will be measured as the change in UAS7
Measured: 12 months
correlation between serum biomarkers and treatment response
correlation between baseline serum levels of interferon-gamma (IFN-γ), interleukin-6(IL-6) and anti-IgE IgG antibodies and change in UAS7 score after 8 weeks of treatment. serum biomarkers will be measured using ELISA and expressed in pg/ml (for IFN-γ, IL-6) and optical density or concentration units for anti-IgE IgG.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Idiopathic UrticariaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Elsayed Mahmoud Awad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486583
- Sponsor's protocol ID
- MD-142-2025
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relevant participant data shall be provided to researchers who request them on reasonable basis
Publications
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.
PubMed 28380487Kocaturk 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.
PubMed 21801101Chen 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.
PubMed 37952519
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Whole Blood Therapy in Autologous Serum Skin Test (ASST) Positive and Negative Chronic Idiopathic Urticaria Patients, a Clinical and Biochemical Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07486583
- Acronym / sponsor ID
- MD-142-2025
- Conditions
- Chronic Idiopathic Urticaria
- Keywords
- chronic idiopathic urticaria, antihistamines, desloratadine, autologous serum skin test, autologous whole blood therpy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To evaluate the efficacy of Autologous Whole Blood Therapy (AWBT) versus conventional treatment using fourfold dose of antihistamines in ASST positive and negative Chronic Idiopathic Urticaria (CIU) patients and suggest its possible mechanism of action. Also, assessment of serum levels of D-dimer, IFN-γ, IL-6, anti-IgE IgG before and after treatment.
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.
Patients will be advised to record the 7-day urticaria activity score (UAS 7) based on a simple questionnaire, on day 0, 4th week and 8th week of the treatment (End of Therapy (EOT)), and in the follow up period after 4 weeks following EOT (End of Study (EOS)). Dermatology life quality index (DLQI) will be assessed before treatment and at the end of therapy (8 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AWBT plus antihistamines | Experimental | Biological: Autologous whole blood therapy, Drug: DesloratadineAll 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. |
| antihistamines alone | Active comparator | Drug: DesloratadineAll patients will take desloratadine 10 mg at four-fold dose daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic idiopathic urticaria patients of both sexes aging 18 years of age or older who are unresponsive to four-fold of antihistamines.
Key exclusion criteria (8 listed)
- other types of chronic urticaria
- Pregnancy
- Lactation
- Immunocompromised patients
- Patients on Systemic corticosteroid or immunosuppressive drugs used in the past 6 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous whole blood therapyThe 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 | AWBT plus antihistamines |
| DesloratadineAll patients will take desloratadine 10 mg at four-fold dose daily | Drug | AWBT plus antihistamines, antihistamines alone |
Primary outcome
change in urticaria activity score (UAS7) from baseline to 8 weeks
Time frame: 12 months
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
2 secondary outcomes
correlation between ASST result and treatment response
Time frame: 12 months
correlation between serum biomarkers and treatment response
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 28380487Kitsioulis 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.
- Background: PubMed 21801101Kocaturk 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.
- Background: PubMed 37952519Chen 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.
- Individual participant dataSharing planned: Yes. Relevant participant data shall be provided to researchers who request them on reasonable basis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous whole blood therapy and Desloratadine in people with Chronic Idiopathic Urticaria, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Elsayed, MSc, MBBCh (00201094077370, sarahelsaid651@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in urticaria activity score (UAS7) from baseline to 8 weeks (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07486583, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.