Cholinergic UrticariaNCT06201780
Assessment of Serum Levels of Janus Kinase 1 and 2 in Patients With Cholinergic Urticaria
A study testing serum levels of Janus Kinase 1and 2 in people with Cholinergic Urticaria, run by Sohag University at 1 site in Egypt.
Trial summary
Cholinergic Urticaria (CholU) is as a subtype of CIndU caused by an increase in the core body temperature, such as to activate the sweating reflex. It can occur in response to physical exercise, hot bathing and/or emotional stress. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Cholinergic Urticaria
- What is being tested?
- serum levels of Janus Kinase 1and 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2023to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The study will include 45 adult patients complaining of CholU as well as 45 healthy controls.
Who cannot join
- Patients with one or more of the following criteria will be excluded:
- Pregnancy and lactation.
- Patients with systemic diseases especially those with autoimmune diseases and infections.
- Patients with skin diseases.
- Patients on medications such as: antibiotics, non-steroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, anticonvulsants, penicillin, combined oral contraceptives.
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, 0934602963
About this study
Cholinergic Urticaria (CholU) is as a subtype of CIndU caused by an increase in the core body temperature, such as to activate the sweating reflex. It can occur in response to physical exercise, hot bathing and/or emotional stress. Clinically it appears as pinpointing and highly pruritic wheals with surrounding erythema, CholU can be accompanied by severe symptoms such as angioedema, respiratory symptoms or anaphylaxi CholU is frequently associated with atopic dermatitis (AD) The JAK-STAT is a mast cell (MC) signaling pathway activated downstream of IgE and IL-3 with important roles in MC homeostasis via regulation of proliferation, survival, and release of mediators. JAK-STAT activation is associated with polarization toward Th2, B cell isotype switching to IgE production, and IgE-dependent degranulation and cytokine release .
Because both IL-4 and IL-13 use the IL-4Rα as a receptor component, these cytokines activate any common signaling pathways. Both of these cytokines use Janus kinases (JAKs) to initiate signaling and activate signal transducer and activator of transcription-6 (STAT6), which is a transcription factor required for many of their biologic functions.
The non-receptor protein tyrosine kinases JAK1 and JAK3 associate with the IL-4Rα and γC, respectively. The binding of IL-4 to its receptor induces the transphosphorylation of JAK1 and JAK3, an event that activates these kinases and thereby initiates the early events of signal transduction .
- Conditions
- Cholinergic Urticaria
- Being tested
- serum levels of Janus Kinase 1and 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum levels of Janus Kinase 1and 2Diagnostic test
assessment of serum levels of Janus Kinase 1and 2 by ELISA
| Study group | Role | What they receive |
|---|---|---|
| cases group | Active comparator | group of cases with cholinergic urticaria Receives: Diagnostic Test: serum levels of Janus Kinase 1and 2 |
| control group | Active comparator | control group not have cholinergic urticaria Receives: Diagnostic Test: serum levels of Janus Kinase 1and 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum levels of janus kinase 1
assessment of serum levels of janus kinase 1
Measured: 1 year
Secondary outcomes (1)
serum levels of janus kinase 2
assessment of serum levels of janus kinase 2
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Dec 2023
- Primary completion10 Dec 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cholinergic UrticariaStudies of the same condition, open and under way.
- More trials run by Sohag 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Elsayed Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201780
- Sponsor's protocol ID
- soh-Med-23-12-07MS
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Altrichter S, Koch K, Church MK, Maurer M. Atopic predisposition in cholinergic urticaria patients and its implications. J Eur Acad Dermatol Venereol. 2016 Dec;30(12):2060-2065. doi: 10.1111/jdv.13765. Epub 2016 Jun 21.
PubMed 27324252Altrichter S, Salow J, Ardelean E, Church MK, Werner A, Maurer M. Development of a standardized pulse-controlled ergometry test for diagnosing and investigating cholinergic urticaria. J Dermatol Sci. 2014 Aug;75(2):88-93. doi: 10.1016/j.jdermsci.2014.04.007. Epub 2014 May 1.
PubMed 24837213Burchett JR, Dailey JM, Kee SA, Pryor DT, Kotha A, Kankaria RA, Straus DB, Ryan JJ. Targeting Mast Cells in Allergic Disease: Current Therapies and Drug Repurposing. Cells. 2022 Sep 27;11(19):3031. doi: 10.3390/cells11193031.
PubMed 36230993Fricke J, Avila G, Keller T, Weller K, Lau S, Maurer M, Zuberbier T, Keil T. Prevalence of chronic urticaria in children and adults across the globe: Systematic review with meta-analysis. Allergy. 2020 Feb;75(2):423-432. doi: 10.1111/all.14037. Epub 2019 Oct 11.
PubMed 31494963
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Serum Levels of Janus Kinase 1 and 2 in Patients With Cholinergic Urticaria
- ClinicalTrials.gov ID
- NCT06201780
- Acronym / sponsor ID
- soh-Med-23-12-07MS
- Conditions
- Cholinergic Urticaria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 11 Jan 2024 (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.
Cholinergic Urticaria (CholU) is as a subtype of CIndU caused by an increase in the core body temperature, such as to activate the sweating reflex. It can occur in response to physical exercise, hot bathing and/or emotional stress. Clinically it appears as pinpointing and highly pruritic wheals with surrounding erythema, CholU can be accompanied by severe symptoms such as angioedema, respiratory symptoms or anaphylaxi CholU is frequently associated with atopic dermatitis (AD) The JAK-STAT is a mast cell (MC) signaling pathway activated downstream of IgE and IL-3 with important roles in MC homeostasis via regulation of proliferation, survival, and release of mediators. JAK-STAT activation is associated with polarization toward Th2, B cell isotype switching to IgE production, and IgE-dependent degranulation and cytokine release .
Because both IL-4 and IL-13 use the IL-4Rα as a receptor component, these cytokines activate any common signaling pathways. Both of these cytokines use Janus kinases (JAKs) to initiate signaling and activate signal transducer and activator of transcription-6 (STAT6), which is a transcription factor required for many of their biologic functions.
The non-receptor protein tyrosine kinases JAK1 and JAK3 associate with the IL-4Rα and γC, respectively. The binding of IL-4 to its receptor induces the transphosphorylation of JAK1 and JAK3, an event that activates these kinases and thereby initiates the early events of signal transduction .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases group | Active comparator | Diagnostic Test: serum levels of Janus Kinase 1and 2group of cases with cholinergic urticaria |
| control group | Active comparator | Diagnostic Test: serum levels of Janus Kinase 1and 2control group not have cholinergic urticaria |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The study will include 45 adult patients complaining of CholU as well as 45 healthy controls.
Key exclusion criteria (6 listed)
- Patients with one or more of the following criteria will be excluded:
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 |
|---|---|---|
| serum levels of Janus Kinase 1and 2assessment of serum levels of Janus Kinase 1and 2 by ELISA | Diagnostic test | cases group, control group |
Primary outcome
serum levels of janus kinase 1
Time frame: 1 year
assessment of serum levels of janus kinase 1
1 secondary outcome
serum levels of janus kinase 2
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 27324252Altrichter S, Koch K, Church MK, Maurer M. Atopic predisposition in cholinergic urticaria patients and its implications. J Eur Acad Dermatol Venereol. 2016 Dec;30(12):2060-2065. doi: 10.1111/jdv.13765. Epub 2016 Jun 21.
- Background: PubMed 24837213Altrichter S, Salow J, Ardelean E, Church MK, Werner A, Maurer M. Development of a standardized pulse-controlled ergometry test for diagnosing and investigating cholinergic urticaria. J Dermatol Sci. 2014 Aug;75(2):88-93. doi: 10.1016/j.jdermsci.2014.04.007. Epub 2014 May 1.
- Background: PubMed 36230993Burchett JR, Dailey JM, Kee SA, Pryor DT, Kotha A, Kankaria RA, Straus DB, Ryan JJ. Targeting Mast Cells in Allergic Disease: Current Therapies and Drug Repurposing. Cells. 2022 Sep 27;11(19):3031. doi: 10.3390/cells11193031.
- Background: PubMed 31494963Fricke J, Avila G, Keller T, Weller K, Lau S, Maurer M, Zuberbier T, Keil T. Prevalence of chronic urticaria in children and adults across the globe: Systematic review with meta-analysis. Allergy. 2020 Feb;75(2):423-432. doi: 10.1111/all.14037. Epub 2019 Oct 11.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serum levels of Janus Kinase 1and 2 in people with Cholinergic Urticaria, run by Sohag 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 6 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum levels of janus kinase 1 (time frame: 1 year). 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 NCT06201780, which also lists 4 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 11 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.