Assessment of Serum Levels of Janus Kinase 1 and 2 in Patients With Cholinergic Urticaria

NCT ID: NCT06201780

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2024-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholinergic Urticaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cases group

group of cases with cholinergic urticaria

Group Type ACTIVE_COMPARATOR

serum levels of Janus Kinase 1and 2

Intervention Type DIAGNOSTIC_TEST

assessment of serum levels of Janus Kinase 1and 2 by ELISA

control group

control group not have cholinergic urticaria

Group Type ACTIVE_COMPARATOR

serum levels of Janus Kinase 1and 2

Intervention Type DIAGNOSTIC_TEST

assessment of serum levels of Janus Kinase 1and 2 by ELISA

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

serum levels of Janus Kinase 1and 2

assessment of serum levels of Janus Kinase 1and 2 by ELISA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The study will include 45 adult patients complaining of CholU as well as 45 healthy controls.

Exclusion Criteria

* 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marwa Elsayed Mohamed

Resident-Dermatology department-sohag hospital university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag university Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Magdy M Amin

Role: primary

0934602963

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27324252 (View on PubMed)

Altrichter 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.

Reference Type BACKGROUND
PMID: 24837213 (View on PubMed)

Burchett 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.

Reference Type BACKGROUND
PMID: 36230993 (View on PubMed)

Fricke 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.

Reference Type BACKGROUND
PMID: 31494963 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

soh-Med-23-12-07MS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Janus Kinase Inhibition in Granuloma Annulare
NCT05650736 ACTIVE_NOT_RECRUITING PHASE2
Janus Kinase Inhibition in Sarcoidosis
NCT05696795 COMPLETED PHASE2