Ignite Creation Date:
2024-07-17 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-04
Brief Title:
Efficacy and Safety of Dupilumab in Combination With Tofacitinib in Moderate to Severe Adult AD Patients
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
A Randomized Controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Combination With Short-term Low-dose Tofacitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Atopic dermatitis AD is a common chronic inflammatory skin disease characterized by intense pruritus and sleep disturbances The clinical manifestations of AD are varied with the most basic features being dry skin chronic eczema-like dermatitis and intense pruritus The prevalence in children and adults is about 30 and 10 respectively Most patients respond well to topical anti-inflammatory drugs but approximately 10 percent of patients with moderate-to-severe AD require one or more systemic therapies to achieve good disease control Although nonspecific immunosuppressive drugs including glucocorticoids cyclosporine A methotrexate azathioprine or mycophenolate mofetil are effective in alleviating or controlling these disorders to some extent their overall efficacy in patients is limited and associated with significant side effects with long-term use
The main hallmarks of systemic type II inflammation are eosinophilia and elevated serum immunoglobulin E IgE levels Type II inflammatory response is not only associated with allergic reactions but is also a driver of such diseases The release of cytokines interleukins 4 5 and 13 in the response to type II inflammation can trigger a lymphocyte-mediated type II inflammatory response inducing the onset and progression of allergic diseases Reducing the inflammatory response by inhibiting the above-mentioned inflammatory factors is a potential therapeutic means for the treatment of allergic diseases represented by AD
Investigational drug Dupilumab injection an interleukin-4 receptor α IL-4Rα antagonist is a human monoclonal antibody that binds IL-4Rα and inhibits IL-4 and IL-13 signaling With a molecular weight of about 147 kDa it inhibits the signaling of interleukin 4 and interleukin 13 and blocks its signaling pathway through the atopic binding of the interleukin 4Ra subunit shared with the interleukin 4 and interleukin 13 receptor complex and blocks their signaling pathways which can achieve continuous efficient and safe improvement of skin lesions itching and other symptoms and alleviate the condition
Tofacitinib is a Janus kinase JAK inhibitor JAK is an intracellular enzyme that conducts signals generated by cytokine or growth factor-receptor interactions on cell membranes thereby affecting cell hematopoiesis and cellular immune function
The main hallmarks of systemic type II inflammation are eosinophilia and elevated serum immunoglobulin E IgE levels Type II inflammatory response is not only associated with allergic reactions but is also a driver of such diseases The release of cytokines interleukins 4 5 and 13 in the response to type II inflammation can trigger a lymphocyte-mediated type II inflammatory response inducing the onset and progression of allergic diseases Reducing the inflammatory response by inhibiting the above-mentioned inflammatory factors is a potential therapeutic means for the treatment of allergic diseases represented by AD
Investigational drug Dupilumab injection an interleukin-4 receptor α IL-4Rα antagonist is a human monoclonal antibody that binds IL-4Rα and inhibits IL-4 and IL-13 signaling With a molecular weight of about 147 kDa it inhibits the signaling of interleukin 4 and interleukin 13 and blocks its signaling pathway through the atopic binding of the interleukin 4Ra subunit shared with the interleukin 4 and interleukin 13 receptor complex and blocks their signaling pathways which can achieve continuous efficient and safe improvement of skin lesions itching and other symptoms and alleviate the condition
Tofacitinib is a Janus kinase JAK inhibitor JAK is an intracellular enzyme that conducts signals generated by cytokine or growth factor-receptor interactions on cell membranes thereby affecting cell hematopoiesis and cellular immune function
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None