Ignite Creation Date:
2024-05-06 @ 12:22 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03749135
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2018-07-12
Brief Title:
Dupilumab in Chronic Spontaneous Urticaria
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Proof-of-concept Phase 2 16-week Treatment Study With a 16 Week Follow-up Period to Assess the Efficacy and Safety of Dupilumab Anti-IL4Ra in Adult Patients With Chronic Spontaneous Urticaria Despite H1-antihistamine Treatment
Status:
COMPLETED
Status Verified Date:
2022-02
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:
DUPICSU
Brief Summary:
The purpose of this study is to assess the efficacy in reducing disease activity and safety of Dupilumab in adult patients with chronic spontaneous urticaria CSU who are symptomatic despite H1-antihistamine treatment
Detailed Description:
Treatment with Dupilumab has been shown to reduce clinically significant exacerbations and to improve skin symptom control as well as quality of life in moderate to severe atopic dermatitis patients and in moderate to severe asthma patients It has been approval by European Medicines Agency EMA for the treatment of atopic dermatitis patients in September 2017
Dupilumab is a novel monoclonal antibody that inhibits interleukin-4 IL-4 and interleukin-13 IL-13 signaling and was previously found to be effective in atopic dermatitis and asthma Considering that CSU and atopic diseases share many common features eg key pathogenic role of mast cells and immunoglobulin E IgE itch is a dominant symptom Th2 dominance it is reasonable to expect that Dupilumab is beneficial in CSU
These results suggest that Dupilumab may provide an effective treatment option for patients with insufficient treatment responses to H1-antihistamines exhibiting wheal and flare type skin reactions
The gold standard treatment of CSU consists of administration of antihistamines In more than 50 of the patients symptoms persist with standard dosing of antihistamines In antihistamine-refractory patients with chronic spontaneous urticaria the currently only licensed treatment is omalizumab a monoclonal anti-IgE antibody In 2014 omalizumab has been licensed for add-on therapy in CSU patients who still have symptoms despite standard-dosed antihistamine treatment There is however still a great medical need for additional treatment options as 20-40 of patients are still without effective therapy These patients have no other licensed treatment option and can only be treated off-label with therapeutics with several known safety risks such as Cyclosporine A
Dupilumab has excellent potential to provide symptom control in CSU This study will provide additional valuable insights into the therapeutic potential of Dupilumab in improving quality of life in these patients in addition to managing CSU symptoms
Dupilumab is a novel monoclonal antibody that inhibits interleukin-4 IL-4 and interleukin-13 IL-13 signaling and was previously found to be effective in atopic dermatitis and asthma Considering that CSU and atopic diseases share many common features eg key pathogenic role of mast cells and immunoglobulin E IgE itch is a dominant symptom Th2 dominance it is reasonable to expect that Dupilumab is beneficial in CSU
These results suggest that Dupilumab may provide an effective treatment option for patients with insufficient treatment responses to H1-antihistamines exhibiting wheal and flare type skin reactions
The gold standard treatment of CSU consists of administration of antihistamines In more than 50 of the patients symptoms persist with standard dosing of antihistamines In antihistamine-refractory patients with chronic spontaneous urticaria the currently only licensed treatment is omalizumab a monoclonal anti-IgE antibody In 2014 omalizumab has been licensed for add-on therapy in CSU patients who still have symptoms despite standard-dosed antihistamine treatment There is however still a great medical need for additional treatment options as 20-40 of patients are still without effective therapy These patients have no other licensed treatment option and can only be treated off-label with therapeutics with several known safety risks such as Cyclosporine A
Dupilumab has excellent potential to provide symptom control in CSU This study will provide additional valuable insights into the therapeutic potential of Dupilumab in improving quality of life in these patients in addition to managing CSU symptoms
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004458-41 | EUDRACT_NUMBER | None | None |