Dupilumab tested in cholinergic urticaria patients
- Conditions
- Cholinergic urticaria despite H1-antihistamine treatmentTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-001262-25-DE
- Lead Sponsor
- Charité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 72
1.Patient is informed about study procedures and medications and has given written informed consent before any assessment.
2.Patient is able to communicate with the investigator, understands and complies with the requirements of the study.
3.Male or Female of any race
4.Patient is 18-70 years of age
5.Patient is diagnosed with moderate to severe CholU and refractory to standard of care treatment at the time of randomization, as defined by the following:
•The presence of itch, hives and recurrent angioedema for = 6 consecutive weeks at any time prior to enrollment despite current use of licensed dose H1 antihistamine
•UCT <12 prior to randomization (Day 1)
•Patients must have been on standard of care for treatment of CholU for at least the 3 consecutive days immediately prior to the screening visit and must have documented current use on the day of the initial screening visit.
•CholU diagnosis for >= 6 months
6.Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
7.Patients must not have had any missing eDiary entries in the 7 days prior to randomization. Re-screening may be considered.
8.Women of childbearing potential have to agree to use an acceptable form of contraception (as determined by the site investigator) and have to continue its use for the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. History of hypersensitivity to Dupilumab or their components.
2. Clearly dominating other form of urticaria as etiology for wheal and flare type reactions. This includes the following:
- Chronic spontaneous urticaria
- Inducible urticaria: urticaria factitia, cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, or contact-urticaria
These diseases are allowed a comorbidities, if cholinergic urticaria is the dominating form of chronic urticaria
3. Any other active severe skin disease associated with chronic itching that might confound the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus etc.)
4. Previous treatment with omalizumab within 3 months prior to screening.
5. History of anaphylactic shock.
6. Patients with confirmed active SARS-CoV-2 infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is the evaluation of Dupilumab 600 mg as loading dose and/or Dupilumab 300 mg and/or placebo in patients with CholU regarding the difference in the change of CholUAS7 (Itch 7) from baseline to week 16 in adult patients with H1-antihistamine resistent CholU. ;Secondary Objective: CholU when added to H1-AH alone based on changes of following secondary objectives: <br>Itch score, UCT (Urticaria control test), CholU-QoL (cholinergic urticaria quality of life questionnaire), Symptom free days, DLQI, Time to first recurrence after discontinuation of Dupilumab in comparison to placebo therapy within follow-up period, Need for non-sedating H1-antihistamine rescue medication, Investigator’s Global Assessment of efficacy, Patient´s Global Assessment of efficacy<br>;Primary end point(s): difference in the change of CholUAS7 (Itch 7) ;Timepoint(s) of evaluation of this end point: When all of the planned patients have completed the Week 16 visit (or discontinued prior to that).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): changes of following secondary objectives: <br>Itch score, UCT (Urticaria control test), CholU-QoL (cholinergic urticaria quality of life questionnaire), Symptom free days, DLQI, Time to first recurrence after discontinuation of Dupilumab in comparison to placebo therapy within follow-up period, Need for non-sedating H1-antihistamine rescue medication, Investigator’s Global Assessment of efficacy, Patient´s Global Assessment of efficacy<br>;Timepoint(s) of evaluation of this end point: from baseline (visit 1) to week 16 (visit 9).