A

Phase 1

• Conditions: Chronic Inducible Urticaria; MedDRA version: 23.0Level: LLTClassification code 10012499Term: Dermatographic urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-006447-95-PL
• Lead Sponsor: Celldex Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-13
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1.Males and females, >/= 18 years of age.
2.Diagnosis of ColdU or SD >/= 3 months.
3.Diagnosis of chronic ColdU or SD despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
a.The presence of recurrent pruritic wheals with or without angioedema for >/= 6 weeks at any time prior to Visit 1 despite the use of H1 antihistamines.
b.Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
c.UCT of < 12 during the 14 days prior to treatment.
4.Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
5.Willing and able to complete a daily symptom electronic diary and comply with study visits.

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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

1.Women who are pregnant or nursing.
2.Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SD.
3.Active, pruritic skin condition in addition to CIndU.
4.Medical condition that would cause additional risk or interfere with study procedures.
5.Known HIV, hepatitis B or hepatitis C infection.
6.Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
7.History of anaphylaxis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified