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Clinical Trials List

Protocol NumberCDX0159-12
Active

2024-12-01 - 2027-11-30

Phase III

Recruiting10

ICD-10L50.0

Allergic urticaria

ICD-9708.0

Allergic urticaria

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ – CSU1)

  • Sponsor

    Celldex Therapeutics, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yun-Ting Chang Division of Dermatology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hung Lee Division of Dermatology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 邱顯鎰 Division of Dermatology
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 譚國棟 Division of Dermatology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Hung Chung Division of Dermatology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 洪千惠 Division of Dermatology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Yu Chu Division of Dermatology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳南霖 Division of Dermatology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Po-Yuan Wu Division of Dermatology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Woan-Ruoh Lee
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ – CSU1)

Objectives

To evaluate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria activity as assessed by weekly urticaria activity score (UAS7) at Week 12

Test Drug

injection

Active Ingredient

CDX-0159
EPINEPHRINE HCL

Dosage Form

230
230

Dosage

150mg
0.3mg

Endpoints

Mean change from baseline in UAS7 at Week 12

Inclution Criteria

Key Inclusion Criteria

1. After the nature of the trial has been fully explained, read, understand, and provide written informed consent and Health Insurance Portability and Responsibility Act (HIPAA) authorization (if applicable). Participants must be able to provide informed consent independently.

2. Male or female aged ≥ 18 years at the time of signing the informed consent form.

3. The duration of the pre-screening CSU must be ≥ 6 months.

Note: The trial administrator should confirm the existence of the CSU during the aforementioned period based on all available supporting documentation, including written medical records and communications with the participant's previous healthcare provider (if applicable).

4. CSU that is difficult to cure with a stable dose and regimen of second-generation H1AH is defined as follows:

• Recurrent pruritic hives, with or without angioedema, lasting ≥ 6 weeks at any time prior to screening (follow-up visit 1), despite H1AH treatment (urticaria consistent with CSU should be documented and confirmed by the trial administrator prior to randomization).

• Subjects must have received a stable dose and regimen of second-generation H1 antihistamine (H1AH) prior to randomization, at the approved or increased (up to 4 times the approved dose) dose as background therapy for CSU, lasting ≥ 4 weeks, and expected to remain stable throughout the trial.

• UAS7 (range: 0 to 42) ≥ 16 and ISS7 (range: 0 to 21) ≥ 8 during the 7-day period prior to randomization (day -7 to day -1).

5. Willing and able to comply with all trial requirements and procedures, including completing a daily symptom log during the screening period and throughout the trial.

Exclusion Criteria

Important Exclusion Criteria

1. Having a condition that may include symptoms such as urticaria or angioedema, such as urticarial vasculitis, erythema multiforme, mast cell hyperplasia of the skin (urticaria pigmentosa), autoimmune syndromes associated with urticarial lesions (e.g., Schnitzler's syndrome), and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency).

2. Chronic urticaria with chronic induced urticaria (CIndU) as the primary manifestation, including symptomatic dermographism (artificial urticaria), cold, heat, sunburn, stress, delayed stress, aquagenic, cholinergic, or contact urticaria.

Note: CIndU itself is not an exclusion criterion.

3. Having any other active pruritic skin condition that could confound the CSU assessment, according to the clinical judgment of the trial administrator (e.g., atopic dermatitis, psoriasis, bullous pemphigoid, herpetic dermatitis, nodular prurigo, unexplained chronic pruritus). 4. Previously received barzolvolimab or other anti-KIT therapy.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    915 participants

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