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Completed

NCT Number: NCT05368285

A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Spontaneous Urticaria

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Key information

Conditions

Chronic Spontaneous Urticaria Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

"Diagnostic Consultative Center Pulmed" EOOD, Plovdiv, Bulgaria

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About this study

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Spontaneous Urticaria.

There is a screening period of up to 4 weeks, followed by a 16-week placebo-controlled treatment period (Placebo-Controlled Treatment Phase) where patients will receive either barzolvolimab at a dose level of 75mg, 150mg, or 300mg, or placebo, and then a 36-week treatment period where all patients will receive barzolvolimab. Patients who receive barzolvolimab 75mg or placebo in the placebo-controlled treatment phase will be re-randomized to receive either barzolvolimab 150mg or 300mg in the active treatment phase.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key inclusion criteria:

  • Males and females, >/= 18 years of age.
  • Diagnosis of chronic spontaneous urticaria (CSU) >/= 6 months.
  • Diagnosis of CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
  • The presence of hives for >/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
  • Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
  • UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to treatment.
  • Normal blood counts and liver function tests
  • Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
  • Willing and able to complete a daily symptom electronic diary and comply with study visits.

Key exclusion criteria:

  • Women who are pregnant or nursing.
  • Clearly defined cause for chronic urticaria.
  • Active, pruritic skin condition in addition to CSU.
  • Medical condition that would cause additional risk or interfere with study procedures.
  • Known active HIV, hepatitis B or hepatitis C infection.
  • 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.
  • History of anaphylaxis
  • Prior treatment with barzolvolimab

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Treatment and study plan

barzolvolimab

Biological

Subcutaneous Administration

Other names: CDX-0159

Matching Placebo

Drug

Subcutaneous Administration

Primary outcomes

  1. Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)

    Time frame: From baseline to Day 85 (Week 12)

    Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). UAS7 is the sum of the itch severity score measured over 7 days (ISS7) and the hives severity score measured over 7 days (HSS7). The possible range of UAS7 is 0 - 42.

    Itch severity score (ISS) is on a scale of 0 - 3.

    0 = None

    • = mild (present, but not annoying or troublesome)
    • = moderate (troublesome, but does not interfere with normal daily activity or sleep)
    • = intense (severe itch, which is sufficiently troublesome to interfere with normal daily activity or sleep)

    Hives severity score (HSS) is on a scale of 0 - 3.

    0 = None

    • = less than 20 hives
    • = between 20 and 50 hives
    • = greater than 50 hives

Secondary outcomes

  1. Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)

    Time frame: From baseline to Day 85 (Week 12)

    ISS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21.

  2. Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)

    Time frame: From baseline to Day 85 (Week 12)

    HSS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21.

  3. Mean change from baseline to Week 12 of AAS7 (Angioedema Activity Score)

    Time frame: From baseline to Day 85 (Week 12)

    AAS captures the presences of swelling over the last 24 hours and rates the severity with 5 questions. The possible range of the weekly score is 0 - 105.

Sponsors and collaborators

Lead sponsor

Celldex Therapeutics

Industry

Registry information

Official study title

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Spontaneous Urticaria

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 10, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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