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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05368285
Recruitment Status : Recruiting
First Posted : May 10, 2022
Last Update Posted : March 9, 2023
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Chronic Spontaneous Urticaria Biological: barzolvolimab Drug: Matching Placebo Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 19, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arms and Interventions
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Arm Intervention/treatment
Experimental: barzolvolimab 75 mg then 150 mg
barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks
 Biological: barzolvolimab
Subcutaneous Administration
Other Name: CDX-0159
Experimental: barzolvolimab 75 mg then 300 mg
barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks
 Biological: barzolvolimab
Subcutaneous Administration
Other Name: CDX-0159
Experimental: barzolvolimab 150 mg
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks
 Biological: barzolvolimab
Subcutaneous Administration
Other Name: CDX-0159
Experimental: barzolvolimab 300 mg
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks
 Biological: barzolvolimab
Subcutaneous Administration
Other Name: CDX-0159
Experimental: Placebo then barzolvolimab 150 mg
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks
 Biological: barzolvolimab
Subcutaneous Administration
Other Name: CDX-0159

Drug: Matching Placebo
Subcutaneous Administration
Experimental: Placebo then barzolvolimab 300 mg
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks
 Biological: barzolvolimab
Subcutaneous Administration
Other Name: CDX-0159

Drug: Matching Placebo
Subcutaneous Administration


Outcome Measures
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Primary Outcome Measures :
  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

    1. = mild (present, but not annoying or troublesome)
    2. = moderate (troublesome, but does not interfere with normal daily activity or sleep)
    3. = 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

    1. = less than 20 hives
    2. = between 20 and 50 hives
    3. = greater than 50 hives


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key inclusion criteria:

  1. Males and females, >/= 18 years of age.
  2. Diagnosis of chronic spontaneous urticaria (CSU) >/= 6 months.

  3. Diagnosis of CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:

    1. The presence of hives for >/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
    2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
    3. UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to treatment.
  4. Normal blood counts and liver function tests
  5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
  6. Willing and able to complete a daily symptom electronic diary and comply with study visits.

Key exclusion criteria:

  1. Women who are pregnant or nursing.
  2. Clearly defined cause for chronic urticaria.
  3. Active, pruritic skin condition in addition to CSU.
  4. Medical condition that would cause additional risk or interfere with study procedures.
  5. Known active 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
  8. Prior treatment with barzolvolimab

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05368285


Contacts
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Contact: Celldex Therapeutics 844-723-9363 info@celldex.com

Locations
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Sponsors and Collaborators
Celldex Therapeutics
More Information
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Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT05368285    
Other Study ID Numbers: CDX0159-06
2021-006413-11 ( EudraCT Number )
First Posted: May 10, 2022    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celldex Therapeutics:
CDX-0159
barzolvolimab
Additional relevant MeSH terms:
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Urticaria
Chronic Urticaria
Skin Diseases, Vascular
Skin Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases