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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Biological: barzolvolimab; Drug: Matching Placebo

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 Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
  • Plovdiv, Bulgaria, 4002
    • "Diagnostic Consultative Center Pulmed" EOOD
  • Razgrad, Bulgaria, 7200
    • Outpatient clinic for individual practice for specialized outpatient medical care in allergology-Doctor Thalat Sally Cholak EOOD
  • Sofia, Bulgaria, 1504
    • Medical Center Iskar EOOD Office of Clinical Allergology
  • Sofia, Bulgaria, 1784
    • Medical Center "SYNEXUS SOFIA", EOOD
• Estonia
  • Tallinn, Estonia, 10134
    • Vahlberg & Pild Clinic
• Georgia
  • Tbilisi, Georgia, 0186
    • Multiprofile Clinic Consilium Medulla
  • Tbilisi, Georgia, 0159
    • Center of Allergy and Immunology
  • Tbilisi, Georgia, 0119
    • Healthy Future
• Germany
  • Berlin, Germany, 12203
    • Charite - Institute of Allergology IFA Campus Benjamin Franklin
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg - Dermatologie
  • Bayern
    • München, Bayern, Germany, 80337
      • LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien Zentrum
  • Hessen
    • Marburg, Hessen, Germany, 35043
      • Universitaetsklinikum Giessen u. Marburg GmbH
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Hannover Medical University
    • Oldenburg, Niedersachsen, Germany, 26133
      • Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie
  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Universitätsklinikum Düsseldorf - Dermatologie
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie
  • Sachsen
    • Dresden, Sachsen, Germany, 1307
      • Universitätsklinikum Dresden
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankunge
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem, ÁOK és KK, Bőrgyógyászati Tanszék és Bőrgyógyászati Klinika
  • Szolnok, Hungary, 5000
    • Allergo-Derm Bakos Kft. Bőrgyógyászati Magánrendelő
  • Zalaegerszeg, Hungary, 8900
    • Obudai Egeszsegugyi Centrum Kft.
• Poland
  • Krakow, Poland, 30-363
    • Centrum Medyczne Plejady
  • Krakow, Poland, 31-624
    • Malopolskie Centrum Alergologii
  • Lodz, Poland, 90-153
    • Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
  • Lublin, Poland, 20-573
    • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskie
  • Opole, Poland, 45-401
    • Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii
  • Oświęcim, Poland, 21-600
    • Medicome Sp. z o.o.
  • Torun, Poland, 87-100
    • Medicover Integrated Clinical Services Sp. Z.o.o.
  • Warsaw, Poland, 02-953
    • Klinika Ambroziak Sp. Z O.O.
• South Africa
  • Cape Town, South Africa, 7700
    • The University of Cape Town - Lung Institute
  • Free State
    • Bloemfontein, Free State, South Africa, 9324
      • Iatros International
  • Gauteng
    • Benoni, Gauteng, South Africa, 1500
      • Worthwhile Clinical Trials
    • Johannesburg, Gauteng, South Africa, 2113
      • Newtown Clinical Research
    • Lenasia, Gauteng, South Africa, 1827
      • Ubuntu Clinical Research
    • Vereeniging, Gauteng, South Africa, 1935
      • FCRN Clinical Trial Centre Vaal Triangle
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4001
      • Synapta Clinical Research
    • Durban, KwaZulu-Natal, South Africa, 4092
      • Dr PJ Sebastian
• Spain
  • Alicante, Spain, 3010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Barcelona, Spain, 8907
    • Hospital Bellvitge
  • Madrid, Spain, 28027
    • Universidad de Navarra
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • Clinical Research Center of Alabama dba Allervie Clinical Research
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Medical Research of Arizona
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Allergy & Asthma CRC
  • California
    • Bakersfield, California, United States, 93301
      • Kern Research, Inc
    • Redwood City, California, United States, 94063
      • Allergy & Asthma Consultants
  • Colorado
    • Centennial, Colorado, United States, 80112
      • IMMUNOe Research Centers
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Allergy & Asthma Specialists, PSC
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Institute for Asthma and Allergy
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Respiratory Medicine Research Institute of Michigan, PLC
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center/Subspeciality-Allergy and Immunology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / 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 Names: 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 Names: CDX-0159
Experimental: barzolvolimab 150 mg; barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks	Biological: barzolvolimab; Subcutaneous Administration; Other Names: CDX-0159
Experimental: barzolvolimab 300 mg; barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks	Biological: barzolvolimab; Subcutaneous Administration; Other Names: 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 Names: 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 Names: CDX-0159; Drug: Matching Placebo; Subcutaneous Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)	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	From baseline to Day 85 (Week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)	ISS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21.	From baseline to Day 85 (Week 12)
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)	HSS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21.	From baseline to Day 85 (Week 12)
Mean change from baseline to Week 12 of AAS7 (Angioedema Activity Score)	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.	From baseline to Day 85 (Week 12)

Collaborators and Investigators

• Sponsor: Celldex Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: CDX-0159; barzolvolimab
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Vascular; Chronic Urticaria; Urticaria
• Other Study ID Numbers: CDX0159-06; 2021-006413-11 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No