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

NCT05368285 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: CDX0159-062021-006413-11
• Study Type: interventional
• Target: 208
• Locations: 8 countries
• Sites: 52

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

Conditions

Chronic Spontaneous Urticaria

Keywords

CDX-0159; barzolvolimab

Outcome Measures

Primary Outcomes (1)

• 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 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

  From baseline to Day 85 (Week 12)

Secondary Outcomes (3)

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

  From baseline to Day 85 (Week 12)

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

  From baseline to Day 85 (Week 12)

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

  From baseline to Day 85 (Week 12)

Study Arms (6)

barzolvolimab 75 mg then 150 mg

EXPERIMENTAL

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

barzolvolimab 75 mg then 300 mg

EXPERIMENTAL

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

barzolvolimab 150 mg

EXPERIMENTAL

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks

Biological: barzolvolimab

barzolvolimab 300 mg

EXPERIMENTAL

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks

Biological: barzolvolimab

Placebo then barzolvolimab 150 mg

EXPERIMENTAL

Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks

Biological: barzolvolimab; Drug: Matching Placebo

Placebo then barzolvolimab 300 mg

EXPERIMENTAL

Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks

Biological: barzolvolimab; Drug: Matching Placebo

Interventions

barzolvolimab BIOLOGICAL

Subcutaneous Administration

Also known as: CDX-0159

Placebo then barzolvolimab 150 mg; Placebo then barzolvolimab 300 mg; barzolvolimab 150 mg; barzolvolimab 300 mg; barzolvolimab 75 mg then 150 mg; barzolvolimab 75 mg then 300 mg

Matching Placebo DRUG

Subcutaneous Administration

Placebo then barzolvolimab 150 mg; Placebo then barzolvolimab 300 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (56)

Clinical Research Center of Alabama dba Allervie Clinical Research

Birmingham, Alabama, 35249, United States

Location

Medical Research of Arizona

Scottsdale, Arizona, 85251, United States

Location

Little Rock Allergy & Asthma CRC

Little Rock, Arkansas, 72205, United States

Location

Kern Research, Inc

Bakersfield, California, 93301, United States

Location

Allergy & Asthma Consultants

Redwood City, California, 94063, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Allergy & Asthma Specialists, PSC

Owensboro, Kentucky, 42301, United States

Location

Institute for Asthma and Allergy

Chevy Chase, Maryland, 20815, United States

Location

Chesapeake Clinical Research

White Marsh, Maryland, 21162, United States

Location

Respiratory Medicine Research Institute of Michigan, PLC

Ypsilanti, Michigan, 48197, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Montefiore Medical Center/Subspeciality-Allergy and Immunology

The Bronx, New York, 10461, United States

Location

"Diagnostic Consultative Center Pulmed" EOOD

Plovdiv, 4002, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

Plovdiv, 4002, Bulgaria

Location

Outpatient clinic for individual practice for specialized outpatient medical care in allergology-Doctor Thalat Sally Cholak EOOD

Razgrad, 7200, Bulgaria

Location

Medical Center Iskar EOOD Office of Clinical Allergology

Sofia, 1504, Bulgaria

Location

Medical Center "SYNEXUS SOFIA", EOOD

Sofia, 1784, Bulgaria

Location

Vahlberg & Pild Clinic

Tallinn, 10134, Estonia

Location

Healthy Future

Tbilisi, 0119, Georgia

Location

Center of Allergy and Immunology

Tbilisi, 0159, Georgia

Location

Multiprofile Clinic Consilium Medulla

Tbilisi, 0186, Georgia

Location

LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien Zentrum

München, Bavaria, 80337, Germany

Location

Universitaetsklinikum Giessen u. Marburg GmbH

Marburg, Hesse, 35043, Germany

Location

Hannover Medical University

Hanover, Lower Saxony, 30625, Germany

Location

Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie

Oldenburg, Lower Saxony, 26133, Germany

Location

Universitätsklinikum Düsseldorf - Dermatologie

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitätsklinikum Dresden

Dresden, Saxony, 1307, Germany

Location

Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankunge

Kiel, Schleswig-Holstein, 24105, Germany

Location

Charite - Institute of Allergology IFA Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Universitätsklinikum Heidelberg - Dermatologie

Heidelberg, 69120, Germany

Location

Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika

Budapest, 1085, Hungary

Location

Debreceni Egyetem, ÁOK és KK, Bőrgyógyászati Tanszék és Bőrgyógyászati Klinika

Debrecen, 4032, Hungary

Location

Allergo-Derm Bakos Kft. Bőrgyógyászati Magánrendelő

Szolnok, 5000, Hungary

Location

Óbudai Egészségügyi Centrum Kft.

Zalaegerszeg, 8900, Hungary

Location

Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

Malopolskie Centrum Alergologii

Krakow, 31-624, Poland

Location

Uniwersytecki Szpital Kliniczny nr 1 w Lodzi

Lodz, 90-153, Poland

Location

Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskie

Lublin, 20-573, Poland

Location

Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii

Opole, 45-401, Poland

Location

Medicome Sp. z o.o.

Oświęcim, 21-600, Poland

Location

Medicover Integrated Clinical Services Sp. Z.o.o.

Torun, 87-100, Poland

Location

Klinika Ambroziak sp. z o.o.

Warsaw, 02-953, Poland

Location

Iatros International

Bloemfontein, Free State, 9324, South Africa

Location

WorthWhile Clinical Trials

Benoni, Gauteng, 1500, South Africa

Location

Newtown Clinical Research

Johannesburg, Gauteng, 2113, South Africa

Location

Ubuntu Clinical Research

Lenasia, Gauteng, 1827, South Africa

Location

FCRN Clinical Trial Centre Vaal Triangle

Vereeniging, Gauteng, 1935, South Africa

Location

Synapta Clinical Research

Durban, KwaZulu-Natal, 4001, South Africa

Location

Dr Pj Sebastian

Durban, KwaZulu-Natal, 4092, South Africa

Location

The University of Cape Town - Lung Institute

Cape Town, 7700, South Africa

Location

Hospital General Universitario de Alicante

Alicante, 3010, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Bellvitge

Barcelona, 8907, Spain

Location

Universidad de Navarra

Madrid, 28027, Spain

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 10, 2022
• Study Start: May 19, 2022
• Primary Completion: September 28, 2023
• Study Completion: December 20, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

PL (8); ES (1); US (13); BU (5); HU (4); ZA (8); DE (10); GE (3)