Clinical trial NCT05368285: A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Spontaneous Urticaria
Keywords: CDX-0159
barzolvolimab
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-05-10
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
timeFrame: From baseline to Day 85 (Week 12)
Secondary outcomes:
measure: Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
timeFrame: From baseline to Day 85 (Week 12)
measure: Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
timeFrame: From baseline to Day 85 (Week 12)
measure: Mean change from baseline to Week 12 of AAS7 (Angioedema Activity Score)
timeFrame: From baseline to Day 85 (Week 12)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama dba Allervie Clinical Research
state: Alabama
city: Scottsdale
country: United States
facility: Medical Research of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Allergy & Asthma CRC
state: Arkansas
city: Bakersfield
country: United States
facility: Kern Research, Inc
state: California
city: Redwood City
country: United States
facility: Allergy & Asthma Consultants
state: California
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Owensboro
country: United States
facility: Allergy & Asthma Specialists, PSC
state: Kentucky
city: Chevy Chase
country: United States
facility: Institute for Asthma and Allergy
state: Maryland
city: White Marsh
country: United States
facility: Chesapeake Clinical Research
state: Maryland
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan, PLC
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center/Subspeciality-Allergy and Immunology
state: New York
city: Plovdiv
country: Bulgaria
facility: "Diagnostic Consultative Center Pulmed" EOOD
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
city: Razgrad
country: Bulgaria
facility: Outpatient clinic for individual practice for specialized outpatient medical care in allergology-Doctor Thalat Sally Cholak EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Iskar EOOD Office of Clinical Allergology
city: Sofia
country: Bulgaria
facility: Medical Center "SYNEXUS SOFIA", EOOD
city: Tallinn
country: Estonia
facility: Vahlberg & Pild Clinic
city: Tbilisi
country: Georgia
facility: Healthy Future
city: Tbilisi
country: Georgia
facility: Center of Allergy and Immunology
city: Tbilisi
country: Georgia
facility: Multiprofile Clinic Consilium Medulla
city: München
country: Germany
facility: LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien Zentrum
state: Bayern
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen u. Marburg GmbH
state: Hessen
city: Hannover
country: Germany
facility: Hannover Medical University
state: Niedersachsen
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf - Dermatologie
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
state: Sachsen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankunge
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite - Institute of Allergology IFA Campus Benjamin Franklin
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg - Dermatologie
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, ÁOK és KK, Bőrgyógyászati Tanszék és Bőrgyógyászati Klinika
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft. Bőrgyógyászati Magánrendelő
city: Zalaegerszeg
country: Hungary
facility: Óbudai Egészségügyi Centrum Kft.
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Malopolskie Centrum Alergologii
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
city: Lublin
country: Poland
facility: Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskie
city: Opole
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii
city: Oświęcim
country: Poland
facility: Medicome Sp. z o.o.
city: Torun
country: Poland
facility: Medicover Integrated Clinical Services Sp. Z.o.o.
city: Warsaw
country: Poland
facility: Klinika Ambroziak sp. z o.o.
city: Bloemfontein
country: South Africa
facility: Iatros International
state: Free State
city: Benoni
country: South Africa
facility: WorthWhile Clinical Trials
state: Gauteng
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research
state: Gauteng
city: Lenasia
country: South Africa
facility: Ubuntu Clinical Research
state: Gauteng
city: Vereeniging
country: South Africa
facility: FCRN Clinical Trial Centre Vaal Triangle
state: Gauteng
city: Durban
country: South Africa
facility: Synapta Clinical Research
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Dr Pj Sebastian
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: The University of Cape Town - Lung Institute
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Bellvitge
city: Madrid
country: Spain
facility: Universidad de Navarra
Study officials:
References: