A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Drug: Matching Placebo
- Registration Number
- NCT05368285
- Lead Sponsor
- Celldex Therapeutics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description barzolvolimab 150 mg barzolvolimab barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks barzolvolimab 75 mg then 150 mg barzolvolimab barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks barzolvolimab 75 mg then 300 mg barzolvolimab barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks barzolvolimab 300 mg barzolvolimab barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks Placebo then barzolvolimab 150 mg barzolvolimab Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks Placebo then barzolvolimab 150 mg Matching Placebo Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks Placebo then barzolvolimab 300 mg barzolvolimab Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks Placebo then barzolvolimab 300 mg Matching Placebo Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks
- Primary Outcome Measures
Name Time Method Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) 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
Name Time Method Mean change from baseline to Week 12 of ISS7 (Itch Severity Score) 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.
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score) 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.
Mean change from baseline to Week 12 of AAS7 (Angioedema Activity Score) 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.
Trial Locations
- Locations (56)
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Kern Research, Inc
🇺🇸Bakersfield, California, United States
Allergy & Asthma Specialists, PSC
🇺🇸Owensboro, Kentucky, United States
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
🇧🇬Plovdiv, Bulgaria
Medicover Integrated Clinical Services Sp. Z.o.o.
🇵🇱Torun, Poland
Óbudai Egészségügyi Centrum Kft.
🇭🇺Zalaegerszeg, Hungary
Synapta Clinical Research
🇿🇦Durban, KwaZulu-Natal, South Africa
Dr Pj Sebastian
🇿🇦Durban, KwaZulu-Natal, South Africa
Vahlberg & Pild Clinic
🇪🇪Tallinn, Estonia
Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie
🇩🇪Oldenburg, Niedersachsen, Germany
Universitaetsklinikum Giessen u. Marburg GmbH
🇩🇪Marburg, Hessen, Germany
Outpatient clinic for individual practice for specialized outpatient medical care in allergology-Doctor Thalat Sally Cholak EOOD
🇧🇬Razgrad, Bulgaria
Center of Allergy and Immunology
🇬🇪Tbilisi, Georgia
Multiprofile Clinic Consilium Medulla
🇬🇪Tbilisi, Georgia
Centrum Medyczne Plejady
🇵🇱Krakow, Poland
Newtown Clinical Research
🇿🇦Johannesburg, Gauteng, South Africa
Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
🇭🇺Budapest, Hungary
Hannover Medical University
🇩🇪Hannover, Niedersachsen, Germany
Medical Center "SYNEXUS SOFIA", EOOD
🇧🇬Sofia, Bulgaria
Healthy Future
🇬🇪Tbilisi, Georgia
Debreceni Egyetem, ÁOK és KK, Bőrgyógyászati Tanszék és Bőrgyógyászati Klinika
🇭🇺Debrecen, Hungary
Allergo-Derm Bakos Kft. Bőrgyógyászati Magánrendelő
🇭🇺Szolnok, Hungary
Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
🇵🇱Lodz, Poland
Charite - Institute of Allergology IFA Campus Benjamin Franklin
🇩🇪Berlin, Germany
FCRN Clinical Trial Centre Vaal Triangle
🇿🇦Vereeniging, Gauteng, South Africa
Universidad de Navarra
🇪🇸Madrid, Spain
Iatros International
🇿🇦Bloemfontein, Free State, South Africa
Hospital del Mar
🇪🇸Barcelona, Spain
Medical Center Iskar EOOD Office of Clinical Allergology
🇧🇬Sofia, Bulgaria
Malopolskie Centrum Alergologii
🇵🇱Krakow, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskie
🇵🇱Lublin, Poland
Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii
🇵🇱Opole, Poland
WorthWhile Clinical Trials
🇿🇦Benoni, Gauteng, South Africa
Universitätsklinikum Dresden
🇩🇪Dresden, Sachsen, Germany
Universitätsklinikum Heidelberg - Dermatologie
🇩🇪Heidelberg, Germany
Hospital Bellvitge
🇪🇸Barcelona, Spain
Klinika Ambroziak sp. z o.o.
🇵🇱Warsaw, Poland
Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankunge
🇩🇪Kiel, Schleswig-Holstein, Germany
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Clinical Research Center of Alabama dba Allervie Clinical Research
🇺🇸Birmingham, Alabama, United States
Medical Research of Arizona
🇺🇸Scottsdale, Arizona, United States
Institute for Asthma and Allergy
🇺🇸Chevy Chase, Maryland, United States
Little Rock Allergy & Asthma CRC
🇺🇸Little Rock, Arkansas, United States
Chesapeake Clinical Research
🇺🇸White Marsh, Maryland, United States
Respiratory Medicine Research Institute of Michigan, PLC
🇺🇸Ypsilanti, Michigan, United States
Montefiore Medical Center/Subspeciality-Allergy and Immunology
🇺🇸Bronx, New York, United States
"Diagnostic Consultative Center Pulmed" EOOD
🇧🇬Plovdiv, Bulgaria
LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien Zentrum
🇩🇪München, Bayern, Germany
Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie
🇩🇪Münster, Nordrhein-Westfalen, Germany
Medicome Sp. z o.o.
🇵🇱Oświęcim, Poland
Ubuntu Clinical Research
🇿🇦Lenasia, Gauteng, South Africa
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
The University of Cape Town - Lung Institute
🇿🇦Cape Town, South Africa
Allergy & Asthma Consultants
🇺🇸Redwood City, California, United States
IMMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
Universitätsklinikum Düsseldorf - Dermatologie
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany