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The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials.
This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.
This is a global, multicenter, long-term extension phase 3b study to determine the time to disease worsening or treatment failure in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods the phase 3 clinical trials.
The study will consist of 2 Groups: Group 1 (Observation Group), comprising participants whose UAS7 score is less than 16 at entry and Group 2 (Barzolvolimab Retreatment Group) comprising participants whose UAS7 score is 16 or greater.
Participation in this trial will last for approximately 52 weeks for participants assigned to Group 1 (Observation Group) and who do not receive barzolvolimab during the trial. Participants assigned to Group 1 who require barzolvolimab rescue during the trial will be in the trial for up to 68 weeks. Participants assigned to Group 2 (Barzolvolimab Retreatment Group), trial participation will last for approximately 68 weeks from the start of treatment (Day 1).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Observation Group | Experimental | Standard of care treatment (at least 2nd generation Type 1 antihistamines [H1AH] with or without other permitted background medications) for 52 weeks. For participants with worsening disease (UAS7 score of 16 or greater at any time between Weeks 0-24), barzolvolimab will be administered once as a 300 mg subcutaneous injection followed by 150 mg every 4 weeks for up to 52 weeks. |
|
| Group 2 Barzolvolimab Retreatment Group | Experimental | Barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| barzolvolimab | Biological | Subcutaneous Administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease worsening or treatment failure through Week 52 based on the occurrence of UAS7 (Urticaria Activity Score) of 16 or greater. | The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0. | From Day 1 (baseline) to Week 52. |
| Time to disease worsening or treatment failure through Week 52 based on the occurrence of the discontinuation of barzolvolimab in Group 2 due to lack of efficacy or to a treatment related adverse event. | Evaluate duration of efficacy of barzolvolimab on urticaria activity or to a treatment related adverse event. | From Day 1 (baseline) to Week 52. |
| Time to disease worsening or treatment failure through Week 52 based on the occurrence of first use of strongly confounding prohibited medication (Group 1 or 2) or use of barzolvolimab in Group 1. | Evaluate duration of efficacy of barzolvolimab on urticaria activity leading to initiation of either a confounding prohibited medication (Group 1 or 2) or barzolvolimab in Group 1. | From Day 1 (baseline) to Week 52. |
| Measure | Description | Time Frame |
|---|---|---|
| Group 1: Change from baseline in Urticaria Activity Score (UAS7) at Week 26. | Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7). The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology & Skin Health Center, LLC | Birmingham | Alabama | 35244 | United States | ||
| Medical Research of Arizona |
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| Standard of Care | Other | Observational/Standard of Care |
|
| From Day 1 (baseline) in phase 3 trial to Week 26. |
| Group 1: Change from baseline in UAS7 at Week 52/End of Study. | Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS) The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0. | From Day 1 (baseline) in phase 3 trial to Week 52/End of Study. |
| Percentage of Group 1 participants with UAS7 ≤ 6 at week 26. | Group 1: Proportion of participants who maintained at least well-controlled disease (UAS7 ≤ 6) at Week 26. | From Day 1 (baseline) to Week 26. |
| Percentage of Group 1 participants with UAS7 ≤ 6 at week 52. | Group 1: Proportion of participants who maintained at least well-controlled disease (UAS7 ≤ 6) at Week 52. | From Day 1 (baseline) to Week 52/End of Study. |
| Percentage of Group 1 participants with UAS7 = 0 at Day 1 who have UAS7 ≤ 6 at Week 26. | Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0) at Day 1 who have well controlled CSU (UAS7 ≤ 6) at Week 26. | From Day 1 (baseline) to Week 26. |
| Percentage of Group 1 participants with UAS7 = 0 at Day 1 who have UAS7 ≤ 6 at Week 52. | Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0) at Day 1 who have well-controlled disease (UAS7 ≤ 6) at Week 52. | From Day 1 (baseline) to Week 52/End of Treatment. |
| Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0 AAS7 = 0) at Day 1 who maintained complete control at Week 26. | Angioedema Activity Score over 7 days [AAS7] describes the effect of angioedema on five categories with 0 being none and 3 being most severe. The final score is calculated by adding together daily scores which can range from 0-15 for 7 days. The resulting maximum score is then 105. | From Day 1 (baseline) to Week 26. |
| Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0 AAS7 = 0) at Day 1 who maintained complete control at Week 52. | Angioedema Activity Score over 7 days [AAS7] describes the effect of angioedema on five categories with 0 being none and 3 being most severe. The final score is calculated by adding together daily scores which can range from 0-15 for 7 days. The resulting maximum score is then 105. | From Day 1 (baseline) to Week 52/End of Study. |
| Group 1: Participants with UAS7 ≤ 6 at Day 1, time to loss of well-controlled disease through Week 52. | Group 1: Participants with at least well-controlled disease (UAS7 ≤ 6) at Day 1, time to loss of well-controlled disease through Week 52. | From Day 1 (baseline) to Week 52/End of Study. |
| Group 1: Participants with UAS7 = 0 at Day 1, time to loss of complete controlled disease through Week 52. | Group 1: Participants with complete absence of hives and itch (UAS7 = 0) at Day 1, time to loss of complete controlled disease through Week 52. | From Day 1 (baseline) to Week 52/End of Study. |
| Group 1: Participants with UAS7 = 0 and AAS7 = 0 at Day 1, time to loss of CSU completely controlled through Week 52. | Group 1: Participants with complete controlled CSU (UAS7 = 0 and AAS7 = 0) at Day 1, time to loss of CSU completely controlled through Week 52. | From Day 1 (baseline) to Week 52/End of Study. |
| Group 2: Change from baseline in UAS7 at Week 12. | Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7). | From Day 1 (baseline) to Week 12. |
| Group 2: Change from baseline in UAS7 at Week 24. | Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7). | From Day 1 (baseline) to Week 24. |
| Group 2: Change from baseline in UAS7 at Week 52. | Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7). | From Day 1 (baseline) to Week 52. |
| Group 2: Change from baseline in UAS7 at Week 68. | Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7). | From Day 1 (baseline) to Week 68. |
| Group 2: Percentage of participants with UAS7 ≤ 6 at Week 12. | Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 12. | From Day 1 (baseline) to Week 12. |
| Group 2: Percentage of participants with UAS7 ≤ 6 at Week 24. | Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 24. | From Day 1 (baseline) to Week 24. |
| Group 2: Percentage of participants with UAS7 ≤ 6 at Week 52. | Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 52. | From Day 1 (baseline) to Week 52. |
| Group 2: Percentage of participants with UAS7 ≤ 6 at Week 68. | Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 68. | From Day 1 (baseline) to Week 68. |
| From Day 1 (baseline) to Week 68. | Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12. | From Day 1 (baseline) to Week 12. |
| Group 2: Percentage of participants with UAS7 = 0 at Week 24. | Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 24. | From Day 1 (baseline) to Week 24. |
| Group 2: Percentage of participants with UAS7 = 0 at Week 52. | Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 52. | From Day 1 (baseline) to Week 52. |
| Group 2: Percentage of participants with UAS7 = 0 at Week 68. | Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 68. | From Day 1 (baseline) to Week 68. |
| Group 1 Incidence of adverse events. | Group 1: Proportion of participants experiencing adverse events during the study. | From Day 1 to Week 52. |
| Group 1 Incidence of non-treatment emergent adverse events. | Group 1: Proportion of participants who never receive barzolvolimab retreatment experiencing non-treatment emergent adverse events. | From Day 1 to Week 52. |
| Group 1 Incidence of treatment emergent adverse events in participants receiving barzolvolimab retreatment. | Group 1: Proportion of participants who receive barzolvolimab retreatment experiencing treatment emergent adverse events. | From Day 1 to Week 68. |
| Group 1 Incidence of treatment emergent adverse events leading to treatment discontinuation. | Group 1: Proportion of participants who receive barzolvolimab retreatment experiencing treatment emergent adverse events leading to treatment discontinuation during the study. | From Day 1 to Week 68. |
| Group 2 Incidence of treatment emergent adverse events. | Group 2: Proportion of participants experiencing treatment emergent adverse events during the study. | Time Frame: From Day 1 to Week 68. |
| Group 2 Incidence of treatment emergent adverse events leading to treatment discontinuation. | Group 2: Proportion of participants experiencing treatment emergent adverse events leading to treatment discontinuation during the study. | From Day 1 to Week 68. |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Center for Dermatology & Plastic Surgery - Avacare | Scottsdale | Arizona | 85260 | United States |
| Kern Research | Bakersfield | California | 93301 | United States |
| Allergy and Asthma Associates of Southern California - Laguna Niguel - CRN | Laguna Niguel | California | 92677 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| LA Universal Research Center, Inc. | Los Angeles | California | 90057 | United States |
| Encore Medical Research of Boynton Beach LLC | Boynton Beach | Florida | 33436 | United States |
| Dolphin Medical Research | Doral | Florida | 33172 | United States |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | United States |
| Deluxe Health Center | Miami Lakes | Florida | 33014 | United States |
| Sarasota Clinical Research | Sarasota | Florida | 34239 | United States |
| Advanced Clinical Research Institute (ACRI) - Florida | Tampa | Florida | 33607 | United States |
| Centricity Research Columbus Dermatology | Columbus | Georgia | 31904 | United States |
| Endeavor Health | Skokie | Illinois | 60026 | United States |
| The South Bend Clinic - Avacare | South Bend | Indiana | 46617 | United States |
| John Hopkins University | Baltimore | Maryland | 21224 | United States |
| Institute for Asthma and Allergy | Wheaton | Maryland | 20902 | United States |
| Michigan Center for Research Co., LLC | Clarkston | Michigan | 48346 | United States |
| Respiratory Medicine Research Institute of Michigan PLC | Ypsilanti | Michigan | 48197 | United States |
| Midwest Clinical Research | St Louis | Missouri | 63141 | United States |
| Montana Medical Research, Inc. | Missoula | Montana | 59808 | United States |
| Bexley Dermatology Research | Bexley | Ohio | 43209 | United States |
| Toledo Institute for Clinical Research | Toledo | Ohio | 43617 | United States |
| Portland Allergy and Asthma | Clackamas | Oregon | 97015 | United States |
| Clinical Partners LLC | Johnston | Rhode Island | 02919 | United States |
| Western Sky Medical Research | El Paso | Texas | 79912 | United States |
| Rainey & Finklea San Antonio (RFSA) Dermatology | San Antonio | Texas | 78213 | United States |
| Conexa Investigación Clínica S.A. | CABA | Buenos Aires F.D. | 1012 | Argentina |
| Aprillus Asistencia e Investigacion de Arcis Salud SRL | CABA | Buenos Aires F.D. | 1406 | Argentina |
| Instituto de Especialidades de la Salud Rosario - Clínica del Tórax | Rosario | Sante Fe | 2000 | Argentina |
| Instituto Médico de la Fundación Estudios Clínicos | Rosario | Sante Fe | S2000DEJ | Argentina |
| Clinica Mayo de Urgencias | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Cornerstone Dermatology | Coorparoo | QSL | 4151 | Australia |
| The Alfred Hospital - Kern | Melbourne | Victoria | 3004 | Australia |
| Outpatient Clinic for IP for Specialized Outpatient Medical Care in Allergology-Dr.Cholak | Razgrad | 7200 | Bulgaria |
| Medical Center Iskar EOOD | Sofia | 1000 | Bulgaria |
| Medical Center Hera EOOD | Sofia | 1510 | Bulgaria |
| University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD | Sofia | 1606 | Bulgaria |
| Medical Center Pulmovision | Sofia | 1756 | Bulgaria |
| Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. | Hamilton | Ontario | L8L 3C3 | Canada |
| Lynderm Research Inc | Markham | Ontario | L3P 1X3 | Canada |
| Evidence Based Medical Educator Inc. | Toronto | Ontario | M5G1E2 | Canada |
| Joel Liem Medicine Professional Corporation | Windsor | Ontario | N8X 2G1 | Canada |
| CHRU Nantes Hôtel Dieu | Nantes | 44093 | France |
| Hospital A. Syggros | Athens | 16121 | Greece |
| Centrum Badan Klinicznych PI-House sp. z o.o. | Gdansk | 80-546 | Poland |
| Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. | Krakow | 31-011 | Poland |
| MICS Centrum Medyczne Toruń | Torun | 87-100 | Poland |
| Klinika Ambroziak Dermatologia | Warsaw | 02-953 | Poland |
| Ginemedica Sp. z o.o. | Wroclaw | 50-414 | Poland |
| EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu | Wroclaw | 54-144 | Poland |
| Worthwhile Clinical Trials | Benoni | Gauteng | 1501 | South Africa |
| Global Clinical Trials (Pty) Ltd - Pretoria | Pretoria | Gauteng | 0157 | South Africa |
| About Allergy | Pretoria | Gauteng | 0181 | South Africa |
| Synapta Clinical Research Centre | Durban | KwaZulu-Natal | 4001 | South Africa |
| University of Cape Town Lung Institute (UCTLI) | Mowbray | Western Cape | 7700 | South Africa |
| Ajou University Hospital | Suwon | 16499 | South Korea |
| Hospital General Universitario Dr. Balmis | Alicante | 03010 | Spain |
| Hospital Clinico San Carlos - Lopez Bran | Madrid | 28040 | Spain |
| Hospital Universitario de La Plana | Villarreal de Huerva | 12540 | Spain |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 813414 | Taiwan |
| China Medical University Hospital | Taichung | 404 | Taiwan |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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