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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519469-23-00 | EU Trial (CTIS) Number |
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The primary purpose of this study is to evaluate the long-term safety and efficacy of verekitug (UPB-101) in participants who complete the VALIANT study (NCT06196879).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verekitug 100 mg Q12W and Placebo | Experimental | Participants will receive 0.5 mL of verekitug (100 mg) and 2.0 mL of matching placebo, subcutaneous (SC) injections, every 12 weeks (Q12W) for up to 48 weeks. |
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| Verekitug 400 mg Q24W and Placebo | Experimental | Participants will receive 2.0 mL of verekitug (400 mg) and 0.5 mL of matching placebo, SC injections, at Weeks 24 and 48 visits. Participants will also receive 2.0 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verekitug | Drug | Verekitug subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | From VALOUR baseline up to Week 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Asthma Exacerbation Rate (AAER) | An asthma exacerbation is defined as a worsening of asthma that required treatment with systemic (oral or intravenous) corticosteroids for at least three consecutive days or a single depo-injectable dose of corticosteroids or an emergency room (ER) or urgent care visit that required systemic corticosteroids or an admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for greater than or equal to 24 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Salciccioli, MD | Upstream Bio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kern Research, Inc. | Bakersfield | California | 93301 | United States | ||
| California Medical Research Associates Inc. |
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| Placebo | Drug | Verekitug matching placebo. |
|
| From VALOUR baseline up to Week 60 |
| Change from LTE Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Spirometry will be performed pre-bronchodilator (BD) to measure lung function. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. | From VALOUR baseline to Week 60 |
| Change from LTE Baseline in Fractional Exhaled Nitric Oxide (FeNO) | Standardized single breath FeNO test is performed to evaluate airway inflammation. | From VALOUR baseline up to Week 60 |
| Change from LTE Baseline in Asthma Control Questionnaire-6 (ACQ-6) | ACQ-6 is a participant-reported questionnaire to assess asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses. | From VALOUR baseline to Week 60 |
| Northridge |
| California |
| 91324 |
| United States |
| Integrated Research of Inland Inc | Upland | California | 91786 | United States |
| Allergy & Asthma Clinical Research | Walnut Creek | California | 94598 | United States |
| Allianz Research Institute | Westminster | California | 92683 | United States |
| Advance Pharma Research | Cutler Bay | Florida | 33189 | United States |
| Clinical Site Partners, LLC dba Flourish Research | Miami | Florida | 33135 | United States |
| Phoenix Medical Research | Miami | Florida | 33165 | United States |
| Research Institute of South Florida | Miami | Florida | 33173 | United States |
| Health and Life Research Institute, LLC | Miami | Florida | 33176 | United States |
| Nouvelle Clinical Research | Miami | Florida | 33189 | United States |
| Edward Jenner Research Group, LLC | Plantation | Florida | 33317 | United States |
| R&B Medical Center | Tampa | Florida | 33614 | United States |
| Clinical Site Partners dba Flourish research | Winter Park | Florida | 32789 | United States |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | United States |
| Chesapeake Clinical Research Inc | White Marsh | Maryland | 21162 | United States |
| Pulmonary Research Institute of Southeast Michigan (PRISM) | Farmington Hills | Michigan | 48336 | United States |
| AA MRC | Flint | Michigan | 48504 | United States |
| M3 Wake Research | Las Vegas | Nevada | 89106 | United States |
| Urban Health Plan INC | The Bronx | New York | 10459 | United States |
| Toledo Institute of Clinical Research Inc | Toledo | Ohio | 43617 | United States |
| OK Clinical Research, LLC | Edmond | Oklahoma | 73034 | United States |
| Horizon Clinical Research | Cypress | Texas | 77429 | United States |
| Alina Clinical Trials, LLC | Dallas | Texas | 75209 | United States |
| El Paso Pulmonary Association | El Paso | Texas | 79902 | United States |
| California Medical Research Associates Inc. | Houston | Texas | 77008 | United States |
| Metroplex Pulmonary and Sleep Center Drive | McKinney | Texas | 75069 | United States |
| DM Clinical Tomball | Tomball | Texas | 77375 | United States |
| Fundacion Cidea | CABA | Argentina | C1121ABE | Argentina |
| Instituto de Medicina Respiratoria, IMeR/ Instituto Médico DAMIC | Córdoba | Córdoba Province | X5003DCE | Argentina |
| Centro de Medicina Respiratoria | Concepción del Uruguay | Entre Ríos Province | E3260 | Argentina |
| Fundacion Scherbovsky | Mendoza | Mendoza Province | 5500 | Argentina |
| Investigaciones En Patologias Respiratorias | San Miguel de Tucumán | Tucumán Province | CP T4000IAP | Argentina |
| CARE: Centro de Alergia y Enfermedades Respiratorias | Buenos Aires | C1414AIF | Argentina |
| Investigaciones en Alergias y Enfermedades Respiratorias-InAER | Buenos Aires | Argentina |
| INSARES | Mendoza | 5500 | Argentina |
| Centro Medico Dharma | Mendoza | M5500 | Argentina |
| Office of Hector H. Altieri MD | San Miguel de Tucumán | 4000 | Argentina |
| Instituto Especialidades de la Salud Rosario | Santa Fe | 2000 | Argentina |
| MHAT "Rahila Angelova" Pernik | Pernik | Pernik | 2300 | Bulgaria |
| Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd | Rousse | Ruse | 7000 | Bulgaria |
| Medical Center Excelsior (Todor Popov) | Sofia | Sofia | 1407 | Bulgaria |
| MC Convex/DCC Convex | Sofia | Sofia | 1680 | Bulgaria |
| Medical Center New Rehabilitation Center EOOD | Stara Zagora | Stara Zagora | 6001 | Bulgaria |
| MC Zdrave 1 | Kozloduy | Vratsa | 3320 | Bulgaria |
| Medical Center HERA EOOD | Sofia | 1510 | Bulgaria |
| Medical center Pulmovizhyn | Sofia | 1756 | Bulgaria |
| Dynamic Drug Advancement | Ajax | Ontario | L1S 2J5 | Canada |
| CIMER | Ñuñoa | Santiago Metropolitan | 7770484 | Chile |
| Fundacion Medica San Cristobal | Santiago | Santiago Metropolitan | 7630226 | Chile |
| Sociedad medica Sy G Limitada | Providencia | Santiago Metropolitana | CHL 7501126 | Chile |
| Estudios Clínicos de Enfermedades Respiratorias e Inmunológicas (CIERI) | Valparaíso | Valparaiso | 2531172 | Chile |
| Plicni Stredisko Teplice S.R.O | Teplice | 415 01 | Czechia |
| ME Clinical Respiratory Research Hamburg GmbH | Hamburg | Free and Hanseatic City of Hamburg | 22299 | Germany |
| RCMS/Lungenpraxis Hohenzollerndamm | Berlin | Germany | 10717 | Germany |
| IKF Pneumologie Frankfurt, Clinical Research Center Respiratory Diseases | Hessen | Germany | 60596 | Germany |
| POIS Sachsen GmbH | Leipzig | Germany | 04347 | Germany |
| KPPK Studienzentrum | Bendorf | 56170 | Germany |
| IKF Pneumologie GmbH & Co. KG | Mainz | 55128 | Germany |
| UOC Pneumologia AOU Renato Dulbecco | Catanzaro | Catanzaro | 88100 | Italy |
| Tokyo-Eki Center-building Clinic | Tokyo | Chuo-ku | 103-0027 | Japan |
| Oji General Hospital | Hokkaido | Hokkaido | 053-8506 | Japan |
| Osaka Habikino Medical Center | Osaka | Japan | 583-8588 | Japan |
| Kishiwada City Hospital | Osaka | Japan | 596-8501 | Japan |
| National Hospital Organization Ibarakihigashi National Hospital | Ibaraki | Osaka | 319-1113 | Japan |
| Osaka Metropolitan University Hospital | Osaka | Osaka | 545-0051 | Japan |
| Fukuwa Clinic | Tokyo | Tokyo | 104-0031 | Japan |
| Centrum Badan Klinicznych Piotr Napora lekarze Spp | Wroclaw | Dolnoslaskie Voivodeship | 51-162 | Poland |
| ALL-MED Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy Marek Jutel | Wroclaw | Dolnoslaskie Voivodeship | 53-201 | Poland |
| NZOZ J. Małolepszy i Partnerzy | Wroclaw | Dolnoslaskie Voivodeship | 54-239 | Poland |
| Centrum Medyczne "All-Med" Badania Kliniczne | Krakow | Malopolskie Voivodeship | 30-033 | Poland |
| ATOPIA Niepubliczny Zakład Opieki Zdrowotnej Poradnie Specjalistyczne | Krakow | Malopolskie Voivodeship | 31-141 | Poland |
| Małopolskie Centrum Alergologii Spółka z ograniczoną odpowiedzialnością | Krakow | Malopolskie Voivodeship | 31-624 | Poland |
| "Alergo-Med" Specjalistyczna Przychodnia Lekarska Spolka Z Ograniczona Odpowiedzialnoscia | Tarnów | Malopolskie Voivodeship | 33-100 | Poland |
| Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz | Rzeszów | Podkarpackie Voivodeship | 35-051 | Poland |
| Centrum Medycyny Oddechowej, Mroz Spolka Jawna | Bialystok | Podlaskie Voivodeship | 15-044 | Poland |
| Uniwersyteckie Centrum Kliniczne, Klinika Alergologii i Pneumonologii | Gdansk | Pomorskie Voivodeship | 80-214 | Poland |
| Ostrowieckie Centrum Medyczne spolka cywilna Anna Olech-Cudzik, Krzysztof Cudzik | Ostrowiec Świętokrzyski | Świętokrzyskie Voivodeship | 27-400 | Poland |
| Emmed Research | Pretoria | Gauteng | 0002 | South Africa |
| Newtown CRC | Newtown | Johannesburg | 2001 | South Africa |
| St Augustine's Hospital/Dr. IA Abdullah | Durban | KwaZulu-Natal | 4001 | South Africa |
| Synapta Clinical Research Centre | Durban | KwaZulu-Natal | 4001 | South Africa |
| Allergy & Immunology Unit, UCT Lung Institute | Cape Town | Western Cape | 7700 | South Africa |
| Yeungnam University Hospital | Daegu | Republic of Korea | 42415 | South Korea |
| Kyung Hee University Hospital | Seoul | Republic of Korea | 02447 | South Korea |
| Seoul National University Hospital | Seoul | Republic of Korea | 03080 | South Korea |
| Yonsei University Health System - Severance Hospital | Seoul | Republic of Korea | 03722 | South Korea |
| Asan Medical Center | Seoul | Republic of Korea | 05505 | South Korea |
| Samsung Medical Center | Seoul | Republic of Korea | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Marys Hospital | Seoul | Republic of Korea | 06591 | South Korea |
| Chungbuk National University Hospital | Taebuk | Republic of Korea | 28644 | South Korea |
| Eunpyeong St. Marys Hospital | Seoul | South Korea | 03312 | South Korea |
| Pectus Respiratory Health | Barcelona | Catalonia | 08017 | Spain |
| Hospital Gregorio Marañon | Madrid | Madrid | 28007 | Spain |
| Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital" | Chernivtsi | Chernivtsi Oblast | 58000 | Ukraine |
| Municipal Non-Profit Enterprise "Center for Infectious Diseases of the Ivano-Frankivsk Regional Council" | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
| Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust | Cottingham | East Yorkshire | HU16 5JQ | United Kingdom |
| Gartnavel General Hospital (Glasgow Clinical Research Facility) | Glasgow | Scotland | G12 0YN | United Kingdom |
| Ashford & St Peters Hospital | Chertsey | Surrey | KT16 0PZ | United Kingdom |
| Gannochy Research Suite, Perth Royal Infirmary | Perth | Tayside | PH1 1NX | United Kingdom |
| Bradford Royal Infirmary | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Churchill Hospital - Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) | Oxford | OX3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D012140 | Respiratory Tract Diseases |
| D001982 | Bronchial Diseases |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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