Clinical Trials in Italy / NCT06966479
Active, not recruiting
Phase 2
A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)
NCT06966479 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Severe Asthma
Investigational drug(s) / intervention(s)
Verekitug →Placebo
Verekitug: Verekitug subcutaneous injection.
Placebo: Verekitug matching placebo.
Study summary
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).
Eligibility
Inclusion Criteria:
1. Completion of the VALIANT study (UPB-CP-04 \[NCT06196879\]) per protocol.
2. Participant has signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) for the LTE study.
3. Contraceptive use by participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
1. Abnormal medical history, physical finding, or safety finding that in the opinion of the Investigator may obscure the study data or interfere with the participant's safety.
2. Any clinical laboratory test result outside of the reference ranges considered by the Investigator as clinically significant and that may obscure the study data or interfere with the participant's safety.
3. Participant with a history or evidence of a clinically significant pulmonary condition (other than asthma), including significant restrictive findings on pulmonary function testing, chronic bronchitis, emphysema, bronchiectasis, pulmonary fibrosis, or any other related condition that may obscure the study data (e.g., gastroesophageal reflux and vocal cord paralysis/dysfunction).
4. Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active.
5. Participants with significant protocol deviations in VALIANT, assessed at the discretion of the Sponsor.
6. Participant is unreliable, incapable of adhering to the protocol and visit schedule according to the judgment of the Investigator or has any disorder that may compromise their ability to give informed consent.
Primary outcome measure(s)
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — From VALOUR baseline up to Week 64
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.
Trial sites (102)
| Facility | City | Region | Status |
|---|---|---|---|
| Kern Research, Inc. | Bakersfield | California | |
| California Medical Research Associates Inc. | Northridge | California | |
| Integrated Research of Inland Inc | Upland | California | |
| Allergy & Asthma Clinical Research | Walnut Creek | California | |
| Allianz Research Institute | Westminster | California | |
| Advance Pharma Research | Cutler Bay | Florida | |
| Clinical Site Partners, LLC dba Flourish Research | Miami | Florida | |
| Phoenix Medical Research | Miami | Florida | |
| Research Institute of South Florida | Miami | Florida | |
| Health and Life Research Institute, LLC | Miami | Florida | |
| Nouvelle Clinical Research | Miami | Florida | |
| Edward Jenner Research Group, LLC | Plantation | Florida | |
| R&B Medical Center | Tampa | Florida | |
| Clinical Site Partners dba Flourish research | Winter Park | Florida | |
| Treasure Valley Medical Research | Boise | Idaho | |
| Chesapeake Clinical Research Inc | White Marsh | Maryland | |
| Pulmonary Research Institute of Southeast Michigan (PRISM) | Farmington Hills | Michigan | |
| AA MRC | Flint | Michigan | |
| M3 Wake Research | Las Vegas | Nevada | |
| Urban Health Plan INC | The Bronx | New York | |
| Toledo Institute of Clinical Research Inc | Toledo | Ohio | |
| OK Clinical Research, LLC | Edmond | Oklahoma | |
| Horizon Clinical Research | Cypress | Texas | |
| Alina Clinical Trials, LLC | Dallas | Texas | |
| El Paso Pulmonary Association | El Paso | Texas | |
| California Medical Research Associates Inc. | Houston | Texas | |
| Metroplex Pulmonary and Sleep Center Drive | McKinney | Texas | |
| DM Clinical Tomball | Tomball | Texas | |
| Fundacion Cidea | CABA | Argentina | |
| Instituto de Medicina Respiratoria, IMeR/ Instituto Médico DAMIC | Córdoba | Córdoba Province | |
| Centro de Medicina Respiratoria | Concepción del Uruguay | Entre Ríos Province | |
| Fundacion Scherbovsky | Mendoza | Mendoza Province | |
| Investigaciones En Patologias Respiratorias | San Miguel de Tucumán | Tucumán Province | |
| CARE: Centro de Alergia y Enfermedades Respiratorias | Buenos Aires | Argentina | |
| Investigaciones en Alergias y Enfermedades Respiratorias-InAER | Buenos Aires | Argentina | |
| INSARES | Mendoza | Argentina | |
| Centro Medico Dharma | Mendoza | Argentina | |
| Office of Hector H. Altieri MD | San Miguel de Tucumán | Argentina | |
| Instituto Especialidades de la Salud Rosario | Santa Fe | Argentina | |
| MHAT "Rahila Angelova" Pernik | Pernik | Pernik |
+ 62 more sites — see the full list on the official registry below.
Other trials for the same condition
Beyond EOsinophils: proteoMICS to Identify Potential Biomarker of Organ Damage and Response to MEPOLIZUMAB in EGPA
Enrolling by invitation
Severe Asthma Network Italy
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06966479 on ClinicalTrials.gov ↗ ← All trials in Italy