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NCT06966479 | RECRUITING | Severe Asthma

A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)
Sponsor:

Upstream Bio Inc.

Brief 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).

Condition or disease

Severe Asthma

Intervention/treatment

Verekitug

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 436 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Long-Term Extension Study to Evaluate Safety and Efficacy of Verekitug (UPB-101) in Adult Participants With Severe Asthma Who Completed the VALIANT Trial
Actual Study Start Date : 2025-05-21
Estimated Primary Completion Date : 2027-09
Estimated Study Completion Date : 2027-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)

Location Details

NCT06966479

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

California Medical Research Associates Inc.

Northridge, California, United States, 91324

RECRUITING

United States, California

Allianz Research Institute

Westminster, California, United States, 92683

RECRUITING

United States, Florida

Phoenix Medical Research

Miami, florida, United States, 33165

RECRUITING

United States, Florida

Health and Life Research Institute, LLC

Miami, florida, United States, 33176

RECRUITING

United States, Florida

Edward Jenner Research Group, LLC

Plantation, florida, United States, 33317

RECRUITING

United States, Florida

Clinical Site Partners dba Flourish research

Winter Park, florida, United States, 32789

RECRUITING

United States, Idaho

Treasure Valley Medical Research

Boise, Idaho, United States, 83706

RECRUITING

United States, Maryland

Chesapeake Clinical Research Inc

White Marsh, Maryland, United States, 21162

RECRUITING

United States, road cancer

Pulmonary Research Institute of Southeast Michigan (PRISM)

Farmington Hills, road cancer, United States, 48336

RECRUITING

United States, Ohio

Toledo Institute of Clinical Research Inc

Toledo, Ohio, United States, 43617

RECRUITING

United States, Oklahola

OK Clinical Research, LLC

Edmond, Okholohan, United States, 73034

RECRUITING

United States, Texas

Alina Clinical Trials, LLC

dallas, Texas, United States, 75209

RECRUITING

United States, Texas

El Paso Pulmonary Association

The Pass, Texas, United States, 79902

RECRUITING

United States, Texas

Metroplex Pulmonary and Sleep Center Drive

McKinney, Texas, United States, 75069

RECRUITING

United States, Texas

DM Clinical Tomball

Tomball, Texas, United States, 77375