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

Purpose

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

  • Severe Asthma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Verekitug 100 mg Q12W and Placebo 		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.
  • Drug: Verekitug
    Verekitug subcutaneous injection.
    Other names:
    • UPB-101
  • Drug: Placebo
    Verekitug matching placebo.
Experimental
Verekitug 400 mg Q24W and Placebo 		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.
  • Drug: Verekitug
    Verekitug subcutaneous injection.
    Other names:
    • UPB-101
  • Drug: Placebo
    Verekitug matching placebo.

Recruiting Locations

Kern Research, Inc.
Bakersfield 5325738, California 5332921 93301

California Medical Research Associates Inc.
Northridge 5377985, California 5332921 91324

Integrated Research of Inland Inc
Upland 5404915, California 5332921 91786

Allergy & Asthma Clinical Research
Walnut Creek 5406990, California 5332921 94598

Allianz Research Institute
Westminster 5408406, California 5332921 92683

Advance Pharma Research
Cutler Bay 6332309, Florida 4155751 33189

Phoenix Medical Research
Miami 4164138, Florida 4155751 33165

Research Institute of South Florida
Miami 4164138, Florida 4155751 33173

Health and Life Research Institute, LLC
Miami 4164138, Florida 4155751 33176

Nouvelle Clinical Research
Miami 4164138, Florida 4155751 33189

Edward Jenner Research Group, LLC
Plantation 4168782, Florida 4155751 33317

R&B Medical Center
Tampa 4174757, Florida 4155751 33614

Clinical Site Partners dba Flourish research
Winter Park 4178560, Florida 4155751 32789

Treasure Valley Medical Research
Boise 5586437, Idaho 5596512 83706

Chesapeake Clinical Research Inc
White Marsh 4373426, Maryland 4361885 21162

Pulmonary Research Institute of Southeast Michigan (PRISM)
Farmington Hills 4992523, Michigan 5001836 48336

AA MRC
Flint 4992982, Michigan 5001836 48504

M3 Wake Research
Las Vegas 5506956, Nevada 5509151 89106

Urban Health Plan INC
The Bronx 5110266, New York 5128638 10459

Toledo Institute of Clinical Research Inc
Toledo 5174035, Ohio 5165418 43617

OK Clinical Research, LLC
Edmond 4535740, Oklahoma 4544379 73034

Alina Clinical Trials, LLC
Dallas 4684888, Texas 4736286 75209

El Paso Pulmonary Association
El Paso 5520993, Texas 4736286 79902

California Medical Research Associates Inc.
Houston 4699066, Texas 4736286 77008

Metroplex Pulmonary and Sleep Center Drive
McKinney 4710178, Texas 4736286 75069

DM Clinical Tomball
Tomball 4737094, Texas 4736286 77375

More Details

Status
Recruiting
Sponsor
Upstream Bio Inc.

Study Contact

Upstream Bio Clinical Trials Information (Privacy Notice: https://upstreambio.com/privacy-policy/)
888-446-3130
clinicaltrials@upstreambio.com