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

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Status and phase: Enrolling; Phase 2

Conditions: Severe Asthma

Treatments: Drug: Verekitug; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06966479

UPB-CP-05

2024-519469-23-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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).

Enrollment: 436 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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436 participants in 2 patient groups

Verekitug 100 mg Q12W and Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Verekitug

Verekitug 400 mg Q24W and Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Verekitug