Orion Clinical Research | Austin, TX
Status and phase
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About
The primary purpose of this study is to assess the effect of verekitug (UPB-101) on the endoscopically determined size and extend of nasal polyps in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) and to assess the safety and tolerability of verekitug (UPB-101) compared to placebo.
Full description
This is a multicenter, randomized, placebo controlled, parallel group study to assess the efficacy and safety of verekitug (UPB-101) administered subcutaneously (SC) in participants with CRSwNP on background therapy with stable dosage of intranasal corticosteroids (INCS). Approximately 70 participants will be randomized. Participants will receive verekitug (UPB-101) or placebo over a 24-week treatment period. In addition, this study consists of a 3 to 5-week Screening Period and a 4-week Follow-up Period.
Enrollment
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Ages
Volunteers
Inclusion criteria
Participant has signed, dated and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF).
Participant is aged 18 to 75 years of age (inclusive) at the time of signing the ICF.
Participant has physician diagnosed CRSwNP for at least 6 months prior to Visit 1 that fulfills all of the following:
Participant has at least one of the following:
Stable standard of care treatment for CRSwNP for at least 30 days prior to Visit 1.
At Visit 2, at least 21 days of background mometasone furoate nasal spray (MFNS) (or equivalent) background therapy.
>=70 percent (%) diary compliance for MFNS (or equivalent) in the 14 days prior to Visit 2.
Agrees to follow the required contraceptive techniques/methods
Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug intervention or at the Final Visit, whichever occurs last
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
70 participants in 2 patient groups, including a placebo group
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Upstream Bio Clinical Trials Information (Privacy Notice: https://www.upstreambio.com/privacy)
Data sourced from clinicaltrials.gov
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