A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Rhinosinusitis With Nasal Polyps
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 injection compared with placebo in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) receiving background treatment with mometasone furoate nasal spray (MFNS).
Eligibility criteria
Qualifiers
Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF).
Bilateral CRSwNP with prior treatment with systemic corticosteroids (SCS), contraindications to or intolerance of SCS, and/or prior nasal polyp surgery.
Nasal Polyp Score (NPS) ≥5, with a minimum score of 2 in each nasal cavity, at screening and baseline.
Ongoing nasal congestion/obstruction, with a Nasal Congestion Score (NCS) of 2 or 3 at screening and baseline.
Disqualifiers
History of sinonasal surgery (including nasal polypectomy) within 6 months prior to screening, or prior nasal surgery resulting in structural changes that preclude adequate assessment of Nasal Polyp Score (NPS).
Antrochoanal polyp;
Persistent rhinitis medicamentosa;
Allergic fungal rhinosinusitis with symptoms and/or CT findings.
Trial design
Treatments tested in this trial
- AK139
- Placebo
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov