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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AK139
Biological/VaccineAK139 administered subcutaneously
Placebo
Biological/VaccinePlacebo administered subcutaneously
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: AK139 regimen 1Experimental treatment 1 intervention
Group B: AK139 regime 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Nasal Polyp Score (NPS)
Change from baseline in Nasal Polyp Score (NPS). NPS is a bilateral endoscopic assessment scale for nasal polyposis, where each nasal cavity is scored from 0 to 4. The total score is the sum of the left and right sides, ranging from 0 to 8, with higher scores indicating more severe nasal polyp disease.
Time frame
Baseline and Week 162
Nasal Congestion Score (NCS)
Change from baseline in Nasal Congestion Score (NCS). NCS is a patient-reported outcome measure using a 4-point Verbal Rating Scale (VRS) ranging from 0 to 3. Higher scores indicate more severe nasal congestion.
Time frame
Baseline and Week 16Secondary outcomes
1
Nasal Polyp Score (NPS)
Change from baseline in Nasal Polyp Score (NPS) at each assessment visit.
Time frame
From baseline to Week 20 (excluding Week 16)2
Nasal Congestion Score (NCS)
Change from baseline in Nasal Congestion Score (NCS) at each assessment visit.
Time frame
From baseline through Week 20 (excluding Week 16)3
Total Symptom Score (TSS)
Change from baseline in Total Symptom Score (TSS) at each assessment visit. TSS ranged from 0 to 9, with higher scores indicating greater nasal symptom severity.
Time frame
From baseline to Week 204
Sino-Nasal Outcome Test-22 (SNOT-22)
Change from baseline in Total Score of Sino-Nasal Outcome Test-22 (SNOT-22) at each assessment visit. SNOT-22 is a validated patient-reported questionnaire used to assess symptom severity and health-related quality of life (HRQoL) in patients with chronic rhinosinusitis (CRS). Scores range from 0 to 110, with higher scores indicating greater symptom burden and poorer HRQoL.
Time frame
From baseline to Week 20 Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: