A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Rhinosinusitis With Nasal Polyps

NCT07755371 | Not Yet Recruiting Phase 2

• 1 other identifier: AK139-204
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and Week 16

• 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.

  Baseline and Week 16

Secondary Outcomes (9)

• Nasal Polyp Score (NPS)

  From baseline to Week 20 (excluding Week 16)

• Nasal Congestion Score (NCS)

  From baseline through Week 20 (excluding Week 16)

• Total Symptom Score (TSS)

  From baseline to Week 20

• Sino-Nasal Outcome Test-22 (SNOT-22)

  From baseline to Week 20

• Lund-Mackay Score

  Baseline and Week 16

Study Arms (3)

AK139 regimen 1

EXPERIMENTAL

AK139 regimen 1 will be administered by subcutaneous injection

Biological: AK139

AK139 regime 2

EXPERIMENTAL

AK139 regime 2 will be administered by subcutaneous injection.

Biological: AK139

Placebo

PLACEBO COMPARATOR

Placebo will be administered by subcutaneous injection.

Biological: Placebo

Interventions

Placebo BIOLOGICAL

Placebo administered subcutaneously

Placebo

AK139 BIOLOGICAL

AK139 administered subcutaneously

AK139 regime 2; AK139 regimen 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Use of intranasal corticosteroids for at least 4 weeks prior to screening.

You may not qualify if:

• 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).
• Presence of any of the following conditions:
• Antrochoanal polyp;
• Persistent rhinitis medicamentosa;
• Allergic fungal rhinosinusitis with symptoms and/or CT findings.
• Nasal malignant or benign tumors.
• Severe nasal septal deviation causing obstruction of at least one nostril.
• Known eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, cystic fibrosis, primary ciliary dyskinesia, or other systemic diseases associated with nasal polyposis.
• Participants with asthma and FEV1 ≤50% of the predicted value at screening or baseline.
• Parasitic infection, active tuberculosis, recurrent or chronic infectious diseases, or autoimmune diseases.
• Acute sinusitis, nasal infection, or upper respiratory tract infection within 2 weeks prior to screening or during the screening period.
• Chronic infection with hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), or syphilis.
• Treatment with anti-IL-4Rα monoclonal antibodies, anti-thymic stromal lymphopoietin (TSLP) monoclonal antibodies, anti-immunoglobulin E (IgE) monoclonal antibodies, or other biologic agents within 10 weeks or 5 half-lives (whichever is longer) before randomization, or prior treatment with AK139.
• Treatment with short- or intermediate-acting systemic corticosteroids within 4 weeks prior to screening, or long-acting systemic corticosteroids within 6 weeks prior to screening.
• Prior treatment with anti-IL-4Rα monoclonal antibodies with inadequate clinical response.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, China

Location

Central Study Contacts

Guoqin Wang

CONTACT

+86 (0760) 8987 399; global.trials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)