Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Phase 2NCT07755371
A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Rhinosinusitis With Nasal Polyps
A Phase 2 study testing AK139 in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Akeso at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- What is being tested?
- AK139
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2026to 31 Jul 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study Evaluating the Efficacy and Safety of AK139 in Participants With Chronic Rhinosinusitis With Nasal Polyps
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).
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 in participants with chronic rhinosinusitis with nasal polyps (CRSwNP).
Eligible participants will be randomized to receive AK139 or placebo in addition to background treatment with mometasone furoate nasal spray (MFNS). The study will assess the effect of AK139 on nasal polyp burden, disease symptoms, health-related quality of life, safety, PK, PD, and immunogenicity throughout the study period.
- Being tested
- AK139, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK139Biological
AK139 administered subcutaneously
PlaceboBiological
Placebo administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| AK139 regimen 1 | Experimental | AK139 regimen 1 will be administered by subcutaneous injection Receives: Biological: AK139 |
| AK139 regime 2 | Experimental | AK139 regime 2 will be administered by subcutaneous injection. Receives: Biological: AK139 |
| Placebo | Placebo comparator | Placebo will be administered by subcutaneous injection. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Week 16
Secondary outcomes (9)
Nasal Polyp Score (NPS)
Change from baseline in Nasal Polyp Score (NPS) at each assessment visit.
Measured: From baseline to Week 20 (excluding Week 16)
Nasal Congestion Score (NCS)
Change from baseline in Nasal Congestion Score (NCS) at each assessment visit.
Measured: From baseline through Week 20 (excluding Week 16)
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.
Measured: From baseline to Week 20
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.
Measured: From baseline to Week 20
Lund-Mackay Score
Change from baseline in Lund-Mackay Score on CT scan. The Lund-Mackay score ranges from 0 to 24, with higher scores indicating more severe sinonasal disease.
Measured: Baseline and Week 16
Safety parameters
Assessment of safety, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant findings from physical examinations, laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs).
Measured: Up to Week 20
Pharmacokinetics (PK)
Serum concentrations of AK139 following administration.
Measured: Up to Week 20
Pharmacodynamics (PD)
Change from baseline in serum biomarker levels.
Measured: From baseline to Week 20
Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb)
Incidence of Anti-drug antibodies(ADA) and Neutralizing antibody (Nab) after treatment.
Measured: Up to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Studies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755371
- Sponsor's protocol ID
- AK139-204
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No