Can a new drug shrink nasal polyps and restore smell?

NCT ID NCT05891483

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether an experimental drug called SHR-1905 can reduce nasal polyps and improve symptoms like congestion and loss of smell in people with chronic sinusitis. Participants will receive either the drug or a placebo alongside their usual nasal spray treatment. The study aims to find a safe and effective dose for this condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental drug called SHR-1905
What this could lead to
If effective, SHR-1905 could offer a new treatment option for people with chronic sinusitis and nasal polyps who still have symptoms despite standard nasal sprays.
What could go wrong
This is an early phase 2 trial with only 114 participants, so results may not apply to everyone. The drug's safety and effectiveness are still unproven, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

114 people

The number who actually took part.

Started

Sep 2023

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Weight ≥40kg 2. Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP). 3. Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril. 4. NCS ≥2 at screening and baseline. 5. SNOT-22≥20 at screening period and baseline. 6. Recorded persistent NP symptoms for over 4 weeks prior to screening. 7. Subjects received standard therapy with intranasal corticosteroids (INCS) and remained stable during the 4 weeks prior to randomization. 8. NP surgery in the past and/or ACERS treated with SCS occurred within 2 years before randomization (or with contraindications/ intolerances). Exclusion Criteria: 1. Any comorbidities that may affect the efficacy evaluation of nasal polyps. 2. Any comorbidities except for asthma that may affect blood EOS levels. 3. Concomitant with immunodeficiency. 4. Concomitant with contraindications or not suitable for nasal endoscopy. 5. Uncontrolled hypertension. 6. Uncontrolled diabetes. 7. Infection within 2 weeks prior to screening to randomization that is clinically significant and/or should be treated with systemic antibiotics. 8. Uncontrolled epistaxis within 4 weeks prior to randomization. 9. Major surgery performed within 3 months prior to randomization, or surgery planned during the study, or treatments that may affect evaluations according to investigators. 10. Parasitic infection within 6 months before randomization. 11. Sinus or intranasal surgery (except for diagnostic biopsy) within 6 months prior to randomization, or changes in the nasal walls caused by sinus or intranasal surgery that made NPS evaluation impossible. 12. Malignancies diagnosed within 5 years before randomization (except those with a low risk of metastasis or death). 13. Abnormalities of laboratory tests at screening or baseline. 14. Concomitant with active hepatitis B, positive hepatitis C virus antibodies, positive human immunodeficiency virus antibodies, or positive treponema pallidum antibodies. 15. Prolonged QTc interval (\>450ms for male and \>470ms for female) or other clinically significant abnormal results of ECG at screening or baseline that may cause significant safety risks to subjects. 16. FEV1 before the use of bronchodilator (pre-BD) was less than 50% at screening. 17. Transfusion of blood products or immunoglobulin within 4 weeks prior to randomization. 18. SCS or additional INCS use within 4 weeks before randomization, or planned use during treatment period. 19. Regular use of decongestants (local or systemic) within 4 weeks before randomization, except for during the endoscopic procedure. 20. Adnimistration of live vaccine or viral vector vaccine within 4 weeks before randomization. 21. Allergen immunotherapy within 8 weeks before randomization. 22. Smoking history ≥10 pack-years, smoking at screening, or smoking cessation less than 6 months at screening. 23. Substance abuse, drug abuse, and/or excessive alcohol consumption within 1 year prior to randomization. 24. Pregnancy (including positive pregnancy test at screening or baseline), lactation, or pregnancy plan during study period.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Eye & Ent Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200031, China

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