Phase 3 Chronic Rhinosinusitis Trial, Recruiting NCT06338995 Sponsor: Eli Lilly and Company Condition: Chronic Rhinosinusitis
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Phase 3 Chronic Rhinosinusitis Trial, Recruiting

NCT06338995
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed by a doctor with chronic rhinosinusitis (long-term sinus inflammation) with nasal polyps in both nostrils.
  • You have either had steroid tablets/injections in the last 2 years (or cannot take them due to a medical reason), had surgery for nasal polyps, or both.
  • Your nasal polyps are large enough to meet a minimum size score when examined with a small camera inside the nose (confirm with trial site).
  • You have had ongoing symptoms for at least 8 weeks before joining, including moderate or severe nasal blockage, plus at least one other symptom such as reduced or total loss of smell, or a runny nose (dripping from the front or back of the nose).
  • If you have asthma, it must have been stable and well-controlled for at least 3 months before joining.
  • You are a young person aged 12 to 17 years old and weigh at least 40 kg (about 88 lbs).

Who may not be able to join:

  • You have previously received a medication called lebrikizumab.
  • You needed rescue medication or surgery for nasal polyps during the study screening or run-in period.
  • You started allergy immunotherapy (allergy shots or under-the-tongue drops) within the last 6 months and are not yet on a stable dose.
  • You have received a biological medicine approved for nasal polyps, asthma, or eczema within the past 4 months or longer (confirm with trial site).
  • You have received certain other biological medicines or medicines that suppress the immune system within specific time periods before joining (confirm with trial site for exact timeframes).
  • You have had any nasal or sinus surgery, including nasal polyp removal, within 6 months before joining.
  • You have had past nasal or sinus surgery that changed the structure of the inside of your nose in a way that makes it hard to assess your polyps (confirm with trial site).
  • You have any of the following conditions: a deviated nasal septum blocking at least one nostril, a specific type of polyp called antrochoanal, a current sinus or upper respiratory infection, overuse of nasal decongestant sprays, certain rare conditions linked to nasal polyps (such as cystic fibrosis or specific inflammatory diseases), a nasal tumour (cancerous or non-cancerous), or evidence of a fungal sinus infection.
  • Your loss of smell is caused by COVID-19 or any reason other than your nasal polyp condition.
  • Your lung function test result (measuring how much air you can breathe out quickly) is 50% or below the normal expected level.
  • You are female and are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Phone: 1-317-615-4559

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
29 April 2024
Est. completion
1 May 2027

Where this trial is recruiting

🇦🇷 Argentina 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇩🇰 Denmark 🇫🇮 Finland 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity; Mean CFBL in Endoscopic Nasal Polyp Score (NPS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov