Benralizumab for Nasal Polyps

(ORCHID Trial)

Recruiting at 107 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests benralizumab injections in patients with severe nasal polyps who haven't responded to other treatments. The medication reduces specific cells that cause inflammation, aiming to improve symptoms. Benralizumab has been studied for its effects on severe asthma and nasal polyps.

Research Team

Luo Zhang, Prof. Dr.

Principal Investigator

Beijing Tongren Hospital

Eligibility Criteria

Adults aged 18-75 with severe nasal polyps, stable on intranasal corticosteroids, and a history of systemic steroids or sinus surgery. Must have ongoing symptoms for at least 12 weeks, moderate to severe nasal blockage, and certain blood eosinophil levels. Excludes those who've had recent biologic treatments or sinus surgery, are pregnant/breastfeeding, or have conditions affecting trial evaluation.

Inclusion Criteria

Your SNOT-22 score is 20 or higher when you join the study.

I have been diagnosed with asthma by a doctor.

I have had symptoms for at least 3 months before joining.

Exclusion Criteria

I do not have conditions like severe nasal blockage or specific sinus issues that would prevent accurate assessment of the treatment's effectiveness.

I haven't taken any experimental or approved biologic drugs in the last 6 months.

Currently pregnant or breastfeeding

Treatment Details

Interventions

• Benralizumab (Monoclonal Antibodies)

Trial Overview The study is testing the effectiveness and safety of Benralizumab (30 mg) compared to a placebo in patients with severe nasal polyposis. It's randomized and double-blind meaning neither participants nor researchers know who gets the real treatment versus placebo.

Participant Groups

Group I: Benralizumab Experimental Treatment 1 Intervention

Benralizumab administered subcutaneously

Group II: Placebo Placebo Group 1 Intervention

Placebo administered subcutaneously

Benralizumab is already approved in Canada, Japan for the following indications:

Approved in Canada as Fasenra for:

• Severe eosinophilic asthma

Approved in Japan as Fasenra for:

• Severe eosinophilic asthma

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology