Dupilumab for Nasal Polyps

Recruiting in Palo Alto (17 mi)

Overseen byRoy F Thomas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Madigan Army Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Investigators will investigate an alternate Dupilumab administration schedule in patients with recurrent chronic rhinosinusitis with nasal polyposis, who have a history of full endoscopic sinus surgery and are on appropriate topical medical therapies. Specifically, investigators will investigate if the alternate schedule of drug administration is non-inferior in both subjective and objective outcomes.

Research Team

Renee M Serra, MD

Principal Investigator

ENT/Audiology Department Chair

Roy F Thomas, MD

Principal Investigator

Rhinologist

Eligibility Criteria

This trial is for patients with chronic rhinosinusitis and nasal polyps who've had full sinus surgery and are on topical meds. It's not clear what excludes someone from participating, but typically, it would involve factors like other health issues or treatments that could interfere with the study.

Inclusion Criteria

I am currently using a nasal spray or rinse that contains steroids.

I am over 18 and have recurring severe nasal polyps confirmed by symptoms and a nasal endoscopy.

I have had sinus surgery before.

See 1 more

Exclusion Criteria

My asthma causes my lung function to be below 50%.

Patient is a pregnant woman, may become pregnant, or breastfeeding.

I haven't used any biologic therapy in the last 6 months.

See 1 more

Treatment Details

Interventions

Dupilumab (Monoclonal Antibodies)

Trial OverviewThe study is testing a different schedule for taking Dupilumab to see if it works as well as the regular schedule for people with sinus issues and nasal polyps after surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B - Alternate AdministrationExperimental Treatment1 Intervention

Eligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 8 weeks and then every 4 weeks up until 28 weeks

Group II: Arm A - Regular AdminstrationActive Control1 Intervention

Eligible patient will receive 300 mg Subcutaneous Dupilumab every 2 weeks for 28 weeks