Allakos AK001-002 NASAL POLYPOSIS
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis
IRAS ID
201877
Contact name
Omer Siddiqui
Contact email
Sponsor organisation
Allakos, Inc.
Eudract number
2016-000460-42
Duration of Study in the UK
0 years, 10 months, 30 days
Research summary
Nasal polyps are soft, painless, noncancerous growths on the lining of nasal passages or sinuses. They hang down like teardrops or grapes inside the nose. They are caused by inflammation due to asthma, recurring infection, allergies, drug sensitivity or certain immune problems.
This study involves the use of an investigational medicinal product called AK001 which is intended for the possible treatment of nasal polyps.
The purpose of this research study is to study if taking AK001 with Nasonex, compared to Nasonex alone may be an effective treatment of nasal polyps. Nasonex is an authorized steroid medication used to treat and prevent nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. Nasonex is also used to treat nasal polyps in adults.
The study will evaluate if it is safe to take AK001 in combination with Nasonex and also if taking AK001 with Nasonex, compared to Nasonex alone, can shrink the nasal polyps, clear the nose passages, improve ability to smell, and reduce nasal symptoms.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/0842
Date of REC Opinion
1 Jun 2016
REC opinion
Further Information Favourable Opinion