Etokimab in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Status: | Recruiting |
---|---|
Conditions: | Sinusitis |
Therapuetic Areas: | Otolaryngology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 3/27/2019 |
Start Date: | December 27, 2018 |
End Date: | December 2019 |
Contact: | Kham Phenis |
Email: | info@anaptysbio.com |
Phone: | 858-362-6295 |
A Phase 2 Double-Blind, Placebo-Controlled Multi-dose Study to Investigate Etokimab (ANB020) Activity in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps
A study to evaluate the safety and efficacy multiple doses of Etokimab in subjects with
Chronic Rhinosinusitis with Nasal Polyps.
Chronic Rhinosinusitis with Nasal Polyps.
This study is a Phase II, randomized, placebo controlled, double-blind, multi-dose study to
evaluate the efficacy and safety of Etokimab in subjects with Chronic Rhinosinusitis with
Nasal Polyps.
evaluate the efficacy and safety of Etokimab in subjects with Chronic Rhinosinusitis with
Nasal Polyps.
Inclusion Criteria:
- Clinically confirmed diagnosis of CRSwNP
- Nasal polyp score ≥ 5 out of a maximum score for both nostrils (with at least a score
of 2 for each nostril).
- SNOT-22 score > 7.
- Presence of at least two of the following symptoms prior to screening: nasal
blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip);
facial pain/pressure; reduction or loss of smell
- Body mass index (BMI) of 18 to 38 kg/m2 (inclusive) and total body weight >50 kg (110
lb). BMI=weight (kg)/(height [m2]).
Exclusion Criteria:
- Use of investigational drugs or prohibited therapy for this study within 2 months
before screening or 5 half-lives, whichever is longer.
- Have experienced severe life threatening anaphylactic reactions.
- Participation in any interventional study for the treatment of CRSwNP in the 6 months
before screening.
- If female, is pregnant or lactating, or intend to become pregnant during the study
period.
- History (or suspected history) of alcohol or substance abuse.
- Current smokers or former smokers with a smoking history of ≥15 pack years. If a
patient has less than 15 pack years smoking history, he or she should have quit
smoking at least 6 months before screening to enroll in the study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
14
sites
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Sacramento, California 95815
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