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

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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.

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.

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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San Diego, CA
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Baltimore, Maryland 21236
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Boca Raton, FL
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Brandon, Florida 33511
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Brandon, FL
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Canoga Park, California 91304
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Canoga Park, CA
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Colorado Springs, Colorado 80909
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Colorado Springs, CO
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Greenfield, Wisconsin 53228
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Greenfield, WI
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Matthews, North Carolina 28105
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Matthews, NC
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Medford, OR
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North Charleston, South Carolina 29420
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North Charleston, SC
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Oklahoma City, Oklahoma 73120
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Oklahoma City, OK
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Sacramento, CA
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Tulsa, OK
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Tulsa, Oklahoma 74136
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Tulsa, OK
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