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Etokimab in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03614923
Recruitment Status : Active, not recruiting
First Posted : August 3, 2018
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
AnaptysBio, Inc.

Brief Summary:
A study to evaluate the safety and efficacy multiple doses of Etokimab in subjects with Chronic Rhinosinusitis with Nasal Polyps.

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis Biological: Etokimab Biological: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Double-Blind, Placebo-Controlled Multi-dose Study to Investigate Etokimab (ANB020) Activity in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Active Comparator: Dose 1
SC administration, Q4W
Biological: Etokimab
SC, Q4W
Other Name: ANB020

Active Comparator: Dose 2
SC administration, Q8W
Biological: Etokimab
SC, Q8W
Other Name: ANB020

Placebo Comparator: Placebo
SC administration, Q4W
Biological: Placebo
SC, Placebo Q4W




Primary Outcome Measures :
  1. Change From Baseline in Nasal Polyp Score (NPS) to Week 16. [ Time Frame: Week 16 ]
    Total scoring 0-8, scoring of 0-4 [0 - no polyps, 4 - large polyps causing complete obstruction] bilateral

  2. Change From Baseline in Sino-Nasal Outcome Test -22 (SNOT-22) Score from Week 16. [ Time Frame: Week 16 ]
    Total scoring 0-110, scoring of 0-5 [0 - no problem, 5 - problem as bad as it can be] (22 items)


Secondary Outcome Measures :
  1. Time to first response in nasal polyp score. [ Time Frame: Week 16 ]
  2. Responder analysis: response defined as a reduction of at least 1 point from Baseline to Week 16 in nasal polyp score [ Time Frame: Week 16 ]
  3. Responder analysis: response defined as a reduction of at least 12 points from Baseline to Week 16 in SNOT-22. [ Time Frame: Week 16 ]
  4. Change from Baseline to Week 16 in sense of smell as assessed by the University of Pennsylvania Smell Identification Test (UPSIT). [ Time Frame: Week 16 ]
  5. Incidence of adverse events and treatment emergent adverse events. [ Time Frame: Week 24 ]
  6. Incidence of serious adverse events. [ Time Frame: Week 24 ]
  7. Changes in clinical laboratory tests (hematology, chemistry and urinalysis). [ Time Frame: Week 24 ]
  8. Changes in vital signs (BP, temperature, respiration rate, and pulse rate). [ Time Frame: Week 24 ]
  9. Changes in ECG parameters. [ Time Frame: Week 24 ]
  10. Immunogenicity (ADA and neutralizing ADA) [ Time Frame: Week 24 ]
  11. CL/F, apparent volume of distribution, Cmax, tmax. [ Time Frame: Week 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically confirmed diagnosis of CRSwNP
  • Nasal polyp score ≥ 4 out of a maximum score for both nostrils (with at least a score of 1 for each nostril).
  • SNOT-22 score > 15.
  • 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 42 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 8 weeks 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 3 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 ≥10 pack years. If a patient has less than 10 pack years smoking history, he or she should have quit smoking at least 2 months before screening to enroll in the study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614923


Locations
Show Show 28 study locations
Sponsors and Collaborators
AnaptysBio, Inc.
Investigators
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Study Director: SM_ANB020-006@syneoshealth.com AnaptysBio, Inc.
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Responsible Party: AnaptysBio, Inc.
ClinicalTrials.gov Identifier: NCT03614923    
Other Study ID Numbers: ANB020-006
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AnaptysBio, Inc.:
ANB020
Etokimab
CRSwNP
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical