OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps

NCT03747458 | Recruiting Phase 3 FDA Drug

• 1 other identifier: OPN-FLU-NP-3103
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 40

Brief Summary

This is a 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase. The total planned number of subjects is approximately 72 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 2:1 ratio (OPN-375 186 μg: Placebo). For the PK sub-study, up to 14 subjects will be enrolled to obtain 10 completers.

Conditions

Bilateral Nasal Polyposis

Outcome Measures

Primary Outcomes (2)

• Change in nasal congestion/obstruction symptoms (mild, moderate, severe) at the end of Week 4

  Change in nasal congestion/obstruction symptoms at the end of Week 4 measured by the 7-day average instantaneous morning (AM) diary symptom scores (ADS7-IA). The nasal symptom scale is what is used to score the nasal congestion/obstruction score, which is recorded in the diary. Nasal symptom scale is graded on a scale of 0=no symptom, 1=mild symptom, 2=moderate symptom, 3=severe symptom.

  4 Weeks

• Mean change from baseline at Week 16 in total polyp grade

  Change in total polyp grade (sum of scores from both nasal cavities) at Week 16 as determined by a nasal polyp grading scale score measured using a 0 to 6 point severity grading scale, with 0 (no polyps) to 3 (severe polyps) points per nostril

  16 Weeks

Secondary Outcomes (11)

• Change in bilateral polyp grade over time

  16 Weeks

• Percentage of subjects with a ≥1 point improvement in polyp grade

  16 Weeks

• Percentage of subject with a grade of 0 on at least one side of the nose

  16 Weeks

• Change in diary symptom scores for the symptoms of nasal congestion/obstruction, measured as instantaneous and reflective scores for the morning and the afternoon (AM and PM scores)

  16 Weeks

• Change in diary symptom scores for the symptoms of rhinorrhea, measured as instantaneous and reflective scores for the morning and the afternoon (AM and PM scores)

  16 Weeks

Other Outcomes (16)

• Assessment of safety from physical examination-measuring weight

  Visit 1 (Screening) and Visit 6 (Week 16/ End of Double-Blind/Early Termination)

• Assessment of safety from physical examination-measuring height

  Visit 1 (Screening) and Visit 6 (Week 16/ End of Double-Blind/Early Termination)

• Assessment of safety by recording the severity of AEs

  16 Weeks

Study Arms (2)

OPN-375 186 μg BID

ACTIVE COMPARATOR

Double-Blind Treatment Phase: OPN-375 186 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 186 μg BID x 12 weeks

Drug: OPN-375

Placebo

PLACEBO COMPARATOR

Double-Blind Treatment Phase: Matching Placebo BID x 16 weeks

Drug: OPN-375

Interventions

OPN-375 DRUG

OPN-375, BID

OPN-375 186 μg BID; Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subjects aged 12 to 17 years, inclusive, at time of Visit 1 (Screening).
• Female subjects, if sexually active, must,
• be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method \[e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel\], or male partner sterilization) before entry and throughout the study, or
• be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
• be abstinent.
• All female subjects not documented to be infertile (e.g., infertility due to congenital abnormality or surgical sterilization) must have a negative serum or urine beta-human chorionic gonadotropin (hCG) at Visit 1 (Screening) and a negative urine pregnancy test at the Visit 2 (Day 1/Randomization/Baseline).
• Must have bilateral nasal polyposis with a grade of 1 to 3 in each of the nasal cavities as determined by a nasal polyp grading scale score measured by nasoendoscopy at Visit 1 (Screening).
• Subjects with comorbid asthma must be stable, defined as no exacerbations (e.g., no emergency room visits, hospitalization, or oral or parenteral steroid use) within the 3 months before Visit 1 (Screening). Subjects who received inhaled corticosteroids are required to be on no more than a moderate dosage regimen as defined by 2015 Global Initiative for Asthma Guidelines (GINA) for 1 month before Visit 1 (Screening) and to be expected to remain on it throughout the study (GINA 2015). Subjects receiving inhaled fluticasone alone or in combination may not participate in the PK sub-study.
• Must be able to cease treatment with intranasal medications including, but not limited to, intranasal oxymetazoline or any other decongestants, intranasal antihistamines, intranasal steroids, intranasal sodium cromolyn, nasal atropine, nasal ipratropium bromide, inhaled corticosteroids (except permitted doses listed above for asthma) at Visit 1 (Screening). \[Note: intranasal antibiotics and saline are permissible\]
• If taking oral antihistamines, must be on a stable regimen for at least 2 weeks prior to Visit 1 (Screening), and agree to not change the dose of these medications until after Visit 3 (Week 4) of the study.
• Subjects (with assistance from parent or legal guardian if needed) must demonstrate the ability to complete the daily diary during the run-in period to be eligible for randomization.
• Must demonstrate correct use of the demo EDS.
• Must be capable, in the opinion of the investigator, of providing assent and the appropriate parent(s) or guardian must provide an informed consent to participate in the study.

You may not qualify if:

• Pregnancy or lactation
• Has a history of cystic fibrosis
• Have used XHANCE (fluticasone propionate) nasal spray within the past 2 months
• Inability to achieve bilateral nasal airflow for any reason, including nasal septum deviation
• Inability to examine both nasal cavities for any reason, including severe nasal septum deviation
• Have known history of nasal septum erosion, ulceration or perforation, or evidence of such lesion on Visit 1 (Screening) nasal examination/nasoendoscopy
• Other significant nasal pathology or abnormal anatomy
• Has had any episode of epistaxis with frank bleeding in the 3 months before Visit 1 (Screening)
• History of more than 5 sinus or nasal surgeries for either nasal polyps or nasal/sinus inflammation (lifetime)
• Have had any surgery on the nasal septum
• History of sinus or nasal surgery within 6 months before Visit 1 (Screening)
• History of any surgical procedure that prevents the ability to accurately diagnose or grade polyps
• Current, ongoing rhinitis medicamentosa (rebound rhinitis)
• Have significant oral structural abnormalities (e.g., a cleft palate)
• History of Churg-Strauss syndrome or dyskinetic ciliary syndromes

Sponsors & Collaborators

• Optinose US Inc.: lead

Study Sites (40)

Clinical Research Center of Alabama

Birmingham, Alabama, 35209, United States

WITHDRAWN

San Tan Allergy & Asthma

Gilbert, Arizona, 85234, United States

COMPLETED

Kern Research

Bakersfield, California, 93301, United States

COMPLETED

Central California Clinical Research

Fresno, California, 93720, United States

COMPLETED

Sensa Health

Los Angeles, California, 90006, United States

RECRUITING

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Children's Hospital of Orange County

Orange, California, 92868, United States

RECRUITING

Allergy and Asthma Consultants

Redwood City, California, 94063, United States

RECRUITING

Sacramento ENT

Roseville, California, 95661, United States

RECRUITING

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

COMPLETED

Yale School of Medicine, Section of Otolaryngology

New Haven, Connecticut, 06519, United States

WITHDRAWN

Nemours Children's Specialty Care

Jacksonville, Florida, 32207, United States

WITHDRAWN

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

COMPLETED

Rush University Medical Center - Department of Otorhinolaryngology

Chicago, Illinois, 60612, United States

WITHDRAWN

Chicago ENT

Chicago, Illinois, 60657, United States

RECRUITING

Kentuckiana ENT

Louisville, Kentucky, 40205, United States

RECRUITING

Ochsner Medical Center, Otorhinolaryngology Department

New Orleans, Louisiana, 70121, United States

WITHDRAWN

Children's Minnesota

Minneapolis, Minnesota, 55102, United States

WITHDRAWN

University of Missouri Medical Center

Columbia, Missouri, 65212, United States

WITHDRAWN

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Allergy Asthma & Immunology Research Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, 74136, United States

RECRUITING

MUSC Department of Otolaryngology, Head and Neck Surgery

Charleston, South Carolina, 29425, United States

WITHDRAWN

Carolina ENT

Orangeburg, South Carolina, 29118, United States

RECRUITING

STAAMP Research

San Antonio, Texas, 78229, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

COMPLETED

Eastern Virginia Medical School - Otolaryngology

Norfolk, Virginia, 23507, United States

RECRUITING

Spokane ENT

Spokane Valley, Washington, 99216, United States

COMPLETED

West Virginia University

Morgantown, West Virginia, 26506, United States

WITHDRAWN

Instituto Medico Rio Cuarto

Río Cuarto, Córdoba Province, X5008AEV, Argentina

RECRUITING

Instituto Medico de la Fundacion de Estudios Clinicos - Consultorios Integrados Rosario

Rosario, Santa Fe Province, S2000DEJ, Argentina

RECRUITING

Centro de Investigaciones Clinicas - Instituto de la Salud Rosario

Rosario, Santa Fe Province, S200DBS, Argentina

RECRUITING

Clinica Mayo, UMCB

San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina

RECRUITING

Sanatorio Guemes

Buenos Aires, C1180AAX, Argentina

RECRUITING

Fundacion CIDEA

Buenos Aires, C1411ABE, Argentina

RECRUITING

InAER - Investigaciones en Alergia y Enfermedades Respiratorias

Buenos Aires, C1425BEN, Argentina

RECRUITING

Instituto de Asma Alergia y Enfermedades Respiratoria (IAAER)

Corrientes, W3400AVV, Argentina

RECRUITING

Centro Medico INSARES

Mendoza, M5500CCG, Argentina

RECRUITING

Study Officials

• Amy Manley

  Paratek Pharma

  STUDY CHAIR

Central Study Contacts

Alissa Sirbu

CONTACT

484-751-4926; alissa.sirbu@paratekpharma.com

Amy Manley

CONTACT

amy.manley@paratekpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 20, 2018
• Study Start: December 31, 2018
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

AR (9); US (31)