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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Bilateral Nasal Polyposis

In brief

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.

Key facts

Study ID

NCT03747458

Run by

Optinose US Inc.

People needed

72

Starts

2018-12-31

Expected to finish

2026-06-30

Last updated by the study team

2026-05-08

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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).
• Must report at least mild symptoms of nasal congestion/obstruction as demonstrated by an average morning nasal congestion/obstruction score of at least 1.0 over a 7 day period during the single-blind run-in period. (Subjects not meeting this inclusion criterion may be re-screened once after at least 4 weeks.)
• 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
• Purulent nasal infection (recent fever or symptoms of lethargy), acute sinusitis, or upper respiratory tract infection within 2 weeks before Visit 1 (Screening). Potential subjects presenting with one of these infections may be rescreened after 4 weeks.
• Have an allergy, hypersensitivity, or contraindication to corticosteroids or steroids
• Have a hypersensitivity to any excipients in the study drug
• Exposure to any glucocorticoid treatment with potential for systemic effects (e.g., oral or parenteral steroids, high dose topical steroids) within 1 month before Visit 1 (Screening); except as noted in inclusion criteria for subjects with comorbid asthma
• Have received mepolizumab (Nucala®), reslizumab (Cinquair®), dupilumab (Dupixent®), omalizumab (Xolair®), or benralizumab (Fasenra™) within 6 months of Visit 1
• Have nasal or oral candidiasis
• Have taken a potent CYP3A4-inhibitor within 14 days before Visit 1 (Screening)
• Any serious or unstable concurrent disease, psychiatric disorder, or any significant concomitant medical condition that, in the opinion of the investigator could confound the results of the study or could interfere with the subject's participation or compliance in the study, or pose a specific risk to the subject due to study participation
• History or current diagnosis of any form of glaucoma or ocular hypertension (i.e., >21 mm Hg)
• History of intraocular pressure elevation on any form of steroid therapy

Where it is running

• San Tan Allergy & Asthma — Gilbert, Arizona, United States
• Kern Research — Bakersfield, California, United States
• Central California Clinical Research — Fresno, California, United States
• Sensa Health — Los Angeles, California, United States
• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Allergy and Asthma Consultants — Redwood City, California, United States
• Sacramento ENT — Roseville, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Chicago ENT — Chicago, Illinois, United States
• Kentuckiana ENT — Louisville, Kentucky, United States
• University of Rochester — Rochester, New York, United States
• Allergy Asthma & Immunology Research Institute — Charlotte, North Carolina, United States
• Allergy, Asthma & Clinical Research Center — Oklahoma City, Oklahoma, United States
• Vital Prospects Clinical Research Institute, P.C. — Tulsa, Oklahoma, United States
• Carolina ENT — Orangeburg, South Carolina, United States
• STAAMP Research — San Antonio, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Eastern Virginia Medical School - Otolaryngology — Norfolk, Virginia, United States
• Spokane ENT — Spokane Valley, Washington, United States
• Instituto Medico Rio Cuarto — Río Cuarto, Córdoba Province, Argentina
• Instituto Medico de la Fundacion de Estudios Clinicos - Consultorios Integrados Rosario — Rosario, Santa Fe Province, Argentina
• Centro de Investigaciones Clinicas - Instituto de la Salud Rosario — Rosario, Santa Fe Province, Argentina

Full record on ClinicalTrials.gov

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