Bilateral nasal polyposis MedDRA version: 20.0 Level: PT Classification code 10028756 Term: Nasal polyps System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: ACT-774312
Product Code: ACT-774312
Pharmaceutical Form: Capsule
INN or Proposed INN: ACT-774312
Current Sponsor code: ACT-774312
Other descriptive name: ACT-774312
Concentration unit: m
Sponsors
Idorsia Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent in the local language prior to any study-mandated procedure. • A minimum bilateral nasal polyp score (NPS) of 5 out of a maximum of 8 for both nostrils (with at least a score of 2 for each nostril) despite completion of a prior intranasal corticosteroids (INCS) treatment for at least 8 weeks before screening, with at least the 6 last weeks on INCS spray. • Presence of at least 2 of the following symptoms at screening: o nasal blockade/obstruction o nasal discharge (anterior/posterior nasal drip) o reduction or loss of smell • Male and female subjects aged between 18 and 70 years (inclusive) at screening. • Subjects with a body mass index (BMI) = 18 kg/m2. • Systolic blood pressure 90 to 160 mmHg, diastolic blood pressure 50 to 100 mmHg, pulse rate 45 to 100 bpm (inclusive), measured on the dominant arm, after 5 min in the supine position at screening. • Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test pre-dose on Day 1. Women of childbearing potential must consistently and correctly use (from at least first dosing, during the entire study, and for at least 30 days after last study treatment intake) 1 highly effective method of contraception with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: • CYP2C9 poor metabolizer subject. • Subject with severe renal function impairment (= 29 mL/min/1.73 m2) which is defined by eGFR estimated at screening using the Modification of Diet in Renal Disease (MDRD) formula. • Subject with Sino-Nasal Outcome Test (SNOT-22) 24 h) for treatment of asthma has occurred within 3 months prior screening OR o They are on a dose higher than 1000 µg fluticasone or the equivalent of inhaled corticosteroids (ICS) • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. • Subject with active autoimmune disease (e.g., Hashimoto’s thyroiditis, Graves’ disease, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, psoriasis vulgaris, rheumatoid arthritis). • Subject with evidence of acute or chronic infection. • Subject considered as vulnerable (e.g., sponsor or site employee, investigator subordinate, subject incapable of giving consent, subject committed to an institution by way of official or judicial order). • Subject with liver injury related criteria: o Underlying hepatobiliary disease OR o ALT>3 (Upper Limit of Normal) ULN OR o or Bilirubin>2 ULN • Subject with any contraindications or warning/precautions of use related to mometasone furoate nasal spray.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of ACT-774312 on bilateral nasal polyposis (NP).;Secondary Objective: - To evaluate the safety and tolerability of ACT-774312 during 12 weeks of treatment; - To evaluate the pharmacokinetics (PK) of ACT-774312 in subjects with NP; - To evaluate the pharmacodynamic (PD) responses to ACT-774312 based on Th-2 biomarkers ;Primary end point(s): Change from baseline to Week 12 in NPS as measured by nasal endoscopy assessed centrally;Timepoint(s) of evaluation of this end point: From baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1), 2): from baseline to week 12 3) to 7): from baseline to week 2, 4, 8, 12 and End of study;Secondary end point(s): 1) Change from baseline to Week 12 in sinus opacifications as assessed by CT scan using the Zinreich-modified Lund Mackay Score assessed centrally. 2) Change from baseline to Week 12 in 3D volumetric computerized values. 3) Change from baseline to Week 2, 4, 8, 12, and EOS in University of Pennsylvania Smell Identification Test (UPSIT). 4) Change from baseline to Week 2, 4, 8, 12, and EOS in the sum of Visual Analog Scale (VAS) symptoms score for nasal obstruction, nasal discharge, mucus in the throat, loss of smell, and facial pain. 5) Change from baseline to Week 2, 4, 8, 12, and EOS in Physician Global Assessment (PGA) score. 6) Change from baseline to Week 2, 4, 8, 12, and EOS in SNOT-22. 7) Patient global impression of change in disease severity at Week 2, 4, 8, 12, and EOS. | — |
Countries
Belgium, Germany
Contacts
Public ContactClinical Trial Disclosure Desk
Idorsia Pharmaceuticals Ltd
Outcome results
None listed