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A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis

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: NCT03688555
Recruitment Status : Active, not recruiting
First Posted : September 28, 2018
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
The study will evaluate the effect of ACT-774312 on the nasal polyps and will assess the safety and tolerability of ACT-774312 in the patients with bilateral nasal polyposis

Condition or disease Intervention/treatment Phase
Bilateral Nasal Polyposis Drug: ACT-774312 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, 12-week Treatment Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: ACT-774312
Subjects will receive ACT-774312 400 mg b.i.d. for 12 weeks together with mometasone furoate nasal spray (200 μg) either b.i.d. or o.d.
Drug: ACT-774312
ACT-774312 will be available as hard gelatin capsules containing 200 mg of ACT-774312

Placebo Comparator: Placebo
Subjects will receive placebo b.i.d. for 12 weeks together with mometasone furoate nasal spray (200 μg) either b.i.d. or o.d.
Drug: Placebo
Matching placebo capsules




Primary Outcome Measures :
  1. Change from baseline to Week 12 in NPS as measured by nasal endoscopy assessed centrally [ Time Frame: From baseline to up to 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline to Week 12 in sinus opacifications as assessed by CT scan using the Zinreich-modified Lund Mackay Score assessed centrally [ Time Frame: From baseline to up to 12 weeks ]
  2. Change from baseline to Week 12 in 3D volumetric computerized values [ Time Frame: From baseline to up to 12 weeks ]
  3. Change from baseline to Week 2 in University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: From baseline to up to 2 Weeks ]
  4. Change from baseline to Week 4 in University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: From baseline to up to 4 Weeks ]
  5. Change from baseline to Week 8 in University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: From baseline to up to 8 Weeks ]
  6. Change from baseline to Week 12 in University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: From baseline to up to 12 Weeks ]
  7. Change from baseline to EOS in University of Pennsylvania Smell Identification Test (UPSIT) [ Time Frame: From baseline to up to 20 Weeks ]
  8. Change from baseline to Week 2 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 [ Time Frame: From baseline to up to 2 Weeks ]
  9. Change from baseline to Week 4 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 [ Time Frame: From baseline to up to 4 Weeks ]
  10. Change from baseline to Week 8 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 [ Time Frame: From baseline to up to 8 Weeks ]
  11. Change from baseline to Week 12 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 [ Time Frame: From baseline to up to 12 Weeks ]
  12. Change from baseline to 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 [ Time Frame: From baseline to up to 20 Weeks ]
  13. Change from baseline to Week 2 in Physician Global Assessment (PGA) score [ Time Frame: from baseline to up to 2 Weeks ]
  14. Change from baseline to Week 4 in Physician Global Assessment (PGA) score [ Time Frame: from baseline to up to 4 Weeks ]
  15. Change from baseline to Week 8 in Physician Global Assessment (PGA) score [ Time Frame: from baseline to up to 8 Weeks ]
  16. Change from baseline to Week 12 in Physician Global Assessment (PGA) score [ Time Frame: from baseline to up to 12 Weeks ]
  17. Change from baseline to EOS in Physician Global Assessment (PGA) score [ Time Frame: From baseline to up to 20 Weeks ]
  18. Change from baseline to Week 2 in SNOT-22. [ Time Frame: from baseline to up to 2 Weeks ]
  19. Change from baseline to Week 4 in SNOT-22. [ Time Frame: from baseline to up to 4 Weeks ]
  20. Change from baseline to Week 8 in SNOT-22. [ Time Frame: from baseline to up to 8 Weeks ]
  21. Change from baseline to Week 12 in SNOT-22. [ Time Frame: from baseline to up to 12 Weeks ]
  22. Change from baseline to EOS in SNOT-22. [ Time Frame: From baseline to up to 20 Weeks ]
  23. Patient global impression of change in disease severity at Week 2 [ Time Frame: from baseline to up to 2 Weeks ]
  24. Patient global impression of change in disease severity at Week 4 [ Time Frame: from baseline to up to 4 Weeks ]
  25. Patient global impression of change in disease severity at Week 8 [ Time Frame: from baseline to up to 8 Weeks ]
  26. Patient global impression of change in disease severity at Week 12 [ Time Frame: from baseline to up to 12 Weeks ]
  27. Patient global impression of change in disease severity at EOS [ Time Frame: From baseline to up to 20 Weeks ]


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:

  • 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:

    • nasal blockade/obstruction
    • nasal discharge (anterior/posterior nasal drip)
    • reduction or loss of smell.
  • Male and female subjects aged between 18 and 70 years (inclusive) at screening.
  • 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 minutes 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 predose 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 < 1% per year, be sexually abstinent, or have a vasectomized partner. Hormonal contraceptive must have been initiated at least 1 month before first study treatment administration.

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) <20.
  • Subject who has required oral corticosteroids (OCS) within the 2 months before screening or is scheduled to receive OCS during the study period for another condition.
  • Subject who has required INCS drops within the 6 weeks before screening.
  • Subject who was injected with long-lasting activity corticosteroids within the 3 months before screening or is scheduled to receive these during the study period for another condition.
  • Subject who has undergone any nasal surgery within 6 months before screening.
  • Subjects with conditions/concomitant diseases making them nonevaluable for the primary efficacy endpoint such as:

    • Antrochoanal polyps
    • Nasal septal deviation that occludes at least one nostril
    • Acute sinusitis, nasal infection or upper respiratory infection at screening or in the 2 weeks before screening
    • Ongoing rhinitis medicamentosa
    • Churg-Strauss syndrome, Young's syndrome, Kartagener's syndrome or dyskinetic ciliary syndromes, Cystic fibrosis
    • Signs or a CT scan suggestive of Allergic fungal rhinosinusitis.
  • Subjects with co-morbid asthma are excluded if:

    • Forced expiratory volume in one second (FEV1) ≤ 60% of predicted normal OR
    • An exacerbation requiring systemic (oral and/or parenteral) steroid treatment or hospitalization (>24 h) for treatment of asthma has occurred within 3 months prior screening OR
    • 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 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:

    • Underlying hepatobiliary disease OR
    • ALT>3 ULN OR
    • or Bilirubin>2 ULN.

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): NCT03688555


Locations
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Belgium
University Hospital Ghent
Gent, Belgium, 9000
Germany
Charité Research Organisation GmbH
Berlin, Germany, 10117
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.
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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03688555    
Other Study ID Numbers: ID-084A201
2018-000851-42 ( EudraCT Number )
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Nasopharyngeal Neoplasms
Nasal Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Nose Diseases
Respiratory Tract Diseases
Polyps
Pathological Conditions, Anatomical