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Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis (SAR)

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ACT-129968
Placebo
Cetirizine
Sponsored by
Idorsia Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring seasonal allergic rhinitis

Eligibility Criteria

12 Years - 76 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Males and females aged 12-76 years with documented clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last 2 years.
  • Evening reflective Total Nasal Symptom Score (p.m.rTNSS) at least 42 out of a maximum potential score of 84 over the 7-day run-in period, or > or = 6 out of a maximum score of 12 on each of the last 4 consecutive days during the run-in period.

Exclusion Criteria

  • Non-allergic rhinitis.
  • Severe physical nasal obstruction.
  • Acute or significant chronic sinusitis.
  • Bacterial or viral infection of the upper or lower respiratory tract, nasal sinuses, or middle ear.
  • Ongoing chronic respiratory disorders.
  • Asthma requiring use of short-acting beta2-agonists > 2 times a week or any asthma treatment other than inhaled short-acting beta2-agonists.
  • Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma.
  • Nasal biopsy or surgery, sinus surgery, or perforation within the 8 weeks prior to the Screening Visit.
  • Ocular surgery within the 8 weeks prior to the Screening Visit.
  • Ocular infections (bacterial or viral) within the 4 weeks before screening.
  • Use of forbidden medications (prescribed or over-the-counter [OTC])
  • Congenital or acquired severe immunodeficiency or known Human immunodeficiency virus (HIV)infection.

Sites / Locations

  • Clinical Investigative Site 7905
  • Clinical Investigative Site 7907
  • Clinical Investigative Site 7903
  • Clinical Investigative Site 7901
  • Clinical Investigative Site 7902
  • Clinical Investigative Site 7904
  • Clinical Investigative Site 7906

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Investigational Drug

Comparative Drug

Reference Drug

Arm Description

ACT-129968

matching placebo tablets and capsules

Cetirizine

Outcomes

Primary Outcome Measures

The mean change in Daytime Nasal Symptom Score

Secondary Outcome Measures

The mean change in other daytime/nighttime symptom scores of allergic rhinitis

Full Information

First Posted
November 29, 2011
Last Updated
September 26, 2018
Sponsor
Idorsia Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01484119
Brief Title
Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis
Acronym
SAR
Official Title
Multi-center, Double-blind, Double-dummy, Randomized, Placebo-controlled, Active-reference, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-129968 in Adolescent, Adult & Elderly Patients With Seasonal Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the efficacy and safety of ACT-129968 in adolescent, adult and elderly patients with seasonal allergic rhinitis, due to mountain cedar pollen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
seasonal allergic rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Drug
Arm Type
Active Comparator
Arm Description
ACT-129968
Arm Title
Comparative Drug
Arm Type
Placebo Comparator
Arm Description
matching placebo tablets and capsules
Arm Title
Reference Drug
Arm Type
Active Comparator
Arm Description
Cetirizine
Intervention Type
Drug
Intervention Name(s)
ACT-129968
Other Intervention Name(s)
Setipiprant
Intervention Description
daily tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo tablets and capsules
Intervention Type
Drug
Intervention Name(s)
Cetirizine
Intervention Description
daily capsules
Primary Outcome Measure Information:
Title
The mean change in Daytime Nasal Symptom Score
Time Frame
baseline to end of treatment period (2 weeks)
Secondary Outcome Measure Information:
Title
The mean change in other daytime/nighttime symptom scores of allergic rhinitis
Time Frame
baseline to end of treatment period (2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Males and females aged 12-76 years with documented clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last 2 years. Evening reflective Total Nasal Symptom Score (p.m.rTNSS) at least 42 out of a maximum potential score of 84 over the 7-day run-in period, or > or = 6 out of a maximum score of 12 on each of the last 4 consecutive days during the run-in period. Exclusion Criteria Non-allergic rhinitis. Severe physical nasal obstruction. Acute or significant chronic sinusitis. Bacterial or viral infection of the upper or lower respiratory tract, nasal sinuses, or middle ear. Ongoing chronic respiratory disorders. Asthma requiring use of short-acting beta2-agonists > 2 times a week or any asthma treatment other than inhaled short-acting beta2-agonists. Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma. Nasal biopsy or surgery, sinus surgery, or perforation within the 8 weeks prior to the Screening Visit. Ocular surgery within the 8 weeks prior to the Screening Visit. Ocular infections (bacterial or viral) within the 4 weeks before screening. Use of forbidden medications (prescribed or over-the-counter [OTC]) Congenital or acquired severe immunodeficiency or known Human immunodeficiency virus (HIV)infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Grabo, PhD
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Investigative Site 7905
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Clinical Investigative Site 7907
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
Clinical Investigative Site 7903
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Clinical Investigative Site 7901
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Investigative Site 7902
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Investigative Site 7904
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Investigative Site 7906
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28392807
Citation
Ratner P, Andrews CP, Hampel FC, Martin B, Mohar DE, Bourrelly D, Danaietash P, Mangialaio S, Dingemanse J, Hmissi A, van Bavel J. Efficacy and safety of setipiprant in seasonal allergic rhinitis: results from Phase 2 and Phase 3 randomized, double-blind, placebo- and active-referenced studies. Allergy Asthma Clin Immunol. 2017 Apr 4;13:18. doi: 10.1186/s13223-017-0183-z. eCollection 2017.
Results Reference
derived

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Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis

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