search
Back to results

Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis (SAR)

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ACT-129968
ACT-129968
Cetirizine
Placebo
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, SAR, Allergic rhinitis, Allergies

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females aged 18 to 70 years.
  • Clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last two years.
  • Adequate exposure to mountain cedar pollen.
  • Positive skin prick test to mountain cedar allergen within 12 months of screening.
  • Sufficient nasal symptom score during a run-in period.

Exclusion Criteria:

  • Non-allergic rhinitis.
  • Bacterial or viral respiratory tract infection.
  • Chronic respiratory disorders.
  • Asthma requiring treatment other than inhaled short-acting Beta2-agonists.
  • Ocular infections or surgery, nasal obstruction, nasal biopsy or surgery, sinus surgery or perforation.
  • Smoking within the last year.
  • Ongoing or recent treatment for seasonal allergic rhinitis.
  • Initiation of allergen immunotherapy within 6 months of screening.

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 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Other

Placebo Comparator

Arm Label

Investigational drug - Dose 1

Investigational drug - Dose 2

Investigational drug - Dose 3

Investigational Drug - Dose 4

Active Matching Reference

Matching Placebo

Arm Description

Outcomes

Primary Outcome Measures

To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo

Secondary Outcome Measures

To demonstrate a change in Daytime Nasal Symptom Score while taking either Dose 1, Dose 2, or Dose 4 of ACT-129968 verses placebo.

Full Information

First Posted
November 12, 2010
Last Updated
May 10, 2019
Sponsor
Idorsia Pharmaceuticals Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01241214
Brief Title
Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis
Acronym
SAR
Official Title
A Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group, Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (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 different doses of ACT-129968 in adult 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, SAR, Allergic rhinitis, Allergies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
579 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational drug - Dose 1
Arm Type
Experimental
Arm Title
Investigational drug - Dose 2
Arm Type
Experimental
Arm Title
Investigational drug - Dose 3
Arm Type
Experimental
Arm Title
Investigational Drug - Dose 4
Arm Type
Experimental
Arm Title
Active Matching Reference
Arm Type
Other
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ACT-129968
Intervention Description
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
ACT-129968
Intervention Description
ACT-129968 (Dose 4) & matching placebo administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Cetirizine
Intervention Description
Ceterizine administered once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo administered twice daily.
Primary Outcome Measure Information:
Title
To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo
Time Frame
Baseline to week 2
Secondary Outcome Measure Information:
Title
To demonstrate a change in Daytime Nasal Symptom Score while taking either Dose 1, Dose 2, or Dose 4 of ACT-129968 verses placebo.
Time Frame
Baseline to week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females aged 18 to 70 years. Clinical history of symptomatic seasonal allergic rhinitis associated with mountain cedar pollen for the last two years. Adequate exposure to mountain cedar pollen. Positive skin prick test to mountain cedar allergen within 12 months of screening. Sufficient nasal symptom score during a run-in period. Exclusion Criteria: Non-allergic rhinitis. Bacterial or viral respiratory tract infection. Chronic respiratory disorders. Asthma requiring treatment other than inhaled short-acting Beta2-agonists. Ocular infections or surgery, nasal obstruction, nasal biopsy or surgery, sinus surgery or perforation. Smoking within the last year. Ongoing or recent treatment for seasonal allergic rhinitis. Initiation of allergen immunotherapy within 6 months of screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Mangialaio, MD
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

Learn more about this trial

Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis

We'll reach out to this number within 24 hrs