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

September 26, 2018 updated by: Idorsia Pharmaceuticals Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

630

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78731
        • Clinical Investigative Site 7905
      • Kerrville, Texas, United States, 78028
        • Clinical Investigative Site 7907
      • New Braunfels, Texas, United States, 78130
        • Clinical Investigative Site 7903
      • San Antonio, Texas, United States, 78229
        • Clinical Investigative Site 7901
      • San Antonio, Texas, United States, 78229
        • Clinical Investigative Site 7902
      • San Antonio, Texas, United States, 78229
        • Clinical Investigative Site 7904
      • San Antonio, Texas, United States, 78229
        • Clinical Investigative Site 7906

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 76 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Investigational Drug
ACT-129968
Drug: ACT-129968
daily tablets
Other Names:
  • Setipiprant
PLACEBO_COMPARATOR: Comparative Drug
matching placebo tablets and capsules
Drug: Placebo
matching placebo tablets and capsules
ACTIVE_COMPARATOR: Reference Drug
Cetirizine
Drug: Cetirizine
daily capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean change in Daytime Nasal Symptom Score
Time Frame: baseline to end of treatment period (2 weeks)
baseline to end of treatment period (2 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
The mean change in other daytime/nighttime symptom scores of allergic rhinitis
Time Frame: baseline to end of treatment period (2 weeks)
baseline to end of treatment period (2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idorsia Pharmaceuticals Ltd.

Investigators

  • Study Director: Michael Grabo, PhD, Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

December 1, 2011

First Posted (ESTIMATE)

December 2, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-060B307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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