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

May 10, 2019 updated by: Idorsia Pharmaceuticals Ltd.

A Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group, Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

579

Phase

  • Phase 2

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Matching Placebo
Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Drug: ACT-129968
ACT-129968 (Dose 4) & matching placebo administered orally once daily
Drug: Cetirizine
Ceterizine administered once daily
Drug: Placebo
Matching placebo administered twice daily.
Experimental: Investigational drug - Dose 1
Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Drug: ACT-129968
ACT-129968 (Dose 4) & matching placebo administered orally once daily
Experimental: Investigational drug - Dose 2
Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Drug: ACT-129968
ACT-129968 (Dose 4) & matching placebo administered orally once daily
Experimental: Investigational drug - Dose 3
Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Drug: ACT-129968
ACT-129968 (Dose 4) & matching placebo administered orally once daily
Experimental: Investigational Drug - Dose 4
Drug: ACT-129968
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
Drug: ACT-129968
ACT-129968 (Dose 4) & matching placebo administered orally once daily
Other: Active Matching Reference
Drug: Cetirizine
Ceterizine administered once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo
Time Frame: Baseline to week 2
Baseline to week 2

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to week 2

Collaborators and Investigators

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

Sponsor

Idorsia Pharmaceuticals Ltd.

Investigators

  • Study Director: Sara Mangialaio, MD, 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

November 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 15, 2010

First Posted (Estimate)

November 16, 2010

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 10, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-060B202

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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