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CompletedNCT01484119SARUpdated Sep 28, 2018

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

A Phase 3 interventional study of ACT-129968 and Placebo in Seasonal Allergic Rhinitis, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 7 sites in United States. Open to participants aged 12 Years to 76 Years. Per ClinicalTrials.gov, last updated 2018-09-28.

Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
630
Allocation
Randomized
Ages
12 Years to 76 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Seasonal Allergic Rhinitis

Keywords

  • seasonal allergic rhinitis
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 630 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Idorsia Pharmaceuticals Ltd. is the lead sponsor of 102 studies on the registry; 5 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 9 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 76 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
630 participants (actual)

Study arms

  • Active comparator
    Investigational Drug

    ACT-129968

    Drug: ACT-129968

  • Placebo comparator
    Comparative Drug

    matching placebo tablets and capsules

    Drug: Placebo

  • Active comparator
    Reference Drug

    Cetirizine

    Drug: Cetirizine

Interventions

  • DrugACT-129968

    daily tablets

    Also known as: Setipiprant

  • DrugPlacebo

    matching placebo tablets and capsules

  • DrugCetirizine

    daily capsules

06

What researchers measure

Primary outcomes

  1. The mean change in Daytime Nasal Symptom Score

    Time frame: baseline to end of treatment period (2 weeks)

Secondary outcomes

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

    Time frame: baseline to end of treatment period (2 weeks)

07

Study locations

7 sites
  • Clinical Investigative Site 7905
    Austin, Texas 78731, United States
  • Clinical Investigative Site 7907
    Kerrville, Texas 78028, United States
  • Clinical Investigative Site 7903
    New Braunfels, Texas 78130, United States
  • Clinical Investigative Site 7901
    San Antonio, Texas 78229, United States
  • Clinical Investigative Site 7902
    San Antonio, Texas 78229, United States
  • Clinical Investigative Site 7904
    San Antonio, Texas 78229, United States
  • Clinical Investigative Site 7906
    San Antonio, Texas 78229, United States
08

References and documents

Publications

  • 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. PubMed 28392807 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01484119
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Responsible party
Sponsor
First posted
Dec 2, 2011
Start date
Dec 2011
Primary completion
Feb 2012
Completion
Mar 2012
Last update
Sep 28, 2018

Study contacts

Michael Grabo, PhD
study director · Actelion

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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