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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01241214

Acronym

SAR

Enrollment

579

Registered

2010-11-16

Start date

2010-11-30

Completion date

2011-02-28

Last updated

2019-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal allergic rhinitis, SAR, Allergic rhinitis, Allergies

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.

Interventions

DRUGACT-129968

ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily

DRUGCetirizine

Ceterizine administered once daily

DRUGPlacebo

Matching placebo administered twice daily.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

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

Secondary

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.	Baseline to week 2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026