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

Phase 2

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: ACT-129968; Drug: Cetirizine; Drug: Placebo

• Registration Number: NCT01241214
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Disposition First Submitted: 2012-01-06
• Disposition First Submitted QC: 2012-01-06
• Disposition First Posted: 2012-01-11
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 579

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching Placebo	Placebo	-
Matching Placebo	ACT-129968	-
Investigational drug - Dose 2	ACT-129968	-
Investigational drug - Dose 1	ACT-129968	-
Investigational drug - Dose 3	ACT-129968	-
Investigational Drug - Dose 4	ACT-129968	-
Active Matching Reference	Cetirizine	-
Matching Placebo	Cetirizine	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Clinical Investigative Site 7902; 🇺🇸 San Antonio, Texas, United States

Clinical Investigative Site 7901; 🇺🇸 San Antonio, Texas, United States

Clinical Investigative Site 7906; 🇺🇸 San Antonio, Texas, United States

Clinical Investigative Site 7903; 🇺🇸 New Braunfels, Texas, United States

Clinical Investigative Site 7905; 🇺🇸 Austin, Texas, United States

Clinical Investigative Site 7907; 🇺🇸 Kerrville, Texas, United States

Clinical Investigative Site 7904; 🇺🇸 San Antonio, Texas, United States