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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Placebo; Drug: Cetirizine; Drug: ACT-129968

Study type: Interventional

Funder types: Industry

Identifiers

NCT01241214

AC-060B202

Details and patient eligibility

About

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.

Enrollment: 579 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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579 participants in 6 patient groups, including a placebo group

Investigational drug - Dose 1

Experimental group

Treatment:

Drug: ACT-129968

Drug: ACT-129968

Investigational drug - Dose 2

Experimental group

Treatment:

Drug: ACT-129968

Drug: ACT-129968

Investigational drug - Dose 3

Experimental group

Treatment:

Drug: ACT-129968

Drug: ACT-129968

Investigational Drug - Dose 4

Experimental group

Treatment:

Drug: ACT-129968

Drug: ACT-129968

Active Matching Reference

Other group

Treatment:

Drug: Cetirizine

Matching Placebo

Placebo Comparator group

Treatment:

Drug: ACT-129968

Drug: ACT-129968

Drug: Placebo

Drug: Cetirizine