Seasonal Allergic RhinitisPhase 3SARNCT01484119
Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis
A Phase 3 study testing ACT-129968 and Cetirizine in people with Seasonal Allergic Rhinitis, run by Idorsia Pharmaceuticals Ltd. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 76 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- ACT-129968 and Cetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 630 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2011to Mar 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 76 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Clinical Investigative Site 7905
Austin, Texas, 78731
Clinical Investigative Site 7907
Kerrville, Texas, 78028
Clinical Investigative Site 7903
New Braunfels, Texas, 78130
Clinical Investigative Site 7901
San Antonio, Texas, 78229
Clinical Investigative Site 7902
San Antonio, Texas, 78229
Clinical Investigative Site 7904
San Antonio, Texas, 78229
Clinical Investigative Site 7906
San Antonio, Texas, 78229
About this study
Official title: Multi-center, Double-blind, Double-dummy, Randomized, Placebo-controlled, Active-reference, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-129968 in Adolescent, Adult & Elderly Patients With Seasonal Allergic Rhinitis
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.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- ACT-129968, Placebo, Cetirizine
- Keywords
- seasonal allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-129968Drug
Also called Setipiprant
daily tablets
PlaceboDrug
matching placebo tablets and capsules
CetirizineDrug
daily capsules
| Study group | Role | What they receive |
|---|---|---|
| Investigational Drug | Active comparator | ACT-129968 Receives: Drug: ACT-129968 |
| Comparative Drug | Placebo comparator | matching placebo tablets and capsules Receives: Drug: Placebo |
| Reference Drug | Active comparator | Cetirizine Receives: Drug: Cetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in Daytime Nasal Symptom Score
Measured: baseline to end of treatment period (2 weeks)
Secondary outcomes (1)
The mean change in other daytime/nighttime symptom scores of allergic rhinitis
Measured: baseline to end of treatment period (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Grabo, PhD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484119
- Sponsor's protocol ID
- AC-060B307
- Acronym
- SAR
- Status last verified
- Sep 2018
- First submitted
- 29 Nov 2011
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Double-blind, Double-dummy, Randomized, Placebo-controlled, Active-reference, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-129968 in Adolescent, Adult & Elderly Patients With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01484119
- Acronym / sponsor ID
- SAR / AC-060B307
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- seasonal allergic rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational Drug | Active comparator | Drug: ACT-129968ACT-129968 |
| Comparative Drug | Placebo comparator | Drug: Placebomatching placebo tablets and capsules |
| Reference Drug | Active comparator | Drug: CetirizineCetirizine |
Who may qualify
- Ages
- 12 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-129968Also: Setipiprantdaily tablets | Drug | Investigational Drug |
| Placebomatching placebo tablets and capsules | Drug | Comparative Drug |
| Cetirizinedaily capsules | Drug | Reference Drug |
Primary outcome
The mean change in Daytime Nasal Symptom Score
Time frame: baseline to end of treatment period (2 weeks)
1 secondary outcome
The mean change in other daytime/nighttime symptom scores of allergic rhinitis
Time frame: baseline to end of treatment period (2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Derived from this study: PubMed 28392807Ratner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Grabo, PhD study director
Actelion
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ACT-129968 and Cetirizine in people with Seasonal Allergic Rhinitis, run by Idorsia Pharmaceuticals Ltd. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in Daytime Nasal Symptom Score (time frame: baseline to end of treatment period (2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01484119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.