Seasonal Allergic RhinitisPhase 2SARNCT01241214
Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis
A Phase 2 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 different doses of ACT-129968 in adult patients with seasonal allergic rhinitis, due to mountain cedar pollen. Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 579 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2010to Feb 2011
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 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: A Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group, Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis
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.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- ACT-129968, Cetirizine, Placebo
- Keywords
- Seasonal allergic rhinitis, SAR, Allergic rhinitis, Allergies
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-129968Drug
ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
ACT-129968Drug
ACT-129968 (Dose 4) \& matching placebo administered orally once daily
CetirizineDrug
Ceterizine administered once daily
PlaceboDrug
Matching placebo administered twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Investigational drug - Dose 1 | Experimental | Not described Receives: Drug: ACT-129968 |
| Investigational drug - Dose 2 | Experimental | Not described Receives: Drug: ACT-129968 |
| Investigational drug - Dose 3 | Experimental | Not described Receives: Drug: ACT-129968 |
| Investigational Drug - Dose 4 | Experimental | Not described Receives: Drug: ACT-129968 |
| Active Matching Reference | Other | Not described Receives: Drug: Cetirizine |
| Matching Placebo | Placebo comparator | Not described Receives: Drug: ACT-129968; Drug: Cetirizine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo
Measured: Baseline to week 2
Secondary outcomes (1)
To demonstrate a change in Daytime Nasal Symptom Score while taking either Dose 1, Dose 2, or Dose 4 of ACT-129968 verses placebo.
Measured: Baseline to week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionFeb 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Mangialaio, MD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241214
- Sponsor's protocol ID
- AC-060B202
- Acronym
- SAR
- Status last verified
- May 2019
- First submitted
- 12 Nov 2010
- Last updated
- 15 May 2019
- 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 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo-controlled, Active Reference, Parallel-group, Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01241214
- Acronym / sponsor ID
- SAR / AC-060B202
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Seasonal allergic rhinitis, SAR, Allergic rhinitis, Allergies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 16 Nov 2010 (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 different doses of ACT-129968 in adult patients with seasonal allergic rhinitis, due to mountain cedar pollen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Investigational drug - Dose 1 | Experimental | Drug: ACT-129968 |
| Investigational drug - Dose 2 | Experimental | Drug: ACT-129968 |
| Investigational drug - Dose 3 | Experimental | Drug: ACT-129968 |
| Investigational Drug - Dose 4 | Experimental | Drug: ACT-129968 |
| Active Matching Reference | Other | Drug: Cetirizine |
| Matching Placebo | Placebo comparator | Drug: ACT-129968, Drug: Cetirizine, Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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-129968ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily | Drug | Investigational drug - Dose 1, Investigational drug - Dose 2, Investigational drug - Dose 3, Matching Placebo |
| ACT-129968ACT-129968 (Dose 4) \& matching placebo administered orally once daily | Drug | Investigational Drug - Dose 4, Matching Placebo |
| CetirizineCeterizine administered once daily | Drug | Active Matching Reference, Matching Placebo |
| PlaceboMatching placebo administered twice daily. | Drug | Matching Placebo |
Primary outcome
To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo
Time frame: Baseline to week 2
1 secondary outcome
To demonstrate a change in Daytime Nasal Symptom Score while taking either Dose 1, Dose 2, or Dose 4 of ACT-129968 verses placebo.
Time frame: Baseline to week 2
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 15 May 2019.
- 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.
Sara Mangialaio, MD 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 2 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 5 inclusion and 8 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 15 May 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To demonstrate a change in Daytime Nasal Symptom Score while taking Dose 3 of ACT-129968 versus placebo (time frame: Baseline to week 2). 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 NCT01241214, 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 15 May 2019.