Seasonal Allergic Rhinitis (SAR)Phase 2ALDP001NCT07219849
A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure
A Phase 2 study testing ALDP001 Nasal Spray in people with Seasonal Allergic Rhinitis (SAR), run by Alixer Nexgen Therapeutics Limited at 1 site in Canada.
Trial summary
This study aims to evaluate the effectiveness and safety of ALDP001 Nasal Spray in treating seasonal allergic rhinitis, and to identify the optimal dosage and administration frequency for this formulation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis (SAR)
- What is being tested?
- ALDP001 Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteCanada
- Study dates
- 17 Oct 2025to Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Allergic Rhinitis (AR), as determined by the presence of seasonal rhinitis symptoms for several months per year, for more than 1 year and are not attributed to infections or nasal abnormalities
- Positive skin prick test (SPT) response to ragweed pollen (allergen induced wheal diameter at least 3 mm larger than the negative control) in the previous 12 months
- Healthy as determined by a responsible and experienced Investigator, based on a medical evaluation including medical history, physical examination, vital signs, ECG, and lab tests.
Who cannot join
- Nasal abnormalities likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, sinusitis and other nasal malformations.
- History of frequent nosebleeds.
- Participants with rhinitis medicamentosa.
- Current or chronic history of hepatic disease.
- A QTcF (Fridericia-corrected QT interval) >450 ms in males or >470 ms in females.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Cliantha Research
Mississauga, Ontario
Patricia Couroux, MD, (905) 282-1808, pcouroux@cliantha.com
Patricia Couroux, MD
About this study
Official title: A Two-part Adaptive Double-blind Randomized Placebo-controlled Study to Assess the Appropriate Dose and the Appropriate Dosing Frequency of ALDP 001 in Adults With Seasonal Allergic Rhinitis (SAR) Assessed Using an Allergen Challenge Chamber/EEC
This study aims to evaluate the effectiveness and safety of ALDP001 Nasal Spray in treating seasonal allergic rhinitis, and to identify the optimal dosage and administration frequency for this formulation.
Read the detailed description
The study will be conducted in two Parts. In Part A, participants will receive a once-daily (OD) dose of the nasal spray for eight days. An interim analysis will then be performed to identify the optimal dose for the next part. In Part B, participants will be administered a twice-daily (BD) dose of the selected formulation from Part A to evaluate the appropriate dosing frequency for the regimen.
- Conditions
- Seasonal Allergic Rhinitis (SAR)
- Being tested
- ALDP001 Nasal Spray, Placebo Nasal spray
- Keywords
- ALDP001 Nasal Spray
- 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.
ALDP001 Nasal SprayDrug
Experimental Arm
Placebo Nasal sprayDrug
Controlled arm
| Study group | Role | What they receive |
|---|---|---|
| ALDP001 0.125% w/v | Experimental | Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days Receives: Drug: ALDP001 Nasal Spray |
| ALDP001 (0.25% w/v) | Experimental | Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days Receives: Drug: ALDP001 Nasal Spray |
| ALDP001 (0.5% w/v) Nasal Spray | Experimental | Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days Receives: Drug: ALDP001 Nasal Spray |
| Placebo Nasal Spray | Placebo comparator | Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days Receives: Drug: Placebo Nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Total Nasal Symptom Score
Total Nasal Symptom Score (TNSS) is calculated by summing scores from four nasal symptoms: itchy nose, nasal congestion, runny nose, and sneezing. Each symptom is rated on a scale from 0 to 3, where:
0 - None (no symptoms)
- - Mild (minimal awareness, easily tolerated)
- - Moderate (noticeable and bothersome, but tolerable)
- - Severe (difficult to tolerate, interferes with daily activities or sleep)
The total score ranges from 0 to 12. Participants will record TNSS at multiple timepoints: 0, 30, 60, 90, 120, 180, and 240 minutes, both at baseline and after 8 days of treatment.
The change from baseline (CFB) at each timepoint will be calculated and compared between study arms to evaluate the treatment effect of ALDP001 Nasal Spray.
Measured: Day 9
Secondary outcomes (1)
Change from baseline in the Area Under the Curve of the Total Nasal Symptom Score at Day 9
The Area Under the Curve (AUC) for the Total Nasal Symptom Score (TNSS) will be calculated based on measurements taken at multiple timepoints: 0, 30, 60, 90, 120, 180, and 240 minutes, both at baseline and after 8 days of treatment. The TNSS is a composite score assessing nasal symptoms including congestion, rhinorrhea, itching, and sneezing. Each symptom is rated on a scale from 0 (no symptoms) to 3 (severe symptoms), resulting in a total score range of 0 to 12, where higher scores indicate worse nasal symptoms. The change from baseline in the AUC for TNSS after the treatment period will be analyzed and compared across study arms to assess the efficacy of the intervention. A lower AUC value indicates better symptom control, and the AUC is expected to be lowest for the optimum dose group, reflecting improved treatment efficacy. The change from baseline in AUC of the TNSS for each dose group will be analyzed to identify the optimum dose.
Measured: Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start17 Oct 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic Rhinitis (SAR)Studies 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
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alixer Nexgen Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Couroux, MD, Principal investigator, Cliantha Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219849
- Sponsor's protocol ID
- ALK45-ALDP001/ C2D05456
- Acronym
- ALDP001
- Status last verified
- Oct 2025
- First submitted
- 17 Oct 2025
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: masked Lab reports, masked Total Nasal symptom Score etc
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Adaptive Double-blind Randomized Placebo-controlled Study to Assess the Appropriate Dose and the Appropriate Dosing Frequency of ALDP 001 in Adults With Seasonal Allergic Rhinitis (SAR) Assessed Using an Allergen Challenge Chamber/EEC
- ClinicalTrials.gov ID
- NCT07219849
- Acronym / sponsor ID
- ALDP001 / ALK45-ALDP001/ C2D05456
- Conditions
- Seasonal Allergic Rhinitis (SAR)
- Keywords
- ALDP001 Nasal Spray
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Alixer Nexgen Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 22 Oct 2025 (actual)
- 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 aims to evaluate the effectiveness and safety of ALDP001 Nasal Spray in treating seasonal allergic rhinitis, and to identify the optimal dosage and administration frequency for this formulation.
Detailed description
The study will be conducted in two Parts. In Part A, participants will receive a once-daily (OD) dose of the nasal spray for eight days. An interim analysis will then be performed to identify the optimal dose for the next part. In Part B, participants will be administered a twice-daily (BD) dose of the selected formulation from Part A to evaluate the appropriate dosing frequency for the regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALDP001 0.125% w/v | Experimental | Drug: ALDP001 Nasal SprayParticipants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days |
| ALDP001 (0.25% w/v) | Experimental | Drug: ALDP001 Nasal SprayParticipants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days |
| ALDP001 (0.5% w/v) Nasal Spray | Experimental | Drug: ALDP001 Nasal SprayParticipants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days |
| Placebo Nasal Spray | Placebo comparator | Drug: Placebo Nasal sprayParticipants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Allergic Rhinitis (AR), as determined by the presence of seasonal rhinitis symptoms for several months per year, for more than 1 year and are not attributed to infections or nasal abnormalities
- Positive skin prick test (SPT) response to ragweed pollen (allergen induced wheal diameter at least 3 mm larger than the negative control) in the previous 12 months
- Healthy as determined by a responsible and experienced Investigator, based on a medical evaluation including medical history, physical examination, vital signs, ECG, and lab tests.
Key exclusion criteria (5 listed)
- Nasal abnormalities likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, sinusitis and other nasal malformations.
- History of frequent nosebleeds.
- Participants with rhinitis medicamentosa.
- Current or chronic history of hepatic disease.
- A QTcF (Fridericia-corrected QT interval) >450 ms in males or >470 ms in females.
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 |
|---|---|---|
| ALDP001 Nasal SprayExperimental Arm | Drug | ALDP001 (0.25% w/v), ALDP001 (0.5% w/v) Nasal Spray, ALDP001 0.125% w/v |
| Placebo Nasal sprayControlled arm | Drug | Placebo Nasal Spray |
Primary outcome
Change from Baseline in Total Nasal Symptom Score
Time frame: Day 9
Total Nasal Symptom Score (TNSS) is calculated by summing scores from four nasal symptoms: itchy nose, nasal congestion, runny nose, and sneezing. Each symptom is rated on a scale from 0 to 3, where: 0 - None (no symptoms) 1. - Mild (minimal awareness, easily tolerated) 2. - Moderate (noticeable and bothersome, but tolerable) 3. - Severe (difficult to tolerate, interferes with daily activities or sleep) The total score ranges from 0 to 12. Participants will record TNSS at multiple timepoints: 0, 30, 60, 90, 120, 180, and 240 minutes, both at baseline and after 8 days of treatment. The change from baseline (CFB) at each timepoint will be calculated and compared between study arms to evaluate the treatment effect of ALDP001 Nasal Spray.
1 secondary outcome
Change from baseline in the Area Under the Curve of the Total Nasal Symptom Score at Day 9
Time frame: Day 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No. masked Lab reports, masked Total Nasal symptom Score etc
Related trials for Seasonal Allergic Rhinitis (SAR)
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
RecruitingPhase 3
Study on the Treatment of Adolescent Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR)
Not yet recruitingPhase 2
Study of Stapokibart Injection in Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
Seasonal Allergic Rhinitis (SAR)
Not yet recruitingObservational study
A Prospective Study of Stapokibart Injection in Patients With Seasonal Allergic Rhinitis (SAR)
SAR
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
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.
Patricia Couroux, MD principal investigator
Cliantha Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALDP001 Nasal Spray in people with Seasonal Allergic Rhinitis (SAR), run by Alixer Nexgen Therapeutics Limited at 1 site in Canada.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akhilesh Sharma (+912239829999, akhilesh.sharma@alkem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Total Nasal Symptom Score (time frame: Day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2025.