Cedar PollinosisPhase 1NCT02469688
A Study of ASP4070 to Confirm Safety and Immunological Response in Patients With Pollen Allergy
A Phase 1 study testing ASP4070 in people with Cedar Pollinosis, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
Examine safety and immunological response for ASP4070 when vaccinated in patients with pollen allergy Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Cedar Pollinosis
- What is being tested?
- ASP4070
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteJapan
- Study dates
- 18 Jun 2015to 26 Jul 2016
- Phase
- Phase 1
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject who has medical history of nasal symptoms (sneezing, itching, rhinorrhoea, and congestion), and/or eye symptoms (itching, redness, and lacrimation) at least in 2 cedar pollen dispersion seasons prior to the screening test.
- Subject who had the Japanese cedar pollen-specific antibody test result of Class 3 or higher in the allergy test at screening.
- Subject who had a positive prick test result for Japanese cedar pollen in the screening test.
- Subject whose past and present medical conditions are considered medically stable.
Who cannot join
- Subject who had the test result of IgE antibody specific to other antigen than Japanese cedar pollen
- Subject who is scheduled to receive other vaccination during the primary study period.
- Subject who has received or is planning to receive vaccination of live vaccine within 28 days prior to the first vaccination of the study drug, and/or a subject who has received or is planning to receive vaccination of inactivated vaccine/toxoid within 7 days prior to the first vaccination of the study drug.
- Subject who received specific immunotherapy for cedar pollinosis in the past.
- Subject who received specific or non-specific immunotherapy within 5 years prior to the screening test.
- Subject who has used the following drug(s) prior to the first vaccination of the study drug:
Show all 30Show fewer
- Within 56 days prior to the first vaccination of the study drug: Topical steroid, histamine H1-receptor antagonist, chemical mediator-isolation inhibitor, Th2 cytokine inhibitor, thromboxane A2 synthesis inhibitor, thromboxane A2 receptor antagonist, and/or leukotriene receptor antagonist
- Within 84 days prior to the first vaccination of the study drug: Systemic steroid, and antibody drugs (including anti-TNF-alpha antibody and anti-IgE monoclonal antibody)
- Subject who has history of allergic reactions such as anaphylactic shock and exanthema generalized caused by food and/or medical products (including vaccine) in the past, and/or a subject who had a fever of 39.0 degrees Celsius or higher within 2 days after the previous vaccination.
- Subject who has evidently high fever (37.5 degrees Celsius or higher) on the day of vaccination, or subject who has severe acute disease.
- Subject who meets any of the following criteria for laboratory and other tests at screening. The reference range for each test is the range used in the study site.
- Blood biochemistry test:
- AST (GOT) or ALT (GPT) value over 100 IU/L
- Creatinine value over 1.5 mg/dL
- Urine drug screening:
- 1. Subject who had a positive drug test result for: benzodiazepines, cocaine and similar narcotics, stimulant drugs, cannabis, barbituric acids, morphine and similar narcotics, PCPs, or tricyclic antidepressants.
- Immunological test:
- Subject who had a positive test results for HBs antigen, HCV antibody, or HIV antigen/antibody
- Subject who has autoimmune disease or other serious primary disease.
- Subject who was diagnosed with immunodeficiency in the past.
- Subject who has a complication of perennial allergic rhinitis, rhinitis medicamentosa, or non-allergic rhinitis which requires medical treatment.
- Subject who has a complication of cardiovascular disease (including cardiac failure congestive, angina pectoris, and cardiac arrhythmias which requires medical treatment).
- Subject who has a complication of hepatic disease (including hepatitis viral and drug-induced liver injury).
- Subject who has a complication of renal disease (including acute kidney injury, glomerulonephritis, and nephritis interstitial, but not including medical history of calculus).
- Subject who has a complication of respiratory disease (including asthma bronchial which requires medical treatment, and bronchitis chronic, but not including medical history of asthma in the childhood).
- Subject has a complication of malignant tumor or has been diagnosed or has received treatment for malignant tumor within 5 years prior to the first vaccination of the study drug.
- Subject who was diagnosed with schizophrenia, other mental conditions including bipolar disorder and major depressive disorder, or dementia, or a subject who has received drug(s) for the treatment of dementia.
- Subject who has a complication of dermatitis atopic.
- Subject who has a complication which may have an impact on the results of the local and systemic reaction or prick test assessment.
- Subject who has received a vaccination of Cryj2-LAMP vaccine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of ASP4070 to Confirm the Safety and Immunological Response in Patients With Cedar Pollinosis When Administered as Intramuscular Vaccination and as Intradermal Vaccination
Examine safety and immunological response for ASP4070 when vaccinated in patients with pollen allergy
Read the detailed description
This study consists of 2 parts: Part 1 and Part 2. [Part 1] An open-label, un-controlled study Examine the safety for the ASP4070 intramuscular vaccination group (high dose x 4 times) and the ASP4070 intradermal vaccination group (high dose x 4 times).
[Part 2] A placebo-controlled, double-blinded, randomized, parallel-group comparative study Assess the immunological response and safety for the ASP 4070 intramuscular vaccination group (high dose x 1 time and high dose x 4 times) and the ASP4070 intradermal vaccination group (low dose x 1 time, low x 4 times, high dose x 1 time, and high dose x 4 times) as compared to those for the placebo group. The study will be double-blinded within the same route of vaccination, and non-blinded between the routes of vaccination (between the intramuscular vaccination group and intradermal vaccination group).
The first vaccination to the subjects in Part 2 will start at least 14 days after the first vaccination to the subjects in Part 1 (6 subjects).
For both Part 1 and Part 2, primary study period is for 3 months starting from the last dose of the study drug at Day 43 (until Day 127). After the primary study period, safety information will be collected for 9 months (for 1 year from the last dose of the study drug) as the long-term safety follow-up study period. Safety information will be collected for 1 year starting from the last vaccination of the study drug also from the patients who discontinued the participation in the study during the primary study period if the patients agree.
- Conditions
- Cedar Pollinosis
- Being tested
- ASP4070, Placebo
- Keywords
- cedar pollinosis, immunological response,, ASP4070, vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP4070Drug
intramuscular or intradermal
PlaceboDrug
intramuscular or intradermal
| Study group | Role | What they receive |
|---|---|---|
| Part1 ASP4070 intramuscular vaccination group | Experimental | ASP4070 high dose x 4 times Receives: Drug: ASP4070 |
| Part1 ASP4070 intradermal vaccination group | Experimental | ASP4070 high dose x 4 times Receives: Drug: ASP4070 |
| Part2 ASP4070 intramuscular vaccination group 1 | Experimental | ASP4070 high dose x 4 times Receives: Drug: ASP4070 |
| Part2 ASP4070 intramuscular vaccination group 2 | Experimental | ASP4070 high dose x 1 time, Placebo x 3 times Receives: Drug: ASP4070; Drug: Placebo |
| Part2 Placebo intramuscular vaccination group | Placebo comparator | Placebo x 4 times Receives: Drug: Placebo |
| Part2 ASP4070 intradermal vaccination group 1 | Experimental | ASP4070 high dose x 4 times Receives: Drug: ASP4070 |
| Part2 ASP4070 intradermal vaccination group 2 | Experimental | ASP4070 low dose x 4 times Receives: Drug: ASP4070 |
| Part2 ASP4070 intradermal vaccination group 3 | Experimental | ASP4070 high dose x 1 time, Placebo x 3 times Receives: Drug: ASP4070; Drug: Placebo |
| Part2 ASP4070 intradermal vaccination group 4 | Experimental | ASP4070 low dose x 1 time, Placebo x 3 times Receives: Drug: ASP4070; Drug: Placebo |
| Part2 Placebo intradermal vaccination group | Placebo comparator | Placebo x 4 times Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events developed after the first vaccination of the study drug
Measured: Up to Day 127
Secondary outcomes (6)
Local reaction(injection site pain, erythema, swelling, and induration) and systemic reaction(queasy, vomiting, diarrhoea, headache, malaise, myalgia, allergic reaction, and pyrexia) due to the vaccination developed
Measured: within 14 days after the vaccination of the study drug
Vital signs (axillary temperature, blood pressure in a sitting position, and pulse rate in a sitting position)
Measured: Screening period, :Day 1, 15, 29, 43, 71, 99, and 127
12-lead ECG
ECG: Electrocardiogram
Measured: Day 1 and 43
Laboratory test (hematology, biochemistry, and urinalysis)
Measured: Screening period, Day 1, 43, and 127
Prick test for Japanese cedar pollen
Measured: Screening period, Day 15, 29, 43, 71, 99 and 127
Parameters developed by antibody and histamine release test
Antibody: IgG antibody, specific IgG antibody (anti-JRC, anti-Cry j 1, and anti-Cry j 2), specific IgG4 antibody (anti-JRC), IgE antibody, specific IgE antibody (anti-JRC), cytokine (IFN-gamma, IL-4, IL-5, IL-10, IL-12, and IL-13), anti-LAMP antibody
Measured: Day 1, 71, 99 and 127
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study start18 Jun 2015
- Primary completion27 Nov 2015
- Study completion26 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cedar PollinosisStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immunomic Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469688
- Sponsor's protocol ID
- 4070-CL-0010
- Status last verified
- Oct 2024
- First submitted
- 5 Jun 2015
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of ASP4070 to Confirm the Safety and Immunological Response in Patients With Cedar Pollinosis When Administered as Intramuscular Vaccination and as Intradermal Vaccination
- ClinicalTrials.gov ID
- NCT02469688
- Acronym / sponsor ID
- 4070-CL-0010
- Conditions
- Cedar Pollinosis
- Keywords
- cedar pollinosis, immunological response,, ASP4070, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Immunomic Therapeutics, Inc.
- Study start
- 18 Jun 2015 (actual)
- Primary completion
- 27 Nov 2015 (actual)
- Study completion
- 26 Jul 2016 (actual)
- First posted
- 11 Jun 2015 (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.
Examine safety and immunological response for ASP4070 when vaccinated in patients with pollen allergy
Detailed description
This study consists of 2 parts: Part 1 and Part 2. [Part 1] An open-label, un-controlled study Examine the safety for the ASP4070 intramuscular vaccination group (high dose x 4 times) and the ASP4070 intradermal vaccination group (high dose x 4 times).
[Part 2] A placebo-controlled, double-blinded, randomized, parallel-group comparative study Assess the immunological response and safety for the ASP 4070 intramuscular vaccination group (high dose x 1 time and high dose x 4 times) and the ASP4070 intradermal vaccination group (low dose x 1 time, low x 4 times, high dose x 1 time, and high dose x 4 times) as compared to those for the placebo group. The study will be double-blinded within the same route of vaccination, and non-blinded between the routes of vaccination (between the intramuscular vaccination group and intradermal vaccination group).
The first vaccination to the subjects in Part 2 will start at least 14 days after the first vaccination to the subjects in Part 1 (6 subjects).
For both Part 1 and Part 2, primary study period is for 3 months starting from the last dose of the study drug at Day 43 (until Day 127). After the primary study period, safety information will be collected for 9 months (for 1 year from the last dose of the study drug) as the long-term safety follow-up study period. Safety information will be collected for 1 year starting from the last vaccination of the study drug also from the patients who discontinued the participation in the study during the primary study period if the patients agree.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part1 ASP4070 intramuscular vaccination group | Experimental | Drug: ASP4070ASP4070 high dose x 4 times |
| Part1 ASP4070 intradermal vaccination group | Experimental | Drug: ASP4070ASP4070 high dose x 4 times |
| Part2 ASP4070 intramuscular vaccination group 1 | Experimental | Drug: ASP4070ASP4070 high dose x 4 times |
| Part2 ASP4070 intramuscular vaccination group 2 | Experimental | Drug: ASP4070, Drug: PlaceboASP4070 high dose x 1 time, Placebo x 3 times |
| Part2 Placebo intramuscular vaccination group | Placebo comparator | Drug: PlaceboPlacebo x 4 times |
| Part2 ASP4070 intradermal vaccination group 1 | Experimental | Drug: ASP4070ASP4070 high dose x 4 times |
| Part2 ASP4070 intradermal vaccination group 2 | Experimental | Drug: ASP4070ASP4070 low dose x 4 times |
| Part2 ASP4070 intradermal vaccination group 3 | Experimental | Drug: ASP4070, Drug: PlaceboASP4070 high dose x 1 time, Placebo x 3 times |
| Part2 ASP4070 intradermal vaccination group 4 | Experimental | Drug: ASP4070, Drug: PlaceboASP4070 low dose x 1 time, Placebo x 3 times |
| Part2 Placebo intradermal vaccination group | Placebo comparator | Drug: PlaceboPlacebo x 4 times |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject who has medical history of nasal symptoms (sneezing, itching, rhinorrhoea, and congestion), and/or eye symptoms (itching, redness, and lacrimation) at least in 2 cedar pollen dispersion seasons prior to the screening test.
- Subject who had the Japanese cedar pollen-specific antibody test result of Class 3 or higher in the allergy test at screening.
- Subject who had a positive prick test result for Japanese cedar pollen in the screening test.
- Subject whose past and present medical conditions are considered medically stable.
Key exclusion criteria (30 listed)
- Subject who had the test result of IgE antibody specific to other antigen than Japanese cedar pollen
- Subject who is scheduled to receive other vaccination during the primary study period.
- Subject who has received or is planning to receive vaccination of live vaccine within 28 days prior to the first vaccination of the study drug, and/or a subject who has received or is planning to receive vaccination of inactivated vaccine/toxoid within 7 days prior to the first vaccination of the study drug.
- Subject who received specific immunotherapy for cedar pollinosis in the past.
- Subject who received specific or non-specific immunotherapy within 5 years prior to the screening test.
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 |
|---|---|---|
| ASP4070intramuscular or intradermal | Drug | Part1 ASP4070 intradermal vaccination group, Part1 ASP4070 intramuscular vaccination group, Part2 ASP4070 intradermal vaccination group 1, Part2 ASP4070 intradermal vaccination group 2, Part2 ASP4070 intradermal vaccination group 3, Part2 ASP4070 intradermal vaccination group 4, Part2 ASP4070 intramuscular vaccination group 1, Part2 ASP4070 intramuscular vaccination group 2 |
| Placebointramuscular or intradermal | Drug | Part2 ASP4070 intradermal vaccination group 3, Part2 ASP4070 intradermal vaccination group 4, Part2 ASP4070 intramuscular vaccination group 2, Part2 Placebo intradermal vaccination group, Part2 Placebo intramuscular vaccination group |
Primary outcome
Adverse events developed after the first vaccination of the study drug
Time frame: Up to Day 127
6 secondary outcomes
Local reaction(injection site pain, erythema, swelling, and induration) and systemic reaction(queasy, vomiting, diarrhoea, headache, malaise, myalgia, allergic reaction, and pyrexia) due to the vaccination developed
Time frame: within 14 days after the vaccination of the study drug
Vital signs (axillary temperature, blood pressure in a sitting position, and pulse rate in a sitting position)
Time frame: Screening period, :Day 1, 15, 29, 43, 71, 99, and 127
12-lead ECG
Time frame: Day 1 and 43
Laboratory test (hematology, biochemistry, and urinalysis)
Time frame: Screening period, Day 1, 43, and 127
Prick test for Japanese cedar pollen
Time frame: Screening period, Day 15, 29, 43, 71, 99 and 127
Parameters developed by antibody and histamine release test
Time frame: Day 1, 71, 99 and 127
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 31 Oct 2024.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Related trials for Cedar Pollinosis
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.
Medical Director study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP4070 in people with Cedar Pollinosis, run by Astellas Pharma Inc at 1 site in Japan.
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 4 inclusion and 30 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 31 Oct 2024. 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 Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse events developed after the first vaccination of the study drug (time frame: Up to Day 127). 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 31 Oct 2024.