Allergic ConjunctivitisPhase 1NCT03038971
Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections
A Phase 1 study testing Dose Level 1 and Dose Level 2 in people with Allergic Conjunctivitis and Allergic Rhinitis, run by Woodmont Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic injections of 2 different dose levels of the investigational short and tall ragweed product. Biomarkers will be assessed at baseline and at multiple time points post-treatment. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Allergic Conjunctivitis, Allergic Rhinitis
- What is being tested?
- Dose Level 1 and Dose Level 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2017to 29 Apr 2017
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Between the ages of 16 and 65 years old
- Seasonal Allergic Conjunctivitis (with or without Allergic Rhinitis) to ragweed pollen
- Positive skin test reaction at screening visit to short ragweed extract
- Avoid disallowed medications
- Females of childbearing potential must have pregnancy test and must agree to use an acceptable method of birth control
- Have blood and urine analysis within normal limits
- Manifest a positive reaction to a conjunctival allergen challenge with ragweed pollen
- Have a specific IgE ≥ 0.70 kU/L to short ragweed
Who cannot join
- Have ocular or nasal conditions that could affect subject safety or trial parameters
- Have a presence of an active sinus, nasal, or ocular infections
- Have had allergy immunotherapy to ragweed pollen
- Have a compromised lung function ≤80% of predicted
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: A Single-Center, Double-Blinded, Placebo-Controlled, Phase 1 Evaluation of the Safety of Ragweed Mix Given in Four Monthly Doses by Intralymphatic Node Injections for Inducing Tolerance in Subjects With Ragweed Induced Allergic Conjunctivitis and Allergic Rhinitis
A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic injections of 2 different dose levels of the investigational short and tall ragweed product. Biomarkers will be assessed at baseline and at multiple time points post-treatment.
- Conditions
- Allergic Conjunctivitis, Allergic Rhinitis
- Being tested
- Dose Level 1, Dose Level 2, Placebo
- Medical subject headings
- Conjunctivitis, Allergic, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose Level 1Biological
Short and Tall Ragweed Mix
Dose Level 2Biological
Short and Tall Ragweed Mix
PlaceboBiological
Saline with 0.4% Phenol
| Study group | Role | What they receive |
|---|---|---|
| Concentration 1: Short and Tall Ragweed Mix | Other | Not described Receives: Biological: Dose Level 1 |
| Concentration 2: Short and Tall Ragweed Mix | Other | Not described Receives: Biological: Dose Level 2 |
| Placebo: Saline with 0.4% Phenol | Other | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (reported, elicited and observed)
Measured: 47 weeks
Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale
Measured: 47 weeks
Local Injection Site Tolerability and Reactivity; tenderness will be assessed using 0-4 scale
Measured: 47 weeks
Local Injection Site Tolerability and Reactivity; redness will be assessed using 0-4 scale
Measured: 47 weeks
Local Injection Site Tolerability and Reactivity; swelling will be assessed using 0-4 scale
Measured: 47 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start30 Mar 2017
- Primary completion29 Apr 2017
- Study completion29 Apr 2017
Why it stopped: Sponsor withdrew IND from FDA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woodmont Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Emily Schoemmell, Study director, ORA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038971
- Sponsor's protocol ID
- 16-290-0010
- Status last verified
- Feb 2018
- First submitted
- 7 Oct 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Blinded, Placebo-Controlled, Phase 1 Evaluation of the Safety of Ragweed Mix Given in Four Monthly Doses by Intralymphatic Node Injections for Inducing Tolerance in Subjects With Ragweed Induced Allergic Conjunctivitis and Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT03038971
- Acronym / sponsor ID
- 16-290-0010
- Conditions
- Allergic Conjunctivitis, Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor withdrew IND from FDA
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Woodmont Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 29 Apr 2017 (actual)
- Study completion
- 29 Apr 2017 (actual)
- First posted
- 1 Feb 2017 (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.
A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic injections of 2 different dose levels of the investigational short and tall ragweed product. Biomarkers will be assessed at baseline and at multiple time points post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Concentration 1: Short and Tall Ragweed Mix | Other | Biological: Dose Level 1 |
| Concentration 2: Short and Tall Ragweed Mix | Other | Biological: Dose Level 2 |
| Placebo: Saline with 0.4% Phenol | Other | Biological: Placebo |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Between the ages of 16 and 65 years old
- Seasonal Allergic Conjunctivitis (with or without Allergic Rhinitis) to ragweed pollen
- Positive skin test reaction at screening visit to short ragweed extract
- Avoid disallowed medications
- Females of childbearing potential must have pregnancy test and must agree to use an acceptable method of birth control
Key exclusion criteria (4 listed)
- Have ocular or nasal conditions that could affect subject safety or trial parameters
- Have a presence of an active sinus, nasal, or ocular infections
- Have had allergy immunotherapy to ragweed pollen
- Have a compromised lung function ≤80% of predicted
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 |
|---|---|---|
| Dose Level 1Short and Tall Ragweed Mix | Biological | Concentration 1: Short and Tall Ragweed Mix |
| Dose Level 2Short and Tall Ragweed Mix | Biological | Concentration 2: Short and Tall Ragweed Mix |
| PlaceboSaline with 0.4% Phenol | Biological | Placebo: Saline with 0.4% Phenol |
Primary outcome
Adverse events (reported, elicited and observed)
Time frame: 47 weeks
Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale
Time frame: 47 weeks
Local Injection Site Tolerability and Reactivity; tenderness will be assessed using 0-4 scale
Time frame: 47 weeks
Local Injection Site Tolerability and Reactivity; redness will be assessed using 0-4 scale
Time frame: 47 weeks
Local Injection Site Tolerability and Reactivity; swelling will be assessed using 0-4 scale
Time frame: 47 weeks
Results and safety
The study was stopped early (reason given: Sponsor withdrew IND from FDA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Emily Schoemmell study director
ORA, 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 Dose Level 1 and Dose Level 2 in people with Allergic Conjunctivitis and Allergic Rhinitis, run by Woodmont Pharmaceuticals, Inc. at 1 site 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 26 Feb 2018. 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 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. 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 was stopped early (reason given: Sponsor withdrew IND from FDA). Results are not available in the source record.
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 (reported, elicited and observed) (time frame: 47 weeks). The study lists 5 primary outcomes in all. 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 26 Feb 2018.