AllergyPhase 2/3ILITNCT01166269
Study to Asses Efficacy of Intralymphatic Immunotherapy
A Phase 2/3 study testing phleum pratense (grass-allergen), phleum pratense (grass allergen) and physiological saline in people with Allergy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the study is to try a new route for specific immunotherapy (SIT). The current treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50 injections subcutaneously in the upper arm. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergy
- What is being tested?
- phleum pratense (grass-allergen), phleum pratense (grass allergen) and physiological saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2010to Nov 2012
- Phase
- Phase 2/3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- grass pollen allergy through at least 2 seasons
- positive skin prick test
- positive Specific IgE of at least 2. (CAP)
- Signed informed consent
- for females a negative pregnancy test.
Who cannot join
- out of age limits
- rhinoconjunctivitis all year round.
- uncontrolled seasonal asthma
- patients treated with steroids continuously or beta-blockers.
- pregnancy and breastfeeding
- HIV, Hepatitis B+c, and other immunological diseases.
Show all 9Show fewer
- psychiatric disease
- treatment with SCIT or SLIT within the last 5 years
- participation in other clinical trials within the last 3 months.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dermato-allergological dept. K
Gentofte Municipality, Hellerup, 2900
About this study
Official title: Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects
The purpose of the study is to try a new route for specific immunotherapy (SIT). The current treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50 injections subcutaneously in the upper arm.
The investigators believe that there is additional effect if the allergen is injected directly into the lymph node, since it is here, the allergen presentation is happening. The trial has been performed in Switzerland with significant effect of only three injections of grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457).
Read more
The investigators would like to see what happens if the the dose is doubled, so the patients will receive 6 injections all in all, with the same amount of allergen as the earlier study (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note their symptoms in a diary.
The patients will be divided into three groups using allocation:
1 group with 6 injections of allergen
1 group with 3 injections of allergen and 3 injections of placebo
1 group with 6 injections of placebo. The trial will be double blinded.
- Conditions
- Allergy
- Being tested
- phleum pratense (grass-allergen), phleum pratense (grass allergen), physiological saline
- Keywords
- grass-pollen allergy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phleum pratense (grass-allergen)Biological
6 injections of grass-allergen. Every dose will be 1000 SQ-U.
phleum pratense (grass allergen)Biological
3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)
physiological salineOther
6 injections of placebo (physiological saline)in a lymph node.
| Study group | Role | What they receive |
|---|---|---|
| Grass-Allergen x 6 | Experimental | This arm will receive 6 injections of allergen. Receives: Biological: phleum pratense (grass-allergen) |
| grass-allergen x 3 and placebo x 3 | Active comparator | this arm will receive 3 injections of allergen, and 3 injections of placebo. Receives: Biological: phleum pratense (grass allergen) |
| placebo x 6 | Placebo comparator | this arm will receive 6 injections of placebo. Receives: Other: physiological saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom improvement
The patients will fill out a diary during the grasspollen-season before and after treatment. Also they will fill out a form for the general status of the season passed.
Measured: 2 seasons. (2 years)
Secondary outcomes (1)
Improvement of reactivity of skin prick test and Specific IgE
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation
- Responsible party
- Principal investigator, Professor, Dr. Med Hans-Joergen Malling, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Hans-Joergen Malling, Prof. Dr. Med., Principal investigator, Copenhagen University Hospital, Gentofte, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166269
- Sponsor's protocol ID
- ILIT
- Acronym
- ILIT
- Status last verified
- Nov 2012
- First submitted
- 20 Jul 2010
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects
- ClinicalTrials.gov ID
- NCT01166269
- Acronym / sponsor ID
- ILIT / ILIT
- Conditions
- Allergy
- Keywords
- grass-pollen allergy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- TRYG Foundation
- Study start
- Jul 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 21 Jul 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.
The purpose of the study is to try a new route for specific immunotherapy (SIT). The current treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50 injections subcutaneously in the upper arm.
The investigators believe that there is additional effect if the allergen is injected directly into the lymph node, since it is here, the allergen presentation is happening. The trial has been performed in Switzerland with significant effect of only three injections of grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457).
The investigators would like to see what happens if the the dose is doubled, so the patients will receive 6 injections all in all, with the same amount of allergen as the earlier study (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note their symptoms in a diary.
The patients will be divided into three groups using allocation:
1 group with 6 injections of allergen
1 group with 3 injections of allergen and 3 injections of placebo
1 group with 6 injections of placebo. The trial will be double blinded.
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 |
|---|---|---|
| Grass-Allergen x 6 | Experimental | Biological: phleum pratense (grass-allergen)This arm will receive 6 injections of allergen. |
| grass-allergen x 3 and placebo x 3 | Active comparator | Biological: phleum pratense (grass allergen)this arm will receive 3 injections of allergen, and 3 injections of placebo. |
| placebo x 6 | Placebo comparator | Other: physiological salinethis arm will receive 6 injections of placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- grass pollen allergy through at least 2 seasons
- positive skin prick test
- positive Specific IgE of at least 2. (CAP)
- Signed informed consent
- for females a negative pregnancy test.
Key exclusion criteria (9 listed)
- out of age limits
- rhinoconjunctivitis all year round.
- uncontrolled seasonal asthma
- patients treated with steroids continuously or beta-blockers.
- pregnancy and breastfeeding
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 |
|---|---|---|
| phleum pratense (grass-allergen)6 injections of grass-allergen. Every dose will be 1000 SQ-U. | Biological | Grass-Allergen x 6 |
| phleum pratense (grass allergen)3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline) | Biological | grass-allergen x 3 and placebo x 3 |
| physiological saline6 injections of placebo (physiological saline)in a lymph node. | Other | placebo x 6 |
Primary outcome
symptom improvement
Time frame: 2 seasons. (2 years)
The patients will fill out a diary during the grasspollen-season before and after treatment. Also they will fill out a form for the general status of the season passed.
1 secondary outcome
Improvement of reactivity of skin prick test and Specific IgE
Time frame: 2 years
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 8 Nov 2012.
Related trials for Allergy
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Asthma
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.
Hans-Joergen Malling, Prof. Dr. Med. principal investigator
Copenhagen University Hospital, Gentofte, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing phleum pratense (grass-allergen), phleum pratense (grass allergen) and physiological saline in people with Allergy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 9 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 8 Nov 2012. 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 Denmark. 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 combined 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.
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?
symptom improvement (time frame: 2 seasons. (2 years)). 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 8 Nov 2012.