Study to Asses Efficacy of Intralymphatic Immunotherapy

NCT01166269 | Completed Phase 2 DMC

• 1 other identifier: ILIT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Allergy

Keywords

grass-pollen allergy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 seasons. (2 years)

Secondary Outcomes (1)

• Improvement of reactivity of skin prick test and Specific IgE

  2 years

Study Arms (3)

Grass-Allergen x 6

EXPERIMENTAL

This arm will receive 6 injections of allergen.

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.

Biological: phleum pratense (grass allergen)

placebo x 6

PLACEBO COMPARATOR

this arm will receive 6 injections of placebo.

Other: physiological saline

Interventions

phleum pratense (grass-allergen) BIOLOGICAL

6 injections of grass-allergen. Every dose will be 1000 SQ-U.

Grass-Allergen x 6

phleum pratense (grass allergen) BIOLOGICAL

3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)

grass-allergen x 3 and placebo x 3

physiological saline OTHER

6 injections of placebo (physiological saline)in a lymph node.

placebo x 6

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• psychiatric disease
• treatment with SCIT or SLIT within the last 5 years
• participation in other clinical trials within the last 3 months.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• TRYG Foundation: collaborator

Study Sites (1)

Dermato-allergological dept. K

Gentofte Municipality, Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

PHLPVI protein, Phleum pratense

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Hans-Joergen Malling, Prof. Dr. Med.

  Copenhagen University Hospital, Gentofte, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Med.

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 21, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 8, 2012

Record last verified: 2012-11

Locations

DK (1)