Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen

Anergis

Status and phase: Completed; Phase 1

Conditions: Allergic Rhinitis

Treatments: Drug: Histamine; Drug: placebo; Drug: AllerT5; Drug: mix of AllerT4-T5; Drug: AllerT2; Drug: AllerT3; Drug: AllerT1; Drug: AllerT4; Drug: mix of AllerT1-T2-T3

Study type: Interventional

Funder types: Industry

Identifiers

NCT01719133

AN002

Details and patient eligibility

About

Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the major birch allergen bet v 1, in subjects allergic to birch pollen.

Full description

The study tested - all by skin tests - in the same group of 20 trial subjects, one positive control (histamine solution), one negative control (placebo saline) and five experimental peptides called T1, T2, T3, T4 and T5. Results of the skin prick tests were scored as negative (no reaction) or positive (wheal diameter > 4 mm with erythema)

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• history of allergy symptoms during previous birch pollen season
• positive skin prick test to birch pollen extract

Exclusion criteria

• pregnancy
• uncontrolled asthma
• other significant clinical conditions or immune disorders
• subjects taking antihistamines or drugs with antihistamine activity

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

All subjects

Other group

Description:

placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5

Treatment:

Drug: mix of AllerT1-T2-T3

Drug: AllerT4

Drug: AllerT3

Drug: AllerT1

Drug: AllerT5

Drug: mix of AllerT4-T5

Drug: AllerT2

Drug: Histamine

Drug: placebo