Safety and Efficacy of Low-dose IL-2 in Allergy to Birch Pollen

• Status: Unknown status
• Trial end date: 2020-06-22
• Target enrollment: 0
• Participant gender: All

Summary

Several studies have reported a deficit and/or a defect in regulatory T cells in allergic subjects, which can be correlated with the immune dysfunction of allergic responses, especially for respiratory allergies. Low-dose IL-2 (ld-IL2) acts to specifically target and activate regulatory T cells, which are cells that exert targeted immunosuppressive action. Thus by stimulating regulatory T cells, ld-IL2 would restore a balance of allergic responses and protection by controls of allergic mechanisms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Iltoo Pharma

Criteria

Inclusion Criteria:

• with allergic rhinoconjunctivitis to birch pollen with an apple Oral Allergic Syndrome (OAS) to apple; and with a positive skin prick test to birch pollen;

• Contraception for over four weeks for confirmation of inclusion criteria and beta negative HcG to levy the inclusion visit (D-30 to D-7) in women of childbearing age;

• Free, informed and written, signed by the patient and the investigator, before any examination required by the test;

• Affiliation to a social security scheme (beneficiary or assignee).

Exclusion Criteria:

• Asthma;

• Eosinophilia >0.6.109/mL;

• Any history of anaphylactic reactions,

• Specific immunotherapy present;

• Specific immunotherapy past for birch-pollens within 3 years;

• Use of Omalizumab therapy;

• Use of Systemic corticosteroid or others immunosuppressive treatment;

• Use of Systemic antihistamines;

• Contraindications known to treatment with IL-2:

Hypersensitivity to the active substance or to any of the excipients; Signs of active infection requiring treatment; Immunosuppressed patient; Hepatotoxic, nephrotoxic, myelotoxic or cardiotoxic drugs; Other chronic diseases not clinically controlled; Previous history of organ transplantation; Heart failure (≥ grade II, class. NYHA), kidney failure (Cockroft < 60 ml/min/1.73m²), liver failure (transaminase> 3N), pulmonary insufficiency (any grade);

• Leukocytes<3000 / mm3, lymphocytes <800 / mm3, platelets <80 000 / mm3, Hemoglobin < 10.0 g/dL or 6.2 mmol/L red cell blood < 3.5 T/L;

• Arterial hypertension (Systolic BP > 140 mmHg and/or Diastolic BP > 90 mmHg);

• Poor venous capital will forbid blood samples;

• Vaccination with attenuated live vaccine in the month before the inclusion or planned during the study;

• Surgery in the previous three months or anticipated under study;

• Participation in other interventional research in the previous month and during the study;

• Psychiatric illness or any other concomitant chronic illness or addiction that could interfere with the ability to meet the requirements of the protocol or provide informed consent;

• Presence or history of unhealed cancer for more than five years , presence or history of healed cancer for less than five years, except carcinoma in situ of the cervix or basal cell carcinoma;

• Pregnant or lactating women;

• Men and women of childbearing age without effective contraception during the treatment period;

• Patient with a measure of legal protection.