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

NCT03776643 | Completed Phase 2 DMC

• 1 other identifier: P160936J
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

Several studies have reported a deficit and/or a defect in regulatory T cells in allergic subjects, which can be correlated with the allergic responses, especially for respiratory allergies. Low-dose IL-2 (ld-IL2) specifically targets and activates regulatory T cells (Tregs), which are cells that regulate immune responses. Thus by stimulating Tregs, ld-IL2 would control allergic responses. This study is designed to evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on the nasal response assessed by Total Nasal Symptom Score (TNSS) during a controlled birch allergen exposure.

Conditions

Allergic Rhinoconjunctivitis to Birch Pollen; With a Positive Skin Prick Test to Birch Pollen

Outcome Measures

Primary Outcomes (1)

• Change in nasal congestion expressed as area under the curve (AUC), during birch allergen exposure in ALYATEC's Environmental Exposure Chamber (EEC)

  Change in nasal congestion expressed as area under the curve (AUC), during birch allergen exposure in ALYATEC's Environmental Exposure Chamber (EEC)

  on day 40

Secondary Outcomes (30)

• Change in nasal congestion expressed as area under the curve (AUC), assessed during 4 hours of exposure

  at Day 8

• Change in nasal response intensity

  at Day 8

• Changes in Tregs expressed in percentag (%)

  at day 8

• Changes in Tregs expressed in percentag (%)

  at day 40

• Changes in Tregs expressed in percentag (%)

  at day 70

Study Arms (2)

ILT-101 (ld-IL2)

EXPERIMENTAL

Subcutaneous injections of ILT-101

Drug: ILT-101 ld-(IL2)

placebo

PLACEBO COMPARATOR

Subcutaneous injections of placebo

Drug: ILT-101 ld-(IL2)

Interventions

ILT-101 ld-(IL2) DRUG

Subcutaneous injections of ILT-101 or Placebo starting with once-daily administration for 5 consecutive days followed by once every two weeks administration during five months

Also known as: Placebo

ILT-101 (ld-IL2); placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• male or female aged between18-55 years
• Negative beta-HcG pregnancy test at screening visit for women of childbearing age;
• Normal electrocardiogram without clinically significant abnormalities;
• Ability to stay in the EEC for up to 4 hours, without any conditions or factors which could make this not possible
• Positive nasal response (TNSS≥5) at baseline exposure
• Free, informed and written consent signed by the patient and the investigator, before any specific examination required by the study;
• Affiliation to a social security scheme (beneficiary or assignee)
• Negative SARS-CoV-2 test less than 72 hours prior to screening visit

You may not qualify if:

• Asthma: GINA 2 to 5
• Eosinophilia \> 0.6x109/mL;
• Any history of anaphylactic reactions;
• Specific immunotherapy treatment at the moment, including Omalizumab;
• Specific immunotherapy for birch-pollens within 3 previous years;
• Use of systemic corticosteroid or others immunosuppressive treatment within previous 6 months;
• Moderate to severe allergic rhinoconjunctivitis with or without asthma due to grass pollen, if the study is performed during grass pollen season (according to ARIA)
• Significant rhinitis, or sinusitis, due to daily contact with other allergen causing symptoms that are expected to coincide with exposures, as assessed by the investigator
• Contraindications known to treatment with IL-2:
• Hypersensitivity to the active substance or to any of the excipients;
• Immunosuppressed patient;
• Psychotropic, hepatotoxic, nephrotoxic, myelotoxic or cardiotoxic drugs;
• Other chronic diseases not clinically controlled;
• Signs of active infection requiring treatment;
• Previous history of organ transplantation.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Iltoo Pharma: collaborator

Study Sites (2)

Centre d'essais cliniques, ALYATEC

Strasbourg, Environmental Exposure Chamber, Alyatec, 1 Place de L'hôpital, 67000, France

Location

CIC Biothérapies - Service de Biothérapies

Paris, Groupe Hospitalier Pitié-Salpêtrière 47 -83 BD de L'hopital, 75013, France

Location

Study Officials

• David Klatzmann, Pr

  APHP / CIC BTI / Hopital Pitie Salpétrière, Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Safety/Efficacy

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: December 17, 2018
• Study Start: February 1, 2019
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: September 16, 2025

Record last verified: 2022-12

Locations

FR (2)