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Trial record 6 of 6 for:    alyatec

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03776643
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : February 10, 2022
Sponsor:
Collaborator:
Iltoo Pharma
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis to Birch Pollen With a Positive Skin Prick Test to Birch Pollen Drug: ILT-101 ld-(IL2) Phase 2

Detailed Description:

Primary objective To evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on nasal response on day 40

Secondary objectives To evaluate the efficacy of ILT-101 on rhino-conjunctivitis symptoms, on inflammatory mediators, allergic specific immune responses and safety.

Experimental design This is a monocentric, randomized, placebo controlled, double-blind trial in parallel-groups, evaluating a treatment by ILT-101/placebo, 1 MIU daily for 5 days and 1 MIU every week, until day 36.

Population involved Male or female, aged between 18 and 55 years, with allergic rhinitis to birch pollen.

Number of subjects: 24

Duration of patient participation: 3 months (treatment period: 36 days months, follow-up period: 34 days)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Safety/Efficacy
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 3, 2022
Estimated Study Completion Date : March 23, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Experimental: ILT-101 (ld-IL2)
Subcutaneous injections of ILT-101
Drug: ILT-101 ld-(IL2)
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
Other Name: Placebo

Placebo Comparator: placebo
Subcutaneous injections of placebo
Drug: ILT-101 ld-(IL2)
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
Other Name: Placebo




Primary Outcome Measures :
  1. Change in nasal congestion expressed as area under the curve (AUC), during birch allergen exposure in ALYATEC's Environmental Exposure Chamber (EEC) [ Time Frame: on day 40 ]
    Change in nasal congestion expressed as area under the curve (AUC), during birch allergen exposure in ALYATEC's Environmental Exposure Chamber (EEC)


Secondary Outcome Measures :
  1. Change in nasal congestion expressed as area under the curve (AUC), assessed during 4 hours of exposure [ Time Frame: at Day 8 ]
    TNSS, expressed as area under the curve (AUC), assessed during 4 hours of exposure: TOTAL NASAL SYMPTOM SCORE Definition of response choices (drop down menu for each of the 4 questions below) 0 = None 1 = Mild (symptom clearly present but easily tolerated) 2 = Moderate (annoying but tolerable symptom) 3 = Severe (difficult to tolerate symptom, disrupts activities)

  2. Change in nasal response intensity [ Time Frame: at Day 8 ]
    determined by Visual Analogue Scale (VAS) ranged from 0 to 10 cm where higher values correspond to more intense symptoms

  3. Changes in Tregs expressed in percentag (%) [ Time Frame: at day 8 ]
    Changes in Tregs in percentag compared to baseline

  4. Changes in Tregs expressed in percentag (%) [ Time Frame: at day 40 ]
    Changes in Tregs in percentag compared to baseline

  5. Changes in Tregs expressed in percentag (%) [ Time Frame: at day 70 ]
    Changes in Tregs in percentag compared to baseline

  6. Changes in absolute count in Tregs [ Time Frame: at day 8 ]
    Changes in absolute count in Tregs compared to baseline

  7. Changes in absolute count in Tregs [ Time Frame: at day 40 ]
    Changes in absolute count in Tregs compared to baseline

  8. Changes in absolute count in Tregs [ Time Frame: at day 70 ]
    Changes in absolute count in Tregs compared to baseline

  9. Changes in eosinophils expressed in percentag (%) [ Time Frame: at day 8 ]
    Changes in eosinophils in percentag compared to baseline

  10. Changes in eosinophils expressed in percentag (%) [ Time Frame: at day 40 ]
    Changes in eosinophils in percentag compared to baseline

  11. Changes in eosinophils expressed in percentag (%) [ Time Frame: at day 70 ]
    Changes in eosinophils in percentag compared to baseline

  12. Changes in absolute count in eosinophils [ Time Frame: at day 8 ]
    Changes in absolute count in eosinophils compared to baseline

  13. Changes in absolute count in eosinophils [ Time Frame: at day 40 ]
    Changes in absolute count in eosinophils compared to baseline

  14. Changes in absolute count in eosinophils [ Time Frame: at day 70 ]
    Changes in absolute count in eosinophils compared to baseline

  15. Changes in Inate Lymphoid Cell type 2(ILC2) expressed in percentag (%) [ Time Frame: at day 8 ]
    Changes in Inate Lymphoid Cell type 2 in percentag compared to baseline

  16. Changes in Inate Lymphoid Cell type 2(ILC2) expressed in percentag (%) [ Time Frame: at day 40 ]
    Changes in Inate Lymphoid Cell type 2 in percentag compared to baseline

  17. Changes in Inate Lymphoid Cell type 2(ILC2) expressed in percentag (%) [ Time Frame: at day 70 ]
    Changes in Inate Lymphoid Cell type 2 in percentag compared to baseline

  18. Changes in absolute count in Inate Lymphoid Cell type 2(ILC2) [ Time Frame: at day 8 ]
    Changes (in absolute count in Inate Lymphoid Cell type 2 compared to baseline

  19. Changes in absolute count in Inate Lymphoid Cell type 2(ILC2) [ Time Frame: at day 40 ]
    Changes (in absolute count in Inate Lymphoid Cell type 2 compared to baseline

  20. Changes in absolute count in Inate Lymphoid Cell type 2(ILC2) [ Time Frame: at day 70 ]
    Changes (in absolute count in Inate Lymphoid Cell type 2 compared to baseline

  21. Changes of antigen-specific T-cell immune responses (cytokine IL-4 ) [ Time Frame: at day 40 ]
    cytokine IL-4 at day 40

  22. Changes of antigen-specific T-cell immune responses (cytokine IL-4 ) [ Time Frame: at day 70 ]
    cytokine IL-4 at day 70

  23. Changes of antigen-specific T-cell immune responses (cytokine IL-5) [ Time Frame: at day 40 ]
    cytokine IL-5 at day 40

  24. Changes of antigen-specific T-cell immune responses (cytokine IL-5) [ Time Frame: at day 70 ]
    cytokine IL-5 at day 70

  25. Changes of antigen-specific T-cell immune responses [ Time Frame: at day 40 ]
    IL-13 secretion after antigen restimulation at day 40

  26. Changes of antigen-specific T-cell immune responses [ Time Frame: at day 70 ]
    IL-13 secretion after antigen restimulation at day 70

  27. Changes in allergen-specific IgE dosages basophil activation test with pollen allergen [ Time Frame: at day 40 ]
    allergen-specific IgE dosages at day 40

  28. Incidence of adverse events at day 8 [ Time Frame: up to Day 8 ]
    Adverse events throughout the study (according to NCI-CTC AE classification)

  29. Incidence of adverse events at day 40 [ Time Frame: up to Day 40 ]
    Adverse events throughout the study (according to NCI-CTC AE classification)

  30. Incidence of adverse events at 70 [ Time Frame: up to Day 70 ]
    Adverse events throughout the study (according to NCI-CTC AE classification)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • male or female aged between18-55 years
  • Positive clinical history of seasonal allergic rhinitis to birch pollen for at least 2 consecutive pollinic seasons before inclusion and requiring medication intake with or without GINA 1 associated asthma, with documentation of sensitivity within 12 months before enrollment by : *Positive skin prick test (SPT) and validated in vitro tests for specific Immunoglobulin E (IgE); *Positive Skin prick test (SPT): wheal for birch pollen ≥ 5 mm in diameter for histamine wheal ≥ 3 mm (positive control) and NaCl reaction < 2 mm (negative control) *Positive specific IgE to birch pollen >0.75 kUI/L;
  • 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

Exclusion Criteria:

  • 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.
    • 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;
  • Positivity of at least one of the thyroid-specific antibodies (anti-TPO, anti-TG, or anti-TRAKS) associated with an abnormal thyroid workup (TSH, T3, or T4) at inclusion;
  • Chronic uncontrolled 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;
  • Vaccination against COVID-19 during the study period or if the 2nd dose of vaccine is planned during the 15 days preceding Visit 3
  • Surgery in the previous three months or anticipated under study;
  • Participation in other interventional research with study drug 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776643


Contacts
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Contact: David Klatzmann, Pr (1)42 16 74 61 ext +33 david.klatzmann@upmc.fr
Contact: LOREZON Roberta, MD (1)42 16 74 61 ext +33 roberta.lorenzon@upmc.fr

Locations
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France
CIC Paris Est GH Pitié Salpétrière Recruiting
Paris, France, 75013
Contact: David KLATZMANN, Pr    (1) 42 16 74 61 ext +33    david.klatzmann@aphp.fr   
Contact: Roberta LORENZON, MD    (1) 42 16 74 61 ext +33    roberta.lorenzon@aphp.fr   
Principal Investigator: Angèle SORIA, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Iltoo Pharma
Investigators
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Study Chair: David Klatzmann, Pr APHP / CIC BTI / Hopital Pitie Salpétrière, Paris
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03776643    
Other Study ID Numbers: P 160936J
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rhinitis, Allergic, Seasonal
Hypersensitivity
Immune System Diseases
Rhinitis, Allergic
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate