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Trial record 37 of 248 for:    test AND provocation

Safety and Efficacy of Low-dose IL-2 in Allergy to Birch Pollen (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 1, 2019
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 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.

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

Detailed Description:

Main objective:

To assess the safety and efficacy of ILT-101 (ld-IL2) in patients with allergic rhinitis and apple Oral Allergic Syndrome (OAS).

Conduct of the study:

Selection of patients is performed based on medical history and disease history. The selection visit takes place at the time of the previous allergic season.

The inclusion visit (V0) will take place within the framework of consultation. Before any examination or any acts related to the research, the investigator will check that the written consent has been received from the patient undergoing the research.

During inclusion (V0), different tests are performed to check selection criteria:

  • Medical examination
  • Biological analyses.

All following visits in hospital include evaluations wich will be carried out to insure patient safety: physical examination, Temperature, Pulse, blood pressure, respiratory frequency, oximetry, AE and SAE recording if any, concomitant medications, rhinitis episodes will be recorded. Different specific tests will be performed:

  • Immunological explorations;
  • Allergologic tests;
  • Combined Symptom and Medication Score (CSMS);
  • Biological analyses.

For the induction course, the first injection will be performed in the hospital (V1), and every day from V2 to V5 for the following 4 injections will be performed at home by a research nurse, or in hospital according to physician and patient decision.

The following visit (V6) will take place during a consultation at hospital.

For the maintenance course (V7 to V15), injections ld-IL2 or PLACEBO injection will be performed at home by a research nurse or in hospital according to physician and patient decision. Except V12 that will be performed at hospital.

Follow-up period (V16) and end of research V17 will be performed in the hospital.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 Allergy to Birch Pollen
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : October 23, 2019
Estimated Study Completion Date : June 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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. Percentage of patients with a negative oral provocation test (OPT) with fresh apple at the end of low dose IL-2 treatment [ Time Frame: at Month 5 ]
    Percentage of patients with a negative oral provocation test (OPT) with fresh apple at the end of low dose IL-2 treatment


Secondary Outcome Measures :
  1. The percentage of patients with a negative oral provocation test (OPT) with fresh apple [ Time Frame: at Day 8 ]
    The percentage of patients with a negative oral provocation test (OPT) with fresh apple

  2. Percentage of patient with negative skin prick test to birch pollen and apple allergens [ Time Frame: at Month 3 ]
    Percentage of patient with negative skin prick test to birch pollen and apple allergens

  3. Percentage of patient with negative skin prick test to birch pollen and apple allergens [ Time Frame: at Month 5 ]
    Percentage of patient with negative skin prick test to birch pollen and apple allergens

  4. Percentage of patient with negative skin prick test to birch pollen and apple allergens [ Time Frame: at Month 8 ]
    Percentage of patient with negative skin prick test to birch pollen and apple allergens

  5. Change of intensity of the rhinoconjunctivitis symptoms during the pollen season [ Time Frame: at inclusion ]

    evaluated with Combined Symptom and medication Score (CSMS): a Task Force recommendation providing a homogeneous terminology for nasal and conjunctival symptoms in allergen immunotherapy trials using a combined symptom and medication score (CSMS). Briefly, a daily Symptom Score (dSS) is used with six organ-related categories, a daily Medication Score (dMS) is calculated with rescue medication summed and the CSMS is based on an equal weight of the dSS and of the dMS.

    1. Symptom score: (Total daily symptom score (dSS) is 0 to 18 points/divided by 6 symptoms: 0-3 Score 0-3: 0 = no symptoms; 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms
    2. Medication score: (Total daily medication score (dMS) is 0 to 3 Oral and/or topical (eyes or nose) nonsedative H1 antihistamines (H1A): 1 Intranasal corticosteroids (INS) with/without H1A: 2 Oral corticosteroids with/without INS, with/without H1A: 3 Combined symptom and medication score: CSMS is dSS (0-3) + dMS (0-3): 0-6

  6. Change of intensity of the rhinoconjunctivitis symptoms during the pollen season [ Time Frame: at baseline (Day 1) ]

    evaluated with Combined Symptom and medication Score (CSMS): a Task Force recommendation providing a homogeneous terminology for nasal and conjunctival symptoms in allergen immunotherapy trials using a combined symptom and medication score (CSMS). Briefly, a daily Symptom Score (dSS) is used with six organ-related categories, a daily Medication Score (dMS) is calculated with rescue medication summed and the CSMS is based on an equal weight of the dSS and of the dMS.

    1. Symptom score: (Total daily symptom score (dSS) is 0 to 18 points/divided by 6 symptoms: 0-3 Score 0-3: 0 = no symptoms; 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms
    2. Medication score: (Total daily medication score (dMS) is 0 to 3 Oral and/or topical (eyes or nose) nonsedative H1 antihistamines (H1A): 1 Intranasal corticosteroids (INS) with/without H1A: 2 Oral corticosteroids with/without INS, with/without H1A: 3 Combined symptom and medication score: CSMS is dSS (0-3) + dMS (0-3): 0-6

  7. Change of intensity of the rhinoconjunctivitis symptoms during the pollen season [ Time Frame: at day 8, after induction course ]

    evaluated with Combined Symptom and medication Score (CSMS): a Task Force recommendation providing a homogeneous terminology for nasal and conjunctival symptoms in allergen immunotherapy trials using a combined symptom and medication score (CSMS). Briefly, a daily Symptom Score (dSS) is used with six organ-related categories, a daily Medication Score (dMS) is calculated with rescue medication summed and the CSMS is based on an equal weight of the dSS and of the dMS.

    1. Symptom score: (Total daily symptom score (dSS) is 0 to 18 points/divided by 6 symptoms: 0-3 Score 0-3: 0 = no symptoms; 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms
    2. Medication score: (Total daily medication score (dMS) is 0 to 3 Oral and/or topical (eyes or nose) nonsedative H1 antihistamines (H1A): 1 Intranasal corticosteroids (INS) with/without H1A: 2 Oral corticosteroids with/without INS, with/without H1A: 3 Combined symptom and medication score: CSMS is dSS (0-3) + dMS (0-3): 0-6

  8. Change of intensity of the rhinoconjunctivitis symptoms during the pollen season [ Time Frame: at Month 3, during allergic season ]

    evaluated with Combined Symptom and medication Score (CSMS): a Task Force recommendation providing a homogeneous terminology for nasal and conjunctival symptoms in allergen immunotherapy trials using a combined symptom and medication score (CSMS). Briefly, a daily Symptom Score (dSS) is used with six organ-related categories, a daily Medication Score (dMS) is calculated with rescue medication summed and the CSMS is based on an equal weight of the dSS and of the dMS.

    1. Symptom score: (Total daily symptom score (dSS) is 0 to 18 points/divided by 6 symptoms: 0-3 Score 0-3: 0 = no symptoms; 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms
    2. Medication score: (Total daily medication score (dMS) is 0 to 3 Oral and/or topical (eyes or nose) nonsedative H1 antihistamines (H1A): 1 Intranasal corticosteroids (INS) with/without H1A: 2 Oral corticosteroids with/without INS, with/without H1A: 3 Combined symptom and medication score: CSMS is dSS (0-3) + dMS (0-3): 0-6

  9. Change of intensity of the rhinoconjunctivitis symptoms during the pollen season [ Time Frame: at Month 5 ]

    evaluated with Combined Symptom and medication Score (CSMS): a Task Force recommendation providing a homogeneous terminology for nasal and conjunctival symptoms in allergen immunotherapy trials using a combined symptom and medication score (CSMS). Briefly, a daily Symptom Score (dSS) is used with six organ-related categories, a daily Medication Score (dMS) is calculated with rescue medication summed and the CSMS is based on an equal weight of the dSS and of the dMS.

    1. Symptom score: (Total daily symptom score (dSS) is 0 to 18 points/divided by 6 symptoms: 0-3 Score 0-3: 0 = no symptoms; 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms
    2. Medication score: (Total daily medication score (dMS) is 0 to 3 Oral and/or topical (eyes or nose) nonsedative H1 antihistamines (H1A): 1 Intranasal corticosteroids (INS) with/without H1A: 2 Oral corticosteroids with/without INS, with/without H1A: 3 Combined symptom and medication score: CSMS is dSS (0-3) + dMS (0-3): 0-6

  10. Change of intensity of the rhinoconjunctivitis symptoms during the pollen season [ Time Frame: at Month 8 ]

    evaluated with Combined Symptom and medication Score (CSMS): a Task Force recommendation providing a homogeneous terminology for nasal and conjunctival symptoms in allergen immunotherapy trials using a combined symptom and medication score (CSMS). Briefly, a daily Symptom Score (dSS) is used with six organ-related categories, a daily Medication Score (dMS) is calculated with rescue medication summed and the CSMS is based on an equal weight of the dSS and of the dMS.

    1. Symptom score: (Total daily symptom score (dSS) is 0 to 18 points/divided by 6 symptoms: 0-3 Score 0-3: 0 = no symptoms; 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms
    2. Medication score: (Total daily medication score (dMS) is 0 to 3 Oral and/or topical (eyes or nose) nonsedative H1 antihistamines (H1A): 1 Intranasal corticosteroids (INS) with/without H1A: 2 Oral corticosteroids with/without INS, with/without H1A: 3 Combined symptom and medication score: CSMS is dSS (0-3) + dMS (0-3): 0-6

  11. Change of intensity of the rhinoconjunctivitis symptoms during the pollen season, [ Time Frame: at inclusion ]
    evaluated with Combined Symptom and and Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) : the collect is doing in accordance of Euroqol user guide (https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-5L_UserGuide_2015.pdf) and the calculation of the index is doing with EQ-5D-5L Crosswalk Index Value Calculator (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/valuation-standard-value-sets/crosswalk-index-value-calculator/). In France, the index values are between: -0.530 and 1.000

  12. Change of intensity of the rhinoconjunctivitis symptoms during the pollen season, [ Time Frame: at Month 3 ]
    evaluated with Combined Symptom and and Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ): the collect is doing in accordance of Euroqol user guide (https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-5L_UserGuide_2015.pdf) and the calculation of the index is doing with EQ-5D-5L Crosswalk Index Value Calculator (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/valuation-standard-value-sets/crosswalk-index-value-calculator/). In France, the index values are between: -0.530 and 1.000

  13. Change of intensity of the rhinoconjunctivitis symptoms during the pollen season, [ Time Frame: at Month 5 ]
    evaluated with Combined Symptom and and Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ):the collect is doing in accordance of Euroqol user guide (https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-5L_UserGuide_2015.pdf) and the calculation of the index is doing with EQ-5D-5L Crosswalk Index Value Calculator (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/valuation-standard-value-sets/crosswalk-index-value-calculator/). In France, the index values are between: -0.530 and 1.000

  14. Changes (absolute and relative) in Tregs [ Time Frame: at Day 8, after the induction course of ILT-101 ]
    Changes (absolute and relative) in Tregs compared to baseline (Day 1)

  15. Changes (absolute and relative) in Tregs [ Time Frame: at Month 5 ]
    Changes (absolute and relative) in Tregs compared to baseline (Day 1)

  16. Changes (absolute and relative) in Tregs [ Time Frame: at Month 8 ]
    Changes (absolute and relative) in Tregs compared to baseline (Day 1)

  17. Changes (absolute and relative) in Eosinophils [ Time Frame: at Day 8, after the induction course of ILT-101 ]
    Changes (absolute and relative) in Eosinophils compared to baseline (Day 1)

  18. Changes (absolute and relative) in Eosinophils [ Time Frame: at Month 5 ]
    Changes (absolute and relative) in Eosinophils compared to baseline (Day 1)

  19. Changes (absolute and relative) in Eosinophils [ Time Frame: at Month 8 ]
    Changes (absolute and relative) in Eosinophils compared to baseline (Day 1)

  20. Changes (absolute and relative) in Inate Lymphoid Cell type 2 (ILC2) [ Time Frame: at Day 8, after the induction course of ILT-101 ]
    Changes (absolute and relative) in Inate Lymphoid Cell type 2 (ILC2) compared to baseline (Day 1)

  21. Changes (absolute and relative) in Inate Lymphoid Cell type 2 (ILC2) [ Time Frame: at Month 5 ]
    Changes (absolute and relative) in Inate Lymphoid Cell type 2 (ILC2) compared to baseline (Day 1)

  22. Changes (absolute and relative) in Inate Lymphoid Cell type 2 (ILC2) ILC2 [ Time Frame: at Month 8 ]
    Changes (absolute and relative) in Inate Lymphoid Cell type 2 (ILC2) compared to baseline (Day 1)

  23. Changes in allergen-specific IgE dosages [ Time Frame: at Day 8, after induction course ]
    Changes in allergen-specific IgE dosages compared to Baseline (Day 1)

  24. Changes in allergen-specific IgE dosages [ Time Frame: at Month 5 ]
    Changes in allergen-specific IgE dosages compared to Baseline (Day 1)

  25. Changes in allergen-specific IgE dosages [ Time Frame: at month 8 ]
    Changes in allergen-specific IgE dosages compared to Baseline (Day 1)

  26. Changes in allergen-specific IgG dosages [ Time Frame: at Day 8, after induction course ]
    Changes in allergen-specific IgG dosages compared to baseline (Day 1)

  27. Changes in allergen-specific IgG dosages [ Time Frame: at Month 5 ]
    Changes in allergen-specific IgG dosages compared to baseline (Day 1)

  28. Changes in allergen-specific IgG dosages [ Time Frame: at Month 8 ]
    Changes in allergen-specific IgG dosages compared to baseline (Day 1)

  29. Changes in allergen-specific basophil activation test with pollen and apple specific allergens [ Time Frame: at Day 8, after induction course ]
    Changes in allergen-specific basophil activation test with pollen and apple specific allergens compared to baseline (Day 1)

  30. Changes in allergen-specific basophil activation test with pollen and apple specific allergens [ Time Frame: at Month 5 ]
    Changes in allergen-specific basophil activation test with pollen and apple specific allergens compared to baseline (Day 1)

  31. Changes in allergen-specific basophil activation test with pollen and apple specific allergens [ Time Frame: at Month 8 ]
    Changes in allergen-specific basophil activation test with pollen and apple specific allergens compared to baseline (Day 1)

  32. Changes in antigen-specific T-cell immune responses (cytokine secretion after antigen restimulation) [ Time Frame: at Day 8, after induction course ]
    Changes in antigen-specific T-cell immune responses (cytokine secretion after antigen restimulation) compared to Baseline (Day 1 )

  33. Changes in antigen-specific T-cell immune responses (cytokine secretion after antigen restimulation) [ Time Frame: at Month 5 ]
    Changes in antigen-specific T-cell immune responses (cytokine secretion after antigen restimulation) compared to Baseline (Day 1 )

  34. Changes in antigen-specific T-cell immune responses (cytokine secretion after antigen restimulation) [ Time Frame: at Month 8 ]
    Changes in antigen-specific T-cell immune responses (cytokine secretion after antigen restimulation) compared to Baseline (Day 1 )



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
Layout table for location contacts
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

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03776643     History of Changes
Other Study ID Numbers: P 160936J
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: November 2018

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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
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases