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A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04184895
Recruitment Status : Suspended (Due to COVID-19)
First Posted : December 4, 2019
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:

The purpose of this study is to evaluate the safety and tolerability of multiple ascending intradermal doses of ASP2390 in adult male and female participants allergic to house dust mites (HDM).

This study will also evaluate the effect of multiple ascending intradermal doses of ASP2390 on HDM-specific immunoglobulin G subclass 4 (IgG4) levels in adult male and female participants allergic to HDM.


Condition or disease Intervention/treatment Phase
Allergic to House Dust Mites Biological: ASP2390 Biological: Placebo Phase 1

Detailed Description:

Screening will occur up to 6 weeks prior to enrollment. Eligible participants will return to the clinical unit on day 1.

After the first dose on day 1, all participants will remain in the clinical unit for observation for approximately 24 hours postdose. After the 24 hours, participants will be discharged from the clinical unit provided no reactions have occurred that require additional observation.

For all subsequent doses, participants will remain under direct observation for a minimum of 1 hour postdose. Participants will be discharged from the clinical unit provided no reactions have occurred that require additional observation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1 Multiple Ascending Intradermal Dose Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites
Actual Study Start Date : February 17, 2020
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2026

Arm Intervention/treatment
Experimental: ASP2390 Low Dose (Cohort 1)
Participants will receive a low dose of ASP2390 once weekly for a total of 12 doses. After all participants in cohort 1 complete 4 doses of treatment, the overall safety and tolerability of the dose will be evaluated by the Dose Escalation Committee (DEC).
Biological: ASP2390
Intradermal

Placebo Comparator: Placebo Low Dose (Cohort 1)
Participants will receive a low dose of matching Placebo once weekly for a total of 12 doses.
Biological: Placebo
Intradermal; normal saline solution

Experimental: ASP2390 High Dose (Cohort 2)
Participants will receive a high dose of ASP2390 once weekly for a total of 12 doses. The dose for cohort 2 may be adapted after the DEC evaluates emergent safety and tolerability data.
Biological: ASP2390
Intradermal

Placebo Comparator: Placebo High Dose (Cohort 2)
Participants will receive a high dose of matching Placebo once weekly for a total of 12 doses.
Biological: Placebo
Intradermal; normal saline solution




Primary Outcome Measures :
  1. Number of participants with Adverse Events (AEs) [ Time Frame: Up to 5 years ]
    AEs will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. An AE is considered "serious" if the event: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE); or other medically important events.

  2. Number of participants with laboratory value abnormalities and/or AEs [ Time Frame: Up to week 63 ]
    Number of participants with potentially clinically significant laboratory values.

  3. Number of participants with vital sign abnormalities and/or AEs [ Time Frame: Up to week 63 ]
    Number of participants with potentially clinically significant vital sign values.

  4. Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs [ Time Frame: Up to week 63 ]
    Routine 12-lead ECGs will be taken after the participant has been resting in the supine position for at least 5 minutes. Routine 12-lead ECGs will be taken in triplicate.

  5. Number of participants with subcutaneous immunotherapy systemic reaction events [ Time Frame: Up to week 11 ]

    Subcutaneous immunotherapy systemic reaction events will be graded using the World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System.

    Each grade is based on organ system involved and severity. Organ systems are defined as cutaneous, conjunctival, upper respiratory, lower respiratory, gastrointestinal, cardiovascular and other. A reaction from a single organ system such as cutaneous, conjunctival or upper respiratory, but not asthma, gastrointestinal, or cardiovascular is classified as a grade 1. Symptom(s)/sign(s) from more than 1 organ system or asthma, gastrointestinal, or cardiovascular are classified as grades 2 or 3. Respiratory failure or hypotension with or without loss of consciousness define grade 4 and death grade 5. The grade is determined by the physician's clinical judgement.


  6. Number of participants with specific local reactogenicity events [ Time Frame: Up to week 12 ]
    Participants will be asked to record local reactogenicity (pain, tenderness, erythema/redness, Induration/Swelling) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (potentially life-threatening).

  7. Number of participants with specific systemic reactogenicity events [ Time Frame: Up to week 12 ]
    Participants will be asked to record systemic reactogenicity (nausea/vomiting, diarrhea, headache, fatigue, myalgia) on a daily basis for 7 consecutive days after the injection, each treatment will be summarized. Grades range from 1 (mild) to 4 (potentially life-threatening).


Secondary Outcome Measures :
  1. Change from baseline in immunological response to ASP2390 as assessed by HDM allergen-specific IgG4 levels [ Time Frame: Baseline and up to week 24 ]
    The house dust mite (HDM) allergen-specific IgG4 immunological response for all participants will be presented for each treatment by visit using descriptive statistics.



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 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a history of house dust mite (HDM) induced allergic rhinitis with or without conjunctivitis of 1 year or longer in duration at screening 1.
  • Subject has positive skin prick test (SPT) to D. pteronyssinus.
  • Subject has a positive serum specific immunoglobulin E (IgE) level to D. pteronyssinus at screening 1.
  • Subject shows a positive symptomatic reaction to an HDM based on total nasal symptom score (TNSS) during the challenge test at screening 2.
  • Subject has a forced expiratory volume in 1 second (FEV1) of 80% of predicted value or greater at screening 1.
  • Subject has a body mass index (BMI) range of 18.5 to 35.0 kg/m2, inclusive and weighs at least 50 kg at screening 1.
  • A female subject is eligible to participate if the female subject is not pregnant and at least 1 of the following conditions applies:

    • Not a woman of childbearing potential (WOCBP), OR
    • WOCBP who agrees to follow the contraceptive guidance starting at screening 1 and throughout the initial safety follow-up period and for at least 28 days after the final study drug administration.
  • Female subject must agree not to breastfeed starting at screening 1 and throughout the initial safety follow-up period and for 28 days after the final study drug administration.
  • Female subject must not donate ova starting at screening 1 and throughout the initial safety follow-up period and for 28 days after the final study drug administration.
  • A male subject with female partner(s) of childbearing potential must agree to use contraception until after completion of the initial safety follow-up period and for at least 90 days after the final study drug administration.
  • A male subject must not donate sperm until after completion of the initial safety follow-up period and for at least 90 days after the final study drug administration.
  • Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner(s) is(are) breastfeeding until after completion of the initial safety follow-up period and for 90 days after the final study drug administration.
  • Subject agrees not to participate in another interventional study while receiving study drug in present study and until after completion of the initial safety follow-up period.

Exclusion Criteria:

  • Subject with concomitant allergies to seasonal aeroallergens which are anticipated to be or become active through the completion of the week 18 daily symptom diary.
  • Subject with a concomitant allergy to an animal dander who has exposure on a regular basis to the respective animal dander.
  • Subject has received immunosuppressive treatment within 3 months prior to screening 1.
  • Subject has received previous immunotherapy treatment with any HDM allergen within 3 years prior to screening 1.
  • Subject is receiving ongoing treatment with any specific immunotherapy for other allergies or plans to receive during the course of the primary study period.
  • Subject who has used systemic (or inhaled) steroid, mast cell stabilizing drug, T-helper cell type 2 (Th2) cytokine inhibitor, thromboxane A2 synthesis inhibitor, thromboxane A2 receptor antagonist, β-blocker, α-adrenergic blockers, ergot alkaloids, angiotensin-converting enzyme inhibitors and/or angiotensin-receptor blockers within 2 months prior to first study drug administration.
  • Subject who has used biologics that are immune modulators within 3 months prior to first study drug administration.
  • Subject who has received or is planning to receive vaccination of a live vaccine within 28 days prior to the first administration of the study drug and/or subject who has received or is planning to receive vaccination of an inactive vaccine/toxoid within 7 days prior to the first administration of the study drug during the primary study period.
  • Subject with mild to severe asthma receiving therapy.
  • Subject has a nasal condition that could confound the efficacy or safety assessments.
  • Subject who has history of allergic reactions such as anaphylactic shock, exanthema generalized, angioedema or hypotension caused by HDM and/or any medical products (including vaccine) in the past.
  • Subject who has immune disorders and/or diseases requiring immunosuppressive drugs.
  • Subject who was diagnosed with immunodeficiency in the past.
  • Subject who is unable to discontinue antihistamines.
  • Subject has received investigational study drug within 28 days or 5 half-lives, whichever is longer, prior to screening 1.
  • Subject has a known or suspected intolerance to lactose and/or milk products.
  • Subject has used any prescribed or nonprescribed drugs in the 2 weeks prior to first study drug administration, except for occasional use of paracetamol, topical dermatological products, hormonal contraceptives or hormone replacement therapy (HRT), beta-2-agonist for treatment of asthma or rescue medications for rhinitis and for conjunctivitis.
  • Subject has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to screening 1.
  • Subject has a history of drinking more than 21 units of alcohol per week (> 14 units of alcohol for female subjects) within 3 months prior to screening 1 or the subject tests positive for alcohol or drugs of abuse
  • Subject has had significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to screening 1.
  • Other exclusion criteria apply.

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): NCT04184895


Locations
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Germany
Site DE49001
Berlin, Germany
Site DE49002
Hannover, Germany
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
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Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.
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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT04184895    
Other Study ID Numbers: 2390-CL-0001
2018-004678-83 ( EudraCT Number )
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Tolerability
HDM
ASP2390
Safety