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Study to Assess the Efficacy and Safety of MEDI3506 in Adults With Uncontrolled Moderate-to-severe Asthma (FRONTIER-3)

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ClinicalTrials.gov Identifier: NCT04570657
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

Study D9181C00001 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of MEDI3506 in adult participants with uncontrolled moderate to severe asthma on standard of care (SOC). Up to approximately 80 sites globally will participate in this study.

Approximately 228 participants will be randomized to 3 treatment groups in a 1:1:1 ratio to receive MEDI3506 dose 1, MEDI3506 dose 2, or placebo.


Condition or disease Intervention/treatment Phase
Asthma Biological: MEDI3506 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MEDI3506 in Adult Participants With Uncontrolled Moderate-to-severe Asthma
Actual Study Start Date : September 16, 2020
Estimated Primary Completion Date : March 23, 2022
Estimated Study Completion Date : May 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: MEDI3506 Dose 1
Approximately 76 participants will be randomized to this arm to receive the higher dose of MEDI3506
Biological: MEDI3506
Participants will receive multiple doses of MEDI3506 at dose level 1 or dose level 2

Experimental: MEDI3506 Dose 2
Approximately 76 participants will be randomized to this arm to receive the lower dose of MEDI3506
Biological: MEDI3506
Participants will receive multiple doses of MEDI3506 at dose level 1 or dose level 2

Placebo Comparator: Placebo
Approximately 76 participants will be randomized to this arm. Participants in this group will receive the placebo.
Drug: Placebo
Participants will receive multiple doses of placebo




Primary Outcome Measures :
  1. Change from baseline to Week 16 in pre-BD FEV1 (L) [ Time Frame: From Baseline to Week 16 ]
    To assess the effect of MEDI3506 compared with placebo on lung function, in adult participants with uncontrolled moderate-to-severe asthma.


Secondary Outcome Measures :
  1. Serum MEDI3506 concentration-time profiles from Study Day 1 until Study Day 169 [ Time Frame: from Study Day 1 to Study Day 169 for a total of 24 weeks ]
    To assess the PK of MEDI3506 in adult participants with uncontrolled moderate-to-severe asthma

  2. ADA during the intervention and follow-up periods [ Time Frame: from Study Day 1 to Study Day 169 for a total of 24 weeks ]
    To assess the immunogenicity of MEDI3506 in adult participants with uncontrolled moderate-to-severe asthma.

  3. Change from baseline to Week 16 in ACQ-6 score. [ Time Frame: Baseline to Week 16 ]
    To assess the effect of MEDI3506 compared with placebo on asthma control in adult participants with uncontrolled moderate-to-severe asthma.

  4. Proportion of participants with a decrease in ACQ-6 score of ≥ 0.5 from baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
    To assess the effect of MEDI3506 compared with placebo on asthma control in adult participants with uncontrolled moderate-to-severe

  5. Proportion of participants achieving ACQ-6 well controlled status (defined as ACQ-6 score ≤ 0.75 at Week 16) [ Time Frame: Week 16 ]
    To assess the effect of MEDI3506 compared with placebo on asthma control in adult participants with uncontrolled moderate-to-severe

  6. Change from baseline in SGRQ at Week 16 [ Time Frame: Baseline to Week 16 ]
    To assess the effect of MEDI3506 compared with placebo on health status in adult participants with uncontrolled moderate-to-severe asthma.

  7. Proportion of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16. [ Time Frame: Baseline to Week 16 ]
    To assess the effect of MEDI3506 compared with placebo on health status in adult participants with uncontrolled moderate-to-severe asthma.

  8. Change from baseline to Weeks 8 and 16 in post-BD FEV1 (L) [ Time Frame: From baseline to Weeks 8 and 16 ]
    To further assess the effect of MEDI3506 compared with placebo on lung function, in adult participants with uncontrolled moderate-to-severe asthma

  9. Time to first CompEx event based on the period from baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
    To assess the effect of MEDI3506 compared with placebo on CompEx in adult participants with uncontrolled moderate-to-severe asthma

  10. Annualised CompEx event rate [ Time Frame: Baseline to Week 16 ]
    To assess the effect of MEDI3506 compared with placebo on CompEx in adult participants with uncontrolled moderate-to-severe asthma.

  11. Percent change from baseline to Week 16 in concentration of FeNO in exhaled breath [ Time Frame: From baseline to Week 16 ]
    To assess the effect of MEDI3506 compared with placebo on concentration of FeNO in adult participants with uncontrolled moderate-to-severe asthma



Information from the National Library of Medicine

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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

  • Aged 18 to < 65 years of age
  • History of ≥ 1 asthma exacerbation in previous 12 months
  • Treated with medium to high dose ICS defined as total daily dose of > 250 g fluticasone dry powder or equivalent, for at least 12 months and on a stable dose for ≥ 3 months.
  • Stable LABA therapy for ≥ 3 months.
  • An ACQ-6 score ≥ 1.5.
  • Morning pre-BD FEV1 ≥ 40% predicted normal and > 1 L.
  • Morning pre-BD FEV1 < 85% predicted normal.
  • Participants with documented evidence of asthma as demonstrated by either:
  • BD reversibility, within 12 months, or at screening, or
  • Positive methacholine challenge test within 12 months.
  • Bodyweight ≥ 40 kg and BMI < 35 kg/m2.
  • For female participants, a negative pregnancy test.
  • Abide by contraception requirements for males and females
  • Provide informed consent

EXCLUSION CRITERIA

  • Participants with a positive diagnostic nucleic acid test for SARS-CoV-2.
  • Participants with a significant COVID-19 illness within 6 months of enrolment:
  • Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for hepatitis B, hepatitis C, or HIV.
  • Evidence of active or latent TB:
  • NT-proBNP level greater than the upper limit of the laboratory reference range during screening.
  • An LVEF < 45% measured by echocardiogram during screening.
  • A family history of heart failure.
  • Current smokers or recent ex-smokers i.e., have quit e cigarettes or other inhaled tobacco products ≤ 6 months prior to SV1.
  • Ex-smokers with a total smoking history of > 10 pack years.
  • As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason (prior to randomisation) that in the investigator's opinion makes it undesirable for the participant to participate in the study.
  • Any clinically important pulmonary disease other than asthma.
  • Any other clinically relevant abnormal findings on physical examination or laboratory testing, that in the opinion of the investigator or medical monitor might compromise the safety of the participant in the study or interfere with evaluation of the study intervention.
  • A known history of severe reaction to any medication including biologic agents or human gamma globulin therapy.
  • History of, or a reason to believe, a participant has a history of, drug or alcohol abuse within the past 2 years.
  • Current diagnosis of cancer.
  • History of cancer, except if treated with apparent success with curative therapy (response duration of > 5 years).
  • History of allogeneic bone marrow transplant.
  • A helminth parasitic infection diagnosed within 6 months prior to SV4 (randomisation) that has not been treated, or has not responded to SOC therapy.
  • An asthma exacerbation within 8 weeks.
  • Receiving any prohibited concomitant medications or therapies as specified in the protocol:

Known history of allergy or reaction to any component of the study intervention formulation, including hereditary fructose intolerance.


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): NCT04570657


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04570657    
Other Study ID Numbers: D9181C00001
2020-000789-40 ( EudraCT Number )
140910 ( Other Identifier: FDA )
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
MEDI3506
lung function
IL-33
inflammation
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases